Sieber and Tolich Lament "Medical Model"

The editors of the Journal of Empirical Research on Human Research Ethics call for researchers to stand up to their IRBs.

[Joan E. Sieber and Martin Tolich. "Research Ethics and Research Governance." Journal of Empirical Research on Human Research Ethics 7, no. 2 (April 2012): 1-2, DOI: 10.1525/jer.2012.7.2.1].

Sieber and Tolich distinguish between research ethics and research governance:

Research ethics is aimed primarily at protecting human subjects. Research governance is an administrative process (typically within a university) which sets standards in research, defines mechanisms to deliver standards (e.g., IRBs, Conflict of Interest Committees, Responsible Conduct of Research Committees, Legal Counsel, Office of Sponsored Projects, Adverse Incident Monitors, ...), and oversees those who enforce the standards.

They lament research governance's ability to crowd out research ethics:

Among other things, the regulations governing institutions and IRBs are based on a medical model of human research in which one observes or experiments on a medical condition, as opposed to research in which one interacts socially, often in a complex field setting. It takes considerable intellectual acumen to respond ethically and intelligently to such mismatches between well-intended regulations and the actual research setting. More than that, it takes knowledgeable researchers who are willing to serve within their institution's research governance structure and educate the members of the governance structure to understand that one size does not fit all.

As I have noted before, such calls to "educate the members of the governance structure" overlook the power dynamics within institutions. The IRB system lacks accountability in the form of appeals processes or the requirement that IRBs justify their decisions with empirical evidence. In such a system, "knowledgeable researchers" lack the leverage needed to gain the attention of institutional officials.

I would suggest that this is an opportunity for the kind of empirical research the journal promotes. While it might be difficult to get people to speak frankly on the issue, one could study institutions that have significantly reformed their human research protections programs and ask what led to the change. My guess is that the most effective reformers are not researchers with the greatest intellectual acumen, but those whose record of securing external grants gives them the most clout among administrators.