The presidents of America's top research universities have come up with a set of proposals for tightening up the policing of research on human subjects.

The plan, published in Washington last week by the Association of American Universities (AAU), addresses mounting public anxiety about the safety of individuals taking part in such trials. Levels of concern have been high since the death last September of teenager Jesse Gelsinger, who died while undergoing gene-therapy trials at the University of Pennsylvania (see Nature 401, 517; 1999).

“University presidents, such as myself, have to be more involved” in the supervision of human-subject research, says Dennis Smith, president of the University of Nebraska at Lincoln and co-chair of the AAU task force behind the plan. University presidents would welcome greater involvement in regulating research, adds Nils Hasselmo, president of the AAU, as the problems that result from lax regulation “end up on the presidents' desks”.

The AAU, which represents the presidents of 59 top US and two Canadian research institutions, says its proposals would require considerable investment from its members. But its plan goes further than the regulations being implemented at the universities by the federal government.

The scheme would involve university presidents more deeply in monitoring clinical research. It would commit resources for better training of the researchers involved in human-subject research, and strengthen the institutional review boards (IRBs) that review clinical trials. “Money needs to be made available to give the IRBs sufficient resources to do the job,” says Smith. “Another priority is to put more members of the public on IRBs.”

The AAU's plan would also establish a system of ‘voluntary accreditation’, similar to that in effect for animal research, to reassure the public that research subjects are protected.

Hasselmo says that most university presidents support the legislation proposed by Representative Diana DeGette (Democrat, Colorado), which aims to strengthen the fragmented IRB network. The Association of American Medical Colleges (AAMC), representing the medical schools, has already endorsed the bill. The AAU has yet to adopt a formal position.

Some patient advocacy groups say that self-regulation of human-subject research has already failed, most notably in Gelsinger's case. They want independent, external regulation, pointing out that neither the AAU nor the legislation before Congress provide this.

Under both DeGette's bill and the AAU's plan, institutions conducting human-subject research would register voluntarily for accreditation with an independent body. The Boston-based non-profit organization Public Responsibility in Medicine and Research (PRIM&R), which trains researchers and IRB members in human-subject protection, is preparing itself to fulfil this role, with the blessing of the AAMC and the AAU.

But Vera Sharav, president of Citizens for Responsible Care and Research, a New York-based group advocating research subjects' rights, dismisses PRIM&R as “an organization that represents the IRBs”. She ridicules the AAU for proposing “independent self-monitoring” at institutions. “Self-monitoring cannot be independent,” she says. The AAU says the phrase refers to monitoring by the universities, independent of the IRBs, and that the accreditation system will provide additional, external monitoring.

A spokesman for DeGette says the bill has strong bipartisan support, and that it should hopefully be the subject of Congressional hearings before the end of the month.