This Article Full Text (PDF) Alert me when this article is cited Alert me if a correction is posted Services Similar articles in this journal Similar articles in PubMed Alert me to new issues of the journal Download to citation manager Citing Articles Citing Articles via Google Scholar Google Scholar Articles by Kahn, J. P. Search for Related Content PubMed PubMed Citation Articles by Kahn, J. P.

Building Public Trust in Research

From the Center for Bioethics, University of Minnesota, Minneapolis, Minnesota.

Correspondence to: Jeffrey Kahn, PhD, MPH, Director, Center for Bioethics, Professor of Medicine, University of Minnesota, N504 Boynton, 410 Church St SE, Minneapolis, MN 55455-0346 (e-mail: jeffrey.p.kahn-1{at}tc.umn.edu).

Received for publication May 14, 2002; accepted for publication May 14, 2002.

At the same time, an editorial in The New York Times called for additional clinical trials regarding hormone replacement therapy for postmenopausal women. It argued that, among other things, the main lesson from recent studies is "the importance of conducting clinical trials 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 the 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 nonfederally funded research. But such an agreement is not universal and does not apply to the many other research entities. Senator Edward Kennedy 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 as 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.

A version of this article appeared in Dr Kahn's column "Ethics Matters" on CNN.com/health.

This Article Full Text (PDF) Alert me when this article is cited Alert me if a correction is posted Services Similar articles in this journal Similar articles in PubMed Alert me to new issues of the journal Download to citation manager Citing Articles Citing Articles via Google Scholar Google Scholar Articles by Kahn, J. P. Search for Related Content PubMed PubMed Citation Articles by Kahn, J. P.