US Lawmakers Propose New Protections for Human Research Subjects

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Lawmakers Propose New Protections for Human Research Subjects

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. DeGette (D-CO) and

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

Gelsinger during a gene therapy trial at Baltimore's s

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.

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