By Eric Krebs, J.D. candidate, Harvard Law School
Federal regulations impose additional requirements and restrictions on any Institutional Review Board-approved research that involves incarcerated individuals as subjects. These rules are designed to protect prisoners, a population which has too-often throughout history been taken advantage of by researchers. But how do Subpart C’s extra protections work—and do they even make sense?
This week, veteran Proof over Precedent guest Shannon Sewards, director of the Human Research Protection Program at Dartmouth Health and former IRB director at Harvard University, joined host Jim Greiner to discuss the puzzling construction of the federal regulations governing research involving incarcerated individuals.
45 C.F.R. Part 46, Subpart C is the portion of the federal human-subjects regulations that imposes “additional protections” for prisoners . These provisions sit alongside similar subparts for children and pregnant women, reflecting a shared concern: certain populations are especially vulnerable to coercion, exploitation, or undue influence in research settings. Prisoners, in particular, occupy a uniquely constrained environment, where ordinary ideas about consent and choice can break down.
Prison populations were once a convenient pool for drug trials and behavioral experiments precisely because they were captive, traceable, and lacked bargaining power. Subpart C responds to that history by layering extra safeguards on top of the baseline “Common Rule” requirements.
One of the most distinctive safeguards is structural: IRBs reviewing prisoner research must include a prisoner representative, someone able to speak to the lived realities of incarceration. As Sewards explains, these representatives are often lawyers, advocates, or formerly incarcerated individuals, and they play a crucial role in grounding abstract risk-benefit analyses in real institutional conditions.
The regulations also tightly constrain what kinds of research are allowed. Federally funded studies involving prisoners must fall into one of four narrow categories—such as research on the causes or effects of incarceration, or studies of prisons as institutions—and many categories are limited to “minimal risk and no more than inconvenience to the subjects.”
“Minimal risk” is a familiar concept in IRB practice, but Subpart C complicates things. Risk is measured against what is ordinarily encountered by healthy persons in daily life, not by what is routine inside a prison. That framing matters. Prison life is already risky and restrictive, but the regulations refuse to normalize those conditions for research purposes. The result is a paradox. Research that might appear trivial relative to the realities of incarceration can still exceed “minimal risk” when judged against the free world.
That tension surfaces repeatedly in the episode, especially when the discussion turns to social-science interventions rather than drugs or devices. “For example, there was a research study that wanted to look at whether providing better quality bedding improved sleep…and it was just wrought with issues,” Sewards counted. “How does the individual weigh the risk or benefit along with that? Are you going to end up in a knife fight in the yard because you got the better bed and [someone else] didn’t?”
One particularly confusing element of Subpart C is its suspicion of incentives. IRBs must ensure that compensation or benefits are not so attractive that they impair a prisoner’s ability to weigh risks rationally. In theory, this protects voluntariness. In practice, it can create odd outcomes.As Greiner notes, compensating prisoners at the same rates used for non-incarcerated participants can look coercive simply because prison wages are so low. A $50 interview payment—routine outside—can dwarf what a prisoner earns in weeks. Yet denying that payment also deprives incarcerated people of opportunities routinely available to everyone else. “The idea is that if the compensation is too good, it seems that in some sense you’re taking away choice, but it also seems like not allowing people to get too good of a deal also takes away their choice,” says Greiner.
This dilemma is not accidental; it reflects the regulations’ dual, and sometimes conflicting, aims: preventing exploitation while also trying to equalize treatment between prisoners and non-prisoners. Subpart C often pulls in both directions at once.
The sharpest tensions arise when Subpart C meets contemporary social and behavioral research, especially studies designed to reduce incarceration or improve reentry outcomes. One requirement states that research risks must be “commensurate with risks accepted by non-prisoner volunteers.” That standard makes sense for biomedical trials. It makes far less sense for interventions that only prisoners can experience—such as programs that shorten sentences, improve parole outcomes, or restructure conditions of confinement.
“If we’re investigating, as we often are in law and in economics and in criminology, remedies that are designed to remove people from incarceration, and we’re going to let them out, it’s difficult—I would say in-part impossible—to see how you could measure the risks of a study like that to non-prisoners,” says Greiner. “In other words, how do you let somebody out who isn’t in?”
Similarly, the rules require assurances that parole boards will not consider research participation in parole decisions. But what if the research itself is meant to improve employability, rehabilitation, or reentry prospects—precisely the factors parole boards care about? As Sewards acknowledges, the regulations were not written with these scenarios in mind.
Moreover, even defining who counts as a “prisoner” can be difficult. Subpart C includes not only sentenced individuals but also people detained pretrial, pending arraignment, or awaiting sentencing. Civil detainees, people in halfway houses, and those under probation or supervision occupy gray zones that different IRBs interpret differently. Because the federal rules offer limited guidance, institutions often “operationalize” their own definitions, reinforcing the importance of early consultation with IRBs. As both Sewards and Greiner emphasize, engaging the IRB at the design stage can mean the difference between a viable study and one derailed by late-discovered constraints.
Static rules written for mid-20th-century biomedical abuses now regulate 21st-century experiments in social policy, criminal justice, and public health. As Greiner and Sewards suggest, reconsideration of these rules may be overdue. Until then, researchers and IRBs alike are left navigating a regime where compliance is sometimes less a matter of ethics than of impossibility.
If you’re interested in more on this topic, listen to our Proof Over Precedent podcast episode.