Apparent Mismatch

The federal regulations that govern human subjects research were created in the wake of gross abuses of medical science, in which subjects undertook significant risks (and were significantly harmed), without consenting to treatment.

Developments in recent years - ably described by Oakes below - have led to the increasingly zealous application of these biomedically-grounded regulations to social science research. But many social scientists feel that IRBs lack an understanding of social science methods and goals. For example, IRBs may require detailed written informed consent that is sometimes at odds with sound social science inquiry. They may overestimate the risks inherent in participation in social science research (for many examples, see the AAUP report and Gunsalus et al. below). Dissatisfaction with the apparent mismatch has led to a national discussion. But federal action that could help resolve key issues is yet to materialize. In the interim, social scientists must develop an understanding of the system.

The four pieces posted provide an orientation to the IRB system and national developments around the apparent mismatch between that system and the conduct of social science research.

Protection of human subjects of research: Recent development and future prospects for the social science

Singer E, Levine F. J. (2003). Public Opinion Quarterly (67):148-164.

A balanced and scholarly piece that describes the development of federal regulation in the biomedical research context. The authors go on to describe recent efforts by social scientists to explore the applicability of the regulatory framework to social science research. Introduces some key stakeholders, reports and recent trends.

The Illinois white paper-improving the system for protecting human subjects: Counteracting IRB mission creep

Gunsalus K.C. et al. 200X

An important and provocative piece. The authors argue that IRBs spend too much time on matters that are not part of their intended mission, and too little time attending to important ethical concerns. A precis of the White Paper recently appeared as an editorial in Science (9 June 2006: Vol. 312. no. 5779, p. 1441).

Risks and wrongs in social science research: An evaluator's guide to the IRB

Oakes JM (2002) Evaluation Review 26(5):443-479.

An astute analysis of how we got to where we are today, and what we might do about it. Oakes argues that the increased stringency of IRB review of social science research emanates from the "credible threat" of a visit from the federal regulators that will result in the cessation of all federal research on the visited campus. Includes a good overview of key terms and the field, and closes with a call for greater activism by social scientists in the IRB system.

Protecting human beings: Institutional review boards and social science research

The American Association of University Professor (AAUP)'s Committee on Academic Freedom and Tenure published this report in 2006. It charges that the current system substantially restricts academic freedom, and it calls for scholars and university administrators to engage in a revision of business as usual under the federal regulatory system.