DeGette, Greenwood Introduce
Bill to Protect Research Participants
May 17, 2002- Reps. Diana DeGette (D-Colo.) and Jim
Greenwood (R-Pa.) May 9 introduced legislation to expand federal
protections for human volunteers in research, regardless of
the funding source. The "Human Research Subjects Protections
Act of 2002" (H.R.
4697) mandates the composition and responsibilities of
institutional review boards (IRBs), including receiving reports
of "actual conflicts of interest, or interests that create
the appearance of a conflict of interest." The bill permits
the Secretary of Health and Human Services to "facilitate"
the voluntary accreditation of IRBs by a private accrediting
entity. The bill also mandates the conditions and process
for informed consent.
The bill provides statutory authority for the Office of Human
Research Protections within HHS, and provides the office with
a range of authorities for compliance and enforcement, ranging
for audits and required corrective action plans, to suspension
or termination of specific research projects or suspension
of all federally funded research at an institution.
The bill creates a new category of "high risk clinical
trials" to be defined by the Secretary that will be subject
to additional data safety and monitoring requirements. The
bill also calls on the Secretary to review the provisions
of the Common Rule and FDA regulations governing human research
with the goal of harmonizing the two sets of rules, and to
issue proposed modifications to one or both sets of rules
within three years of the bill's enactment.
Information:
Dave Moore, Senior Associate Vice President
AAMC Government Relations
dbmoore@aamc.org
(202) 828-0525
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