Indiana University Research & Creative Activity

The Art and Science of Medicine

Volume XXVI Number 1
Fall 2003

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IRBs Inside Out

Ethical questions about scientific research using human subjects boil down to balance: do the benefits of a study equal or outweigh its risks to participants?

Calculating that equation falls to Institutional Review Boards, watchdog committees whose purpose is to protect the rights and welfare of human research subjects.

But in recent years, IRBs themselves have been implicated in episodes of research gone awry. Most seriously, at the University of Pennsylvania and at Johns Hopkins University, study participants died after receiving experimental treatments in clinical trials. In these and other cases, investigators pointed fingers at ethics committees and IRBs, citing them as unaware, inadequately informed, and overworked to the point of mishandling their responsibilities.

No headline-grabbing human subjects' disasters have occurred at Indiana University, but IU research administrators and IRB members are mindful of the pitfalls encountered by other institutions. Consider the workload, for instance. At IU­Purdue University Indianapolis, where the majority of IU's clinical research takes place at the Medical School, there are 200 members serving on five IRBs, four of them focused on medical research alone. "We have about 3,700 active studies right now, and about 2,000 active clinical studies requiring full review," says Shelley Bizila, director of research compliance administration at IUPUI.

And as the number and complexity of the studies grow, so does the knot of ethical issues they present. In this era of commercial and corporate support for scientific research, conflict of interest stands out as an example.

In the University of Pennsylvania case, Bizila notes, the researcher involved owned part of the company that manufactured the virus injected into the patient who died. "The big fear is that a researcher will allow money to cloud his or her judgment, overlooking the safety of a subject for personal financial gain," she says.

And then there's HIPAA, the Health Insurance Portability and Accountability Act. Anyone who's been to the dentist or doctor lately has seen and signed the privacy notices required by the act, but according to Bizila, the act's impact on academic medical research has been sorely overlooked.

"HIPAA is having an enormous impact on medical research," she says. "Before, physician-researchers who wanted to collaborate could share each other's patient data and publish about it. Now, those records may not be examined without permission from an IRB, even if no current human subjects are involved. Data can't flow; information can no longer be freely shared."

Lack of guidance from the government has exacerbated HIPAA headaches, but compliance is the only choice, says Bizila: "We may not like it, but if we want to do research, we have to do it right."

According to Peter Finn, professor of psychology and chair of the 20-person IRB committee at IU Bloomington, IRB's "do it right" when they focus not solely on the application of federal regulations but also on the significance of sometimes risky research.

"At IU, we're very committed to making sure human subjects are protected," he says, "but we're also committed to serving our faculty colleagues by making sure the system is not applied in such a rigid fashion that it unduly hinders research. Research really can be done very well within the system, and we look for ways to make it work."

IU's human subjects review system is strong, says Mark Brenner, IU associate vice president for research and IUPUI vice chancellor for research and graduate education, but he acknowledges room for improvement at IU, and in human subjects review systems around the world. At IUB and IUPUI, new Web-based educational programs for IRB members are being launched to better instruct faculty members about their responsibilities and the policies and procedures they must enforce. At the national level, Brenner points to the Association for the Accreditation of Human Research Protection Programs (AAHRPP), a nonprofit group formed in 2001 that now spearheads a voluntary accreditation process for research institutions.

"The most logical path to respond to the serious problems of two or three years ago was to create a self-monitoring program," says Brenner, who is on the AAHRPP board. "The idea is to create an assurance program that says institutions have thoughtfully organized the ways by which they handle human research studies."

Internationally, IU's collaboration with Kenya's Moi University on human subjects' research about AIDS is a model, says Brenner. He traveled to Kenya not long ago to help hammer out a memo of understanding with Moi. The agreement specifies how the two institutions' IRBs will share information and review studies. It also includes procedures for when the universities may disagree and takes into account how Kenyan cultural and social customs affect the process of getting informed consent from subjects in traditionally organized African communities.

"The Moi program's success in controlling AIDS is remarkable," Brenner says. "It's beginning to save lives in the hundreds. That's why its even more important to figure out how to continue to do good research."

L.B.