Office of the Provost


TO: All Faculty, Research Associates, and Postdoctoral Fellows
FROM: James V. Maher
DATE: February 24, 2004

IRB and Related Human Subjects Protection Issues

Our University is going through a time of great success in advancing our many and varied research programs. Whether measured by research dollars generated, awards received or lives touched, our faculty and staff are tremendously productive. Concurrent with this local record of achievement, however, is a call for increased public accountability of university research programs arising from the well-publicized misadventures of a number of our sister institutions of higher education.

That we have expanded our programs and at the same time maintained our responsibilities to the various oversight and regulatory bodies in the current environment is a tribute both to our research faculty and staff, and to those responsible for managing our compliance programs, particularly Vice Chancellor Randy Juhl. However, these efforts continue to tax us on a variety of fronts. The most visible of our compliance responsibilities is embodied in our Institutional Review Board. The IRB, a federally mandated, peer-review process under the able administrative oversight of Dr. Juhl, is responsible, on behalf of the University, to safeguard the rights and welfare of individuals who volunteer to participate in research studies. The ongoing responsibility for maintaining these protections is shared between the members of the research community and the IRB and is supported by a variety of oversight mechanisms, educational programming and systems of shared values that are both mindful and respectful of the principles of the Belmont Report (

There have been discussions on a variety of issues related to our responsibilities for human research subject protections. Senior Vice Chancellor Levine and Vice Chancellor Juhl have engaged in a series of workshop meetings with the clinical chairs of the School of Medicine regarding IRB interactions. Among a wide variety of issues, the primary topic was the added responsibilities for clinical researchers (both locally and nationally) resulting from the Health Insurance Portability and Accountability Act (HIPAA) and related patient confidentiality concerns. A separate report of those efforts will be distributed to the School of Medicine faculty and other interested parties soon.

There is another IRB initiative underweigh that I would like to report to you. It affects faculty whose research is primarily in the psychosocial realm. Although the social justification for and the regulations governing research involving human subjects are the same for both biomedical and psychosocial research, the implementation can have a different look and feel as a result of the very different research activities involved in psychosocial research. Treating a terminally ill patient with an experimental drug is different, from a risk/benefit perspective, from conducting a survey of middle school children and their parents, even though the principles of informed consent are fundamental to both activities. In order to provide additional insight into the needs of psychosocial researchers, we have created the IRB Advisory Committee for Psychosocial Research. The mission of the advisory committee is to identify and react to opportunities for improving the University’s human subject protection efforts on behalf of psychosocial researchers and to facilitate communication between the psychosocial research community and the IRB.

Irene Frieze, John Levine, Sue Campbell (all from Arts and Sciences), Nancy Elman (Education), and Esther Sales (Social Work) have been invited to serve as charter members of this advisory committee. The committee will meet soon to select its chair and begin tasks related to its mission. I know that they, along with the IRB leadership, would appreciate your thoughts on these issues.

Nearly all of our research compliance activities are based upon a peer-review process, and we always seem to be short of peers who are willing to serve in these important capacities. I encourage you to respond affirmatively when you are asked to serve. Just as the responsibility for our regulatory obligations is shared by all, so too would be the penalties for not living up to our part of this important social contract. I appreciate all that is being done by those who have a role in maintaining our success in research and encourage each you to be diligent in adapting to the new realities we face.

If you have suggestions or comments, I would be happy to hear from you.

James V. Maher

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