Faculty Development and Diversity

The Department of Health and Human Services have released proposed changes to the review of human subjects research. The changes, summarized by the New York Times yesterday, would tighten some controls and loosen others.

On the side of more regulation, it would bring more studies, even those conducted with private funds, under the purview of an Institutional Review Board if the institution accepts any federal money. On the looser side, it would create a category of “excused” research allowing social and behavioral studies to avoid review.

Though the amendments seem thoughtful, they may not address some of the complaints that researchers have with their own IRBs like lack of transparency. It will be helpful if this proposal sparks discussion among university IRBs about how best to communicate their goals to researchers.

When Brown University Associate Professor of Education Jin Li began her research on learning among Chinese immigrant children, she secured funding from private sources, prepared her methodology, and received approval from the IRB. As the research began, she noticed that her plan to provide $600 to all families who participated did not reflect the added effort low-income families expended on the learning assessments, so she decided to offer some families $600 and others $300.

She submitted her modified budget to the IRB and was rejected. Moreover, the Board told her she could not use data collected from families paid only $300 even though they had signed consent forms. Nor could she pay those families an additional $300 because she had run out of funds. So, she is suing Brown for harm to her research.

Originally, IRB approval was intended for research funded by federal sources. A new book, Ethical Imperialism, documents how that mission has grown to encompass all research with human subjects. Social scientists, in particular, find the restrictions ill suited for their work with interviews, archives, and oral histories. Just as under regulation can be harmful, so can overreach.

To conduct research on the effectiveness of the mentoring program we're rolling out on the Boston University Medical Campus, I have been revising an application to the Institutional Review Board. The IRB oversees all research with human subjects to make sure investigators comply with federal regulations.

The motivation for such an oversight body is admirable. Especially with biomedical research, the potential for harm to research subjects is too great to go unchecked. But when it comes to more psycho-social research like the evaluation project I am proposing, the board's requirements can be cumbersome.

A New York Times article from 2007 points out the mission creep of IRBs, which originally applied just to research sponsored by federal grants. As universities require social scientists to go through the process, some of the protections for subjects end up sounding absurd. What's more, the regulations may interfere with a scholar's first amendment right to study and publish freely. I think of the New York Times itself, which does not have to seek any external approval before it writes potentially harmful pieces about subjects in the news.

In the end, though, the process of crafting an IRB application has been helpful for clarifying the safeguards my study has in place to protect research subjects. If it takes a cumbersome on-line form to get researchers to consider the ethical implications of their studies, then it's a worthwhile cost.