Wednesday, February 27, 2013

George Mason University Adopts Shelton Definition, Solicits Faculty Advice

My own institution, George Mason University, has adopted two significant IRB reforms: clarifying the regulatory definition of research, and establishing a faculty advisory board to help shape IRB policies.

First, Mason's new page on the Human Subjects Research Definition presents the guidance offered in James D. Shelton, "How to Interpret the Federal Policy for the Protection of Human Subjects or 'Common Rule' (Part A)," IRB: Ethics and Human Research 21, no. 6 (November 1999): 6–9.

Developed by an unofficial working group of federal officials, the guidance explains that

A key aspect of research is that there be a systematic design in advance, generally utilizing a scientific approach or protocol, for the definite purpose of contributing to generalizable knowledge. Research can include a wide variety of activities, including experiments, observational studies, surveys, tests, and recordings designed to contribute to generalizable knowledge. It generally does not include such operational activities as medical care, quality assurance, quality improvement, certain aspects of public health practice such as routine outbreak investigations and disease monitoring, program evaluation, fiscal or program audits, journalism, history, biography, philosophy, "fact-finding" inquiries (such as criminal, civil, and congressional investigations, intelligence gathering), and simple data collection for other purposes. However, some of these activities may include or constitute research in the specific circumstance where there is clear advance intent to contribute to generalizable knowledge with a formal scientific protocol.

The expectation that history and biography are generally not included in the definition of research will be particularly helpful to researchers in my Department of History and Art History.

Second, the university is in the process of establishing a Faculty Advisory Board for Policy Development (on which I will serve) "to enhance communication and provide opportunities for advice and feedback on proposed policies related to research integrity & assurance developed for the university by [Office of Research Integrity & Assurance], compliance committees, and other offices." That is, the IRB will now be able to consult with facutly when developing policies, rather than springing them as often unwelcome surprises.

These structural changes are just the most visible elements of an improved climate here at Mason. I hope other institutions will consider comparable moves.

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