In Research We Trust?

May 17, 1999
Web posted at: 12:50 p.m. EDT (1650 GMT)

The research scandal of the week is that Duke University Medical Center had its license to carry out clinical research revoked and then reinstated by the federal government. This comes on the heels of disclosures that research was done without consent on some patients at the VA hospital in West Los Angeles. All research at that hospital was shut down to assure the safety of all research subjects, and investigation of ongoing research at numerous other VA hospitals is under way.

What does this mean for how research is carried out, and more importantly, for the patients and other subjects who agree to take part in research? Are these examples a sign that a few bureaucratic requirements have been neglected, or do they mean subjects are at risk of serious harm? Or does the truth lie somewhere in between?

What's your opinion?

Protection of research subjects relies on local review boards, called IRBs (institutional review boards), making sure federal rules to protect human subjects are followed. They review and approve the ethics of all research studies before subjects are recruited, monitor ongoing research, and collect and report all information about harm to subjects in research.

In 1996, Congress asked the federal Government Accounting Office to study the research subjects protection system. Its report painted a picture of a system in crisis -- too much work for IRBs, too few resources to do their work, and too many research studies, forcing IRBs to take it on faith that researchers comply with requirements. And while government oversight officials have the authority to visit institutions to check on research protections, limited funds make site visits rare except when serious violations are reported.

So are all subjects at risk? There is no reason to think that all, or even some, researchers are motivated to mistreat research subjects. But both researchers and subjects may have motivations that work against adequate protection. Researchers are motivated to recruit subjects, and subjects are often motivated by the hope of improved health. Add the fact that both researchers and subjects are sometimes paid for research, and it is clear that more objective oversight is necessary to look after the rights and interests of subjects.

As current events attest, even when protections exist, they don't do their job unless they're adequately applied. But even with conscientious oversight, some research falls through the cracks. There are no special protections for research on those with limited abilities to make decisions, or on individuals who live in institutions -- some mentally ill subjects may fall into both categories. These gaps are the focus of current policy attention, but research on such groups continues in the meantime.

Protection is needed, not because of the information yielded by research or the finances at stake, though both are substantial -- Duke's suspended research is leading-edge science reportedly worth $175 million a year. What really matters is protection of the trust that is fundamental to the existence of the research enterprise. Research subjects can't be expected to scrutinize the records of research institutions to make sure regulations are followed, and they shouldn't have to. Subjects must be able to rely on their trust in investigators, in institutions, and in the policies that exist to protect them.

This is not idle trust but a willingness to put their health and their lives into someone else's hands. It is a trust that must be maintained throughout the research system, because without it individuals won't participate, and society will lose confidence in the value of research altogether. There is much to be gained from research, but even great benefits cannot come at the cost of adequate respect for individuals. Real people, with real lives, make research possible. They deserve real protection.