Kennedy Introduces Human
Research Protections
October 11, 2002-Saying that "reforms are long
overdue," Senator Edward Kennedy (D-Mass.) Oct. 4 introduced
legislation calling for significant changes in the system
of protections for human volunteers in research. The Research
Revitalization Act of 2002 (S.
3060) would extend federal "Common Rule" regulations
protecting human research participants to all research, regardless
of funding source. The bill also provides statutory authority
for the Office of Human Research Protections within the Department
of Health and Human Services.
The bill includes a number of provisions targeted at improving
the effectiveness of institutional review boards (IRBs), including:
- requiring accreditation of all IRBs;
- requiring investigators to notify IRBs if a research
proposal has been rejected by any other IRB;
- establishing rules for financial conflict of interest
for IRB members;
- allowing IRB expenses to be charged as direct costs on
federal grants; and
- allowing, on a voluntary basis, a central IRB to review
projects conducted at multiple local research sites.
The bill strengthens current rules on financial conflict
of interest for researchers, and establishes standards to
govern payments to research subjects. The bill also requires
HHS to establish a model program to train researchers in good
research practices and then provide grants to allow universities
to establish similar programs.
The bill calls for all human subject research conducted overseas
that falls within US regulatory jurisdiction to be reviewed
by a US-accredited IRB. The bill also requires rules governing
the use of placebos or non-treatment when effective therapies
could be administered to research subjects.
Noting that certain areas of research, such as gene therapy
or xenotransplantation, raise unusual safety concerns, the
bill requires special monitoring of adverse events in clinical
trials of such research so that threats to patient safety
can be identified.
Information:
Dave Moore, Senior Associate Vice President
AAMC Government Relations
dbmoore@aamc.org
(202) 828-0525
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