https://orcid.org/0000-0002-1529-916X
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Abstract
Institutional review boards, tasked with facilitating ethical research, are often pulled in competing directions. In what we call the protection-inclusion dilemma, we acknowledge the tensions IRBs face in aiming to both protect potential research participants from harm and include under-represented populations in research. In this manuscript, we examine the history of protectionism that has dominated research ethics oversight in the United States, as well as two responses to such protectionism: inclusion initiatives and critiques of the term vulnerability. We look at what we know about IRB decision-making in relation to protecting and including “vulnerable” groups in research and examine the lack of regulatory guidance related to this dilemma, which encourages protection over inclusion within IRB practice. Finally, we offer recommendations related to how IRBs might strike a better balance between inclusion and protection in research ethics oversight.
Notes
1 It is worth noting that these initiatives, part of what Stephen Epstein has described as the inclusion-and-difference paradigm, are not without their shortcomings and their critics (Epstein Citation2008). Such inclusion efforts often rely on categories of difference that are far from clear cut, built up from historical and social processes that fail to carve nature at its joints, and so may not always be the most effective for medical research. We do not take up the question of whether these inclusion efforts rest on appropriate categories here; see (Spencer Citation2018) and (TallBear Citation2013) for some interesting discussions of the topic.
2 Concerns related to the exclusion of pregnant people from clinical trials persist; for a recent example, see (Shimabukuro et al. Citation2021).
3 It is important to acknowledge that we do not have any empirical data on whether and how often the IRB community acknowledges or seeks to address this dilemma.
4 It’s worth noting that restrictions on prison research imposed by the Common Rule were heavily criticized at the time they were implemented, in part because they only applied to federally funded research and allowed other biomedical research in prisons to continue without regulation (McDermott Citation2013). In response, the Institute of Medicine (now the National Academy of Medicine) formed a committee to evaluate the Subpart C of the common rule which pertained to research in prison, which led to the publication of a report in 2006 entitled “Ethical Considerations for Research Involving Prisoners”, which outlined five recommendations related to the conduct and oversight of research involving prisoners (Pope, Vanchieri, and Gostin Citation2007).
5 For a recent review of exclusions related to English language see (Muthukumar, Morrell, and Bierer Citation2021).
6 This is a significant shift from the 1980s and 1990s, in which, according to Richard Klein, the HIV/AIDS program director in the FDA’s Office of Special Health Issues, there was “an awful lot of resistance” from IRB members to early initiatives related to inclusion (quoted in (Epstein Citation2008, 65)). As Epstein writes, this may have been because IRBs had recently come into being and their development was justified by their role in protecting vulnerable subjects.
7 While we primarily focus on the Common Rule here, we acknowledge that FDA regulations are also an important part of the regulatory infrastructure in the U.S. Much of our critique can be extended to those regulations as well.
8 For comparison, the earlier version of the Common Rule read “When some or all of the subjects are likely to be vulnerable to coercion or undue influence, such as children, prisoners, pregnant women, mentally disabled persons, or economically or educationally disadvantaged persons, additional safeguards have been included in the study to protect the rights and welfare of these subjects” (US Department of Health and Human Services Citation2014).
9 A recent charge to SACHRP (the Secretary’s Advisory Committee on Human Research Protections) asked them to investigate this particular regulatory gap, asking “What measures constitute adequate safeguards in these circumstances, and how should their adequacy be assessed? Should the requirement for such safeguards be limited to those "vulnerable to coercion or undue influence” (i.e., populations with diminished autonomy), or are there concerns of social justice that should lead to a more expansive interpretation of vulnerability to exploitation?” (Office for Human Research Protections Citation2021).
10 When discussing the Common Rule, we follow its language, which uses the term ‘pregnant women’ as opposed to the more inclusive ‘pregnant people’.
11 An important exception to this generalization is with regard to research that can be stigmatizing to a particular community, such as what occurred in the Havasupai case (Reardon and TallBear Citation2012).