DeGette Reintroduces Human
Research Protection Proposal
December 5, 2003 - Rep. Diana DeGette (D-Colo.) Nov.
21 introduced legislation to expand federal protections for
volunteers in human research projects. The "Protection
for Participants in Research Act" (H.R.
3594) is based on a similar proposal (H.R.
4697) introduced in the 107th Congress by Reps. DeGette
and James Greenwood (R-Pa.).
The bill expands federal "Common Rule" protections
to all research participants, regardless of the source of
the funding for the project; calls for harmonization of HHS
and FDA patient safety regulations; outlines the composition
and responsibilities of institutional review boards (IRBs);
and delineates the conditions and process for informed consent.
The bill permits the Secretary of Health and Human Services
to "facilitate" the voluntary accreditation of institutions
and IRBs by a private accrediting entity.
The bill also provides statutory authority for the Office
of Human Research Protections (OHRP) within HHS, and provides
the office with a range of authorities for compliance and
enforcement, ranging from audits and required corrective action
plans, to suspension or termination of specific research projects
or suspension of all federally funded research at an institution.
Information:
Dave Moore, Senior Associate Vice President
AAMC Government Relations
dbmoore@aamc.org
(202) 828-0525
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