Complexity Slows Drive to Revise Human-Subjects Rules

August 31, 2011

Universities knew they faced a complicated and far-reaching challenge when the federal government announced last month that it planned the first overhaul in three decades of regulations governing research on humans.

That realization was confirmed Wednesday with an announcement by the Department of Health and Human Services that it would accept university pleas for a one-month extension of the period for comments on the plan.

Current federal rules governing the protection of human subjects were established in 1981, after abuses such as the Tuskegee syphilis study were publicized, and at a time when most drug trials were carried out at a single location.

The proposed changes are intended to reflect a changing landscape, in which most drug trials are now conducted in various university and nonuniversity settings, with half of those required by the federal Food and Drug Administration taking place outside the United States. One of the key proposed changes would be the use of a single review board to evaluate the proposed protocol of a particular drug trial, rather than the current system of separate reviews at each physical testing location.

The government proposal, however, includes many other suggested changes, including the creation of shorter and easier-to-understand patient-consent forms, and updating and clarifying the types of research that could be considered minimal risk and therefore exempted from review or processed on an expedited basis. That kind of change is especially appealing to historians, who have felt unfairly caught up in restrictions on their ability to merely conduct interviews with people.

Universities are finding the implications far-reaching, making it difficult for their advocacy groups, such as the Association of American Universities, to quickly coordinate recommendations on how the government should proceed, said Carrie D. Wolinetz, associate vice president for federal relations at the AAU.

The Department of Health and Human Services, in an announcement on July 26, had said it would accept comments on its proposal through September 26, before moving to the next stage of writing the regulations. The department announced on Wednesday that it would extend the comment period to October 26.

Groups including the AAU, the Association of American Medical Colleges, and the Association of Public and Land-Grant Universities had asked for the extra time. The original 60-day comment period was "insufficient to provide substantive input on the extensive and detailed questions and proposals," the leaders of the AAU and APLU said in a joint letter this month to the Department of Health and Human Services.

Separately, the Presidential Commission for the Study of Bioethical Issues met this week in Washington to consider its own recommendations for human-subject protections. President Obama requested the commission study last November, after a researcher at Wellesley College, Susan M. Reverby, uncovered evidence that U.S. government scientists in the 1940s intentionally infected hundreds of people in Guatemala with gonorrhea and syphilis as part of a public-health research project. The commission's final report is due next month.