Research ethics committees: A forum where scientists, editors, and policymakers can cooperate during pandemics.

During public health pandemics such as COVID-19, cooperative behaviors among scientists, journal editors, policy makers and research ethics committees, are essential to promote scientific integrity and societal trust in translational research and resultant public health decisions. This cooperation is possible by expanding the current way of working to include stakeholders beyond the research team via community events and special communication channels sponsored by research ethics committees. Research ethics committees with wider communication channels, increased transparency, and enhanced knowledge exchange have the potential to improve research design, performance, dissemination, and ultimately public benefit.

During the Coronavirus Disease 2019 (COVID-19) pandemic, a fast-track peer review of COVID-19 papers submitted to journals has replaced the traditional, more time-consuming peer review process, causing concern among stakeholders in scholarly publishing.[1] However, “quick publishing”[2] is a pandemic-related phenomenon that may produce low-quality literature and, subsequently, more retractions.[3] Sometimes, even retracted articles continue to be repeatedly cited by sloppy scholars. Additionally, predatory journals and researchers can leverage the pandemic as a tool to propel their own goals.[4] Predatory journals were a troublesome presence long-before the emergence of COVID-19; however, the fast pace and competitive pandemic research setting is a ripe arena making researchers an easy target by these unscrupulous journals that provide little or no peer review, rapid publishing, and open access.[5] COVID-19 is one of the biggest public health challenges the world has confronted, and rapid, high-quality research plays a key role in the fight against the virus. Identifying categories of people that should be prioritized for COVID-19 vaccination (including boosters), as well as lockdown and physical distancing policies, are examples of how decision-making relies on scientific findings.[6,7] When scientists and policymakers have different attitudes and goals, this can hamper collaboration;[8] however, by working together during pandemics such as COVID-19, scientific findings can be translated into beneficial policies and procedures for the health of society.

Worldwide, the role of research ethics committees (also known as institutional review boards) has been to review and approve human research proposals to ensure novel research questions, robust study design, and the protection of research participant safety and welfare. Committee structure is generally a mix of lay volunteers and professional scientists, sometimes with subspecialty committees (e.g. social science, medical). Ideally, research ethics committees should have a multidisciplinary membership that reaches beyond the science, and also includes ethicists and patients concerned with the contextual aspects of research that impact methodology, data privacy, and the application of the research across populations.[9] The Chair at the helm of these committees is expected to guide the review process to ensure timely and constructive feedback to researchers so that their research protocols are optimized before receiving approval for study launch.

To do their job effectively, research ethics committees need to understand the research they are reviewing. Part of achieving this is by way of assigning protocol reviews to topic specialists within the committee, as well as the use of external expert reviewers as needed. Additionally, the committees can receive input from the Principal Investigator directly, answering queries and providing clarifications. We propose that the input mechanism to research ethics committees be widened for additional purposes related to understanding research proposals, as well as stakeholder opinions, and community impact. If publishers interface with research ethics committees, they can potentially develop better understandings of jurisdictional approval/exemption requirements, thereby avoiding publication delays due to incorrect assumptions or lack of awareness. If policy makers interface with research ethics committees, they can potentially develop an understanding of research risks and benefits across communities—something that is especially important if their community is facing a public health threat and they are vulnerable (e.g. socioeconomically disadvantaged, special cultural values).

While there is a time for closed [private] sessions, research ethics committees should be open to dialog with all research stakeholders (not only scientists) to gain a fuller understanding of research applications and implications, risks and benefits, and strategies for risk mitigation, as well as optimized delivery of the research review process so as to ensure a timely study launch (reducing study delays). This view is consistent with that of the World Health Organization which states, “For a [committee] decision to be ethically legitimate, it must be made in an open and inclusive process that takes into account the views of all stakeholders. Thus, research ethics committees should be encouraged to include individuals from diverse professional and social backgrounds and, where appropriate, to solicit input proactively from the community.”[9]

Johns Hopkins Medicine Institutional Review Board (a research ethics committee in USA) provides an annual Community Day during which the public is invited to dialog with them about research ethics, research protections, and the research review process.[10] Events like these are important because research ethics committees and research participants (patients/community members) can have differing views regarding priorities.[11] Also, community-based participatory research will benefit from direct interaction with research ethics committees because research has shown that often these committees are not prepared for this type of research with these key stakeholders who are in fact helping shape the research question, recruit participants, collect study data, and disseminate the study results back to their community.[12] Committee events such as these could also provide a mechanism for transparent mediation of power struggles between research stakeholders. Ideally, these external research ethics committee events should be more frequent than annual, especially during public health crises when the public is participating in vaccine and treatment clinical trials, and the pharmaceutical industry has a duality of priorities (i.e. producing safe and effective product and making profit for shareholders). Community Days and other stakeholder events can be held in virtual formats using teleconferencing technology when public health crises demand physical distancing.

In Iran, three main working groups have been set up to manage COVID-19 research, including (1) research on epidemiology and public health, (2) clinical research, and (3) basic science and virology research.[13] These committees are having an additional role in research monitoring, not just protocol review. Monitoring is usually a function performed by the research sponsor, but in this instance, the committees are potentially having additional impact in research quality by checking the conduct of research themselves. In the context of COVID-19 and vaccine research, decisions to pause or abort studies or pause distribution of emergency-authorized vaccines can have profound research and clinical implications.[14]

Research ethics committees and associated data safety monitoring boards are the canaries in the mines who should be audible voices not bullied by sponsors or governments. Their advocacy for science and public safety as well as research integrity means viewing them in the research co-working space, as well as the regulatory/governance space. This lens shift allows for a change in tone in the research workplace, creating a culture which is more conducive to stakeholder collaboration and shared decision-making (rather than bullying). While various governance boards will ultimately render decisions, a shared decision-making approach from the lens of collaboration and co-working potentially fosters data sharing and dialog for public health benefit.

In situations of alleged research misconduct, research ethics committees should collaborate with journal editors and publishers to ensure that the investigative process is not delayed. Timely evidence sharing in tandem with fair and expert investigations will promote prompt retraction of research which has ethical and/or scientific misconduct, limiting its use and reuse. During these situations, it is vital that research ethics committee members are free from external pressures and are able to dialog without intimidation or conflict from research stakeholders. In the end, research outputs should be trusted scientific evidence for use by government policymakers, and health officers in their pursuit of public health and safety.[8]

The time burdens and administrative strain of research ethics committees are well-known, thus the idea of more tasks may not be embraced. Widening the research ethics committee's current work area might at first seem burdensome, but with efficient planning and organization of events and communication channels, the broader benefits could prove worthwhile. It would be interesting to pilot an “enhanced” research ethics committee offering service lines for editors, community, and policy-makers.

In conclusion, cooperation between scientists, editors and policymakers is essential to promote the scientific integrity of COVID-19 research and public trust. Working together does not erode stakeholder autonomy, rather it gives the autonomy of each a voice which needs to be heard, especially during the urgency of a pandemic. Research ethics committees need freedom to perform their tasks without pressure from researchers, politicians, policymakers, and funders. In the setting of a pandemic, there are many stakeholders, scientific unknowns, and time pressure. With a multiplicity of competing interests, the setting can easily be a ‘boxing ring’ of personalities and agendas; however, a collaborative forum for perspectives, debate, and ethically-driven solutions is possible. This shifts the sometimes impression of research ethics committees as a scientific bottleneck[15] to a cooperative working space.[13] Research ethics committees evolve from gatekeepers, to also a forum where all stakeholders come together to speak up for the benefit of science and society.