The College committee that oversees human subject research is reviewing its policies in response to a recent report calling for the reform of procedures dealing with potential financial conflicts in research involving human subjects.
According to the study issued by the American Association of Medical Colleges, academic institutions need to oversee human subject research more carefully, guarding especially against financial conflicts of interest.
At least part of the problem stems from the passage of the Bayh-Dole Act in 1980, which the report says allowed institutions and researchers to share in the return on successful inventions arising from federally-funded research.
While the report's authors note that the Bayh-Dole Act has facilitated collaboration between academia and industry, they find that, as academics receive more funds from commercial sources, they face more financial conflicts of interest.
Such conflicts of interest are especially serious when academics undertake research involving human subjects, according to the AAMC report.
Elizabeth Bankert, director of Dartmouth's Institutional Review Board, which oversees research at Dartmouth, said she believes that Dartmouth already has adequate protections against conflict of interest in place.
For example, the AAMC defines "significant financial conflict" as benefits of more than $10,000 or 5 percent equity in a company arising from a study. Dartmouth's existing conflict of interest policy defines financial conflict in exactly the same terms.
Likewise, she noted that the Food and Drug Administration and the National Institute of Health already have well-established guidelines for research on human subjects in place.
Nonetheless, Bankert said that Dartmouth is "in the early stages" of examining its policies on use of human subjects in research.
Officials at Stanford and Harvard indicated that their schools are at similar stages in reviewing the report.
While Stanford officials have not yet had adequate time to review the entire report and discuss it in detail, they do plan to study it in more detail and possibly reform policies accordingly, spokesperson Kathy McFellund said.
"It looks, on the face, like a very helpful document," she said, "but it's too early to endorse it in its entirety."
She added that Stanford has recently made its Conflict of Interest committee a standing committee in response to increased concerns about the conflicts of interest faced by biomedical researchers.
Similarly, Ed McCarski, chair of the committee on conflict of interest at Stanford Medical School, said that "much current discussion and re-review" of Stanford's standards has centered around discussions of the AAMC report.
Harvard Medical School does not plan to alter its policies regarding conflicts of interests in the near future, according to the Dean of the Medical School's website.
In addition to adhering to the standards of financial conflict of interest currently proposed by the AAMC, Harvard policies specify that no more than 20 percent of a faculty's member's time can be taken up by research for private firms.
Bankert said that the 1999 death of Jesse Gelsinger, who died as a result of participating in a study in gene therapy at the University of Pennsylvania, prompted Dartmouth to examine its policies closely before the release of the AAMC report.
James Wilson, the Head of Penn's Institute for Gene Therapy, was the founder of Genovo, Inc., which held any patents that might have resulted from the study in which Gelsinger participated, according to The Daily Pennsylvanian.
Penn stood to benefit directly from profits from the therapies Wilson was developing. Had more rigid financial conflict of interest guidelines been in place three years ago, the fatal experiment might never have taken place, the Daily Pennsylvanian said.
A task force of 28 members from various professional backgrounds in areas relating to medicine, law, the media and academia wrote the AAMC report.
