Clinical Ethics Enforcers Set for Promotion?

The federal office that watches over the use of human subjects in research is likely to get more clout, if a report to National Institutes of Health (NIH) director Harold Varmus wins acceptance. An independent six-member review panel today presented its recommendations for boosting the status of the enforcement group. Varmus accepted the recommendations without demur.

The report urges NIH to turn over to another agency the responsibility to oversee the 28-person Office for Protection from Research Risks (OPRR), a group that enforces human subject protections and animal welfare rules. Among other things, OPRR watches the methods federally funded researchers use to obtain consent from patients in clinical trials. At present, OPRR is part of Varmus's staff. But because NIH sponsors medical research, the outside reviewers concluded, it has a conflict of interest when it comes to enforcing ethics guidelines. One of the panel co-chairs, bioethicist Nancy Dubler of the Montefiore Medical Center in New York City, said there is a "perception that OPRR might be biased in favor of research" and shy away from aggressively protecting the rights of patients. This, she added, could contribute to "public distrust of research."

To avoid this problem, Dubler and other panel members said, the government should find a new home for OPRR. They suggest that OPRR be moved to the Department of Health and Human Services under the surgeon general or the assistant secretary for health. In addition, they recommend that the office get a larger budget, conduct more site visits, and pursue a bolder public profile. Varmus and his advisers accepted the recommendations, and Varmus announced that he would immediately forward the report to his boss, Secretary of Health and Human Services Donna Shalala, for implementation.