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OF RECORD Statement on Human Subject Research in the Social and Behavioral Sciences Current University policies, based on agreements with the Federal government, require that all research involving human subjects be subject to review by our Institutional Review Board [IRB] system. Under the federal government's regulations, research is defined as "a systematic investigation including research, development, testing and evaluation, designed to develop or contribute to generalizable knowledge." The requirement for IRB review extends to all research on human subjects conducted by faculty, research fellows, and students, whether funded or unfunded. While researchers in biomedical sciences have long been accustomed to human subject review procedures, many social and behavioral researchers have not previously been aware of, nor held to these formal requirements. Full compliance will require the incorporation of the principles of ethical research practice in our teaching and our research, and the development and implementation of systems that will permit the efficient processing of reviews. Efforts in this direction have already resulted in the establishment of IRB number 8, solely devoted to social and behavioral research. An important component of our mutual learning process is the recognition that while all human subject research at the University is subject to IRB review, a majority of proposed studies will be deemed "exempt" from detailed review, and an additional substantial portion will appropriately be given "expedited" review, leaving only a minority for "full review" by an IRB. Exempt from Review Broadly speaking, the following categories of human subjects research are considered exempt from IRB review, although University policies still require that investigators submit their proposals to the IRB:
One area of frequent concern is informed consent. Federal and University policies permit an IRB to waive the requirement for prior informed consent in certain circumstances, including observation of behavior in public, and responding to questions, as in filling out a questionnaire. However, such research may not meet the standards for exemption and may require full review by the IRB. It is important to underscore that even proposals that are ultimately deemed exempt need to be submitted to the IRB system. Our goal is to make this process as efficient as possible. Current efforts by the Office of Regulatory Affairs (ORA) are focused on the development of efficient and transparent mechanisms for screening exempt and expedited research proposals. A new form for requesting exemption of a research project has been posted to the ORA web site and is now available for use (www.upenn.edu/regulatoryaffairs/), together with diagrams defining an exempt study. In addition, the IRB has developed a streamlined procedure for processing and approving exempt research. Expedited Review Categories of research eligible for expedited review are currently defined by Federal regulations to include:
While such research requires approval of an informed consent document, our eventual goal will be to complete expedited reviews within two weeks. The University is committed to the development and implementation of efficient and fair systems of review. In the near future, a joint Faculty Senate and administration Working Group will be charged to propose guidelines for the ethical use of human subjects in sociobehavioral research at the University of Pennsylvania. As we work towards a fully functioning review system it is imperative that we all recognize the importance of addressing these issues in our teaching and research. --Neal Nathanson, Vice Provost for Research --Robert Barchi, Provost Almanac, Vol. 48, No. 8, October 16, 2001 |
ISSUE HIGHLIGHTS: Tuesday,
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