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Building public trust in research


By Jeffrey P. Kahn, Ph.D., M.P.H.
Director, Center for Bioethics
University of Minnesota

The cover of the April 22 issue of Time magazine depicted a woman in a hospital gown crouching in a cage like a lab animal with the banner headline "Human Guinea Pigs."

Inside, numerous scandals at research universities were recounted, describing the shortcomings of researchers and medical centers carrying out clinical trials. That ultimately led to risky situations and inadequate information for prospective research subjects, the magazine says.

Time's conclusion was that people were put in harm's way and that matters are only going to get worse without significant change.

At the same time, an editorial in Sunday's New York Times called for additional clinical trials regarding hormone replacement therapy for post-menopausal women. It argued that, among other things, the main lesson from recent studies is "the importance of conducting clinical trial of medical treatments whenever feasible."

How are we to make sense of the conflicting conclusions in each piece -- making sure research subjects are protected and advocating additional studies with more people for more diseases?

Changing the rules

One answer to the dilemma is to make some changes in federal research policy. Federal regulations have evolved to require inclusion of historically underrepresented groups in clinical trials -- chief among them women, minorities and children. The changes increased these groups' access to the benefits of research.

At the same time, research protections such as informed consent, confidentiality or adequate representation apply only to studies funded by the government or that will end up having their data submitted to the Food and Drug Administration.

However, most research universities voluntarily agree to apply these standards to their federally funded and non-federally funded research. But such an agreement is not universal and does not apply to the many other research entities.

U.S. Sen. Edward Kennedy, D-Massachusetts, recently has joined the growing list of lawmakers who have suggested that federal law be modified to require that all research on human subjects be covered by federal regulations, regardless of the source of funding.

Preventing conflicts of interest

The sources of funding have additional effects on research. One of the soft spots in oversight has been managing the potential for financial conflicts of interest.

Some watchdog groups have argued that financial stakes in the outcome of research by both researchers and institutions are at least partly responsible for some of the recent scandals. Rules from the government as well as professional groups are coming, promising to set higher standards for what financial relationships will be allowed.

The bottom line is if we don't protect subjects better, then the most important commodity in research will be lost -- the trust of the public. Without trust, patients won't participate in research, and the public won't agree to spend tax dollars on it.

The truth is we want the benefits that medical research has to offer and we want it without biases that may affect safety. It is possible to have both, but not without the research community making sure research is performed with the highest ethical and scientific standards.

A system of compliance is important, but as a fail-safe measure rather than the first line of defense of the rights of research subjects. Instead, conscience ought to take priority over compliance, and with that shift will come all-important trust.

Visit the
"Ethics Matters" Archive
where you'll find other columns from Jeffrey Kahn
on a wide range of bioethics topics.

"Ethics Matters" is a biweekly feature from the
Center for Bioethics and CNN Interactive.


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