ethics review medical research

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• Published: 18 August 2017

Improving the process of research ethics review

• Stacey A. Page   ORCID: orcid.org/0000-0001-6494-3671 1 , 2 &
• Jeffrey Nyeboer 3  

Research Integrity and Peer Review volume  2 , Article number:  14 ( 2017 ) Cite this article

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Research Ethics Boards, or Institutional Review Boards, protect the safety and welfare of human research participants. These bodies are responsible for providing an independent evaluation of proposed research studies, ultimately ensuring that the research does not proceed unless standards and regulations are met.

Concurrent with the growing volume of human participant research, the workload and responsibilities of Research Ethics Boards (REBs) have continued to increase. Dissatisfaction with the review process, particularly the time interval from submission to decision, is common within the research community, but there has been little systematic effort to examine REB processes that may contribute to inefficiencies. We offer a model illustrating REB workflow, stakeholders, and accountabilities.

Better understanding of the components of the research ethics review will allow performance targets to be set, problems identified, and solutions developed, ultimately improving the process.

Peer Review reports

Instances of research misconduct and abuse of research participants have established the need for research ethics oversight to protect the rights and welfare of study participants and the integrity of the research enterprise [ 1 , 2 ]. In response to such egregious events, national and international regulations have emerged that are intended to protect research participants (e.g. [ 3 , 4 , 5 ]).

Research Ethics Boards (REBs) also known as Institutional Review Boards (IRBs) and Research Ethics Committees (RECs) are charged with ensuring that research is planned and conducted in accordance with such laws and regulatory standards. In protecting the rights and welfare of participants, REBs must weigh possible harms to individuals against the plausible societal benefits of the research. They must ensure fair participant selection and, where applicable, confirm that appropriate provisions are in place for obtaining participant consent.

REBs often operate under the auspices of post-secondary institutions. Larger universities may support multiple REBs that serve different research areas, such as medical and health research and social science, psychology, and humanities research. Boards are constituted of people from a variety of backgrounds, each of whom contributes specific expertise to review and discussions. Members are appointed to the Board through established institutional practice. Nevertheless, most Board members bring a sincere interest and commitment to their roles. For university Faculty, Board membership may fulfil a service requirement that is part of their academic responsibilities.

The Canadian Tri-Council Policy Statement (TCPS2) advances a voluntary, self-governing model for REBs and institutions. The TCPS2 is a joint policy of Canada’s three federal research agencies (Canadian Institutes of Health Research, Natural Sciences and Engineering Research Council of Canada, and Social Sciences and Humanities Research Council), and institutional and researcher adherence to the policy standards is a condition of funding. Recognizing the independence of REBs in their decision-making, institutions are required to support their functioning. Central to the agreement is that institutions conducting research must establish an REB and ensure that it has the “necessary and sufficient ongoing financial and administrative resources” to fulfil its duties (TCPS2 [ 3 ] p. 68). A similar requirement for support of IRB functioning is included in the US Common Rule (45 CFR 46.103 [ 5 ]). The operationalization of “necessary and sufficient” is subjective and likely to vary widely. To the extent that the desired outcomes (i.e. timely reviews and approvals) depend on the allocation of these resources, they too will vary.

Time and research ethics review

From the academic hallways to the literature, characterizations of REBs and the research ethics review process are seldom complimentary. While numerous criticisms have been levelled, it is the time to decision that is most consistently maligned [ 6 , 7 , 8 , 9 , 10 , 11 ].

Factors associated with lengthy review time include incomplete or poorly completed applications [ 7 , 12 , 13 ], lack of administrative support [ 14 ], inadequately trained REB members [ 15 ], REB member competing commitments, expanding oversight requirements, and the sheer volume of applications [ 16 , 17 , 18 ]. Nevertheless, objective data on the inner workings of REBs are lacking [ 6 , 19 , 20 ].

Consequences of slow review times include centres’ withdrawing from multisite trials or limiting their participation in available trials [ 21 , 22 ], loss of needed research resources [ 23 ], and recruitment challenges in studies dependent on seasonal factors [ 24 ]. Lengthy time to study approval may ultimately delay patient access to potentially effective therapies [ 8 ].

Some jurisdictions have moved to regionalize or consolidate ethics review, using a centralized ethics review of protocols conducted on several sites. This enhances review efficiency for multisite research by removing the need for repeating reviews across centres [ 9 , 25 , 26 , 27 , 28 ]. Recommendations for systemic improvement include better standardization of review practices, enhanced training for REB members, and requiring accreditation of review boards [ 9 ].

The research ethics review processes are not well understood, and no gold standard exists against which to evaluate board practices [ 19 , 20 ]. Consequently, there is little information on how REBs may systematically improve their methods and outcomes. This paper presents a model based on stakeholder responsibilities in the process of research ethics review and illustrates how each makes contributions to the time an application spends in this process. This model focusses on REBs operating under the auspices of academic institutions, typical in Canada and the USA.

Modelling the research ethics review process

The research ethics review process may appear to some like the proverbial black box. An application is submitted and considered and a decision is made:

SUBMIT > REVIEW > DECISION

In reality, the first step to understanding and improving the process is recognizing that research ethics review involves more than just the REB. Contributing to the overall efficiency—or inefficiency—of the review are other stakeholders and their roles in the development and submission of the application and the subsequent movement of the application back and forth between PIs, administrative staff, reviewers, the Board, and the Chair, until ideally the application is deemed ready for approval.

Identifying how a research ethics review progresses permits better understanding of the workflow, including the administrative and technological supports, roles, and responsibilities. The goal is to determine where challenges in the system exist so they can be remediated and efficiencies gained.

One way of understanding details of the process is to model it. We have used a modelling approach based in part on a method advanced by Ishikawa and further developed by the second author (JN) [ 29 , 30 ]. Traditionally, the Ishikawa “fishbone” or cause and effect diagram has been used to represent the components of a manufacturing enterprise and its application facilitates understanding how the elements of an operation may cause inefficiencies. This modelling provides a means of analysing process dispersion (e.g. who is accountable for what specific outcomes) and is frequently used when trying to understand time delays in undertakings.

In our model (Fig.  1 ), “Categories” represent key role actions that trigger a subsequent series of work activities. The “Artefacts” are the products resulting from a set of completed activities and reflect staged movement in the process. Implicit in the model is a temporal sequence and the passage of time, represented by the arrows.

Basic business activity model

Applying this strategy to facilitate understanding of time delays in ethics review requires that the problem (i.e. time) be considered in the context of all stakeholders. This includes those involved in the development and submission of the application, those involved in the administrative movement of the application through the system, those involved in the substantive consideration and deliberation of the application, and those involved in the final decision-making.

The model developed (Fig.  2 ) was based primarily on a review of the lead author’s (SP) institution’s REB application process. The model is generally consistent with the process and practices of several other REBs with which she has had experience over the past 20 years.

Research ethics activity model

What this model illustrates is that the research ethics review process is complex. There are numerous stakeholders involved, each of whom bears a portion of the responsibility for an application’s time in the system. The model illustrates a temporal sequence of events where, ideally, the movement of an application is unidirectional, left to right. Time is lost when applications stall or backflow in the process.

Stakeholders, accountabilities, and the research ethics review model

There are four main stakeholder groups in the research ethics review process: researchers/research teams, research ethics unit administrative staff, REB members, and the institution. Each plays a role in the transit of an application through the process and how well they undertake their role responsibilities affects the time that the application takes to move through. Table  1 presents a summary of recommendations for best practices.

Researchers

The researcher initiates the process of research ethics review by developing a proposal involving human participants and submitting an application. Across standards, the principal investigator is accountable for the conduct of the study, including adherence to research ethics requirements. Such standards are readily available both from the source (e.g. Panel on Research Ethics [Canada], National Institutes of Health [USA], Food and Drug Administration [USA]) and, typically, through institutional websites. Researchers have an obligation to be familiar with the rules for human participant research. Developing a sound proposal where ethics requirements are met at the outset places the application in a good position at the time of submission. Researchers are accountable for delays in review when ethical standards are not met and the application must be returned for revision. Tracking the reasons for return permits solutions, such as targeted educational activities, to be developed.

Core issues that investigators can address in the development of their applications include an ethical recruitment strategy, a sound consent process, and application of relevant privacy standards and legislation. Most research ethics units associated with institutions maintain websites where key information and resources may be found, such as consent templates, privacy standards, “frequently asked questions,” and application submission checklists [ 31 , 32 , 33 ]. Moreover, consulting with the REB in advance of submission may help researchers to prevent potentially challenging issues [ 15 ]. Investigators who are diligent in knowing about and applying required standards will experience fewer requests for revision and fewer stalls or backtracking once their applications are submitted. Some have suggested that researchers should be required, rather than merely expected, to have an understanding of legal and ethics standards before they are even permitted to submit an application [ 19 ].

The scholarly integrity of proposed research is an essential element of ethically acceptable human participant research. Researchers must be knowledgeable about the relevant scientific literature and present proposals that are justified based on what is known and where knowledge gaps exist. Research methods must be appropriate to the question and studies adequately powered. Novice or inexperienced researchers whose protocols have not undergone formal peer review (e.g. via supervisory committees, internal peer review committees, or competitive grant reviews) should seek consultation and informal peer review prior to ethics review to ensure the scientific validity of their proposals. While it is within the purview of REBs to question methods and design, it is not their primary mandate. Using REB resources for science review is an opportunity cost that can compromise efficient ethics review.

Finally, researchers are advised to review and proof their applications prior to submission to ensure that all required components have been addressed and the information in the application and supporting documents (e.g. consent forms, protocol) is consistent. Missing or discrepant information is causal to application return and therefore to time lost [ 7 ].

Administrators

Prior to submission, administrators may be the first point of contact for researchers seeking assistance with application requirements. Subsequently, they are often responsible for undertaking a preliminary, screening review of applications to make sure they are complete, with all required supporting documents and approvals in place. Once an application is complete, the administrative staff assign it to a reviewer. The reviewer may be a Board member or a subject-matter expert accountable to the Board.

Initial consultation and screening activities work best when staff have good knowledge of both institutional application requirements and ethics standards. Administrative checklists are useful tools to help ensure consistent application of standards in this preliminary application review. Poorly screened applications that reach reviewers may be delayed if the application must be returned to the administrator or the researcher for repair.

Reviewers typically send their completed reviews back to the administrators. In turn, the administrators either forward the applications to the Chair to consider (i.e. for delegated approval) or to a Board meeting agenda. In addition to ensuring that applications are complete, administrators may be accountable for monitoring how long a file is out for review. When reviews are delayed or incomplete for any reason, administrators may need to reassign the file to a different reviewer.

Administrators are therefore key players in the ethics review process, as they may be both initial resources for researchers and subsequently facilitate communication between researchers and Board members. Moreover, given past experience with both research teams and reviewers, they may be aware of areas where applicants struggle and when applications or reviews are likely to be deficient or delinquent. Actively tracking such patterns in the review process may reveal problems to which solutions can be developed. For example, applications consistently deficient in a specific area may signal the need for educational outreach and reviews that are consistently submitted late may provide impetus to recruit new Board members or reviewers.

REB members

The primary responsibility for evaluating the substantive ethics issues in applications and how they are managed rests with the REB members and the Chair. The Board may approve applications, approve pending modifications, or reject them based on their compliance with standards and regulations.

Like administrators, an REB member’s efficiency and review quality are enhanced by the use of standard tools, in this case standardized review templates, intended to guide reviewers and Board members to address a consistent set of criteria. Where possible, matching members’ expertise to the application to be reviewed also contributes to timely, good quality reviews.

REB functioning is enhanced with ongoing member training and education, yielding consistent, efficient application of ethics principles and regulatory standards [ 15 ]. This may be undertaken in a variety of ways, including Board member retreats, regular circulation of current articles, and attending presentations and conferences. REB Chairs are accountable to ensure consistency in the decisions made by the Board (TCPS 2014, Article 6.8). This demands that Chairs thoroughly understand ethical principles and regulatory standards and that they maintain awareness of previous decisions. Much time can be spent at Board meetings covering old ground. The use of REB decision banks has been recommended as a means of systematizing a record of precedents, thus contributing to overall quality improvement [ 34 ].

Institution

Where research ethics review takes place under the auspices of an academic institution, the institutions must typically take responsibility to adequately support the functioning of their Boards and promote a positive culture of research ethics [ 3 , 5 ]. Supporting the financial and human resource costs of participating in ongoing education (e.g. retreats, speakers, workshops, conferences) is therefore the responsibility of the institution.

Operating an REB is costly [ 35 ]. It is reasonable to assume that there is a relationship between the adequacy of resources allocated to the workload and flow and the time to an REB decision. Studies have demonstrated wide variability in times to determination [ 8 , 9 , 10 , 22 ]. However, comparisons are difficult to make because of confounding factors such as application volume, number of staff, number of REB members, application quality, application type (e.g. paper vs. electronic), and protocol complexity. Despite these variables, it appears that setting a modal target turnaround time of 6 weeks (±2 weeks) is reasonable and in line with the targets set in the European Union and the UK’s National Health Service [ 36 , 37 ]. Tracking the time spent at each step in the model may reveal where applications are typically delayed for long periods and may be indicative of areas where more resources need to be allocated or workflows redesigned.

As institutions grow their volumes of research, workloads correspondingly increase for institutional REBs. To maintain service levels, institutions need to ensure that resources allocated to REBs match the volume and intensity of work. Benchmarking costs (primarily human resources) relative to the number of applications and time to a decision will help to inform the allocation of resources needed to maintain desired service levels.

Finally, most REB members typically volunteer their Board services to the institution. Despite their good-faith intent to serve, Board members occasionally find that researchers view them as obstacles to or adversaries in the research enterprise. Board members may believe that researchers do not value the time and effort they contribute to review, while researchers may believe the REB and its members are unreasonable, obstructive, and a “thorn in their side” [ 15 ]. Clearly, relationships can be improved. Nevertheless, improving the timeliness and efficiency of research ethics review should help to soothe fevered brows on both sides of the issue.

Upshur [ 12 ] has previously noted that the contributions to research ethics such as Board membership and application review need to be accorded the same academic prestige as serving on peer review grant panels and editorial boards and undertaking manuscript reviews. In doing so, institutions will help to facilitate a culture of respect for, and shared commitment to, research ethics review, which may only benefit the process.

The activities, roles, and responsibilities identified in the ethics review model illustrate that it is a complex activity and that “the REB” is not a single entity. Multiple stakeholders each bear a portion of the accountability for how smoothly a research ethics application moves through the process. Time is used most efficiently when forward momentum is maintained and the application advances. Delays occur when the artefact (i.e. either the application or the application review) is not advanced as the accountable stakeholders fail to discharge their responsibilities or when the artefact fails to meet a standard and it is sent back. Ensuring that all stakeholders understand and are able to operationalize their responsibilities is essential. Success depends in part on the institutional context, where standards and expectations should be well communicated, and resources like education and administrative support provided, so that capacity to execute responsibilities is assured.

Applying this model will assist in identifying activities, accountabilities, and baseline performance levels. This information will contribute to improving local practice when deficiencies are identified and solutions implemented, such as training opportunities or reduction in duplicate activities. It will also facilitate monitoring as operational improvements over baseline performance could be measured. Where activities and benchmarks are well defined and consistent, comparisons both within and across REBs can be made.

Finally, this paper focused primarily on administrative efficiency in the context of research ethics review time. However, the identified problems and their suggested solutions would contribute not only to enhanced timeliness of review but also to enhanced quality of review and therefore human participant protection.

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Acknowledgements

The authors would like to thank Dr. Michael C. King for his review of the manuscript draft.

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Authors’ contributions

The listed authors (SP, JN) have each undertaken the following: made substantial contributions to conception and design of the model; been involved in drafting the manuscript; have read and given final approval of the version to be published and participated sufficiently in the work to take public responsibility for appropriate portions of the content; and agree to be accountable for all aspects of the work in ensuring that questions related to the accuracy or integrity of any part of the work are appropriately investigated and resolved.

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SP is the Chair of the Conjoint Health Research Ethics Board at the University of Calgary. She is also a member of the Human Research Ethics Board at Mount Royal University and a member of the Research Ethics Board at the Alberta College of Art and Design. She serves on the Board of Directors for the Canadian Association of Research Ethics Boards.

JN is an Executive Technology Consultant specializing in Enterprise and Business Architecture. He has worked on process improvement initiatives across multiple industries as well as on the delivery of technology-based solutions. He was the project manager for the delivery of the IRISS online system for the Province of Alberta’s Health Research Ethics Harmonization initiative.

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The authors declare that they have no competing interests.

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Page, S.A., Nyeboer, J. Improving the process of research ethics review. Res Integr Peer Rev 2 , 14 (2017). https://doi.org/10.1186/s41073-017-0038-7

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Nih clinical research trials and you, guiding principles for ethical research.

Pursuing Potential Research Participants Protections

“When people are invited to participate in research, there is a strong belief that it should be their choice based on their understanding of what the study is about, and what the risks and benefits of the study are,” said Dr. Christine Grady, chief of the NIH Clinical Center Department of Bioethics, to Clinical Center Radio in a podcast.

Clinical research advances the understanding of science and promotes human health. However, it is important to remember the individuals who volunteer to participate in research. There are precautions researchers can take – in the planning, implementation and follow-up of studies – to protect these participants in research. Ethical guidelines are established for clinical research to protect patient volunteers and to preserve the integrity of the science.

NIH Clinical Center researchers published seven main principles to guide the conduct of ethical research:

Social and clinical value

Scientific validity, fair subject selection, favorable risk-benefit ratio, independent review, informed consent.

• Respect for potential and enrolled subjects

Every research study is designed to answer a specific question. The answer should be important enough to justify asking people to accept some risk or inconvenience for others. In other words, answers to the research question should contribute to scientific understanding of health or improve our ways of preventing, treating, or caring for people with a given disease to justify exposing participants to the risk and burden of research.

A study should be designed in a way that will get an understandable answer to the important research question. This includes considering whether the question asked is answerable, whether the research methods are valid and feasible, and whether the study is designed with accepted principles, clear methods, and reliable practices. Invalid research is unethical because it is a waste of resources and exposes people to risk for no purpose

The primary basis for recruiting participants should be the scientific goals of the study — not vulnerability, privilege, or other unrelated factors. Participants who accept the risks of research should be in a position to enjoy its benefits. Specific groups of participants  (for example, women or children) should not be excluded from the research opportunities without a good scientific reason or a particular susceptibility to risk.

Uncertainty about the degree of risks and benefits associated with a clinical research study is inherent. Research risks may be trivial or serious, transient or long-term. Risks can be physical, psychological, economic, or social. Everything should be done to minimize the risks and inconvenience to research participants to maximize the potential benefits, and to determine that the potential benefits are proportionate to, or outweigh, the risks.

To minimize potential conflicts of interest and make sure a study is ethically acceptable before it starts, an independent review panel should review the proposal and ask important questions, including: Are those conducting the trial sufficiently free of bias? Is the study doing all it can to protect research participants? Has the trial been ethically designed and is the risk–benefit ratio favorable? The panel also monitors a study while it is ongoing.

Potential participants should make their own decision about whether they want to participate or continue participating in research. This is done through a process of informed consent in which individuals (1) are accurately informed of the purpose, methods, risks, benefits, and alternatives to the research, (2) understand this information and how it relates to their own clinical situation or interests, and (3) make a voluntary decision about whether to participate.

Respect for potential and enrolled participants

Individuals should be treated with respect from the time they are approached for possible participation — even if they refuse enrollment in a study — throughout their participation and after their participation ends. This includes:

• respecting their privacy and keeping their private information confidential
• respecting their right to change their mind, to decide that the research does not match their interests, and to withdraw without a penalty
• informing them of new information that might emerge in the course of research, which might change their assessment of the risks and benefits of participating
• monitoring their welfare and, if they experience adverse reactions, unexpected effects, or changes in clinical status, ensuring appropriate treatment and, when necessary, removal from the study
• informing them about what was learned from the research

More information on these seven guiding principles and on bioethics in general

This page last reviewed on March 16, 2016

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Most WHO departments have their own procedures for supporting research in priority areas - these vary from requesting letters of intent to issuing a call for proposals to commissioning research. If you wish to know how you can get involved with research supported by WHO, please consult the WHO website for more information on research initiatives.

What is research?

The WHO ERC defines "research involving human participants" as any social science, biomedical, behavioral, or epidemiological activity that entails systematic collection or analysis of data with the intent to generate new knowledge; in which human beings (i) are exposed to manipulation, intervention, observation, or other interaction with investigators either directly or through alteration of their environment, or (ii) become inpidually identifiable through investigators’ collection, preparation, or use of biological material or medical or other records.

All research involving human participants that is supported by WHO undergoes final review by the ERC. The ERC does not accept proposals directly from the investigators. Proposals are submitted to the ERC by the WHO responsible technical officers from technical departments who work closely with the Principal Investigators and are in-charge of that particular project. However, if you are planning to apply for a call for grants you are encouraged to develop your project based on the guidance provided here.

The ERC has developed a series of documents to assist researchers and technical officers to meet the requirements of the ERC.

Writing a research protocol

• Recommended format for a 'research protocol'
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Ethics in medical research and publication

Affiliation.

• 1 Department of Family Medicine, Faculty of Medicine, University of Sarajevo, Sarajevo, Bosnia and Herzegovina.
• PMID: 25317288
• PMCID: PMC4192767

To present the basic principles and standards of Ethics in medical research and publishing, as well as the need for continuing education in the principles and ethics in science and publication in biomedicine. An analysis of relevant materials and documents, sources from the published literature. Investing in education of researches and potential researches, already in the level of medical schools. Educating them on research ethics, what constitutes research misconduct and the seriousness of it repercussion is essential for finding a solution to this problem and ensuring careers are constructed on honesty and integrity.

Keywords: Ethics; medical research; publication.

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Conflict of Interest: None declared.

The Declaration of Helsinki. Retrieved…

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4.2 In Practice: Research Ethics Committee Review in Public Health Emergencies

• Open Access
• First Online: 31 August 2024

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• V. Koneti Rao 7  

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In order to conduct clinical research early in an epidemic of a new or poorly understood infectious disease, preparatory requirements include scientific deliberations, essential health care infrastructure, and assessment of readiness for rapid research response, including expedited ethical review. Essential ethical safeguards must be met as for all clinical trials, but review of ethics should not become an impediment and delay clinical trials in an emergency. As with all research involving human participants, emergency response research protocols must be approved prospectively by a research ethics committee (REC) to ensure that study participant safety and welfare are protected. Upholding ethical and scientific standards in medical research cannot be left to the discretion of individual investigators, as was understood at least as far back as the Nuremburg Medical Trial of 1947. The structure of today’s medical research review mechanisms evolved gradually over the decades after World War II, culminating in a deliberative process that is effective at preventing most abuses. In more recent years, there have been concerns that established procedures for funding, reviewing, and implementing clinical research can be too slow and tardy in an outbreak one hopes to contain expeditiously, especially an outbreak of a high-mortality disease or a pandemic with widespread mortality (Ebola and coronavirus disease 2019 [COVID-19]). Since outbreaks are likely to arise in developing countries with little capacity for rapid research response, it is especially important to increase their review and oversight capacity along with their broader research capacity to facilitate rigorous clinical research studies that can provide global benefits.

Learning Track Note: This chapter appears in Learning Tracks: Research Ethics

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• Ethical review
• Clinical trial protocol
• Research ethics review committee
• Institutional review board
• Common rule
• Infectious disease research response
• Public health emergency response research

This chapter will help readers understand and describe:

Advantages and disadvantages of a single research ethics board (REC) for clinical trial review and approval. What safeguards are needed in this case? What are the obstacles to a single ethical review board for a trial with international partners?

Ethics of a small trial early in an outbreak on a medical countermeasure (MCM) that might work, based on biological mechanisms or on observed effects in patients, to get preliminary indications of safety and efficacy.

Why the recommendation of a reputable clinician during a high-mortality outbreak is not sufficient for a regulatory authority to provide emergency use authorization.

Minimum requirements for a REC decision on a request for regulatory concurrence on proof of principle to allow clinical research proposals that seek to provide actionable data to proceed.

1 Introduction

Consideration and debate among stakeholders, including funding agencies, government bodies, medical education and health care delivery systems, and the public continue in many venues on how to better prevent or prepare for the next global pandemic or other public health emergency (Nuffield Council on Bioethics 2020 ; WHO 2022 ). There are many ethical dimensions to the debate. The concept that a research program conceived in the initial phases of an outbreak can be implemented during the outbreak as a vital response element brings new considerations with it. The success of medical countermeasure (MCM) development during the coronavirus disease 2019 (COVID-19) pandemic has demonstrated that such research is an ethical necessity, not merely a potential additional response measure. To be of greatest benefit, such research must begin soon after a new pathogen appears to have the potential to spread widely. Yet, however urgent, emergency response research must go for review to a research ethics board (REC) or institutional review board (IRB) Footnote 1 to ensure compliance with ethical standards, including those governing interactions with individuals recruited as clinical trial participants (Packenham et al. 2021 ). Increasingly, these standards encompass not only individuals but their communities as well; emphasis on the plural since all of us belong to more than one community (MacQueen et al. 2001 ).

2 Historical Notes

The Nuremberg Code promulgated at the War Crimes Tribunal trial of 23 Nazi physicians and medical administrators in 1946–1949 has a fair claim as the watershed event in medical research ethics (Nuremberg Military Tribunals 1949 ). Perhaps the two most important points from the Nuremberg Code are the need for voluntary informed consent on the part of trial participants and a scientifically valid research design. However, widespread acceptance of the moral outrage and insight expressed by the justices in Nuremberg was a slow process in the United States and elsewhere. Indeed, much of the change in attitudes and establishment of guidelines came in response to abuses that demonstrated doctors could not be the sole judges of their own research (London 2022 ).

A few of the milestones on the way to wider acceptance of what are now globally accepted principles:

1964: Declaration of Helsinki, World Medical Association (WMA 1964 )

1966: “Ethics and Clinical Research” article in the New England Journal of Medicine by H.K. Beecher ( 1966 )

1972: Associated Press story on Tuskegee study of untreated syphilis in Black men (Heller 1972 )

1977: The Belmont Report, National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research ( 1979 )

Pharmaceutical companies had research facilities for testing chemotherapeutics near prisons in the 1950s and 1960s (Ledford 2007 ). Even the U.S. National Institutes of Health (NIH) Clinical Center, when it opened in 1953, only required review of research involving healthy volunteers. The Belmont report established three principles that, in essence, continue to govern human-subjects research:

Respect for persons (dignity and autonomy requiring informed consent)

Beneficence (risks minimized and benefits maximized)

Justice (subject selection is equitable)

Routine ethical review of all research proposals began in earnest in the mid-1970s as well. In the United States today, all research sponsored or implemented by the Department of Health and Human Services (HHS) must be conducted under Federal Regulations embodying the Belmont report called, 45 CFR 46 or the Common Rule. This requires prospective review of any proposed research by an IRB. Most countries have analogous standards and regulations, though as noted earlier their capacity to conduct research and carry out ethical review varies greatly.

More recently, NIH and National Institute of Allergy and Infectious Diseases (NIAID) investigators have conducted expeditious scientific and ethical review of research studies to address public health emergencies including severe acute respiratory syndrome coronavirus (SARS-CoV-1), anthrax, various strains of influenza, Ebola, Zika, and Middle East respiratory syndrome coronavirus (MERS-CoV). Then, SARS-CoV-2 affected the entire planet starting in early 2020. In the wake of the 2009 H1N1 influenza pandemic, the Centers for Disease Control and Prevention (CDC) approached the NIH Office of Science Policy with concerns that ethical review of research protocols responding to emergent events could be too slow, delaying urgent research programs. The NIH Office of Science Policy (OSP) agreed to work with CDC and brought together a group including officials from the CDC, U.S. Food and Drug Administration (FDA), NIH (including the author), the Health and Human Services (HHS) Assistant Secretary for Preparedness and Response (ASPR), and the NIH Office of General Counsel to work out legal and ethical questions and logistics and explore the feasibility of establishing a REC/IRB with nationwide jurisdiction to review protocols in anticipation of, during, and after a public health emergency (Packenham et al. 2021 ). This process bore fruit with the publication of a new rule in 2016 mandating review by a single review board for research in the United States (Gordon et al. 2017 ).

3 Research Intervention in a Public Health Emergency

It is often thought that clinical investigators could have an inherent or perceived conflict of interest, as their medical training is oriented to promoting the welfare of individual patients, while their research program is aimed at developing medical countermeasures (MCMs) for society as a whole. For a century, “the axiom that the conscience of the investigator is an adequate judge of the ethics of an experiment” had been the basis of research ethics, but many of the abuses that led to the establishment of independent ethical review were committed by physicians making their own ethical decisions (Jonsen 1998 ). Seeking generalizable knowledge for the ultimate benefit of people other than participants in the research study requires another layer of peer review by a group of diverse, knowledgeable, and disinterested individuals to protect human subjects and ensure research standards are met. The ethical review process has become globally obligatory for virtually any research on humans that goes beyond pure observation.

A research ethics committee must review the risks and benefits to human participants in a proposed trial, considering their social circumstances and the applicable regulatory requirements. In an emergency, the ethics committee must act expeditiously, both because of the need to counter the outbreak if it continues, and because clinical trials are most productive when the risk of infection is high in the included population. If public health measures succeed in ending the outbreak, the opportunity to recruit enough participants to evaluate MCMs for future use may be lost (Higgs et al. 2017 ). The entire research operation needs to be adequately supported, funded, and implemented without burdensome delays. During an outbreak, the primary research goal is to mitigate morbidity and mortality and help end the emergency—not only to develop new medical countermeasures that might be available for future outbreaks. Vaccines against COVID-19 are now the paradigmatic example of what a rapid research response can accomplish during an emergency; they have saved millions of lives globally even though the pandemic continues. To be clear, it is not the role of a REC to develop protocols, but to review them before or during a public health emergency. To the extent anticipatory planning for emergency research response trials is not possible, there should at least be review of resources, available scientific knowledge, and potential methodologies that could form the basis of proposed studies. Finally, it is impossible to develop or complete all the scientific and ethical reviews to prepare for all exigencies in the absence of knowledge of the pathogen at issue.

Collecting epidemiological data to design public health and patient care interventions in the middle of an outbreak, and even more so conducting clinical trials on candidate medical countermeasures, present varied challenges, many of them the subject of other chapters in this book. Yet, the multiple scientific and organizational hurdles of clinical trials in an emergency may seem simple compared to the societal obstacles that we have seen with COVID-19. Social diversity, literacy levels, resistance to accepting both scientific uncertainty and scientific conclusions, and the prevalence of disinformation add a layer of intrigue beyond the remit of clinical sciences (► Chap. 18 ).

Preparations can be made for epidemiological research to begin immediately after an event (i.e., within a few days or a couple of weeks), along with biological sample and data collection, and non-pharmaceutical intervention studies that pose minimal risk. All of these can be based on previous experience with little initial knowledge about the pathogen at issue. Even for MCM trials, it is helpful to have generic, REC-approved protocol templates available in anticipation of some emergencies and to fill in the details later as and when a specific need arises. These could include several different trial designs to be adapted as needed (► Chap. 22 ). How to get research response started and then review an intervention depends in part on whether candidate interventions already exist or can be quickly identified, but also on geography, existing infrastructure, the experience and communication skills of the investigators, and the literacy levels and openness of the affected populations.

For an experimental study of vaccine or therapeutic candidates, the likely risks and/benefits, with or without a placebo arm, must be diligently assessed. An appropriate action sequence might be immediate utilization of an off-the-shelf protocol for data and sample collection, followed by consideration of appropriate intervention study protocols.

4 Seeking and Retaining Stakeholder Commitment

Generally speaking, a foreign-supported research study must be approved by RECs for both (or all) of the research organizations involved, including local ethics committees in developing countries that may have limited capacity to review a surge of research proposals during an infectious disease outbreak. That can lead to time-consuming delays which can be unacceptable in a public health emergency (PHE), although there are legitimate ways to expedite the process without weakening ethical review (► Chap. 33 ). Another possible solution would be single REC reviews of multicenter trials with adequate input to account for the specific laws, cultural concerns, languages, and literacy levels of the prospective research participants. The latest revision of the Declaration of Helsinki (completed in 2013 and currently being updated) requires that investigators must disclose funding, sponsors, and other potential conflicts of interest to both research ethics committees and study participants (Kimmelman et al. 2009 ; WMA 2013 ). Much study information is disclosed publicly, e.g., in clinical trial registries.

Research, notably research in developing countries, should benefit and be responsive to the health needs of the populations in which it is implemented (Emanuel et al. 2004 ). Suspicions about the motives of developed country researchers conducting research in lower income areas have sometimes been well founded, and the principle that clinical research should benefit the community in which it takes place is now widely accepted, even if the nature and extent of the benefit remains a topic of lively discussion (Pratt 2021 ). Among the reactions to previous research perceived as exploitative or unfair, there has been skepticism about whether placebo controls could ethically be used in clinical trials for MCMs in a high-mortality outbreak; insistence on more equal treatment for research partners in developing countries; and the need to publish results more fully, including complete data and negative findings (Adebamowo et al. 2014 ; ICMJE 2022 ).

During the 2014–2016 West Africa Ebola outbreak, collaborative efforts by all parties on ethical review (at NIH and in Liberia) for Ebola-related research including interventions and vaccinations led to development and use of a graphical interface-based consent process that augmented written and oral information sharing (Lavori et al. 1999 ). Social mobilization activities capitalized on the social mobilization pillar being established by the Liberian Ebola response framework. It engaged community leaders, including traditional and religious leaders, Liberian Cultural Ambassador Queen Julie Endi, and larger representation of the community in “town hall” meetings with local, tribal, and youth leaders (Kagan et al. 2021 ; NASEM 2017 ) (◘ Figs. 1 – 4 and 5 ).

Use of graphics to convey key clinical research concepts for informed consent. Pictures are a useful supplement to verbal explanation, especially when study participants may face linguistic, literacy, and cultural obstacles. At a bare minimum the participants must have a basic understanding of the trial they are enrolling in, be aware that they have the right to refuse participation and may get a placebo rather than an active investigational medical countermeasure, and be warned that there could be side effects and toxicities associated with the MCM. Research personnel must be satisfied that participation is not the result of coercion. (Figures courtesy Protocol Navigation/Protocol Development Program supporting NIAID and Scientific Publications, Graphics and Media, Frederick National Laboratory for Cancer Research. U.S. government work, public domain)

Town meeting in Liberia: part of community engagement for controlled trials of Ebola MCMs (faces blurred). (Credit: Laura McNay)

It is generally accepted among investigators that a randomized, placebo-controlled trial is usually the most rapid route to identification of a safe and effective vaccine or novel therapeutic. There are other effective trial designs; ring trials, for example, can provide rigorous results and be more acceptable to the community than providing only a placebo to a patient at death’s door (► In Focus 22.1 ). Multi-arm trials testing various interventions against each other can also find more favor among research participants (► Chap. 22 ). The importance of rigorous trial design was evident early in the COVID-19 pandemic, when numerous small, often non-randomized clinical trials led to widespread use of unproven or harmful medications like hydroxychloroquine and ivermectin in certain populations (Meyerowitz-Katz et al. 2022 ; Yogendrakumar et al. 2022 ). Well-planned, sufficiently powered, randomized controlled trials (RCTs) subsequently provided rigorous, expeditious assessment of safety and efficacy for both vaccines and therapies against SARS-CoV-2. It is an intellectually frustrating perplexity that therapies that showed little or no evidence of efficacy once they were assessed in well-designed trials remain more popular among certain population groups than rigorously tested vaccines and therapies (Schellack et al. 2022 ).

When reviewing protocols for trials of replicating viral vector vaccine candidates (modified adenovirus or vesicular stomatitis virus, for instance), we have considered it imperative to address potential risks to bystanders, i.e., individuals with whom the study participant may come in contact, in case the replicating virus can be transmitted to others. Similar risks could also occur with human challenge trials, in which participants are deliberately exposed to a pathogen against which they have been experimentally protected. In both cases this could be a household contact, intimate contact, or someone outside the protocol-defined group (infants, senior citizens, and pregnant or immunocompromised persons). Federal regulations mandate risk/benefit assessments for study participants conducted by the reviewing ethics committee and specify that it must consider “possible long-range effects” (CFR 2022 ). Potential risks to contacts of participants are thus included in the applicable protocols considered by the REC, along with consent documents and questionnaires to validate that study participants understand the risks adequately (Shah et al. 2018 ). We believe these measures make study participants aware of the risks while cautioning them to avoid exposing household and intimate contacts to potential infection. It should be noted that malaria challenge studies involve no bystander risk per se in United States, as Anopheles mosquitoes are no longer found there; research participants are still barred from donating blood for a year because of the potential risk to blood recipients.

Developing reliance agreements for multisite studies is critical to avoid wasting time and resources through duplication and mission creep (Resnik et al. 2018 ). However, other mechanisms are necessary to ensure buy-in from local communities. These fall under the rubric of good participatory practice (► Chap. 18 ) and must be included in the design, funding, and implementation of clinical research protocols. Funding agencies also need to decide who (experts with no conflict of interest) will undertake scientific review. It is axiomatic, or at least it should be, that research without a solid scientific grounding is by definition unethical—people must not be submitted to risk, however minimal, if there is no prospect of rigorous scientific results (CIOMS 2016 ).

Along the same lines, an assessment of capacity at the location where the research is being implemented is essential. There are complex, demanding logistical requirements for a large study, including personnel, supplies, facilities, patient care in the case of therapeutic interventions, and a huge, complex documentation flow in a large multi-site study. Ethics committees are one small element of a large undertaking, but as with many other small parts, the big machine will not work without it. Research committees must understand both study design and realistic implementation plans, whether for relatively straightforward observational studies, data or biological sample collection, or trials of innovative MCMs. International collaborations spanning academia and industry across geographic boundaries pose their additional coordination challenges, not least the frequent requirement for review by multiple ethics committees. Other considerations include wise stewardship of limited research resources—a failure seen early in the COVID-19 pandemic, for example (Bugin and Woodcock 2021 ; Resnik 2019 ). However, collaborations across international political and geographic boundaries should not entail duplication of unwarranted analysis and review efforts and squander precious time and resources needed for timely evaluations and interventions in public health emergency situations. A centralized single REC/IRB model has been conceptualized, mandated, and implemented in the context of NIH funded multi-site clinical research in the United States.

Trial designs providing for rigorous assessment of safety and efficacy should bolster confidence that the accumulated data will benefit humanity, whether in the course of an ongoing outbreak or pandemic or for future use if intervention strategies and pharmaceutical products can be used in wide-scale treatment, prophylaxis, or vaccination programs for the current pathogen, a related one, or a different emerging pathogen (such as a long-dormant pathogen released by permafrost melting in Arctic tundra) (Canavan 2019 ). Partnership with affected country investigators and officials on a concept that has scientific validity and a study design that ensures transparent and ethical partnership and avoids exploitation of vulnerable populations will be the most likely to yield salutary benefits for all affected in any given society.

5 Future Directions

Leveraging twenty-first century communications and molecular biology technologies for designing, implementing, assessing, and monitoring risks and benefits of clinical research interventions more reliably will be the next step. This requires adequate ethical safeguards and precautions in place for human subject safety, privacy, and confidentiality with no perception of bias or conflict of interest. Ensuring independent review and transparent scientific oversight, including independent data safety monitoring boards (► Chap. 23 ) free of conflicts of interest will allow successful conduct of clinical trials for emerging global challenges. All the stakeholders, including investigators in the field, research participants, and the broader populations at risk, need a basic understanding with a working knowledge of biomedical research and the uncertainty inherent in the endeavor. Objective and unbiased ethical and scientific research review, applying the best available resources and knowledge, is needed to assess the likely benefits of a research study proposal, not only for the human participants in the study and their communities, but for the wider at-risk population. Some have wisely posited that fostering a climate in which investigators perceive that they receive fair and unbiased treatment from ethics boards ensures likelihood of collegial compliance and confidentiality (Keith-Spiegel and Koocher 2005 ). Community acceptance of the review process that cleared the research to proceed is also an essential, though not sufficient, factor in ultimate public acceptance of MCMs that are implemented based on the findings of a research program (Wright et al. 2020 ). Review boards in each country involved should be highly qualified, with minimal conflicts of interest, and able to act on priority reviews quickly, while safeguarding the interests of participants and their communities. This process needs to minimize confirmation bias on the part of both the investigator proposing the research and the reviewing body, which can take the form of pride (Latin superbia ) or hubris (Greek ὕβρις)—the original and most serious of the seven deadly sins. Many lessons have been learned from the recent global pandemic (Yogendrakumar et al. 2022 ). If we hope to meet the next outbreak of an infectious disease without engendering a crisis and manage it most effectively with transparency of purpose, we must not only absorb new technical knowledge; we must work to follow the most promising and transparent scientific leads, reducing the influence of selfish and parochial interests through broad inclusion of stakeholders and encouraging review boards to see themselves as guided by ethical and scientific principles, not by the institution where they happen to sit (Sisk et al. 2022 ; Solbakk 2011 ).

Discussion Questions

Should there be a single international REC so research projects would have to undergo only one in-depth ethics review? How could that be accomplished with adequate safeguards for local socioeconomic and cultural factors? What factors would make it difficult to realize in practice?

Is it ever ethical to conduct a small, non-randomized trial on an MCM early in an outbreak caused by a novel pathogen, or should the study at least be randomized against a putative standard of care?

In a high-mortality outbreak, why should regulatory authorities hesitate to provide emergency use authorization (EUA) for any MCM that a reputable scientist recommends?

What are the minimum requirements for a REC decision on a request for regulatory concurrence on proof of principle, allowing clinical research proposals that seek to provide actionable data to proceed?

Editors’ note: Research ethics committee (REC) is the preferred term in this book because it is more descriptive than the rather opaque term usually used in the United States, institutional review board (IRB), as well as more familiar globally. Other equivalent terms include medical research ethics committee (MREC), comité de protection des personnes (CPP), research ethics board (REB), and human research ethics committee (HREC).

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Koneti Rao, V. (2024). 4.2 In Practice: Research Ethics Committee Review in Public Health Emergencies. In: Sorenson, R.A. (eds) Principles and Practice of Emergency Research Response. Springer, Cham. https://doi.org/10.1007/978-3-031-48408-7_6

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Your environment. your health., what is ethics in research & why is it important, by david b. resnik, j.d., ph.d..

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When most people think of ethics (or morals), they think of rules for distinguishing between right and wrong, such as the Golden Rule ("Do unto others as you would have them do unto you"), a code of professional conduct like the Hippocratic Oath ("First of all, do no harm"), a religious creed like the Ten Commandments ("Thou Shalt not kill..."), or a wise aphorisms like the sayings of Confucius. This is the most common way of defining "ethics": norms for conduct that distinguish between acceptable and unacceptable behavior.

Most people learn ethical norms at home, at school, in church, or in other social settings. Although most people acquire their sense of right and wrong during childhood, moral development occurs throughout life and human beings pass through different stages of growth as they mature. Ethical norms are so ubiquitous that one might be tempted to regard them as simple commonsense. On the other hand, if morality were nothing more than commonsense, then why are there so many ethical disputes and issues in our society?

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One plausible explanation of these disagreements is that all people recognize some common ethical norms but interpret, apply, and balance them in different ways in light of their own values and life experiences. For example, two people could agree that murder is wrong but disagree about the morality of abortion because they have different understandings of what it means to be a human being.

Most societies also have legal rules that govern behavior, but ethical norms tend to be broader and more informal than laws. Although most societies use laws to enforce widely accepted moral standards and ethical and legal rules use similar concepts, ethics and law are not the same. An action may be legal but unethical or illegal but ethical. We can also use ethical concepts and principles to criticize, evaluate, propose, or interpret laws. Indeed, in the last century, many social reformers have urged citizens to disobey laws they regarded as immoral or unjust laws. Peaceful civil disobedience is an ethical way of protesting laws or expressing political viewpoints.

Another way of defining 'ethics' focuses on the disciplines that study standards of conduct, such as philosophy, theology, law, psychology, or sociology. For example, a "medical ethicist" is someone who studies ethical standards in medicine. One may also define ethics as a method, procedure, or perspective for deciding how to act and for analyzing complex problems and issues. For instance, in considering a complex issue like global warming , one may take an economic, ecological, political, or ethical perspective on the problem. While an economist might examine the cost and benefits of various policies related to global warming, an environmental ethicist could examine the ethical values and principles at stake.

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Many different disciplines, institutions , and professions have standards for behavior that suit their particular aims and goals. These standards also help members of the discipline to coordinate their actions or activities and to establish the public's trust of the discipline. For instance, ethical standards govern conduct in medicine, law, engineering, and business. Ethical norms also serve the aims or goals of research and apply to people who conduct scientific research or other scholarly or creative activities. There is even a specialized discipline, research ethics, which studies these norms. See Glossary of Commonly Used Terms in Research Ethics and Research Ethics Timeline .

There are several reasons why it is important to adhere to ethical norms in research. First, norms promote the aims of research , such as knowledge, truth, and avoidance of error. For example, prohibitions against fabricating , falsifying, or misrepresenting research data promote the truth and minimize error.

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Second, since research often involves a great deal of cooperation and coordination among many different people in different disciplines and institutions, ethical standards promote the values that are essential to collaborative work , such as trust, accountability, mutual respect, and fairness. For example, many ethical norms in research, such as guidelines for authorship , copyright and patenting policies , data sharing policies, and confidentiality rules in peer review, are designed to protect intellectual property interests while encouraging collaboration. Most researchers want to receive credit for their contributions and do not want to have their ideas stolen or disclosed prematurely.

Third, many of the ethical norms help to ensure that researchers can be held accountable to the public . For instance, federal policies on research misconduct, conflicts of interest, the human subjects protections, and animal care and use are necessary in order to make sure that researchers who are funded by public money can be held accountable to the public.

Fourth, ethical norms in research also help to build public support for research. People are more likely to fund a research project if they can trust the quality and integrity of research.

Finally, many of the norms of research promote a variety of other important moral and social values , such as social responsibility, human rights, animal welfare, compliance with the law, and public health and safety. Ethical lapses in research can significantly harm human and animal subjects, students, and the public. For example, a researcher who fabricates data in a clinical trial may harm or even kill patients, and a researcher who fails to abide by regulations and guidelines relating to radiation or biological safety may jeopardize his health and safety or the health and safety of staff and students.

Codes and Policies for Research Ethics

Given the importance of ethics for the conduct of research, it should come as no surprise that many different professional associations, government agencies, and universities have adopted specific codes, rules, and policies relating to research ethics. Many government agencies have ethics rules for funded researchers.

• National Institutes of Health (NIH)
• National Science Foundation (NSF)
• Food and Drug Administration (FDA)
• Environmental Protection Agency (EPA)
• US Department of Agriculture (USDA)
• Singapore Statement on Research Integrity
• American Chemical Society, The Chemist Professional’s Code of Conduct
• Code of Ethics (American Society for Clinical Laboratory Science)
• American Psychological Association, Ethical Principles of Psychologists and Code of Conduct
• Statement on Professional Ethics (American Association of University Professors)
• Nuremberg Code
• World Medical Association's Declaration of Helsinki

Ethical Principles

The following is a rough and general summary of some ethical principles that various codes address*:

Strive for honesty in all scientific communications. Honestly report data, results, methods and procedures, and publication status. Do not fabricate, falsify, or misrepresent data. Do not deceive colleagues, research sponsors, or the public.

Objectivity

Strive to avoid bias in experimental design, data analysis, data interpretation, peer review, personnel decisions, grant writing, expert testimony, and other aspects of research where objectivity is expected or required. Avoid or minimize bias or self-deception. Disclose personal or financial interests that may affect research.

Keep your promises and agreements; act with sincerity; strive for consistency of thought and action.

Carefulness

Avoid careless errors and negligence; carefully and critically examine your own work and the work of your peers. Keep good records of research activities, such as data collection, research design, and correspondence with agencies or journals.

Share data, results, ideas, tools, resources. Be open to criticism and new ideas.

Transparency

Disclose methods, materials, assumptions, analyses, and other information needed to evaluate your research.

Accountability

Take responsibility for your part in research and be prepared to give an account (i.e. an explanation or justification) of what you did on a research project and why.

Intellectual Property

Honor patents, copyrights, and other forms of intellectual property. Do not use unpublished data, methods, or results without permission. Give proper acknowledgement or credit for all contributions to research. Never plagiarize.

Confidentiality

Protect confidential communications, such as papers or grants submitted for publication, personnel records, trade or military secrets, and patient records.

Responsible Publication

Publish in order to advance research and scholarship, not to advance just your own career. Avoid wasteful and duplicative publication.

Responsible Mentoring

Help to educate, mentor, and advise students. Promote their welfare and allow them to make their own decisions.

Respect for Colleagues

Respect your colleagues and treat them fairly.

Social Responsibility

Strive to promote social good and prevent or mitigate social harms through research, public education, and advocacy.

Non-Discrimination

Avoid discrimination against colleagues or students on the basis of sex, race, ethnicity, or other factors not related to scientific competence and integrity.

Maintain and improve your own professional competence and expertise through lifelong education and learning; take steps to promote competence in science as a whole.

Know and obey relevant laws and institutional and governmental policies.

Animal Care

Show proper respect and care for animals when using them in research. Do not conduct unnecessary or poorly designed animal experiments.

Human Subjects protection

When conducting research on human subjects, minimize harms and risks and maximize benefits; respect human dignity, privacy, and autonomy; take special precautions with vulnerable populations; and strive to distribute the benefits and burdens of research fairly.

* Adapted from Shamoo A and Resnik D. 2015. Responsible Conduct of Research, 3rd ed. (New York: Oxford University Press).

Ethical Decision Making in Research

Although codes, policies, and principles are very important and useful, like any set of rules, they do not cover every situation, they often conflict, and they require interpretation. It is therefore important for researchers to learn how to interpret, assess, and apply various research rules and how to make decisions and act ethically in various situations. The vast majority of decisions involve the straightforward application of ethical rules. For example, consider the following case:

The research protocol for a study of a drug on hypertension requires the administration of the drug at different doses to 50 laboratory mice, with chemical and behavioral tests to determine toxic effects. Tom has almost finished the experiment for Dr. Q. He has only 5 mice left to test. However, he really wants to finish his work in time to go to Florida on spring break with his friends, who are leaving tonight. He has injected the drug in all 50 mice but has not completed all of the tests. He therefore decides to extrapolate from the 45 completed results to produce the 5 additional results.

Many different research ethics policies would hold that Tom has acted unethically by fabricating data. If this study were sponsored by a federal agency, such as the NIH, his actions would constitute a form of research misconduct , which the government defines as "fabrication, falsification, or plagiarism" (or FFP). Actions that nearly all researchers classify as unethical are viewed as misconduct. It is important to remember, however, that misconduct occurs only when researchers intend to deceive : honest errors related to sloppiness, poor record keeping, miscalculations, bias, self-deception, and even negligence do not constitute misconduct. Also, reasonable disagreements about research methods, procedures, and interpretations do not constitute research misconduct. Consider the following case:

Dr. T has just discovered a mathematical error in his paper that has been accepted for publication in a journal. The error does not affect the overall results of his research, but it is potentially misleading. The journal has just gone to press, so it is too late to catch the error before it appears in print. In order to avoid embarrassment, Dr. T decides to ignore the error.

Dr. T's error is not misconduct nor is his decision to take no action to correct the error. Most researchers, as well as many different policies and codes would say that Dr. T should tell the journal (and any coauthors) about the error and consider publishing a correction or errata. Failing to publish a correction would be unethical because it would violate norms relating to honesty and objectivity in research.

There are many other activities that the government does not define as "misconduct" but which are still regarded by most researchers as unethical. These are sometimes referred to as " other deviations " from acceptable research practices and include:

• Publishing the same paper in two different journals without telling the editors
• Submitting the same paper to different journals without telling the editors
• Not informing a collaborator of your intent to file a patent in order to make sure that you are the sole inventor
• Including a colleague as an author on a paper in return for a favor even though the colleague did not make a serious contribution to the paper
• Discussing with your colleagues confidential data from a paper that you are reviewing for a journal
• Using data, ideas, or methods you learn about while reviewing a grant or a papers without permission
• Trimming outliers from a data set without discussing your reasons in paper
• Using an inappropriate statistical technique in order to enhance the significance of your research
• Bypassing the peer review process and announcing your results through a press conference without giving peers adequate information to review your work
• Conducting a review of the literature that fails to acknowledge the contributions of other people in the field or relevant prior work
• Stretching the truth on a grant application in order to convince reviewers that your project will make a significant contribution to the field
• Stretching the truth on a job application or curriculum vita
• Giving the same research project to two graduate students in order to see who can do it the fastest
• Overworking, neglecting, or exploiting graduate or post-doctoral students
• Failing to keep good research records
• Failing to maintain research data for a reasonable period of time
• Making derogatory comments and personal attacks in your review of author's submission
• Promising a student a better grade for sexual favors
• Using a racist epithet in the laboratory
• Making significant deviations from the research protocol approved by your institution's Animal Care and Use Committee or Institutional Review Board for Human Subjects Research without telling the committee or the board
• Not reporting an adverse event in a human research experiment
• Wasting animals in research
• Exposing students and staff to biological risks in violation of your institution's biosafety rules
• Sabotaging someone's work
• Stealing supplies, books, or data
• Rigging an experiment so you know how it will turn out
• Making unauthorized copies of data, papers, or computer programs
• Owning over $10,000 in stock in a company that sponsors your research and not disclosing this financial interest
• Deliberately overestimating the clinical significance of a new drug in order to obtain economic benefits

These actions would be regarded as unethical by most scientists and some might even be illegal in some cases. Most of these would also violate different professional ethics codes or institutional policies. However, they do not fall into the narrow category of actions that the government classifies as research misconduct. Indeed, there has been considerable debate about the definition of "research misconduct" and many researchers and policy makers are not satisfied with the government's narrow definition that focuses on FFP. However, given the huge list of potential offenses that might fall into the category "other serious deviations," and the practical problems with defining and policing these other deviations, it is understandable why government officials have chosen to limit their focus.

Finally, situations frequently arise in research in which different people disagree about the proper course of action and there is no broad consensus about what should be done. In these situations, there may be good arguments on both sides of the issue and different ethical principles may conflict. These situations create difficult decisions for research known as ethical or moral dilemmas . Consider the following case:

Dr. Wexford is the principal investigator of a large, epidemiological study on the health of 10,000 agricultural workers. She has an impressive dataset that includes information on demographics, environmental exposures, diet, genetics, and various disease outcomes such as cancer, Parkinson’s disease (PD), and ALS. She has just published a paper on the relationship between pesticide exposure and PD in a prestigious journal. She is planning to publish many other papers from her dataset. She receives a request from another research team that wants access to her complete dataset. They are interested in examining the relationship between pesticide exposures and skin cancer. Dr. Wexford was planning to conduct a study on this topic.

Dr. Wexford faces a difficult choice. On the one hand, the ethical norm of openness obliges her to share data with the other research team. Her funding agency may also have rules that obligate her to share data. On the other hand, if she shares data with the other team, they may publish results that she was planning to publish, thus depriving her (and her team) of recognition and priority. It seems that there are good arguments on both sides of this issue and Dr. Wexford needs to take some time to think about what she should do. One possible option is to share data, provided that the investigators sign a data use agreement. The agreement could define allowable uses of the data, publication plans, authorship, etc. Another option would be to offer to collaborate with the researchers.

The following are some step that researchers, such as Dr. Wexford, can take to deal with ethical dilemmas in research:

What is the problem or issue?

It is always important to get a clear statement of the problem. In this case, the issue is whether to share information with the other research team.

What is the relevant information?

Many bad decisions are made as a result of poor information. To know what to do, Dr. Wexford needs to have more information concerning such matters as university or funding agency or journal policies that may apply to this situation, the team's intellectual property interests, the possibility of negotiating some kind of agreement with the other team, whether the other team also has some information it is willing to share, the impact of the potential publications, etc.

What are the different options?

People may fail to see different options due to a limited imagination, bias, ignorance, or fear. In this case, there may be other choices besides 'share' or 'don't share,' such as 'negotiate an agreement' or 'offer to collaborate with the researchers.'

How do ethical codes or policies as well as legal rules apply to these different options?

The university or funding agency may have policies on data management that apply to this case. Broader ethical rules, such as openness and respect for credit and intellectual property, may also apply to this case. Laws relating to intellectual property may be relevant.

Are there any people who can offer ethical advice?

It may be useful to seek advice from a colleague, a senior researcher, your department chair, an ethics or compliance officer, or anyone else you can trust. In the case, Dr. Wexford might want to talk to her supervisor and research team before making a decision.

After considering these questions, a person facing an ethical dilemma may decide to ask more questions, gather more information, explore different options, or consider other ethical rules. However, at some point he or she will have to make a decision and then take action. Ideally, a person who makes a decision in an ethical dilemma should be able to justify his or her decision to himself or herself, as well as colleagues, administrators, and other people who might be affected by the decision. He or she should be able to articulate reasons for his or her conduct and should consider the following questions in order to explain how he or she arrived at his or her decision:

• Which choice will probably have the best overall consequences for science and society?
• Which choice could stand up to further publicity and scrutiny?
• Which choice could you not live with?
• Think of the wisest person you know. What would he or she do in this situation?
• Which choice would be the most just, fair, or responsible?

After considering all of these questions, one still might find it difficult to decide what to do. If this is the case, then it may be appropriate to consider others ways of making the decision, such as going with a gut feeling or intuition, seeking guidance through prayer or meditation, or even flipping a coin. Endorsing these methods in this context need not imply that ethical decisions are irrational, however. The main point is that human reasoning plays a pivotal role in ethical decision-making but there are limits to its ability to solve all ethical dilemmas in a finite amount of time.

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Most academic institutions in the US require undergraduate, graduate, or postgraduate students to have some education in the responsible conduct of research (RCR) . The NIH and NSF have both mandated training in research ethics for students and trainees. Many academic institutions outside of the US have also developed educational curricula in research ethics

Those of you who are taking or have taken courses in research ethics may be wondering why you are required to have education in research ethics. You may believe that you are highly ethical and know the difference between right and wrong. You would never fabricate or falsify data or plagiarize. Indeed, you also may believe that most of your colleagues are highly ethical and that there is no ethics problem in research..

If you feel this way, relax. No one is accusing you of acting unethically. Indeed, the evidence produced so far shows that misconduct is a very rare occurrence in research, although there is considerable variation among various estimates. The rate of misconduct has been estimated to be as low as 0.01% of researchers per year (based on confirmed cases of misconduct in federally funded research) to as high as 1% of researchers per year (based on self-reports of misconduct on anonymous surveys). See Shamoo and Resnik (2015), cited above.

Clearly, it would be useful to have more data on this topic, but so far there is no evidence that science has become ethically corrupt, despite some highly publicized scandals. Even if misconduct is only a rare occurrence, it can still have a tremendous impact on science and society because it can compromise the integrity of research, erode the public’s trust in science, and waste time and resources. Will education in research ethics help reduce the rate of misconduct in science? It is too early to tell. The answer to this question depends, in part, on how one understands the causes of misconduct. There are two main theories about why researchers commit misconduct. According to the "bad apple" theory, most scientists are highly ethical. Only researchers who are morally corrupt, economically desperate, or psychologically disturbed commit misconduct. Moreover, only a fool would commit misconduct because science's peer review system and self-correcting mechanisms will eventually catch those who try to cheat the system. In any case, a course in research ethics will have little impact on "bad apples," one might argue.

According to the "stressful" or "imperfect" environment theory, misconduct occurs because various institutional pressures, incentives, and constraints encourage people to commit misconduct, such as pressures to publish or obtain grants or contracts, career ambitions, the pursuit of profit or fame, poor supervision of students and trainees, and poor oversight of researchers (see Shamoo and Resnik 2015). Moreover, defenders of the stressful environment theory point out that science's peer review system is far from perfect and that it is relatively easy to cheat the system. Erroneous or fraudulent research often enters the public record without being detected for years. Misconduct probably results from environmental and individual causes, i.e. when people who are morally weak, ignorant, or insensitive are placed in stressful or imperfect environments. In any case, a course in research ethics can be useful in helping to prevent deviations from norms even if it does not prevent misconduct. Education in research ethics is can help people get a better understanding of ethical standards, policies, and issues and improve ethical judgment and decision making. Many of the deviations that occur in research may occur because researchers simply do not know or have never thought seriously about some of the ethical norms of research. For example, some unethical authorship practices probably reflect traditions and practices that have not been questioned seriously until recently. If the director of a lab is named as an author on every paper that comes from his lab, even if he does not make a significant contribution, what could be wrong with that? That's just the way it's done, one might argue. Another example where there may be some ignorance or mistaken traditions is conflicts of interest in research. A researcher may think that a "normal" or "traditional" financial relationship, such as accepting stock or a consulting fee from a drug company that sponsors her research, raises no serious ethical issues. Or perhaps a university administrator sees no ethical problem in taking a large gift with strings attached from a pharmaceutical company. Maybe a physician thinks that it is perfectly appropriate to receive a $300 finder’s fee for referring patients into a clinical trial.

If "deviations" from ethical conduct occur in research as a result of ignorance or a failure to reflect critically on problematic traditions, then a course in research ethics may help reduce the rate of serious deviations by improving the researcher's understanding of ethics and by sensitizing him or her to the issues.

Finally, education in research ethics should be able to help researchers grapple with the ethical dilemmas they are likely to encounter by introducing them to important concepts, tools, principles, and methods that can be useful in resolving these dilemmas. Scientists must deal with a number of different controversial topics, such as human embryonic stem cell research, cloning, genetic engineering, and research involving animal or human subjects, which require ethical reflection and deliberation.

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Ethics in Medical Research and Publication

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Ajla Hodzic

Smaila mulic.

To present the basic principles and standards of Ethics in medical research and publishing, as well as the need for continuing education in the principles and ethics in science and publication in biomedicine. An analysis of relevant materials and documents, sources from the published literature. Investing in education of researches and potential researches, already in the level of medical schools. Educating them on research ethics, what constitutes research misconduct and the seriousness of it repercussion is essential for finding a solution to this problem and ensuring careers are constructed on honesty and integrity.

INTRODUCTION

Science is a key link in the educational system, it is part of the culture of the nation, further on it contributes to overall well-being and security in everyday life, and represents a source of real knowledge of mankind. In most cases, the scientist is a person of exceptional diligence, which is at the same time, very focused on what it does. If one deals with the scientific work, can significantly improve the human condition; thus, it will make a great effort and sacrifice many daily pleasures.[ 1 ]

PRINCIPLES OF WRITING A SCIENTIFIC PAPER

Scientific research demands precision.[ 2 , 3 , 4 ] Scientific writing should respect this precision in the form of clarity. Unfortunately, a glance at almost any scientific journal will reveal that the above-stated ideal is often not attained in the real world of scholarly publication.[ 5 , 6 ] Indeed, many of the accusations by nonscientific of “obscurity” and “elitism” within the scientific community probably originate in the sad fact that many scientists are not capable of expressing their hypotheses and conclusions clearly and simply.[ 7 ]

The scientific way of thinking and application of scientific methods require honesty, criticality, trust, creativity and openness, and acceptance of these principles as desirable prerequisites for successful engagement in science by students and young researchers, qualifying research institution that produces competent promoters (initiators) for the future technological cultural and political development of society.[ 1 ]

Defining principles of good scientific and good laboratory practice should encourage the development of standardized principles and guidelines for accurate and quality data in scientific research.[ 1 ]

The text of observational and experimental articles is usually divided into sections in accordance with so-called “IMRAD” structure: Introduction, Methods, Results, and Discussion. Papers related to public health programs and practice might have different than IMRAD structure (drug). There is a key question for each section of the IMRAD structure of the paper, which an author needs to keep in mind, while writing the manuscript.[ 6 ]

Title of the scientific paper contains a brief description of the content. The title should accurately describe the content of the article. There are two types of titles: Indicative title talks about the work that covers and informative title-convey the message of the article and recommended for beginners. A good title should be: (a) Short, (b) correct, (c) a clear, (d) complete, (e) informing, (d) attractive. It should also include: Characteristics of the article, showing what is most important in the work. It is necessary to specify the names of the authors and their affiliations.

Abstract/summary and title can be written in two forms: Reference and Information. It can be written in author's native language and English. The structure of the summary should look like this: Introduction, goal, materials and methods, the location of the study, measuring the outcomes of the study, the results and conclusions.

Summary is the distillate of which will be presented and should show: What has been done, what are the results, what the results means. Writing an introduction has its own rules: A clear definition of a the problem, why exactly this issue was explored, there is no need to explain what can be found in the textbooks, do not need to explain the terms of the title.

Materials and Methods describe how the study was conducted and the characteristics of the sample (experimental group, controls, and their properties). It is necessary to explain what is researched, asked, tested as follows: Sampling (random, consecutive, and representative), the sample size (patient gender, age), the control group, and the criteria for exclusion from the study, the control group if any.

It should be described how the research was done: Type of study (prospective, retrospective or combined), data collection (surveys, inventory or checkup), the technique of measuring results (operative treatment, laboratory tests). It is necessary to specify where the research was conducted. Results are an important part of writing an article.

The research results are usually most carefully read and should be a detailed plan, well-documented at the optimal dose. Discussion is a critical review of the data described in the results. He results should be compared with other findings and discuss the theoretical and practical research outcome. Conclusion should be short, clear and precise. It is necessary to: Make the final statement of what logically follows from the results of the work, list only the most important and give the message. Good conclusions should not surprise attentive reader. The reader should get the impression that he himself had written it. References should be in accordance with the instructions provided by the journal, and otherwise used Vancouver or Harvard citation style.[ 8 ]

Papers related to public health programs and practice might have different than IMRAD structure. Anyhow, the paper should be written in logical order consisting informative or indicative title, an introductory section with description of the subject or public health problem and objectives, the current status or situation, recommended or realized program and activities, lessons learned, experiences, results and recommendations, and finally conclusions and a list of references. Special importance and validity have papers which describe new practice, approach and activities, have clear description, design of the practice, approach and activities, offers possibilities for implementation of the practice, approach and activities in other settings and environments, presents the experiences gained, lessons learned, and recommendations.[ 7 ]

ETHICAL PRINCIPLES FOR MEDICAL RESEARCH INVOLVING HUMAN SUBJECTS

The World Medical Association (WMA) has developed the Declaration of Helsinki [ Figure 1 ] as a statement of ethical principles for medical research involving human subjects, including research on identifiable human material and data. Consistent with the mandate of the WMA, the declaration is addressed primarily to physicians. The WMA encourages others who are involved in medical research involving human subjects to adopt these principles:[ 9 ]

The Declaration of Helsinki. Retrieved from: New edition of Declaration of Helsinki Available: http://www. hopitalmontfort.com/en/new-edition-declaration-helsinki

General principles

The Declaration of Geneva of the WMA binds the physician with the words, “The health of my patient will be my first consideration”, and the International Code of Medical Ethics declares that, “A physician shall act in the patient's best interest when providing medical care”.

It is the duty of the physician to promote and safeguard the health, well-being and rights of patients, including those who are involved in medical research. The physician's knowledge and conscience are dedicated to the fulfillment of this duty.

Medical progress is based on research that ultimately must include studies involving human subjects. The primary purpose of medical research involving human subjects is to understand the causes, development and effects of diseases and improve preventive, diagnostic and therapeutic interventions (methods, procedures, and treatments). Even the best proven interventions must be evaluated continually through research for their safety, effectiveness, efficiency, accessibility, and quality.

Medical research is subject to ethical standards that promote and ensure respect for all human subjects and protect their health and rights.

While the primary purpose of medical research is to generate new knowledge, this goal can never take precedence over the rights and interests of individual research subjects.

It is the duty of physicians who are involved in medical research to protect the life, health, dignity, integrity, right to self-determination, privacy, and confidentiality of personal information of research subjects. The responsibility for the protection of research subjects must always rest with the physician or other health care professionals and never with the research subjects, even though they have given consent.

Physicians must consider the ethical, legal and regulatory norms and standards for research involving human subjects in their own countries as well as applicable international norms and standards. No national or international ethical, legal or regulatory requirement should reduce or eliminate any of the protections for research subjects set forth in this declaration.

Medical research should be conducted in a manner that minimizes possible harm to the environment. Medical research involving human subjects must be conducted only by individuals with the appropriate ethics and scientific education, training and qualifications. Research on patients or healthy volunteers requires the supervision of a competent and appropriately qualified physician or other health care professional.

Groups that are underrepresented in medical research should be provided appropriate access to participation in research.

Physicians who combine medical research with medical care should involve their patients in research only to the extent that this is justified by its potential preventive, diagnostic or therapeutic value and if the physician has good reason to believe that participation in the research study will not adversely affect the health of the patients who serve as research subjects.

Appropriate compensation and treatment for subjects who are harmed as a result of participating in research must be ensured.

Risks, burdens and benefits

In medical practice and in medical research, most interventions involve risks and burdens. Medical research involving human subjects may only be conducted if the importance of the objective outweighs the risks and burdens to the research subjects.

All medical research involving human subjects must be preceded by careful assessment of predictable risks and burdens to the individuals and groups involved in the research in comparison with foreseeable benefits to them and to other individuals or groups affected by the condition under investigation. Measures to minimize the risks must be implemented. The risks must be continuously monitored, assessed and documented by the researcher. Physicians may not be involved in a research study involving human subjects unless they are confident that the risks have been adequately assessed and can be satisfactorily managed.

When the risks are found to outweigh the potential benefits or when there is conclusive proof of definitive outcomes, physicians must assess whether to continue, modify or immediately stop the study.

Vulnerable groups and individuals

Some groups and individuals are particularly vulnerable and may have an increased likelihood of being wronged or of incurring additional harm. All vulnerable groups and individuals should receive specifically considered protection.

Medical research with a vulnerable group is only justified if the research is responsive to the health needs or priorities of this group and the research cannot be carried out in a nonvulnerable group. In addition, this group should stand to benefit from the knowledge, practices or interventions that result from the research.

Scientific requirements and research protocols

Medical research involving human subjects must conform to generally accepted scientific principles, be based on a thorough knowledge of the scientific literature, other relevant sources of information, and adequate laboratory and as appropriate, animal experimentation. The welfare of animals used for research must be respected. The design and performance of each research study involving human subjects must be clearly described and justified in a research protocol.

The protocol should contain:

• A statement of the ethical considerations involved and should indicate how the principles in this declaration have been addressed
• Information regarding funding, sponsors, institutional affiliations, potential conflicts of interest, incentives for subjects and information regarding provisions for treating and/or compensating subjects who are harmed as a consequence of participation in the research study.

In clinical trials, the protocol must also describe appropriate arrangements for posttrial provisions.

Research ethics committees

The research protocol must be submitted for consideration, comment, guidance and approval to the concerned Research Ethics Committee before the study begins. This committee must be transparent in its functioning, must be independent of the researcher, the sponsor and any other undue influence and must be duly qualified. It must take into consideration the laws and regulations of the country or countries in which the research is to be performed as well as applicable international norms and standards, but these must not be allowed to reduce or eliminate any of the protections for research subjects set forth in this declaration.

The committee must have the right to monitor ongoing studies. The researcher must provide monitoring information to the committee, especially information about any serious adverse events. No amendment to the protocol may be made without consideration and approval by the committee. After the end of the study, the researchers must submit a final report to the committee containing a summary of the study's findings and conclusions.

Privacy and confidentiality

Every precaution must be taken to protect the privacy of research subjects and the confidentiality of their personal information.

Informed consent

Participation by individuals capable of giving informed consent as subjects in medical research must be voluntary. Although it may be appropriate to consult family members or community leaders, no individual capable of giving informed consent may be enrolled in a research study unless he or she freely agrees.

In medical research involving human subjects capable of giving informed consent, each potential subject must be adequately informed of the aims, methods, sources of funding, any possible conflicts of interest, institutional affiliations of the researcher, the anticipated benefits and potential risks of the study and the discomfort it may entail, poststudy provisions and any other relevant aspects of the study. The potential subject must be informed of the right to refuse to participate in the study or to withdraw consent to participate at any time without reprisal. Special attention should be given to the specific information needs of individual potential subjects as well as to the methods used to deliver the information.

After ensuring that the potential subject has understood the information, the physician or another appropriately qualified individual must then seek the potential subject's freely-given informed consent, preferably in writing. If the consent cannot be expressed in writing, the nonwritten consent must be formally documented and witnessed. All medical research subjects should be given the option of being informed about the general outcome and results of the study.

When seeking informed consent for participation in a research study the physician must be particularly cautious if the potential subject is in a dependent relationship with the physician or may consent under duress. In such situations the informed consent must be sought by an appropriately qualified individual who is completely independent of this relationship.

For a potential research subject who is incapable of giving informed consent, the physician must seek informed consent from the legally authorized representative. These individuals must not be included in a research study that has no likelihood of benefit for them unless it is intended to promote the health of the group represented by the potential subject, the research cannot instead be performed with persons capable of providing informed consent, and the research entails only minimal risk and minimal burden. When a potential research subject who is deemed incapable of giving informed consent is able to give assent to decisions about participation in research, the physician must seek that assent in addition to the consent of the legally authorized representative. The potential subject's dissent should be respected.

Research involving subjects who are physically or mentally incapable of giving consent, for example, unconscious patients, may be done only if the physical or mental condition that prevents giving informed consent is a necessary characteristic of the research group. In such circumstances the physician must seek informed consent from the legally authorized representative. If no such representative is available and if the research cannot be delayed, the study may proceed without informed consent provided that the specific reasons for involving subjects with a condition that renders them unable to give informed consent have been stated in the research protocol and the study has been approved by a Research Ethics Committee. Consent to remain in the research must be obtained as soon as possible from the subject or a legally authorized representative.

The physician must fully inform the patient, which aspects of their care are related to the research. The refusal of a patient to participate in a study or the patient's decision to withdraw from the study must never adversely affect the patient-physician relationship.

For medical research using identifiable human material or data, such as research on material or data contained in bio banks or similar repositories, physicians must seek informed consent for its collection, storage and/or reuse. There may be exceptional situations where consent would be impossible or impracticable to obtain for such research. In such situations, the research may be done only after consideration and approval of a Research Ethics Committee.

Use of placebo

The benefits, risks, burdens and effectiveness of a new intervention must be tested against those of the best proven intervention(s), except in the following circumstances:

Where no proven intervention exists, the use of placebo, or no intervention, is acceptable; or where for compelling and scientifically sound methodological reasons the use of any intervention less effective than the best proven one, the use of placebo, or no intervention is necessary to determine the efficacy or safety of an intervention and the patients who receive any intervention less effective than the best proven one, placebo, or no intervention will not be subject to additional risks of serious or irreversible harm as a result of not receiving the best proven intervention. Extreme care must be taken to avoid abuse of this option.

Posttrial provisions

In advance of a clinical trial, sponsors, researchers and host country governments should make provisions for posttrial access for all participants who still need an intervention identified as beneficial in the trial. This information must also be disclosed to participants during the informed consent process.

Research registration and publication and dissemination of results

Every research study involving human subjects must be registered in a publicly accessible database before recruitment of the first subject. Researchers, authors, sponsors, editors and publishers all have ethical obligations with regard to the publication and dissemination of the results of research. Researchers have a duty to make publicly available the results of their research on human subjects and are accountable for the completeness and accuracy of their reports. All parties should adhere to accepted guidelines for ethical reporting. Negative and inconclusive as well as positive results must be published or otherwise made publicly available. Sources of funding, institutional affiliations and conflicts of interest must be declared in the publication. Reports of research not in accordance with the principles of this declaration should not be accepted for publication.

Unproven interventions in clinical practice

In the treatment of an individual patient, where proven interventions do not exist or other known interventions have been ineffective, the physician, after seeking expert advice, with informed consent from the patient or a legally authorized representative, may use an unproven intervention if in the physician's judgment it offers hope of saving life, re-establishing health or alleviating suffering. This intervention should subsequently be made the object of research, designed to evaluate its safety and efficacy. In all cases, new information must be recorded and where appropriate, made publicly available.[ 9 ]

PUBLICATION ETHICS

Academic publishing depends, to a great extent, on trust. Editors trust peer reviewers to provide fair assessments, authors trust editors to select appropriate peer reviewers, and readers put their trust in the peer-review process. Academic publishing also occurs in an environment of powerful intellectual, financial, and sometimes political interests that may collide or compete. Good decisions and strong editorial processes designed to manage these interests will foster a sustainable and efficient publishing system, which will benefit academic societies, journal editors, authors, research funders, readers, and publishers.

Good publication practices do not develop by chance, and will become established only if they are actively promoted.[ 10 ]

The general principles of publication ethics are:

Transparency

Sources of funding for research or publication should always be disclosed. Editors should state this directly in their editorial policy. Authors should routinely include information about research funding in all papers they prepare for publication. Where a clinical trial registration number is available, this should be included.

Authorship acknowledgment

The International Committee of Medical Journal Editors (ICMJE) provides a definition of authorship that is applicable beyond the medical sector. The ICMJE authorship criteria state ‘authorship credit should be based on:

• Substantial contributions to conception and design, or acquisition of data, or analysis and interpretation of data;
• Drafting the article or revising it critically for important intellectual content; and
• Final approval of the version to be published.

Authors of research papers should state whether they had complete access to the study data that support the publication. Contributors who do not qualify as authors should also be listed and their particular contribution described. This information should appear as an acknowledgment. Sample authorship description/acknowledgment. Collecting authorship information for research papers, authorship should be decided at the study launch. Policing authorship is beyond the responsibilities of an editor. Editors should demand transparent and complete descriptions of who has contributed to a paper.

Editors should employ appropriate systems to inform contributors about authorship criteria (if used) and/or to obtain accurate information about individuals’ contributions.

Editors should ask authors to submit, as part of their initial submission package, a statement that all individuals listed as authors meet the appropriate authorship criteria, that nobody who qualifies for authorship has been omitted from the list, and that contributors and their funding sources have been properly acknowledged, and that authors and contributors have approved the acknowledgment of their contribution.

Attributing authorship to a group

The ICMJE provides guidance for instances where a number of authors report on behalf of a larger group of investigators.[ 1 ]

This guidance is applicable outside the medical sector.

International Committee of Medical Journal Editors guidance states: “When a large, multi-center group has conducted the work, the group should identify the individuals who accept direct responsibility for the manuscript. These individuals should fully meet the criteria for authorship defined above… When submitting a group author manuscript, the corresponding author should clearly indicate the preferred citation and should clearly identify all individual authors as well as the group name”. The individual authors who accept direct responsibility for the manuscript should list the members of the larger authorship group in an appendix to their acknowledgment.

Protecting research subjects

Journals should ask authors to state that the study they are submitting was approved by the relevant Research Ethics Committee or Institutional Review Board. If human participants were involved, manuscripts must be accompanied by a statement that the experiments were undertaken with the understanding and appropriate informed consent of each.

Editors should reserve the right to reject papers if there is doubt whether appropriate procedures have been followed. If a paper has been submitted from a country where there is no Ethics Committee, Institutional Review Board, or similar review and approval, editors should use their own experience to judge whether the paper should be published. If the decision is made to publish a paper under these circumstances a short statement should be included to explain the situation.[ 10 ]

THE MAIN FORMS OF SCIENTIFIC AND PUBLISHING MISCONDUCT

The Oxford English Dictionary describes fraud as “wrongful or criminal deception intended to result in financial or personal gain” and deceit as “the action or practice of deceiving someone by concealing or misrepresenting the truth”.[ 11 ]

Research organizations and the literature have defined these behavioral patterns within the umbrella title of “Research Misconduct”.[ 12 ]

There are three major and most severe forms of scientific fraud, scientific and publishing dishonesty or misconduct, in proposing, conducting or evaluation of research and presentation of the research results:

• Inventing data and results (fabrication);
• Alteration or changing the results (falsification); and
• Plagiarism (plagiarism), including self-plagiarism (self-plagiarism), fragmented, repetitive and double publication (duplicate publication).

Besides these, there are a number of other kinds of misconduct that scientists should know how to recognize and avoid that is, “pathology” of authorship, conflict of interest, conflicts of loyalty, “pathological” science, etc.

In the process of publishing scientific papers, it is important to know how a completed research should be described in a scientific paper.[ 6 ]

Falsification/fabrication of data

The integrity of research depends on the integrity of the data and the data record. As falsification and fabrication call into question the integrity of data and the data record, they represent serious issues in scientific ethics. Falsification is the practice of omitting or altering research materials, equipment, data, or processes in such a way that the results of the research are no longer accurately reflected in the research record. Fabrication is the practice of inventing data or results and recording and/or reporting them in the research record. Both of these schemes are probably among the most serious offenses in scientific research as they challenge the credibility of everyone and everything involved in a research effort.[ 13 ]

However, it is questionable whether a clinical researcher who fabricates data to enroll a terminally ill patient into a trial that ultimately may lead to that individual receiving treatment that may prolong their life should receive the same penalty as someone fabricating data for their own professional gain.[ 14 ]

These offenses make it very difficult for scientists to move forward as it is unclear to anyone what if anything is true and can be trusted-can lead students and colleagues to waste precious time, effort, and resources investigating dead ends.[ 13 ]

The term plagiarism stems from the Latin word plagium, meaning kidnapping a man. It literary means theft, taking material authored by others and presenting as someone else’ Plagiarism is basically intended to deceive the reader's. Izet Masic reminded of the comment of Samuel Johnson, dealing with a manuscript that he sent for evaluation: “Your work is both good and original. Unfortunately the parts that are good are not original, and the parts that are original are not good”.[ 13 ]

Referring to the United States’ Office of Research Integrity (ORI) definition of plagiarism, which is “unattributed textual copying”, many have questioned its applicability in real life situations. One definition of plagiarism suggests it is the repetition of 11 words or the overlap of 30 letter strings, although this is by no means a standard definition. Furthermore, “salami-slicing”-the selective use of research-project results to maximize the number of presentations possible-has also been classed as a type of plagiarism by some, but not by others.[ 14 ]

Plagiarism can be divided into direct (plagiarism of the text); mosaic (the borrowing ideas and opinions from original source and a few verbatim words of phrases without crediting the author) and self-plagiarism (which refers to re-using one's own work without citations).[ 15 ]

Researchers rely on the published data, and have to be skilled to selectively process these data, to incorporate previous knowledge into a new paper, and to distinguish original ideas and research results from already publicized ones. Authors are obliged to follow ethical, moral, and legal regulations acceptable by the scientific community. To do so, they must properly cite relevant publications and quote borrowed published or unpublished ideas and words. Simply, when an author copies others’ text word for word, the borrowed passage should be enclosed in the quotation marks (inverted commas). The reader should be clearly informed over what is original and recycled from other sources.[ 15 ]

Redundant (multiple) publication

Journal instructions should clearly explain what is, and what is not, considered to be prior publication. Journals may choose to accept (i.e. consider “not redundant”) the re-publication of materials that have been accurately translated from an original publication in a different language. Journals that translate and publish material that has been published elsewhere should ensure that they have appropriate permission (s), should indicate clearly that the material has been translated and re-published, and should indicate clearly the original source of the material. Editors may request copies of related publications if they are concerned about overlap and possible redundancy. Re-publishing in the same language as primary publication with the aim of serving different audiences is more difficult to justify when primary publication is electronic and therefore easily accessible, but if editors feel that this is appropriate they should follow the same steps as for translation. Editors should ensure that sub-group analyses, meta-and secondary analyses are clearly identified as analyses of data that have already been published, that they refer directly to the primary source, and that (if available) they include the clinical trial registration number from the primary publication.[ 16 ]

NATIONAL BODIES

One of the oldest organizations dealing with research misconduct is the ORI in the United States. Set up in 1992, it oversees and directs Public Health Service research integrity activities. With a huge budget of $30 billion, it provides significant funds in the areas of health, research, and development, and oversees bodies such as The National Institute of Health and The Office of Public Health and Science.[ 14 ]

The Committee on Publication Ethics (COPE) was established in 1997 by a small group of medical journal editors in the UK, but now has over 7000 members worldwide from all academic fields. Membership is open to editors of academic journals and others interested in publication ethics. Several major publishers (including Elsevier, Wiley-Blackwell, Springer, Taylor and Francis, Palgrave Macmillan and Wolters Kluwer) have signed up some, if not all, of their journals as COPE members. COPE provides advice to editors and publishers on all aspects of publication ethics and in particular, how to handle cases of research and publication misconduct. It also provides a forum for its members to discuss individual cases. COPE does not investigate individual cases, but encourages editors to ensure that cases are investigated by the appropriate authorities (usually a research institution or employer).[ 17 ]

The UK Research Integrity Office is another body representing the interests of over 50 universities and organizations dedicated to scientific research. Set up in 2006, its aims are to:

• Promote the good governance, management, and conduct of academic, scientific, and medical research;
• Share good practice on how to address poor practice, misconduct, and unethical behavior; and
• Give confidential, independent, and expert advice and guidance about the conduct of academic, scientific, and medical research.[ 18 ]

CONCLUSIONS

If one wants to create a scientific work, must have on his mind that creating a scientific work requires creativity and openness, honesty, trust, and obeying the ethical principles for writing a scientific paper.

As well an author in medical sciences should always follow the words; “The health of my patient will be my first consideration”, (Declaration of Geneva, Adopted by the 2 nd General Assembly of the WMA, Geneva, Switzerland, September 1948).[ 19 ]

While working on a an biomedical research involving human subjects medical workers should have on mind that it is the duty of the physician to remain the protector of the life and health of that person on whom biomedical research is being carried out.

The subjects should be volunteers-either healthy persons or patients for whom the experimental design is not related to the patient's illness.

The investigator or the investigating team should discontinue the research if in his/her or their judgment it may, if continued, be harmful to the individual.

In research on man, the interest of science and society should never take precedence over considerations related to the well-being of the subject.

Investing in education of researches and potential researches already in the level of medical schools, educating them on research ethics, what constitutes research misconduct and the seriousness of it repercussion is essential for finding a solution to this problem and ensuring careers are constructed on honesty and integrity.

Source of Support: Nil

Conflict of Interest: None declared.

• Open access
• Published: 31 August 2024

Opportunities and challenges of a dynamic consent-based application: personalized options for personal health data sharing and utilization

• Ah Ra Lee 1 ,
• Dongjun Koo 1 , 2 ,
• Il Kon Kim 3 ,
• Eunjoo Lee 4 ,
• Sooyoung Yoo 1 &
• Ho-Young Lee 1 , 5  

BMC Medical Ethics volume  25 , Article number:  92 ( 2024 ) Cite this article

Metrics details

The principles of dynamic consent are based on the idea of safeguarding the autonomy of individuals by providing them with personalized options to choose from regarding the sharing and utilization of personal health data. To facilitate the widespread introduction of dynamic consent concepts in practice, individuals must perceive these procedures as useful and easy to use. This study examines the user experience of a dynamic consent-based application, in particular focusing on personalized options, and explores whether this approach may be useful in terms of ensuring the autonomy of data subjects in personal health data usage.

This study investigated the user experience of MyHealthHub, a dynamic consent-based application, among adults aged 18 years or older living in South Korea. Eight tasks exploring the primary aspects of dynamic consent principles–including providing consent, monitoring consent history, and managing personalized options were provided to participants. Feedback on the experiences of testing MyHealthHub was gathered via multiple-choice and open-ended questionnaire items.

A total of 30 participants provided dynamic consent through the MyHealthHub application. Most participants successfully completed all the provided tasks without assistance and regarded the personalized options favourably. Concerns about the security and reliability of the digital-based consent system were raised, in contrast to positive responses elicited in other aspects, such as perceived usefulness and ease of use.

Conclusions

Dynamic consent is an ethically advantageous approach for the sharing and utilization of personal health data. Personalized options have the potential to serve as pragmatic safeguards for the autonomy of individuals in the sharing and utilization of personal health data. Incorporating the principles of dynamic consent into real-world scenarios requires remaining issues, such as the need for powerful authentication mechanisms that bolster privacy and security, to be addressed. This would enhance the trustworthiness of dynamic consent-based applications while preserving their ethical advantages.

Peer Review reports

The advances in big data necessitate a complicated balance between protecting the privacy of individuals whose data are being used and leveraging the societal benefits provided by state-of-the-art data-driven technologies [ 1 ]. Personal health data are a valuable resource that significantly impacts biomedical research and digital health ecosystems [ 2 ]. The integration of sophisticated technologies with the widespread use of personal health data has resulted in groundbreaking work within the realm of medicine and tangible applications in the health care sector [ 3 ]. However, the combination of technology and personal health data has led to concerns associated with data privacy and security, as well as ethical implications in terms of consent and potential exploitation [ 4 , 5 ]. Therefore, to encourage innovation and enhance healthcare outcomes through the use of data, the perspectives of both data subjects and consumers, whose interests sometimes conflict, must be thoroughly considered.

Data sovereignty is indispensable within a data-driven economy [ 6 ]. This concept emphasizes the need for data subjects to have control over the use of their shared data. The absence of such sovereignty could hinder the advancement of the data-driven economy by decreasing the desire for data sharing and utilization [ 7 ]. To ensure the full potential of data utilization, discussions regarding sovereignty have evolved in the digital era. The protection of individual rights and the promotion of trust in data sharing environments are both mandatory in certain regulatory frameworks, such as the General Data Protection Regulation (GDPR) and the Health Insurance Portability and Accountability Act (HIPAA) [ 8 , 9 ]. For instance, the fundamental tenet of the European Union data protection law is that individuals have authority over the sharing of their personal health data [ 10 ]. Provisions granting access, erasure, and transfer rights for personal data in specific circumstances in the GDPR help facilitate its fundamental aim of protecting data subjects. This current shift towards giving individuals autonomy over their data highlights the significance of data sovereignty in contemporary discussions in digital health ecosystems.

While obtaining consent from individuals before using their personal health data is generally crucial in clinical research, it may not always be feasible in every situation. Appropriate safeguards and ethical considerations should be implemented to protect individuals’ privacy in such cases. The fundamental basis of consent is respecting individual autonomy [ 11 ]. The Declaration of Helsinki and the Belmont Report aim to prevent exploitative and manipulative practices in clinical and medical research, and both highlight the importance of autonomy [ 12 , 13 ]. Safeguarding autonomy involves more than just preventing manipulation; it also entails offering guidance and support for making autonomous decisions. These ideas have been incorporated into practice as informed consent, which includes providing comprehensive and precise information to empower individuals to make voluntary decisions [ 14 , 15 ]. The All of Us research program in the United States provides individuals with adequate information to make well-informed decisions concerning their participation [ 16 , 17 ]. This program ensures that potential participants are motivated to join based on their personal interests and the inherent value of their involvement by providing comprehensive details regarding program operations. This approach ensures that individuals make informed decisions according to their preferences. The Guidelines for Tailoring the Informed Consent Process in Clinical Studies (i-CONSENT guidelines) also emphasize the significance of implementing comprehensive and individualized consent procedures [ 18 ]. These guidelines advocate for ongoing, two-way communication, initiated at the outset of participant engagement and sustained throughout the duration of the study.

Dynamic consent, an innovative principle that emphasizes the protection of the data sovereignty of individuals, has attracted considerable interest [ 19 ]. Many academic studies have examined the potential benefits of dynamic consent, specifically regarding its ethical advantages in comparison to conventional consent methods [ 20 , 21 , 22 , 23 , 24 ]. Due to its functionality within digital interfaces that enable uninterrupted communication between data subjects and consumers, irrespective of temporal and spatial constraints, dynamic consent is regarded as the most appropriate approach for acquiring consent in digital health ecosystems [ 25 ]. Furthermore, dynamic consent provides a variety of personalized options for individuals to enhance their autonomy and self-determination with respect to the sharing and utilization of personal health data. Establishing resilient mechanisms through which individuals can exert authority over their personal health data while maintaining continuous communication is essential in the pursuit of genuine informed consent in digital settings. Nevertheless, further considerations of personalized options are still required [ 26 , 27 ]. To assess the efficacy, usability, and ability to uphold individual autonomy of personalized options that are supported by dynamic consent principles, additional investigation is needed.

Therefore, in this study, user experiences based on dynamic consent principles are examined, specifically focusing on sovereignty over health data usage in various settings with personalized options. The evaluation was conducted using MyHealthHub, a digital consent application developed in this study based on dynamic consent principles. The primary objectives of this study are (1) to explore the viewpoints of individuals on the sharing and utilization of personal health data and (2) to assess user acceptance of MyHealthHub as a means for managing data sovereignty in a tailored manner while respecting individual autonomy. This study specifically focuses on individual patients, who are the principal subjects of personal health data. To analyze user acceptance, this study employed the Technology Acceptance Model (TAM), which has been widely used to understand user acceptance of information technology [ 28 ]. This study contributes to the exploration of processes to ensure data sovereignty with dynamic consent in the health care sector by examining user experiences associated with the MyHealthHub application, which facilitates the sharing and utilization of personal health data with personalized options in a tailored manner.

Study design

This study utilized a mixed-methods design, incorporating both a system usability test and questionnaires. MyHealthHub, a digital consent application designed in adherence with dynamic consent principles, was specifically developed for this study to facilitate the usability test. The study participants were provided with access to the MyHealthHub application, which facilitates experiences in a personalized data sharing process using virtual health data. The questionnaire included one open-ended item to elicit a wide range of perspectives from the participants, as well as multiple-choice items. The entire procedure was completed consecutively in a single session and adhered to the required ethical protocols under the necessary ethical clearance of informed consent from the Institutional Review Board of Kyungpook National University (KNU) (KNU IRB No. KNU-2021-0158).

Participant recruitment

Participants for this study were recruited through email invitations. Potential participants were defined as individuals who have interests or experiences in digital health services and were likely to utilize digital consent applications to generate personal health data during their daily lives and to share and utilize their data. Participants were eligible if they were 18 years of age or older, resided in South Korea, had internet access on personal devices, and were proficient in using websites for various activities, such as online shopping and internet banking. The potential participants were provided with basic information materials regarding the study through email. Email addresses of potential participants were obtained through the Smart Health Standards Forum, an organization supporting smart health standards and industry development. They were encouraged to voluntarily reach out to our research team to arrange an appointment if they were interested in participating. All participants provided informed written consent and received a gift voucher as compensation upon completion.

System usability test

MyHealthHub is a digital consent application designed based on dynamic consent principles. This application offers participants an all-encompassing experience of personalized data sharing and consent management. The prototype version of the application was available in the Korean language. The MyHealthHub application included functionalities for managing consent, monitoring data sharing history, and configuring personalized options regarding data usage (Fig.  1 ). Personalized options include specifying the scope of shared data according to the specific institutions and health data involved, conditions for automatic consent, designated representatives if necessary, and preferred communication methods or periods for receiving relevant updates on their data usage. These options were flexible and could be adjusted according to each individual’s preferences.

Screenshots of the English version of the MyHealthHub application

The participants were provided with individual accounts and were instructed to access and log in to the MyHealthHub application. For the system usability test, the provided accounts were populated with temporary log-in credentials and comprised a variety of fictitious dummy personal health data. So that the participants could experience and understand the foundational attributes of dynamic consent, they were required to complete eight tasks via the MyHealthHub application. These tasks were determined through a combination of literature findings and insights from a scoping review on dynamic consent, as detailed in our previous study [ 29 ]. The tasks included providing consent, monitoring data usage history, and configuring personalized options. This approach ensures that the tasks reflected prior knowledge on dynamic consent, allowing for a comprehensive evaluation of the dynamic consent process. The participants were not specifically instructed to meticulously scrutinize each item of content available in the application during the execution of the designated tasks with the purpose of assessing real user interactions with MyHealthHub. The participants were given the autonomy to select the scope and variety of institutions that they wanted to share their data with, based on their individual preferences. After completing the tasks, participants evaluated their experience with a questionnaire designed to capture their feedback on the usability and functionality of the application.

Questionnaire

After the usability test, participants were prompted to complete a questionnaire. The questionnaire consisted of 30 items, which comprised a combination of multiple-choice and open-ended inquiries (Table 1 ). The multiple-choice questions were designed to investigate perceptions of the sharing of personal health data and to assess user acceptance of the MyHealthHub application. The questionnaire items were formulated by integrating findings from the literature and primary concepts derived from the TAM, specifically focusing on perceived ease of use, perceived usefulness, and intention to use. While advancements in the model, such as the Unified Theory of Acceptance and Use of Technology, are acknowledged, this study employed the original TAM for its simplicity and well-established use in similar contexts, which aligns well with the specific focus of this study [ 30 ]. Finally, participants were provided with an open-ended questionnaire to further explore their experiences and perspectives concerning the MyHealthHub application. The participants were encouraged to provide feedback on a multitude of application-related topics, such as interface design, content, usability, potential improvements, information quality, authentication and authorization procedures, and any other pertinent observations derived from the usability test. The full version of the questionnaire was originally written in Korean, and the English-translated version is available in Additional file 1.

Data analysis

To validate the responses gathered from the multiple-choice questionnaire items, statistical methods were utilized. The internal, concentration, and discriminant validity of each category were validated in this process [ 31 , 32 , 33 ]. Subsequently, descriptive statistics were employed to analyze quantitative data derived from the responses to multiple-choice questions. The qualitative data acquired through the open-ended item were analyzed thematically [ 34 ]. Two of the authors first carried out the review, coding, and categorization of the gathered data to construct the initial themes. Then, all the authors reviewed and discussed the themes to enhance their coherence and reasonability. Discrepancies identified among the authors were discussed and resolved. The data analysis procedure was performed using SmartPLS 3.0 and Excel.

Perceptions of the sharing and utilization of personal health data

A total of thirty participants accessed the MyHealthHub application for an average of thirty minutes to provide dynamic consent. The participants successfully accomplished the eight assigned tasks without requiring additional assistance or support. The demographic characteristics of the participants are available in Additional file 2.

Table 2 presents the participants’ perspectives on the sharing of personal health data. Twenty-four out of thirty participants agreed that the exchange of personal data is crucial to the advancement of the health care industry. Regarding the timing of requesting consent, twelve participants responded that consent is needed for each time data is to be shared, whereas three participants preferred providing consent only once, such as during the initial registration process for a specific service such as the MyHealthHub application. The remaining half of the participants indicated a preference for different frequencies of consent requests, contingent upon the purposes and subjects of data usage.

Table 3 presents the participants’ preferences concerning the sharing and utilization of their personal health data. Participants’ degrees of willingness to share their data varied by the type of institution or data. The average number of participants who expressed willingness to share basic health checkup data was 12.17, the highest result of any data type. In contrast, the average value for data concerning mental health was the lowest, at 9.83 individuals. Regarding the institution types, an average of 26.33 individuals considered medical institutions to be favour targets for data sharing. Additionally, private companies were given the lowest preferences, with an average of only 2.00 individuals.

User acceptance of the MyHealthHub application

Table 4 presents the descriptive statistics of participant responses regarding the level of user acceptance of the MyHealthHub application. The responses were validated for internal consistency, convergent validity, and discriminant validity within each category (Additional file 3). Average scores of 6.10 and 5.62 out of 7.00 were obtained for self-evaluated health literacy and health-related interests, respectively. An average of 5.67 was obtained for system usability, whereas a lower average, 4.67, was obtained for system reliability. The average score for the overall intention to use was 5.26, with 5.20 for perceived usefulness and 5.46 for perceived ease of use.

Thematic analysis results

Following an analysis of the responses to the open-ended questionnaire item, three themes were identified: the usability of the MyHealthHub application, the usefulness of the MyHealthHub application, and apprehensions regarding digital environments (Table 5 ).

The usability of the MyHealthHub application

In addition to the quantitative results presented in Table 4 , the overall evaluation results for usability were favorable, as evidenced by the fact that every participant independently completed the assigned tasks. Moreover, participants shared some opinions about enhancing the usability of the MyHealthHub application.

Some participants believed that mobile interfaces would offer greater benefits than web-based environments. Although the prototype distributed to the participants was compatible with desktop and mobile devices, it did not have responsive interface capabilities catering to different device types. Some participants expressed the opinion that the width of the tables utilized to present a record of consent requests or data usage history was excessively large on mobile devices, requiring them to scroll to cover the entire piece of information. They expressed their desire for an iteration of the MyHealthHub application that incorporates user-interface optimization tailored for mobile devices, thereby augmenting accessibility and enabling its utilization from any location without relying on desktop computers.

In addition to mobile optimization, participants commented on the intuitiveness of the interface. The majority of participants expressed satisfaction with the level of information that the MyHealthHub application provided in relation to their decision-making process regarding data usage. On the other hand, certain participants who perceived themselves to be deficient in providing information reported facing challenges in understanding content that included medical terminology. They desired further user interface enhancement through the addition of straightforward icons or descriptions to assist them in making decisions based on a comprehensive understanding of the data types to be shared and the specific purposes for which institutions would utilize the data.

The usefulness of the MyHealthHub application

The participants expressed contentment with the ability to tailor the level of data sharing in accordance with the type of institutions and data. In addition, the study participants highlighted the potential advantages of the MyHealthHub application in health management, monitoring chronic diseases, and insurance payment processing.

Personalized options were found to be the most appealing aspect to participants. Furthermore, this feature complies with dynamic consent principles, which safeguard the autonomy and self-determination of individuals. Some participants who initially expressed a preference for providing consent only once during the registration procedure felt that the option to automatically set conditions for providing consent was quite attractive. Certain participants opined that a more granular degree of options would be beneficial in the selection process for institution types. For example, a participant expressed a preference for choosing a specific insurance company rather than the institution type when they desired to share data with only insurance company A but not insurance company B. On the other hand, a few participants felt that the administration of personalized options was occasionally cumbersome, impeding their motivation to engage in the process of data utilization.

The majority of participants acknowledged the benefits associated with exercising control over data through the MyHealthHub application. They valued the convenience of monitoring their consent and data usage history to help manage their data utilization, in addition to the ability to tailor the extent of shared data to their preferences. Conversely, a subset of the participants conveyed a feeling of inadequate motivation to use the MyHealthHub application. They stated that they were young and currently in excellent health, resulting in a lack of need to manage personal health data, in contrast to financial management services. Some of them suggested that it would be advantageous to employ rewards or incentives as a means of motivating individuals to share their personal health data, thereby fostering their interest in health data management.

Apprehensions regarding digital environments

While the participants expressed contentment with the personalized options, there were some concerns regarding security. The participants highlighted the significance of establishing security protocols to prevent disastrous data breaches in digital environments, with a particular focus on health data that may include sensitive personal information.

In response to the identification procedure, the participants provided mixed responses. The participants were able to access the MyHealthHub application through the login ID and password that were assigned for the usability test in this study. Some participants conveyed a desire to enable effortless login via the single sign-on (SSO) approach in practical situations. These participants were aware of the SSO procedure, which is an authentication approach that enables individuals to access different services with a single set of login credentials [ 35 ]. They perceived the SSO as a dependable and practical approach to accessing multiple applications, owing to its widespread adoption across various services. Conversely, certain participants expressed that they might be hesitant to use the MyHealthHub application in the future out of apprehension, citing a need for increased security measures. One participant suggested that enhanced security technologies be implemented at a level comparable to the authentication process utilized in financial applications, such as two-factor authentication [ 36 ].

An additional noteworthy opinion concerned the criticality of communication in fostering relationships of trust with system end-users. The majority of participants indicated that the functionalities provided by the MyHealthHub application are advantageous for safeguarding individual autonomy and ensuring data sovereignty over their health data. However, they also emphasized the need to provide more comprehensive information regarding data management procedures so as to enhance transparency. One participant underscored the importance of secure and permanent deletion of shared data once a contractual period has expired. Another participant contended that it is critical to convey both technical and emotional aspects pertaining to the secure storage and management of data to foster trust and assurance with system users. For instance, individuals may want to know how their provided data are transmitted to the designated institution in a secure way and how the shared data are protected within the institution.

This study investigated the potential of a digital consent system that adheres to dynamic consent principles for safeguarding the autonomy and data sovereignty of individuals regarding their personal health data. Dynamic consent is an innovative approach to facilitating digital health ecosystems that helps balance the use of personal health data while simultaneously safeguarding individual autonomy [ 19 ]. Previous scholarly investigations have explored dynamic consent, such as its conceptual evolution, user acceptance, and technological advancements that facilitate its practical implementation [ 29 ]. Although previous research has recognized the ethical benefits of dynamic consent in comparison to conventional consent models, a need to assess user acceptance of systems based on dynamic consent for its practical use has been consistently expressed. Notably, very few publications have linked the TAM to dynamic consent, highlighting the originality of this study in understanding user acceptance within the context of personal health data management.

The results of this study provide valuable insights into participants’ preferences and perceptions regarding the sharing and utilization of personal health data through dynamic consent mechanisms. The study demonstrated a strong acceptance of the MyHealthHub application, with participants successfully completing tasks and expressing a preference for personalized consent options tailored to the type of data and institutions involved. Notably, participants showed a higher willingness to share data with medical institutions compared to private companies, and there was a clear preference for dynamic consent methods that allow for continuous and adaptable consent management. Despite the favorable reception, some participants indicated that the abundance of options could be cumbersome, suggesting the need for further refinement of user interfaces and the incorporation of more intuitive design elements. Additionally, participants highlighted concerns about security and the importance of transparent data management practices, underscoring the necessity for robust security measures and clear communication to build trust.

In particular, there has been little effort to investigate whether dynamic consent genuinely upholds individual autonomy through the sharing and utilization of personal health data. This critical question is central to the ethical considerations of digital health technologies and the protection of individual rights and privacy [ 37 ]. It is imperative to assess the efficacy of dynamic consent in preserving these principles amid the complex interplay of technology, healthcare delivery, and individual rights [ 38 , 39 ]. Individuals should be able to modify and update their consent, including actions such as protocol shifts, alterations, and withdrawal [ 40 ]. Furthermore, addressing concerns about the temporal aspect and control over the pace of interaction is essential for maintaining individual autonomy.

The personalization and flexibility of consent are enhanced by dynamic consent principles, which permit individuals to modify their consent preferences as circumstances change. This study used a digital consent application, MyHealthHub that operates on dynamic consent principles. MyHealthHub enables continuous interaction with participants, promoting self-determination in accordance with their consent preferences. The study participants comprehended and accepted the dynamic consent model according to their performance on the usability test. Participants were able to make decisions regarding the sharing of data in accordance with their individual preferences, considering the information at their disposal regarding data usage, including target institution, purpose, and duration of data sharing. Additionally, the questionnaire responses revealed that the perceived usefulness and ease of use of the MyHealthHub application led to positive intentions to use it.

The findings from this study indicate the usefulness of dynamic consent by demonstrating that individuals’ preferences regarding consent are substantially affected by a range of factors, including the kind of data to be shared, the type of institution involved, and the context in which the data is shared. These findings align with the observations made in prior studies regarding individuals’ perspectives on the utilization of their health data [ 41 , 42 , 43 , 44 ]. One study has indicated that individuals may exhibit a preference for providing limited data to for-profit enterprises [ 45 ]. Similarly, significant disparities in consent preferences were observed based on the type of institution in this study. The participants exhibited a greater propensity to provide consent for the sharing of their data with medical institutions or research institutes than with private enterprises. The type of health data also influenced the participants’ inclination to share their data. There was a heightened reluctance to share mental health-related data with specific institutions compared to basic health check-ups and physical health-related data.

Another notable observation from this study is that the participants displayed a mixed reaction to the personalized options. The majority of participants expressed satisfaction with the ability to independently determine the scope and extent of their data sharing, allowing customization. Some participants expressed that the abundance of options available may deter individuals from engaging in their data sharing and utilization processes. They exhibited a greater preference for automatic consent, as it eliminates the need for frequent decision-making or consent provision. The expanded role of individuals in the dynamic consent approach with respect to conventional consent mechanisms may be perceived as burdensome due to the multitude of options available for selection [ 46 ]. This particular concern has been identified as a significant barrier to the widespread adoption of the dynamic consent model in prior scholarly investigations. However, it has been argued that these opinions stem from a misinterpretation of dynamic consent. The concept of autonomy, as outlined in the dynamic consent principles, pertains to the ability to adapt approaches to accommodate various circumstances. This includes allowing individuals to choose the level of involvement they wish to have in their data-sharing processes. For example, passive individuals have the option to utilize broad-informed consent as a means to adopt a more inclusive approach within the framework of the dynamic consent model.

There are several limitations to this study. The recruitment of participants was conducted via convenience sampling. Convenience sampling was carried out by distributing invitations to individuals who were easily accessible and met the study criteria, such as members or subscribers of smart health standard forum. The majority of the study participants expressed interest in utilizing digital health services and personal health data. In fact, since this innovative method, the dynamic consent mechanism, affects the entirety of society, it is crucial to solicit the general public’s opinion. However, despite the satisfactory validity of the questionnaire responses, which suggests their potential for future research, the sample size employed in this study was relatively modest. It was difficult to recruit many public individuals, as well as older individuals, in our sample due to recruitment challenges; consequently, the characteristics of this study sample may not be representative of the general population in South Korea. The presence of such a selection bias may lead to overly optimistic conclusions regarding the level of interest and engagement of participants in utilizing the application.

Additionally, this study did not evaluate uninterrupted communication, a critical component of dynamic consent. The average duration of the participants’ experience was only 30 minutes, which is insufficient for a thorough evaluation. It is imperative to evaluate whether consent is altered over an extended period and whether participants prefer to continue utilizing the system. This limitation should be recognized, as it affects the comprehension of the continuous interaction necessary for dynamic consent systems. Furthermore, the experience was constructed using fictitious data rather than the actual data of the participants, which could potentially influence their responses and engagement. These aspects should be the focus of future research in order to conduct a more comprehensive assessment of dynamic consent systems.

Given the potential for data sharing to expand globally, it is required to address the specific contents of dynamic consent items. Previous studies have defined these items using the Data Use Ontology (DUO) developed by the Global Alliance for Genomics and Health (GA4GH) [ 47 , 48 , 49 ]. Additionally, international standards such as the Fast Healthcare Interoperability Resources (FHIR), developed by Health Level Seven (HL7), offer structured standards for representing consent directives in healthcare, emphasizing the importance of interoperability and consistency [ 50 ]. The Basic Patient Privacy Consents (BPPC) profile by Integrating the Healthcare Enterprise (IHE) also provides a mechanism for managing patient privacy consents, further supporting the need for standardized approaches [ 51 ]. Standardizing and clearly defining the items within dynamic consent, including the types of data shared, the purposes of data use, and the entities involved, is crucial for establishing trust among users and ensuring transparency. However, this study primarily focused on the user experience and did not explore the detailed standardization and definition of dynamic consent items, which constitutes a limitation. Addressing these aspects would enhance the scalability and interoperability of dynamic consent mechanisms on a broader scale.

Nevertheless, a notable aspect of this study was the simulation of real-world scenarios regarding the use of personalized options through the MyHealthHub application. Although the personalized option is an aspect of dynamic consent principles that safeguards individual autonomy in sharing and utilizing personal health data, it has received comparatively less attention than other features, such as withdrawal of consent, contactless communication, and unlimited communication. Participants in this study were not required to carefully read or view any particular page or information; rather, they used the application as usual and completed the assigned tasks by themselves. This statement underscores our endeavors to acquire a more realistic depiction of the circumstances in which individuals are anticipated to operate the application in the future. As evidenced by the fact that not all participants preferred to select personalized options each time rather than specifying conditions for automatic consent, it would appear that the intended reflection of a variety of realistic perspectives in this study was achieved, at least to some degree. Further research that juxtaposes the perspectives of active and passive individuals should provide a more holistic understanding of the effects of dynamic consent protocols on participation rates as well as whether such protocols yield more favorable outcomes while preserving individual autonomy.

In a data-driven economy, personal health data facilitate progress in digital health ecosystems beyond their potential value as an asset. In digital health environments, dynamic consent is a promising strategy for protecting the autonomy and data sovereignty of individuals regarding their personal health data. The findings of this study indicate that by utilizing dynamic consent principles in the implementation of a digital consent application, individuals can be adequately informed regarding the manner in which their data are shared and used, thereby empowering them to make well-informed decisions. Participants highly valued the ability of digital interfaces to modify individual preferences in response to changing circumstances; this feature should be expanded to its fullest potential. Nevertheless, digital consent has certain challenges, such as apprehensions about the identification process and a lack of establishing trustworthy relationships with individuals. Therefore, while embracing the personalized and flexible advantages of the dynamic consent model, it is imperative to continuously contemplate technological and legal measures to ensure individual rights and privacy in the ever-evolving digital landscape.

Availability of data and materials

The datasets used and/or analysed during the current study are available from the corresponding author on reasonable request.

Abbreviations

Health insurance portability and accountability act

General data protection regulation

Technology Acceptance Model

Single sign-on

Data use ontology

Global alliance for genomics and health

Fast healthcare interoperability resources

Health level seven

Basic patient privacy consents

Integrating the healthcare enterprise

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Acknowledgements

This research was supported by a Government-wide R&D Fund project for infectious disease research (GFID), Republic of Korea (grant number: HG22C0024, KH124685).

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Ah Ra Lee, Dongjun Koo, Sooyoung Yoo & Ho-Young Lee

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Dongjun Koo

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AL and IK conceptualized the design of the study. AL and DK performed system implementation, data collection, analysis, and interpretation of the findings. AL wrote the original draft. EL, SY, IK and HL commented. IK and HL reviewed the final version. All authors reviewed and approved the final version of the manuscript.

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The Institutional Review Board of Kyungpook National University (KNU) granted approval for this research (KNU IRB No. KNU-2021-0158). Prior to the commencement of the study, written informed consent was obtained from all participants, and the objectives and scope of the research were explained. They were informed of the possibility and their right to withdraw from the study at any time, and their participation was entirely voluntary. No personally identifiable information was gathered during the data collection process, and no unique identifiable information was included in the presentation of the findings. All methods were conducted in accordance with the relevant guidelines and regulations.

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Additional file 1: questionnaire, additional file 2: demographic characteristics of the study participants, additional file 3: validation results for the questionnaire items, rights and permissions.

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Lee, A.R., Koo, D., Kim, I.K. et al. Opportunities and challenges of a dynamic consent-based application: personalized options for personal health data sharing and utilization. BMC Med Ethics 25 , 92 (2024). https://doi.org/10.1186/s12910-024-01091-3

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• Volume 14, Issue 9
• Mixed-methods protocol for the WiSSPr study: Women in Sex work, Stigma and psychosocial barriers to Pre-exposure prophylaxis in Zambia
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• http://orcid.org/0000-0002-4570-6686 Ramya Kumar 1 , 2 ,
• http://orcid.org/0000-0003-4076-0170 Deepa Rao 3 ,
• http://orcid.org/0000-0002-8189-0732 Anjali Sharma 1 ,
• Jamia Phiri 1 ,
• Martin Zimba 4 ,
• Maureen Phiri 4 ,
• Ruth Zyambo 5 ,
• Gwen Mulenga Kalo 5 ,
• Louise Chilembo 5 ,
• Phidelina Milambo Kunda 6 ,
• Chama Mulubwa 1 ,
• Benard Ngosa 1 ,
• http://orcid.org/0000-0001-5208-7468 Kenneth K Mugwanya 7 ,
• Wendy E Barrington 8 ,
• http://orcid.org/0000-0002-3629-3867 Michael E Herce 1 , 9 ,
• http://orcid.org/0000-0001-9968-7540 Maurice Musheke 1
• 1 Centre for Infectious Disease Research in Zambia , Lusaka , Zambia
• 2 Epidemiology , University of Washington School of Public Health , Seattle , Washington , USA
• 3 University of Washington School of Public Health , Seattle , Washington , USA
• 4 Zambia Sex Workers Alliance , Lusaka , Zambia
• 5 Tithandizeni Umoyo Network , Lusaka , Zambia
• 6 Lusaka District Health Office , Zambia Ministry of Health , Lusaka , Zambia
• 7 Epidemiology, Global Health , University of Washington School of Public Health , Seattle , Washington , USA
• 8 Epidemiology; Child, Family, and Population Health Nursing; Health Systems and Population Health , University of Washington School of Public Health , Seattle , Washington , USA
• 9 Institute for Global Health and Infectious Diseases , University of North Carolina at Chapel Hill , Chapel Hill , North Carolina , USA
• Correspondence to Dr Ramya Kumar; ramya.kumar.mlk{at}gmail.com

Introduction Women engaging in sex work (WESW) have 21 times the risk of HIV acquisition compared with the general population. However, accessing HIV pre-exposure prophylaxis (PrEP) remains challenging, and PrEP initiation and persistence are low due to stigma and related psychosocial factors. The WiSSPr (Women in Sex work, Stigma and PrEP) study aims to (1) estimate the effect of multiple stigmas on PrEP initiation and persistence and (2) qualitatively explore the enablers and barriers to PrEP use for WESW in Lusaka, Zambia.

Methods and analysis WiSSPr is a prospective observational cohort study grounded in community-based participatory research principles with a community advisory board (CAB) of key population (KP) civil society organi sations (KP-CSOs) and the Ministry of Health (MoH). We will administer a one-time psychosocial survey vetted by the CAB and follow 300 WESW in the electronic medical record for three months to measure PrEP initiation (#/% ever taking PrEP) and persistence (immediate discontinuation and a medication possession ratio). We will conduct in-depth interviews with a purposive sample of 18 women, including 12 WESW and 6 peer navigators who support routine HIV screening and PrEP delivery, in two community hubs serving KPs since October 2021. We seek to value KP communities as equal contributors to the knowledge production process by actively engaging KP-CSOs throughout the research process. Expected outcomes include quantitative measures of PrEP initiation and persistence among WESW, and qualitative insights into the enablers and barriers to PrEP use informed by participants’ lived experiences.

Ethics and dissemination WiSSPr was approved by the Institutional Review Boards of the University of Zambia (#3650-2023) and University of North Carolina (#22-3147). Participants must give written informed consent. Findings will be disseminated to the CAB, who will determine how to relay them to the community and stakeholders.

• MENTAL HEALTH
• HIV & AIDS
• EPIDEMIOLOGIC STUDIES
• Health Equity
• QUALITATIVE RESEARCH
• SOCIAL MEDICINE

This is an open access article distributed in accordance with the Creative Commons Attribution Non Commercial (CC BY-NC 4.0) license, which permits others to distribute, remix, adapt, build upon this work non-commercially, and license their derivative works on different terms, provided the original work is properly cited, appropriate credit is given, any changes made indicated, and the use is non-commercial. See: http://creativecommons.org/licenses/by-nc/4.0/ .

https://doi.org/10.1136/bmjopen-2023-080218

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STRENGTHS AND LIMITATIONS OF THIS STUDY

The Women in Sex work, Stigma and PrEP (WiSSPr) study uses a mixed-methods approach which is ideal for intersectional stigma research because it allows quantitative research to be grounded in the lived experiences of people, while ensuring that aspects of stigma that emerge at the intersections of identities are measured in testable ways.

Qualitative aim enrolls peer navigators to capture the perspectives of women who are at the unique interface of recipients of care as sex workers themselves, and supporters of health service delivery.

Uses core principles of community-based participatory research which value key populations as equal contributors to the knowledge production process.

Limitations include an inability to longitudinally assess the alignment of pre-exposure prophylaxis (PrEP) adherence and persistence with HIV risk, and limitations in measuring PrEP adherence by self-report and pharmacy dispensations instead of by drug biomarkers.

Introduction

Women engaging in sex work (WESW) are a key population (KP) that experiences an unacceptably high risk of HIV infection. In 2019, the Joint United Nations Programme on HIV/AIDS (UNAIDS) estimate WESW have 21 times the risk of HIV acquisition compared with the general population of adults aged 15 – 49 years old. 1 In Southern and East Africa, KPs and their sexual partners account for 25% of all new HIV infections. 2 To reduce the burden of HIV in Africa, HIV prevention strategies tailored to the unique needs of WESW are critical to safeguarding their health, as well as the health of people in their sexual networks. 3 4

While HIV pre-exposure prophylaxis (PrEP) is highly effective in preventing HIV infection, its real-world efficacy is closely linked to adherence, which is a complex process for WESW. A systematic review of PrEP usage and adherence among WESW reveals complex interrelationships between individual perceptions of HIV risk, social support and fear of healthcare provider stigma. 5 WESW may experience multiple stigmatised identities, conditions or behaviours, such as participating in sex work, having a substance use disorder, and taking HIV prevention medication. 6

Zambia has a generalised HIV epidemic, and the capital city of Lusaka is a major regional transit hub attracting WESW from the region. Approximately 3,396 live in Lusaka with over half (53%) living with HIV, underscoring the need to urgently tailor prevention strategies for this population. 7 WESW in Zambia are subject to violence and discrimination in the form of verbal, physical and sexual abuse from strangers, acquaintances, clients, intimate partners and even law enforcement. 8 Surveys among WESW in Zambia have identified healthcare provider stigma and discrimination, as well as a lack of confidential care as main barriers to HIV prevention services at public health facilities. 7 9 Therefore, a better understanding of the multiple stigmas that WESW experience is a critical first step to designing interventions to meet their HIV prevention needs.

In recent years, Zambia has made significant progress in reaching WESW and providing them with comprehensive HIV prevention services. Since May 2019, the PEPFAR-funded Key Population Investment Fund (KPIF) has been successfully engaging with KP in Lusaka Province and providing them with community-based HIV prevention and treatment services. KPIF is implemented by the Centre for Infectious Disease Research in Zambia (CIDRZ) in partnership with the Zambian Ministry of Health (MoH), US Centers for Disease Control and Prevention and importantly, key population civil society organisations (KP-CSOs). A key objective of the KPIF programme is to improve PrEP initiation, persistence and adherence for HIV-negative WESW. For this study, we propose to leverage existing KPIF infrastructure to enhance study feasibility and ensure its real-world relevance to achieving this key objective.

Although PrEP initiations are high in the KPIF programme, they may not accurately reflect PrEP effectiveness. 10 A systematic review of 41 studies found high discontinuation rates at 1 month. 11 Despite WHO recommendations and national PrEP guidelines for regular HIV testing and follow-up visits, maintaining client engagement with PrEP has been challenging. 12 13 This has resulted in a lack of data on short-term PrEP persistence among WESW in Zambia. Assessing the percentage of clients who do not return for their first follow-up visit is crucial for determining PrEP effectiveness. Current prevention strategies do not adequately address the multiple stigmas and psychosocial stress that hinder PrEP persistence.

Specific objectives

The Women in Sex work, Stigma and PrEP (WiSSPr) mixed-methods study aims to (1) measure the association between multiple stigmas on PrEP initiation and persistence among HIV-negative adult WESW and (2) qualitatively explore the enablers and barriers (interpersonal, psychosocial and structural) to initiating and persisting on PrEP. The qualitative aim will complement and contextualise 14–16 findings from the quantitative results. We hypothesize that WESW with high levels of any type of stigma will be less likely to initiate and persist on PrEP.

Conceptual framework

Interview guides will be informed by the Community, Opportunity, Motivation – Behaviour (COM-B) framework to assess how these components drive engagement with PrEP services. 17 18 The COM-B model is commonly used in HIV prevention because it offers a framework to guide the development and implementation of targeted interventions, thereby enhancing the efficacy and reach of HIV prevention programmes. 19 This framework will guide us to identify deficits in knowledge or skills (Capability), environmental and social contexts (Opportunity), and personal motivations and attitudes (Motivation). This integrated approach ensures that all relevant aspects of behaviour change are considered, leading to more effective and sustainable health outcomes.

Directed acyclic graph

Directed acyclic graphs (DAG) visually synthesise a priori knowledge about the hypothesised relationships between variables of interest, helping to identify causal pathways and potential confounders that could bias the results. We propose confounders based on their known association with stigmas and PrEP persistence, using evidence from published studies addressing similar questions. Controlling for the following variables will be sufficient to block any unconditionally open, non-causal backdoor paths that could lead to confounding: age, community hub, duration of sex work, and education ( figure 1 ).

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Directed acyclic graph illustrating the causal effect of stigma on PrEP persistence. PrEP, pre-exposure prophylaxis.

Methods and analysis

Study design.

We will use a prospective observational cohort study design with mixed methods to characterise PrEP outcomes for HIV-negative WESW in Lusaka, Zambia. Trained research assistants will administer a one-time, 75-item psychosocial survey to participants and follow them prospectively in the electronic medical record. For the qualitative aim, we will conduct in-depth interviews (IDIs) with WESW to get perspectives of prevention services with peer navigators who are both recipients of care and supporters of health service delivery.

Mixed-methods integration

We will use the NIH ‘Best Practices for Mixed Methods’ guidelines to design, analyse and interpret qualitative and quantitative data in mixed-methods research. 20 Specifically, we will employ a convergent parallel design that collects both qualitative and quantitative data concurrently and separately, prioritising both the quantitative and qualitative strands equally but keeping them independent during analysis. We will interpret the extent to which the two sets of results converge, diverge, relate to each other and/or combine to create a better understanding in response to the study’s overall purpose. 20

Study setting

The study population is composed of adult WESW who are living or working within the catchment areas of two community hubs located within urban Lusaka. Based on CIDRZ’s prior published work, we anticipate that the study population will be comprised largely (63%) of younger women (18 – 29 years old). 10

Study exposures and outcomes

Table 1 identifies the primary outcomes of PrEP initiation and persistence from pharmacy dispensations records in the last 90 days for survey participants. Several studies have accessed this data from the national electronic medical record system SmartCare. 21 22 CIDRZ is a key Smartcare implementing partner and routinely leveraging this data to optimise service delivery for KP in KPIF in order to better understand outcomes for HIV treatment and prevention in the national HIV programme. 23–28 Table 2 identifies the independent variables of interest including sociodemographic history, intersectional stigma (everyday discrimination scale), 29 substance use (ASSIST), 30 depressive symptoms (Patient Health Questionnaire, PHQ), 31 as well as sex work, HIV and PrEP-related stigmas and resulting discrimination using established questionnaires. 32–34 The qualitative outcomes are insights into the enablers and barriers to PrEP use informed by participants’ lived experiences according to the COM-B model.

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WiSSPr study outcomes

WiSSPr study independent variables

Sample size

We determined the minimum sample size using Demidenko’s method for logistic regression with binary interactions, informed by effect size and variance data from Witte et al ’s study on PrEP acceptability among women in Uganda. 35–37 Sample size considerations are based on our primary outcome of PrEP initiation and informed by preliminary programmatic data that formed assumptions about baseline HIV prevalence and estimated PrEP initiations. Each site tests an average of 200 WESW per month, which will allow an estimated 800 women to be tested during the 2-month enrolment period. We project approximately 56% (448) will test HIV-negative, and of these, we estimate 403 (90%) will be eligible, and 350 (87%) will agree to initiate PrEP. Due to time and resource limitations, we seek to enroll a sample of 300 eligible WESW. Assuming 5% of participant medical records cannot be found, a total cohort of 285 PrEP users would allow us to estimate the prevalence ratio of stigma on PrEP initiation of 1.98 or higher (positive association), or 0.50 or lower (negative association) at 80% power with a significance level of 0.05. We aim to recruit 18 participants for IDIs, based on prior research with this population and qualitative methodology guidelines suggesting that 6 – 10 interviews per subgroup are sufficient to reach thematic saturation 14 20

Participant recruitment

The study will start in July 2023. WiSSPr will recruit 300 participants from a convenience sample of WESW who are receiving HIV services from two community-based hubs which have been functioning as MoH drop-in wellness centres since October 2021. All HIV testing and prevention services at these community hubs are led by teams of KP and MoH staff. Outreach activities take place in venues where WESW socialise, such as brothels, bars, or the home of a KP. Recruitment activities will take place during these outreach activities. KPIF programming leverages KP social networks to mobilise WESW for recruitment into the study. A total of 18 participants, including 6 peer navigators, 6 WESW who discontinue PrEP after initiation, and 6 WESW who continue on PrEP, will be purposively sampled for IDIs, or until we achieve thematic saturation. 38 Qualitative data collection will take place at least 30 days after the quantitative recruitment begins, in order to sample women who initiate a 30 day supply of PrEP but do not return to pick up another refill. Figure 2 outlines the WiSSPr study recruitment process.

The WiSSPr study flow diagram summarises the stages of participant recruitment and follow-up. PrEP, pre-exposure prophylaxis; WiSSPr, Women in Sex work, Stigma and PrEP.

Recruitment will end when 300 participants have been enrolled for the survey and 18 participants enrolled for interviews. PrEP event data will be abstracted from SmartCare approximately 3 months after the final participant’s enrollment. Study activities, including qualitative data collection, data quality control and assurance, and data analysis, are anticipated to continue until the planned end of the study in September 2024.

We will engage the community advisory board (CAB) in collaborative decision-making on: (1) how best to conduct outreach to venues that WESW frequent, (2) how to engage leaders in the sex work community to inform them about this study, and (3) to encourage WESW participation in a way that minimises social harms. Box 1 identifies the inclusion and exclusion criteria for the study. Written informed consent in English or local languages (ChiNyanja or IchiBemba) will be obtained before enrollment. As an added measure of protection for this marginalised population, participants must complete an informed consent quiz to ensure that they understand the potential risks of study participation. Participants will receive the Zambia Kwacha equivalent of US$5 per survey and interview as compensation for their time.

Inclusion and exclusion criteria

Cohort inclusion and exclusion criteria are as follows:

Inclusion criteria: (1) identify as a cis-gendered or transgendered woman, (2) age ≥ 18 years, (3) earns a significant amount of income from exchanging sex for money or goods in the last 3 months, (4) HIV-negative status and eligible for PrEP according to national guidelines, (5) not planning to transfer care to another site within the next 30 days, (6) speaks English or ChiNyanja or IchiBemba and (7) willing and able to provide written informed consent

Exclusion criteria: (1) do not identify as a woman, (2) age < 18 years old, (3) has not earned a significant amount of income from exchanging sex for money or goods or has earned for < 3 months, (4) HIV-positive status or status is unknown or ineligible for PrEP, (5) planning to transfer care to another site within the next 30 days, (6) unable to speak English or ChiNyanja or IchiBemba and (7) not willing or able to provide written informed consent

In-depth interviews will be conducted with cohort members, as well as peer navigators. The inclusions and exclusion criteria for peer navigators is as follows:

Inclusion criteria: (1) age ≥ 18 years old, (2) history working as a peer health navigator, (3) history of providing HIV services to women engaging in sex work, (4) speaks English or ChiNyanja or IchiBemba and (5) willing and able to provide written informed consent.

Exclusion criteria: (1) age < 18 years, (2) does not have a history working as a peer health navigator, (3) does not have a history of providing HIV services to women engaging in sex work, (4) unable to speak English or ChiNyanja or IchiBemba and (5) not willing or able to provide written informed consent.

Quantitative data collection

A team of 3–5 trained research assistants will administer a tablet-based survey ( online supplemental file 1 ) for quicker data entry, real-time quality control and logic checks to reduce data entry errors and immediate data backup compared with paper. Surveys, estimated to take 60 min each, will be conducted in English, ChiNyanja or IchiBemba, based on participant preference. The survey tool will be piloted with CAB members and peer navigators. Patient medical records are routinely entered by KPIF programme staff into a secure, standardised electronic data capture system, from which we will extract relevant deidentified data using the participants’ SmartCare ID numbers.

Supplemental material

Qualitative data collection.

We will use a semi-structured interview guide ( online supplemental file 1 ) with open-ended questions and probes to explore specific themes related to HIV prevention and intersectional stigma. This guide allows some flexibility for participants to follow topics of interest to them. The themes we will explore are informed by the COM-B conceptual framework which include perceived and enacted stigma, the impact of intersectional stigmas on health service utilisation service needs, enablers such as psychosocial support or the trustworthiness of the healthcare system. The guide also includes modules on PrEP where the interviewer will explain oral and long-acting injectable PrEP and assess participants perceptions of the advantages and disadvantages and willingness to use these different PrEP options. Participants will be asked about their own perceptions as well as their perceived opinions of their peers, as this approach has yielded richer responses in previous studies. 39 Interviews are estimated to take 60 minutes and will be conducted in English, ChiNyanja, or IchiBemba in a private location at a community safe space or other similarly secure location determined by participant preference. We will request permission to audio record interviews for transcription and translation. All interviews will be conducted by a single trained interviewer. The interview guides will be piloted with CAB members before implementation.

Data management

SmartCare serves as a repository of clinical data for WESW accessing KPIF services. A secure server will be used to store encrypted study data, including the study database. Quantitative data collected on tablets will be transmitted to the server at the end of each day. To ensure data safety, there will be daily backups, and data will also be stored on secure drives.

All IDIs will be audio recorded. Audio recordings will be transcribed verbatim and then translated into English in a single step by qualified research staff. The audio recordings will not be marked with any identifying information. Instead, interviewers will use unique participant codes to label the audio recordings. No personal identifiers will be used, and any identifiers inadvertently mentioned during interviews will be purged from the transcripts prior to analysis.

All medical records that contain participant identities are treated as confidential in accordance with the Zambian Data Protection Act. All study documents related to the participants will only include an assigned participant code. Only research staff will have access to linkable information, which will be kept strictly confidential. All records will be archived in a secure storage facility for 3 years after the completion of the study per local regulatory guidelines, after which time all electronic data will be deleted from project servers and hard drives, and all paper-based records will be disposed of.

Quantitative data analysis

We will conduct univariable analyses to examine whether there are differences in the levels of stigma, discrimination, depressive symptoms and substance use disorders among those who initiate PrEP versus those who do not, stratified by community hub. We will report the prevalences of HIV and PrEP stigmas, discrimination due to intersectional stigma identified by the Everyday Discrimination scale, depression and suicidal ideation identified by PHQ, and substance use disorders identified by ASSIST. We will sum all items within a screener to a total score before collapsing data into categorical variables. For cases where missing data are more limited (approximately < 5%), for single items and measures, we will use mean imputation to derive a score. If there is substantial missingness (> 10%) then we will use missing data methods such as multiple imputation.

A PHQ-9 score ≥ 10 is commonly used in primary care settings as a cut-off for probable major depression. 40 PHQ-9 cut-off scores of 5, 10, 15 and 20 will be categorised as mild, moderate, moderately severe and severe depression, respectively. The ASSIST gives 10 risk scores for tobacco, alcohol, cannabis, cocaine, amphetamine-type stimulants, inhalants, sedatives, hallucinogens, opioids and other drugs. The score is higher the more frequently the participant reports using substances. For alcohol use, we will use cut-offs of 11 and 27 for moderate and high risk of substance use disorder. For all other substances cut-offs of 4, and 27 for moderate and high risk. 30

PrEP initiation will be calculated using the total number of individuals initiated on PrEP over the total number of HIV-negative individuals who were enrolled and eligible for PrEP. We refer to the complement of discontinuation as PrEP persistence. 41 We define immediate discontinuation for those who initiate a 30 day supply of PrEP and do not return for any refills over the 108 day observation period in alignment with national antiretroviral therapy (ART) programme guidelines on continuity of care and management of missed appointments. 21 42 We will calculate a medication possession ratio (MPR) of total days with medication in patient possession to the observation period, as a measure of engagement in services and report both the MPR and IQR ( table 1 ).

We will use Stata (V.16.1, StataCorp) for analysis, reporting descriptive statistics to characterise the study population and bivariate associations between key exposures and immediate discontinuation with Pearson’s χ 2 statistics. We will fit Poisson regression models, which will estimate prevalence ratios of discrimination, PrEP stigma and HIV stigma on immediate discontinuation of PrEP over a 3-month follow-up period, controlling for confounders identified by the DAG. Adjusted prevalence ratio estimates will be reported with 95% CIs and p-values at the alpha = 0.05 significance level.

Qualitative data analysis

We will analyse the qualitative data using established analytical software (NVivo, QSR International, Melbourne, Australia) through deductive reasoning based on our conceptual model and inductive reasoning to identify major and minor themes emerging from audio recordings and transcripts. The process of eliciting themes will involve familiarisation with interview transcripts and noting emergent themes, adapting our conceptual framework as necessary, performing open coding, developing a codebook, performing data reduction, data display using matrices and/or tables, and interpretation to map out relationships in the data. Two coders will review these data, independently identify emergent themes, and confer to agree on final coding and findings. We will apply established qualitative research principles in our analyses, including negative case analysis and respondent validation. 43 44

Participant attitudes and preferences relating to elements of future stigma-reduction intervention, psychosocial support provision and long-acting injectable PrEP will be described qualitatively. We will strive for critical reflexivity by outlining our point of view in relation to the interviewees of the study during data collection and will state how positionality and context may have affected the findings. The credibility and trustworthiness of qualitative data will be assured through member-checking by participants themselves. 45

Ethics and dissemination

WiSSPr was approved by the Institutional Review Boards of the University of Zambia (#3650 -2023) and University of North Carolina, the Zambia National Health Research Authority and the Lusaka Provincial and District Health Offices. A final study notification will be sent on completion of the study, or in the event of early termination. Participants are free to withdraw from the study at any time without affecting their right to medical care.

The study findings will be disseminated to KP community members, providers, researchers and policy-makers. The CAB will review preliminary results and advise on meaningful dissemination to the KP community, National AIDS Council, National HIV and Mental Health Technical Working Groups, investigators and stakeholders. The information will be presented at conferences or published in peer-reviewed journals. Participants’ personal information will not be included in any publications.

Patient and public involvement

We will use principles of community-based participatory research (CBPR) to ensure patient and public involvement in this study. CBPR is a research paradigm that focuses on relationships between academic and community partners, with principles of co-learning, mutual benefit and long-term commitment. 46 CBPR incorporates community theories, participation, and practices into the research efforts and plays a role in expanding the reach of implementation science to influence practice and policies for eliminating health disparities. 46 47

To collaboratively develop this study with clients and the public, we will use CBPR principles and create a CAB with Lusaka District Health Office and two KP-CSOs working in the study sites: Zambia Sex Workers Alliance and Tithandizeni Umoyo Network. As a study team, our first priority is to develop trust with people engaging in sex work. Trust development is a construct of CBPR and has also emerged as a synthesising theory. 48 49 Trust types are ordered along a relative continuum from least (trust deficit) to most (critical reflective) trust which reflects an ability to discuss and move on after a misstep. 48 Given the historical marginalisation and stigmatisation of WESW in Zambia, we anticipate a trust deficit and have allocated time and budget to nurture and develop trust along this continuum. We will build trust through ‘role-based trust’ as researchers, ‘proxy trust’ from the reputation of CIDRZ and KP CSO team members’ work with KPs in Zambia, and ultimately aim to establish ‘critical reflective’ trust.

The research questions and outcome measures were developed in collaboration with the CAB, ensuring they reflect the priorities, experiences and preferences of the sex worker community. Input from the CAB helped tailor the study to address the most pressing issues identified by the community. The study team will work with the CAB to adapt the study within complex systems of organisational and cultural context and knowledge. Collaborative decision-making will occur prior to the study launch, throughout the recruitment period, and during dissemination. The CAB will provide feedback on the potential burden of the intervention and the time required for participation, so that the study minimises inconvenience and respected participants’ time constraints. All partners will decide what it means to have a ‘collaborative, equitable partnership’ and how to make that happen. 50 The CAB will advise on which community hub to recruit from first, and how to work with community leaders to adapt study standard operating procedures to not disrupt service implementation at study sites. They will also advise on how to minimise potential risks to participants, including ways to reduce emotional distress and ensure physical safety. Participants experiencing emotional distress will be referred for psychosocial support with evidence-based mental health therapy specialised for those with depression and substance abuse, with the KPIF providing transportation and a peer navigator accompanying them to the facility providing these services. The CAB will be actively involved in planning the dissemination of study results to participants and the wider community, helping decide what information to share, the timing of the dissemination and the most appropriate formats for communicating the findings.

The WiSSPr study is significant as it addresses the limitations of HIV interventions that focus solely on HIV-related stigma, without considering co-occurring stigmas linked to other identities or conditions. This study will inform the design of PrEP service delivery programmes for WESW in Zambia and the region. Understanding stigmas and related psychosocial factors is crucial for developing effective, evidence-based stigma-reduction interventions for WESW in Africa. Our long-term goal is to optimise person-centred HIV prevention by implementing inclusive, affirming practices for individuals facing multiple barriers.

Strengths of this study include (1) a mixed-methods approach which grounds quantitative research in the lived experiences of people and measures aspects of stigma that emerge at the intersections of identities, (2) qualitative data from peer navigators capturing perspectives of women at the unique interface of being recipients of care as sex workers as well as direct supporters of health service delivery, and (3) incorporation of core principles of CBPR which value KP-CSOs as equal contributors to the knowledge production process.

Several methodological limitations are also inherent in the study. First, we are unable to longitudinally assess the alignment of PrEP adherence and persistence with HIV risk. We will be limited to measuring PrEP adherence by self-report and pharmacy dispensations instead of by biomarkers of tenofovir use. Secondly, recruitment might fall short at some sites, necessitating expansion to additional community outreach venues leveraging our network of KPs. Lastly, cohort studies may have bias, due to recall and social desirability bias of self-reported measures, and missing data.

Ethics statements

Patient consent for publication.

Not applicable.

Acknowledgments

The authors would like to acknowledge the infrastructure support provided by the Centre for Infectious Disease Research in Zambia (CIDRZ) and the Key Populations Investment Fund (KPIF) programme. The authors would also like to thank peer navigators and leaders in the sex work community for their assistance in developing the study approach and recruiting study participants.

• ↵ Global hiv & aids statistics — fact sheet . 2023 . Available : https://www.unaids.org/en/resources/fact-sheet
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MEH and MM are joint senior authors.

X @idlidosa2, @kenmugwanya, @webarrington

Contributors RK, DR, AS, MM, MH, KKM and WB conceived and designed the study. RK, DR, AS, MM, MH, JP, MZ, MP, RZ, GMK, LC, PMK, CM and BN created the interview guides and survey. All authors revised drafts and gave final approval for publication. MM is the guarantor of the study and accepts full responsibility for the finished work and the conduct of the study, had access to the data and controlled the decision to publish.

Funding The study is being supported by the NIH Fogarty Global Health Fellowship awarded by the NIH Fogarty International Center Grant #D43TW009340.

Competing interests None declared.

Patient and public involvement Patients and/or the public were involved in the design, or conduct, or reporting, or dissemination plans of this research. Refer to the Methods section for further details.

Provenance and peer review Not commissioned; externally peer reviewed.

Supplemental material This content has been supplied by the author(s). It has not been vetted by BMJ Publishing Group Limited (BMJ) and may not have been peer-reviewed. Any opinions or recommendations discussed are solely those of the author(s) and are not endorsed by BMJ. BMJ disclaims all liability and responsibility arising from any reliance placed on the content. Where the content includes any translated material, BMJ does not warrant the accuracy and reliability of the translations (including but not limited to local regulations, clinical guidelines, terminology, drug names and drug dosages), and is not responsible for any error and/or omissions arising from translation and adaptation or otherwise.

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Clinical Research Medical Advisor - Israel

About the role.

• Validates study designs, is accountable for, and makes the final decision on the clinical/medical trial and program feasibility of implementing a clinical trial protocol based on medical/clinical practice and analysis of the competitive environment in the country.
• Actively contributes to scientific/clinical/medical aspects of the start-up phase to ensure fast clinical trial site start-up.
• Provides clinical/medical expertise to clinical trial operations team members and clinical trial sites for Institutional Review Boards (IRB)/ Ethics Committee (EC) interactions.
• Decides on site/Country-specific scientific/clinical/medical content of the Informed Consent Form (ICF) as needed and ensures appropriateness of patient suitable language.
• Provides scientific/clinical/medical expertise during interactions with Country/Cluster external Experts (e.g., Regulatory Authorities, Medical Experts, Advisory Boards, Patient Advocacy Groups, etc.).
• Pro-actively identifying early on clinical challenges to recruitment or clinical data quality and drives development of clinical/medical mitigation plans.
• Building disease area expertise, especially for new/rare indications.
• To the clinical operations team in the country, especially to the Clinical Research Associates, and other country line functions as needed.
• Externally as needed in the Country/Cluster at Investigator’s Meetings or scientific venues to support recruitment and trial awareness.
• Leverages innovation in clinical trial planning and decides on clinical/medical recruitment strategy and implementation based upon physician interviews, analysis of competitive trials, and patient engagement.
• As the scientific/clinical/medical expert, supports and partners with internal Stakeholders (e.g., Clinical Trial Team, Regulatory Affairs, Medical Information, Medical Affairs, Marketing, Patient Access, HE&OR, clinical trial operations, etc.), and internal decision boards as needed regarding clinical trials.
• Gathers, informs, and acts on insights from clinical trial Investigators/site staff, Medical Experts, patients, and payers, with internal Stakeholders at the Country/Cluster level with the goal to optimize clinical trial implementation.
• Supports planning, implementation, and follow-up of scientific/clinical/medical components of Regulatory Authority inspections and internal audits.
• Reviews and resolves Country trial-related scientific/clinical/medical issues/questions. If necessary, initiates the discussion with the Global Clinical Development team.
• Provides clinical/medical expertise to support pharmacovigilance activities. 
• May be involved in reviewing the clinical/medical aspects of clinical trial Serious Adverse Events (SAEs) occurring in the Country and supports the patient safety team, and Global as needed to ensure high quality of clinical/medical information.
• Follows-up with the Investigator for additional clinical/medical information or clarifications for AEs and SAEs and provides clinical/medical expertise for safety amendments, Investigator Notifications (INs), Urgent Safety Measures (USM), etc. as needed.
• Supports the Global Clinical Development team as needed to address/clarify clinical/medical Protocol Deviations through follow-up with clinical trial sites.
• May support innovative study designs by identifying and conducting quality assessments of Country datasets (e.g., Registries, Electronic Health Records, Payer data, Real World Data, etc.).
• Drives all clinical/medical activities in adherence to GCP (Good Clinical Practices), and in line with ICH (International Conference on Harmonization) and Country regulations.
• Provides scientific/clinical/medical input to the overall Product strategy at the Country level with an optimized cross-functional Country team.
• May represent Clinical Development at internal and external meetings.
• Provides a superior customer experience for Investigators/site study teams, significantly impacting the external visibility and reputation of Novartis.
• Meets Country/Cluster specific clinical trial operations Key Performance Index (KPI) targets, particularly those related to trial feasibility and recruitment.
• Drives investigator site performance by providing high quality support to Investigators/Clinical trial site staff for Development and Biomedical Research studies, leading to a superior customer experience.
• Prepares high quality Country clinical trial documents according to agreed timelines especially for IRB/EC/Regulatory Authorities, and Investigator queries as needed.
• Timely management of local safety issues.
• Quality of scientific/clinical/medical input to Country, and Global teams.
• Scientific degree M.D., Ph.D., or Pharm.D. (M.D. highly desirable)
•  Subspecialty training desirable
• Speaks and writes English
• Speaks and writes Hebrew    

Experience:

• Ideally, 3 years of clinical development experience in the pharmaceutical industry or clinical practice.
• Sound understanding of the overall clinical development process, and ICH/GCP principles.

Protocol Execution:

• Demonstrates a knowledge of how to adequately review and read a protocol to understand specifics of study design and answer questions regarding the trial.
• Applies a detailed understanding of the drug in question to provide medical context as it relates to disease processes, populations, and standards of care.
• Ability to assess the feasibility of implementing the protocol based on Country/Cluster medical practice and sound understanding of the overall Clinical Development Plan.
• Demonstrates a high level of understanding of the protocol to train others, including site personnel.
• Demonstrates an understanding of the protocol to evaluate compliance on the part of the Investigator/site staff/study participant and any patient safety issues.

Regulatory & Compliance:

• Demonstrates an understanding of Regulatory requirements and internal policies, procedures, and guidelines pertaining to clinical trials.
• Applies knowledge of Regulatory/industry requirements to work in a Country regulated environment.
• Demonstrates current knowledge of relevant Country regulations and compliance requirements and communicates to Global teams as required.
• Demonstrates knowledge of applicable SOPs, policies, procedures, and guidance documents.
• Expertise to represent the company as safety expert for clinical trials to external Regulatory and compliance bodies such as Regulatory Authorities, Health Boards, and REB/EC.

Safety Monitoring:

• Provides clinical, medical, and scientific expertise to facilitate the safe use of product(s) in clinical trials.
• Applies safety expertise to answer clinical trial site safety questions and provides required information to Country/Global where appropriate.
• Applies clinical/medical expertise to provide prompt review and follow-up on all SAEs and other safety documents relevant for clinical trial sites.

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