by Nicolle K. Strand, JD, MBioethics, and Nora Jones, PhD
The article and commentaries on recent revisions to the Common Rule published in the July 2017 issue of AJOB are missing, we believe, a key perspective. The target articles and open peer commentaries suggested strategies for revising or overhauling the Common Rule to best address subject protections in light of the new and unique features of our contemporary research landscape, including the move from prospective research to research using existing data and biospecimens, personalized medicine, the increase in international collaboration, and the uptick in data sharing across institutions. Suggestions included encouraging federal regulators to revisit the regulations more often and bringing more stakeholders to the regulatory conversations.
Both of these suggestions are valid and well-reasoned ways of dealing with the ever-expanding complexities of contemporary research. However, we urge our fellow bioethicists to consider that continuing to change the Common Rule in accordance with mainstream bioethics principles is necessary but not sufficient. We would like to propose a more comprehensive revision of the ethical principles and guideposts that undergird the Common Rule. Thanks to the creation of formal ethical guidelines following the research atrocities of Nazi Germany and the US Public Health Service in Tuskegee, research is more ethical now than in past decades. However, left out of the research ethics toolbox that regulators have used to write and revise the Common Rule and that IRBs use to guide or evaluate research are any tools useful for addressing the ethical problem of the quotidian and seemingly insurmountable injustices of health inequity. It is clear that while current regulations help ensure ethical behavior in individual research protocols, they do nothing to address what we argue is normatively and empirically the biggest problem in health today—systemic health inequity.
There are many sources of health inequities—from being geographically isolated from health care facilities to living in dense and disparate cities characterized by systemic institutional racism. In the July 2017 issue of AJOB, we noted no mention of the ethical issues that arise when doing research in settings characterized by extreme health inequities. In the collection of articles, we were unable to find any references to “equity,” or “social determinants of health” and only two references to “health disparities” (specifically addressing prisoners and American Indians only).
When research is done with populations who have complex, interwoven, negative social determinants of health, and in largely minority urban populations with a history of abuse and mistreatment by the medical and research communities, that work requires an additional set of ethical tools, specifically: comprehensive community input and attention to historical and sociocultural context. However, the regulations and the traditional toolbox of bioethics principles do not require us to examine these features of the research population in the larger context. Considering the negative social determinants of health and sociocultural context of the patient population from which research participants are drawn does not generally fall under the purview of an IRB. The current Common Rule, and most mainstream bioethical principles, do not require us to consider the unique circumstances and vulnerabilities of communities that are not regulated in Subparts B through D.
For example, the new Common Rule requires that IRBs employ a “reasonable person” standard to determine what information should be included in informed consent. An AJOB commentary about the new standard suggested that extensive IRB training will be required to implement it consistently and sensitively across all contexts. We agree, but suggest that it is not entirely feasible to extrapolate a reasonable person in one context to another, and we urge IRBs applying this standard not only to conduct training on the local and sociocultural context of the research population, but to include members of the community as key facilitators of that training. Implementing a reasonable person standard is not sufficient to address the ethical concerns that arise as a direct result of health disparities, and social and cultural factors. The reasonable person standard will not work in many dense, racially diverse communities if the standard continues to be defined without input from populations in that cultural context.
There is no legal incentive to consider the particular vulnerabilities, and craft corresponding protections, for a diverse population outside of the populations covered in Subparts B through D. As a result, the regulations and traditional bioethical principles fail potential research participants, especially those who have complex sets of negative social determinants of health. Part of the promise offered by the new research landscape, including personalized medicine and work with biospecimens, includes the potential to mitigate health inequity—but we must make that a priority. Research ethics regulations are a staple bioethics guidepost. Our concern is that there are other roads, other ethical imperatives, that should also serve to guide us.
Limited health literacy, low income, lack of access to transportation, unsafe neighborhoods, and other factors related to culture, socioeconomic status, gender, and race, impact how potential research participants make decisions about research. These factors impact how well people comprehend informed consent, how much compensation and incentives impact their decision to participate, and other key decisions that are at the crux of what the regulations are meant to address. Based on our collective experience serving on IRBs for close to a decade, if regulations and research ethics fail to directly address the unique vulnerabilities and inequities of the populations they intend to study, investigators and IRBs are unlikely to consider them. In rethinking the Belmont Report and revising the Common Rule, bioethicists and regulators must take into account sociocultural context of research communities. The current formulation does not require us to do so.