My career in research ethics and compliance led me to develop a strong interest in the protection of participants from abuse in research. I can appreciate the challenges IRBs face in that regard. Also, as a researcher, I know how challenging maintaining scientific integrity in research can be. We must delimit our research. In so doing, however, sometimes we miss the bigger picture – that is, the whole person of research subjects. As a result, we often fail to engage in the greater discussion. Engaging in the greater discussion about multifaceted challenges in research ethics and compliance often leads me to reflect on deeper questions. 

One such burning question is whether the product of human research is social goods. Or is it a commodity? Some have argued that it is social goods. If so, then is there a social obligation to ensure equal access to all to those goods? Another burning question is: Why do racial and ethnic minorities continue to be underrepresented in clinical trials? We know that they bear a disproportionate burden for certain diseases. And now, findings from recent research put into question the long-held notion that racial minorities in the U.S. are unwilling to participate in research due to mistrust. Rather, it appears that they are often not even asked to participate. This might help explain the paucity of their participation. 

Considering the devastating effects of COVID-19 on racial minorities, the research world now feels compelled to re-examine various stakeholders’ role in addressing health inequities in American society. But was COVID-19 the catalyst that propelled the realization that poor health outcomes are directly linked to social determinants such as race, ethnicity, and limited-English proficiency? I argue that it did not, for those facts were known before COVID-19. I also argue that COVID-19 did not suddenly create an awareness of the profound negative impacts health inequities have on racial minorities. We knew those facts as well. Rather, COVID-19 exposed a shameful reality in American society – that is, racism leads to poor health outcomes, which may include death. The better question to ask is: What have we done or not about this problem? Also, what role has long-held neglect and inaction played in creating structurally vulnerable populations based on social hierarchies in the U.S.? 

Given the disproportionate – yet preventable – loss of lives from COVID-19 among racial minorities, justice in research should no longer be a pie-in-the-sky goal. Ensuring equity in access to clinical research among racial minorities is an urgent imperative! 

By regulation, IRBs are to protect the rights and welfare of research subjects. Much too often, however, IRBs do not pay attention to social injustices in research as they are not mandated to do so. There is now, however, an emergent idea among stakeholders that centers around the critical role IRBs could play in improving public health by ensuring diversity in clinical trials. 

But how can IRBs engage communities while operating within the boundaries of their current regulatory role? Do IRBs have an ethical obligation to be proactive in ensuring diversity in clinical trials? Indeed, IRBs are uniquely positioned to influence research practices toward an equitable and more inclusive research world. Perhaps, the FDA and HHS should consider revisiting the scope of responsibilities of IRBs to provide broader latitude for making a greater impact on public health.

The questions in this blog are the types of engaging thoughts I plan to discuss during the 2022 PRIM&R Annual Conference. I am most grateful that PRIM&R is providing a forum to discuss these important thoughts and expect more ideas will be generated as we continue the journey of straightening the path towards health equity for all.

Renée Pierre-Louis, Ph.D., MBA, MA, CIP, CHRC, ACRP-CP leads the Division of Human Subjects Research & Academic Affairs Compliance at Nuvance Health and oversees IRB compliance. She also serves as Human Protections Administrator. Before that, Dr. Pierre-Louis served as research faculty and led operations and compliance in all investigator-initiated research and IRB submission and communication processes at Stamford Health. Before that, she served in various leadership roles in the pharmaceutical and medical device industries. She advised executive leaders and oversaw the implementation of strategies in the lifecycle management of drugs. She has 20 years of combined experience in legal operations and ethics and compliance.

Dr. Pierre-Louis’s accomplishments include playing a key role in establishing a Global Ethics & Compliance Clearinghouse for Boehringer Ingelheim Pharmaceuticals in Germany. She has extensive knowledge of the U.S. ethical and regulatory framework and international standards that govern human research. 

Dr. Pierre-Louis is also a health researcher by education and experience. Her research interests include research ethics, health economics and outcomes research, health equity, healthcare delivery systems’ structure, and health policy. She serves as a reviewer for peer-reviewed scientific journals. She earned her Ph.D. in Health Sciences from Seton Hall University, School of Health and Medical Sciences, where she completed a one-year post-doctoral training. 

Dr. Pierre-Louis has presented at national conferences on research ethics and compliance. Recently, she presented on the “Use of Data from Non-Traditional Sources to Conduct Human Research: Emerging Ethical and Compliance Considerations” at the Health Care Compliance Association’s 2022 Research Compliance Conference.