You can't ask that.

• Author: Schrag, Zachary M.
• Position: Abuses of medical researchers and institutional review board

ENACTED A GENERATION AGO IN RESPONSE TO REAL ABUSES BY SOME NOTORIOUS MEDICAL RESEARCHERS, SO-CALLED INSTITUTIONAL REVIEW BOARDS HAVE MORPHED INTO ENTITIES THAT ARE STIFLING AND DISTORTING IMPORTANT RESEARCH THROUGHOUT ACADEMIA.

What's the best way to help recovering female addicts stay clean when they get out of prison? A good place to start researching that question might be to talk with people who have been through the experience. Or at least that's what Harvard graduate student Kimberly Sue thought when she set out to interview female prisoners in Massachusetts with a history of opiate addiction.

But before Sue could even approach any of the women she hoped to interview, she needed to get permission from the Massachusetts Department of Public Health, the Department of Corrections, and, crucially, the Harvard Committee on the Use of Human Subjects, also known as an institutional review board, or IRB. And it was at Harvard that she faced her greatest hurdles.

The Harvard IRB wanted to put all kinds of restrictions on Sue's work. It didn't want her to talk to women who had dealt with trauma or active mental illness. (That would have excluded just about all the women in her study.) It wanted her to get her informants' signatures on written consent forms with complex legal language that, as Sue soon discovered, the women were unable to understand. It fretted that Sue would advise women to terminate pregnancies. And it forbade her from observing women outside of such controlled spaces as hospitals and jails, as much for Sue's safety as for that of the women she studied.

Much of this struck Sue as bizarre. She had worked in tough neighborhoods before, in Durban, South Africa, as well as North Philadelphia and Bedford-Stuyvesant, not to mention local jails, so she knew what kinds of risks she was facing. More importantly, she knew the women she wanted to study, and what kinds of risks they were facing. While the IRB feared that Sue's questions about drug use would spark cravings in recovering addicts, the former addicts themselves knew that friends, family, and familiar places were more likely to spark cravings than a question from a graduate student.

Sue was ready to acknowledge her ethical responsibilities as a researcher, but the IRB seemed detached from reality and left her feeling, she said, "alienated, oppositional, and isolated." She was eventually able to win the approvals she needed, but the experience was searing enough that she subsequently wrote an essay in which she warned others about the ways "IRBs can actually impede, slow down and alter our research." Indeed, anyone who cares about universities' ability to study society and train researchers should worry about the obstacles IRBs can impose.

IRBs exist at just about every university or hospital that gets federal funding for research involving human beings, whether that means medical studies or just phone interviews. (The same rules do not apply to for-profit corporations, except drug companies.) The boards themselves are composed of a mix of researchers, administrators, and some members who are not affiliated with the institution and do not conduct research themselves, but who are supposed to represent the voice of the community. Along with the boards, larger institutions have IRB offices with staffing that can range from just three or four administrators to dozens, with annual budgets easily exceeding $1 million.

Regardless of the number of administrators employed, the IRB machinery exemplifies the way federal regulation can combine with institutional self-preservation to hamper a core mission of the university. The university exists to ask questions, yet IRBs forbid some questions to be asked. The university exists to spread truth, yet IRBs insist on altering facts in published accounts. (See, for example, the story on page 53 about the career aspirations of Harvard and Stanford students. The story contains intentional inaccuracy inserted at the insistence of an...