What are Institutional Review Boards and Why Should We Care? An Interview with Zach Schrag

Interview originally published in The Washington Monthly on November 1, 2013.

In 2010, George Mason University Professor Zach Schrag published a book, “Ethical Imperialism: Institutional Review Boards and the Social Sciences,” exploring the history of federally regulated academic research in the United States.

Institutional Review Boards, or IRBs, as they’re known, were first created in the 1960s to approve, monitor and review biomedical and behavioral research involving humans. The idea was to protect human subjects from harm—a premise everyone could agree with—but in the intervening decades, Schrag argues, they’ve become obsolete, ineffective and overbearing, scaring social scientists out of doing hard-hitting research in their fields.

In a recent conversation with the Washington Monthly, Schrag explains where IRBs came from, how they’re harmful to social science, and what possibilities exist for reform.

What kinds of social science research are most negatively affected by the current IRB?

The one that really leaps out is research on sexuality. Time and again IRBs have been extremely squeamish when researchers come to them and say, “I want to study some kind of group, particularly a sexual minority.” Whether it’s about being gay or about adolescents and their sexuality…it tends to shoot up red flags all over the place.

We have a problem in this country where kids grow up gay, or transgender, or in some other marginalized category, and they feel alienated, misunderstood. One thing that good social science can do for them is to tell them that in fact it gets better, that you’re not alone. When the IRB is trying to protect, say, gay youth, by not letting the researchers talk to them, it may actually in the long run be doing harm by denying them the results that the research would create.

What happens to researchers who don’t comply with the IRB at their university?

There are risks to researchers who complain about this system—those who either deliberately refuse to comply or who choose to read the rules very carefully and comply no more than they have to, which has been my approach. Graduate students and untenured faculty are extremely vulnerable to threats. I have the luxury of tenure but if someone were to decide that I have violated a regulation then tenure won’t protect me. People feel scared. People shy away from research topics. The ethics regime has dissuaded people from doing the kinds of immersive research that for a long time was very important to sociology.

So should IRBs be abolished or should they be reformed?

This is a system that was primarily designed to regulate the kinds of research that people were thinking about it in the 1960s. I frankly question its modern utility in relation to biomedical research, but it’s particularly inept at regulating more exploratory, open-ended qualitative research of the kind that a lot of researchers in the social sciences and humanities pursue.

There are a lot of alternatives, particularly in terms of better communication and training. For example, someone judging the ethics on ethnographic field work in Peru should be expected to learn, let’s say, not about biomedical research but about ethnographic field work in Peru. I value expertise and I hope to see the energy focused on putting researchers in touch with other researchers. They need that kind of ethical questioning.

Some have argued that this process is an insidious form of censorship. Is this a First Amendment issue?

The problem is that even those who believe that the current regulations are not consistent with the First Amendment may not believe that the courts, and particularly the Supreme Court will agree with them. For example, Philip Hamburger at Columbia University argues for the unconstitutionality of IRBs, but at the same time he says that given recent Supreme Court opinions, we can’t trust the court to recognize this. Most people who are affected by IRBs are affected in their role as employees, and employees may have many fewer rights than do general citizens. I don’t think there is a great likelihood that we would find relief in the courts based on the way that precedents have gone.

How else could the rules change?

The federal government has recognized that this is a problem. In 2011, a group of agencies put out an Advanced Notice of Proposed Rule Making that recognized very explicitly that the system is not working well for many researchers. More recently, the National Research Council held a conference in which a lot of possible reforms were floated. Academics are still waiting to see what the next steps are with those options.

There are also a lot of people in Congress, in both parties, who are concerned with government overreach, and are worried about civil liberties. Indeed back in 1980 there was something of a bipartisan coalition thinking that these research regulations had gone too far. The House passed a bill that would have restricted the regulations somewhat. It died in the Senate.

Alternatively, you could find some relief at the university level because the regulations are brief, vague, poorly written, and somewhat contradictory. That gives universities a fair amount of wiggle room on how they actually implement the regulations. Ultimately though, we hope for more substantial reform.


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