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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:

  • Research involving the use of educational tests, survey procedures, interview procedures, or observation of public behavior, unless the subject can be identified and disclosure of the subject's responses could put the individual at risk of criminal or civil liability or could damage the subject's financial standing, employability, or reputation.
  • Research involving elected or appointed officials or candidates for public office.
  • Studies using existing data, documents, or records, as long as these resources are publicly available or the human subjects can not be identified.

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 (, 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:

  • Collection of data from voice, video, digital, or image recordings made for research purposes.
  • Research on individual or group characteristics or behavior, or research employing survey, interview, oral history, focus group, program evaluation, human factors evaluation, or quality assurance methodologies not otherwise exempt.
  • Other research that presents minimal risk to the participant, as specified in the Federal regulations.

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


October 16, 2001
Volume 48 Number8

The grand old Quad will have three new College Houses when renovations are complete next fall.
Getting around University City will be easier for pedestrians and motorists thanks to new signage.
A $6.7 million NIH grant has been awarded to the Institute for Medicine and Engineering.
President Rodin will receive the Beacon Award at the upcoming celebration of 125 Years of Women at Penn.
Professor Peter Stallybrass will receive the MLA's Lowell Prize for most outstanding literary or linguistic study.
La Casa Latina: the Center for Hispanic Excellence has a new director.
The ICA has a new director of marketing and communications.
A new Entrepreneur in Residence program gives students a chance to meet and mingle with experienced entrepreneurs.
Research in the social and behavioral sciences involving human subjects must be reviewed by Penn's Institutional Review Board.