on Human Subject Research in the Social and Behavioral Sciences
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
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.
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.
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:
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.
involving elected or appointed officials or candidates for public
using existing data, documents, or records, as long as these resources
are publicly available or the human subjects can not be identified.
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.
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
of research eligible for expedited review are currently defined
by Federal regulations to include:
of data from voice, video, digital, or image recordings made for
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.
such research requires approval of an informed consent document,
our eventual goal will be to complete expedited reviews within two
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.
Nathanson, Vice Provost for Research
Almanac, Vol. 48, No. 8, October 16, 2001
October 16, 2001
Volume 48 Number8