(Some of) The Trouble with IRB

I’m working on a research project with one of my favorite people, Jennifer Vinopal, and we had to go through the U.S. Institutional Review Board (IRB) process. (Commence collective groan.)

The IRB process is required for human subject research and involves having your proposed study reviewed by a select group from your institution for any potential ethical issues. It can be a very long, painful, drawn-out process, and there’s plenty of critique out there that it often does not serve its purpose to ensure the ethicality of human subject research (Heimer & Petty, 2010). (That last article is paywalled, sorry. ILL at your library or contact me directly for a copy.)

Aside from the personal annoyance of having to deal with IRB—which really wasn’t that bad for me because Jennifer is incredible and took the lead on that part of our work, plus our study was exempt—as I’ve learned more about IRB standards in general, I’ve come across some serious issues.

IRB standards in the U.S. are based on federal regulations issued by the U.S. Department of Health and Human Resources. They lay out the types of research requiring IRB approval and the standards by which that research should be judged for its ethicality. Part of those regulations involves identifying population groups that are particularly vulnerable and require heightened standards for research conducted among them. There are three. Just three. (See a problem already?)

  1. Pregnant women and their fetuses (Subpart B)
  2. Prisoners (Subpart C)
  3. Children (Subpart D)

Now right off the bat, this list is far from adequate. I can come up with several more categories that should be on this list: people who are homeless; members of an immigrant population, particularly if undocumented; sex workers; people with physical or mental disabilities that render them incapable of conveying meaningful consent; and on and on. But those three are the only ones.


“Prison doors” by rytc via Flickr, CC BY-NC-ND 2.0

As if the dearth of categories isn’t enough, there are also problems with the so-called extra protections afforded these categories of people. In particular, I was troubled by what I learned about the requirements for research among prisoner populations.

First off, prisoners only include people who are confined to an institution by court order. Obviously, people in prison but also people on house arrest or in court-mandated rehabilitation or psychiatric wards. However, it does NOT include parolees, even though they are subject to court-ordered monitoring and are susceptible to some of the same vulnerabilities as the currently incarcerated.

Imagine if the director of the halfway house invites a researcher to come in and interview residents for a research project. Even if there’s no overt coercion at play, what might a recently paroled resident think about refusing to participate in the study? This person is already struggling to reenter society, get a job, find a permanent place to live—would it pay to potentially piss off a highly educated researcher or the director of the housing facility? What if word gets back to the parole officer? Will there be repercussions there?

Another issue I found lies in the required composition of IRBs reviewing prisoner research. IRBs in general are required to have at least five members. For boards reviewing prisoner research, only one of those members needs to be a prisoner, former prisoner, or someone who can advocate for the prisoners’ rights (such as a prison chaplain, social worker, or other such representative, thankfully excluding wardens, guards, and the like). One of at least five. Only one.

Can you imagine being an ex-con, sitting in a room with a bunch of scholar-types, discussing why it is NOT okay to conduct research on your former fellow inmates? Better yet, can you imagine being a current prisoner, in your orange jumpsuit or whatnot, sitting in a room with a bunch of free and highly educated researchers, discussing why it would not be a good idea to conduct research on you and your fellow inmates?

Talk about power differential. Meaningless agency is no agency at all.

It terrifies me that this is the type of bureaucracy passing as “safeguards” for the interests of vulnerable populations. And when you consider that 60% of male prison inmates are black or Hispanic and that black females are as much as 4x more likely to be imprisoned than white females (U.S. Dept. of Justice, 2015), you can see how this lack of protection and agency can cut across other lines of oppression.

For IRBs to be meaningful, they have to involve more than just an annoying bureaucratic step in the research process. This isn’t just about preventing overt forms of exploitation like the Tuskegee syphilis study; there are also more subtle forms of oppression and exploitation at play.



Heimer, C. A., & Petty, J. (2010). “Bureaucratic ethics: IRBs and the legal regulation of human subject research.” Annual Review of Law and Social Science 6, 601-26.

Tuskegee University (n.d.). “About the USPHS syphilis study.” Retrieved from http://www.tuskegee.edu/about_us/centers_of_excellence/bioethics_center/about_the_usphs_syphilis_study.aspx.

U.S. Dept. of Health & Human Services (2010). “Protection of human subjects.” 45 C.F.R. 46. Retrieved from http://www.hhs.gov/ohrp/humansubjects/guidance/45cfr46.html.

U.S. Dept. of Justice, Bureau of Justice Statistics (2015). Prepared by Dr. E. Ann Carson. Prisoners in 2014. Retrieved from http://www.bjs.gov/content/pub/pdf/p14.pdf.