Committee on Research Using Humans
Interim Report
April 25, 2000
In January, University of Pennsylvania President Judith Rodin established an internal Committee on Research using Humans and charged the group with the task of "reviewing carefully and completely all aspects of Penn's research using human subjects." The Committee has been working actively and will continue its work through the summer before presenting its final report and full recommendations to the President. However, the Committee has identified several areas where immediate attention by the University would both improve our research environment and assist the Committee in fully carrying out its charge. With this in mind, the Committee is forwarding the following recommendations to the President on an interim basis.
- Carry out a Comprehensive Review of the University's Institutional Review Board (IRB) System. The Committee recommends that a formal and comprehensive review of Penn's IRB system be carried out. This review should include an assessment of both its compliance with current regulations and its capacity to serve the needs of the research community. The review should employ a site visit template that evaluates the strengths and achievements of the human subjects protection program. The review should generate specific comments in the areas of: IRB membership (membership standardization, formal recognition for service, use of outside consultants when special expertise is needed); internal functioning of the IRB; and educational mission (orientation of new members, training of investigators, institutional education as IRB goal). The results of this review will assist the Committee in formulating additional recommendations.
- Formal monitoring mechanisms for clinical trials. Penn has over 3900 ongoing research protocols involving humans, of which over 750 involve the use of investigational drugs. Most studies are funded from sources that provide mandatory external monitoring. However, approximately 15 percent of these studies are funded from sources that do not provide such external monitoring and review. While there is confidence that these studies are being conducted with the same high quality and ethical standards applied to all of the University's scientific and clinical research, the Committee recognizes the importance of consistent external review in insuring the safety of humans. Therefore, the Committee recommends that the Vice Provost for Research issue a Request for Proposals to selected professional clinical research oversight organizations for independent monitoring and review of this particular group of studies, and that guidelines be developed for ongoing monitoring and review of all studies through standardized and externally validated processes.
- Conflict of Interest Disclosure to IRB. The Committee recommends that the IRB act expeditiously to require that principal investigators and co-investigators disclose on the forms requesting IRB approval any proprietary interest in the product or procedure under investigation, including potential future compensation both for themselves and their immediate family. The IRB should then determine on a case-by-case basis whether disclosures in the patient consent document or other protections are required, and should note these considerations on the approval form.
- Standard Operating Procedures. The Committee recommends that the IRB, in conjunction with the Vice Provost for Research, undertake the development of a compendium of Standard Operating Procedures that apply to human subjects research, and establish a process for insuring that all investigators have access to, are cognizant of, and are in compliance with these procedures.
- Investigator Survey. The Committee recommends that a brief web-based survey be conducted of Penn investigators involved in human research. The survey should focus on faculty whose protocols have been reviewed by the IRB during the past several years. The goal of the survey should be both to identify areas that investigators perceive as barriers in the human use protocol review process, and to generate ideas for how the University can better facilitate research involving humans. The Committee proposes a survey instrument that will cover six to eight topics, using a limited number of focused questions in each area.
Respectfully submitted by,
- Robert Barchi, M.D., Ph.D., Provost, Chair
- Ralph Amado, Ph.D., Vice Provost for Research
- Linda H. Aiken, Ph.D., FAAN, FRCN, R.N., Professor of Nursing
- Robert Austrian, M.D., Professor Emeritus of Research Medicine
- Arthur Caplan, Ph.D., Director, Center for Bioethics
- Alfred P. Fishman, M.D., Senior Associate Dean, School of Medicine
- Harvey Freedman, M.D., Professor of Medicine
- John H. Glick, M.D., Director of the University of Pennsylvania Cancer Center
- John Jemmott, Ph.D., Director of The Center for Health Behavior and Communication Research
- Samuel Preston, Ph.D., Dean, School of Arts and Sciences
- Ralph Amado, Ph.D., Vice Provost for Research
Almanac, Vol. 46, No. 30, April 25, 2000