Re-Examining Human Research

A national Consortium to Examine Clinical Research Ethics (CECRE) has been established at Duke Medical Center to compile the first comprehensive information on overseeing clinical trials at medical centers, and to develop new ways to protect people enrolled in such trials. Clinical trials at Duke came under scrutiny in 1998 and 1999 ["Managing a Medical Makeover," Duke Magazine, September-October 1999], and the medical center has worked since then to improve its procedures and protections.

The founding of CECRE, funded by an $830,000 grant from the Doris Duke Charitable Foundation, comes amid a mounting demand for better procedures to inform research subjects of the risks of taking part in clinical trials of drugs and other treatments, according to the center's participants. Also, they say new oversight might be needed since some medical researchers have been criticized for conducting trials of drugs produced by companies in which the researchers have a financial interest.

The multidisciplinary CECRE group includes clinical researchers, industry representatives, Institutional Review Board (IRB) members, and bioethicists from across the nation. IRBs are those committees in medical centers charged with local oversight of research involving human subjects.

"The system to protect participants in clinical research recently has been challenged," says Jeremy Sugarman '82, M.D. '86, director of the Center for the Study of Medical Ethics and Humanities at Duke Medical Center.

"Concern has focused on financial conflicts of interest, the workings of the IRB, and haphazard reporting of such adverse events as drug reactions. CECRE should provide unique data and proposals that will shape discussions and public policy for years to come."

One major focus of the consortium will be to evaluate twenty to twenty-five representative research centers to create a comprehensive database on the current characteristics of clinical research, including data on the number and nature of clinical trials being conducted, the number of participants enrolled, the costs of IRB review and oversight, and the source of funding for the research.

The CECRE will develop a systematic framework for determining which research projects require heightened scrutiny. Such projects might involve a vulnerable population, which could be inadvertently misused by researchers.

There will be suggestions clarifying when increased scrutiny should be required. The project will also look at the efforts now used to ensure patient safety in clinical trials and determine whether new approaches are necessary.

The ultimate goal of the project is to provide clinical researchers, funding agencies, human participants, and society the guideposts to recognize an improved and ethical clinical research system. "This is an effort to step back from the existing system of protections for human research participants and to re-examine the goals and assurance mechanisms for an ethical clinical research system and human subjects protection," Sugarman says.