WASHINGTON (Reuters Health) May 09 - Human subjects would have a legal right
to be made aware of researchers' conflicts of interest under a bipartisan bill
introduced in the US House on Thursday.
The proposal would require researchers conducting studies with tax dollars
to disclose their conflicts of interest both to patients and to institutional
review boards (IRBs). Similarly, members of IRBs would have to report their
financial ties with industry to academic institutions.
The bill, introduced by Reps. Diana DeGette (D-CO) and James Greenwood
(R-CA), also writes into law the federal Office of Human Research Protection.
The office already operates within the Department of Health and Human Services
but has no authorization from Congress.
The bill is a largely a rehash of a proposal introduced in the US House in
2000. But the new legislation avoids several controversial areas that thwarted
agreement among lawmakers in the past.
Momentum for passing human research rules in Congress has mounted in the
wake of several highly publicized deaths of patients involved in experiments
at US universities. They include the death of 18-year-old Jesse Gelsinger
during a gene therapy trial at Baltimore's Johns Hopkins University in early
2000.
The proposal applies the Common Rule -- a set of federal research
regulations -- to all public and private research conducted at hospitals and
academic medical centers and by contract research organizations.
It allows IRBs to pay for heightened responsibilities by taking overhead
costs out of grant money coming from funders like the National Institutes of
Health. The money could go to enhanced education and training of members and
new federal reporting requirements ordered under the proposal.
The bill avoids forcing IRBs to obtain federal accreditation before
reviewing research. Some Democrats in the Senate, which is working on its own
research protection legislation, have called for such a requirement.
Sponsors said that they worked closely with the health industry and
academic research groups in crafting the legislation. Those groups have warned
that overly restrictive laws could slow down important research.
"The goal of this legislation is to improve, and not to hinder, medical
research," DeGette said.
The bill calls on federal officials to harmonize government research
regulations that have been a source of confusion for some investigators. It
would compel the HHS Secretary to come up with regulations that find a middle
ground between rules in the Food, Drug and Cosmetics Act, which governs
privately funded research, and the Public Health Services Act, which governs
publicly funded experiments.
Recommendations issued in April 2000 by the HHS Inspector General urged
Congress to address conflicts of interest, mounting IRB workloads, and spotty
federal oversight of human studies.
"We've adopted virtually every one of the recommendations," said Rep.
Greenwood, who chairs the Energy and Commerce health subcommittee.
The new proposal includes no civil or criminal penalties on researchers,
institutions, or companies who break the law. "We want to see how well
compliance works with what we've proposed," one House Democratic aide said.
Greenwood said that the Biotechnology Industry Organization has thrown its
support behind the proposal, though the group was not available to comment on
the bill by press time.