The Role of IRBs in Research Oversight: Information for Potential Participants in Clinical Research

Medical mistrust has a substantial impact on the availability of care, representation in research, and subsequent generalizability of research results. In other words, the mistrust that drives BIPOC away from research also renders research results that may not be accessible or appropriate to BIPOC, further widening physical and mental health disparities. Unfortunately, this medical mistrust has become more evident in the wake of the COVID-19 pandemic. For example, BIPOC have exhibited higher rates of vaccine refusal, citing medical mistrust as a primary source of their reluctance.³

Medical mistrust stems from systemic racism in the healthcare system and has resulted in the mistreatment of BIPOC. Underrepresented communities, including BIPOC, have been underserved by the healthcare system throughout the pandemic, facing higher rates of morbidity and mortality. These disparities are not limited to the impact of COVID-19. BIPOC also see higher rates of maternal and infant mortality⁴ in the US when compared to white individuals. They are more likely to receive a late-stage cancer diagnosis with poorer outcomes. They are also more likely to suffer the effects of hypertension, type 2 diabetes, depression and other mental illnesses, as well as heart disease, when compared to their white counterparts.

These significant health disparities are often attributed to social determinants of health, access to healthcare, comorbidities and other factors. However, the lack of inclusion of minority communities in research impedes our understanding of both the contributors and the clinical and policy-based solutions to these disparities. This lack of representation of minority communities in research is often traced to mistrust resulting from the Tuskegee Syphilis Study. The Tuskegee Syphilis Study, launched in 1932 and continued for 40 years, focused on observing and recording the long-term harm of chronic, untreated syphilis in Black men. The study recruited participants under the guise of “free medical care.” Unfortunately, the real objectives of this study were withheld. Participants were observed, and underwent painful procedures such as spinal taps to collect data, as their health continued to decline. When effective antibiotics for syphilis became available in the 1940’s, treatment was withheld from the subjects to continue to observe the progression of their disease. Unethical conduct of this nature has a ripple effect, contributing to generational medical mistrust that extends to the clinical trial setting, influencing participant representation. Historical atrocities involving research created a greater need for research protections for participants and has led to a better system of oversight.

The challenge of making under-represented communities more willing to consider research participation is complex, involving decades of systemic racism that has contributed to under-representation in medical research. Further complicating the clinical research setting, healthcare professions are statistically less likely to speak with BIPOC patients about participating in research.⁵ Healthcare providers and clinical researchers that focus on serving BIPOC and other underserved populations have less access to research funding and resources,⁶ and the lack of representation of BIPOC in the healthcare professional setting has made facilitating change difficult.⁷ In acknowledging all these barriers to diverse participation in research, it is important to understand the role of the IRB in human research oversight.

Part 1: Purpose

Today, clinical research is tightly regulated through the collaboration of multiple parties. These regulatory and organizational bodies work together to enforce a series of checks and balances, overseeing the rights, and welfare of research participants. While the IRB cannot ensure a participant’s safety in a clinical trial, its oversight provides a safeguard for participants who decide to participate in human research. The IRB serves a critical role in maintaining participant safety and welfare by conducting an independent review of the research. In clinical studies, researchers and sponsors can be limited by their own professional objectives and personal perspectives. While they may have the best interests of the participants at heart, the personal and professional aims they bring into the research setting may influence decision making and research conduct in a manner that impacts participant safety and welfare.

The independent review of clinical research by an IRB supports social and ethical accountability, assessing whether the risks involved in the research are reasonable for participants and ensuring the research is being conducted in a manner that will generate generalizable knowledge. Further, independent review effectively mitigates the impact this bias may have. Potential research participants should feel confident that these elements and other factors related to their safety and welfare have received careful evaluation during the independent review process implemented by the IRB and reach out to the IRB if they have further questions.

Part 2: Structure

These safeguards are echoed through the IRB’s purpose, as well as in its requirements for membership and research review. IRBs are structured to support representation of professionals and members of the community with different expertise and experiences that allow the group to consider each study under review.

The regulations require at least five members with varying backgrounds and diversity. The current regulations specifically require that the IRB consider having members on the Board that represent different races, ethnicities, genders, cultural backgrounds, as well as having members of the Board who are sensitive to issues such as community attitudes in an effort to promote respect for its advice and counsel in safeguarding the rights and welfare of human research participants.⁹

Additionally, each IRB must have at least one member whose primary concerns are in scientific areas, and at least one member whose primary concerns are in nonscientific areas.¹⁰ To maintain impartiality, the regulations also require at least one member who is not affiliated with the institution.¹¹ The regulations prohibit those who have conflicts of interest from voting or participating in initial or continuing review of any project.¹²

Conclusion

Representation of diverse groups in clinical research is critical to improving health outcomes for individuals and communities. IRBs make up one part of a dynamic review process, designed to protect the rights and well-being of research participants.

Understanding the system that is in place for the oversight of clinical research studies, and the roles of the different people and committees that are part of the research oversight system, may help to answer questions and to make people more comfortable with the idea of research participation, which can help move toward the goal of diversity and equitable representation in human participant research. Learn more about WCG’s IRB services today.