Harvard Will Submit Comments on Changes to Research Approval Process

After the federal government proposed the first major changes in two decades to regulations on the conduct of human experiments, Harvard will formally submit comments based on input from professors and administrators.

To protect the rights and privacy of individuals, the federal government in 1979 instituted strict regulations on the conduct of experiments involving humans as test subjects, known as the “Common Rule.” The rule states that anyone who proposes to use human subjects in any research—including human tissue or cells—must obtain prior approval from the appropriate institutional review board, a committee designated to approve and review biomedical and behavioral research involving humans.

Harvard has three such boards, for Harvard Medical School, the School of Public Health, and the Harvard schools in Allston and Cambridge.

The U.S. Department of Health and Human Services proposed major reforms to the Common Rule this fall. Some reforms seek to enhance protections for human subjects, such as strengthening the requirement for informed consent on the use of biospecimens, better facilitating single approval processes for researchers cooperating across universities or other institutions, and enhancing and creating detailed systems to track consent.

A number of researchers across the country criticized the proposed revisions. In response to the large volume of comments made on the proposed revisions, the Department of Health and Human Services has extended the public comment period by 30 days to Jan. 6.

Ara Tahmassian, Harvard’s chief research compliance officer, said the the proposed changes could apply the same regulations on high-risk experiments to lower-risk experiments, such as social science surveys and economics research. Tahmassian said he was uncertain about that potential change.

“I believe that there needs to be a better correlation between the research conducted today and the regulations designed for their oversight,” Tahmassian said.

Tahmassian is tasked with seeking input on the proposed policy change from Harvard affiliates, including faculty members and administrators, before submitting Harvard’s finalized comments on the changes to the regulations before the deadline in early January.

Besides Tahmassian, many people in the wider research community have also been critical of the proposals.

Last week, the Council on Governmental Relations, an association of 190 research universities including Harvard that provides information, analysis, and advice on policy issues affecting research, penned an open letter to the Department of Health and Human Services criticizing the proposed reforms. As a member of the council’s board of directors, Pamela S. Caudill, chief research operations officer for the Medical School, signed the letter. She declined to comment, deferring to Tahmassian.

The letter criticized the revision of the regulations because of the vagueness of rules’ wording, the large costs associated with universities implementing the rules, and the lack of data and information available to indicate that a revision of the regulations would necessarily be beneficial.

“Conversely, there are major proposed revisions that would lead to a significant increase in burden, delay, ambiguity, and cost, and a loss of valuable research without increasing protections for human subjects,” the letter says.