IOM Issues Report on Human
Research Protection Programs
October 11, 2002-The Institute of Medicine (IOM),
at the request of the Department of Health and Human Services,
Oct. 3 issued a report
titled "Responsible Research: A Systems Approach to Protecting
Research Participants," which addresses recent events
and challenges faced by the national system that ensures the
ethical protection of human volunteers who participate in
research. The Committee on Assessing the System for Protecting
Human Research Participants, chaired by Dr. Daniel Federman
of Harvard Medical School, recommends a national strategy
to ensure both the protection and the ethical conduct of research
involving human participants. To achieve these goals, the
committee advocates a systems approach, labeled the Human
Research Participant Protection Program (HRPPP), which would
include several interdependent components: research organizations,
IRBs, investigators, sponsors, and the volunteer participants.
From its analysis, the committee generated tables that delineate
the units (e.g., agencies, organizations, offices, or individuals)
that should be held accountable for implementing each recommendation.
The report strongly endorses federal oversight of all research
involving human participants (regardless of the source of
funding) and federal establishment of a standing independent
committee on human research participant protections. Aside
from these two recommendations that would require Congressional
action, it is noteworthy that the other recommendations in
the report can all be implemented by research organizations,
sponsors, and federal agencies under existing law and regulations.
The committee emphasized the important role of the senior
institutional leadership in establishing a culture of research
excellence and a commitment to research participant protection.
In addition, the report stressed that IRBs should concentrate
on evaluating the ethical aspects of research protocols, and
toward this end, proposes that IRBs be renamed Research Ethics
Review Boards (Research ERBs). The report endorses an earlier
recommendation from the National Bioethics Advisory Commission
that 25 percent of an IRB's membership should be composed
of individuals without ties to the research organization,
to enhance and monitor the quality of the HRPPP's performance
and recognize that the role played by research participants
in the process is pivotal.
The report's recommendations are designed to guide HRPPPs
and policy makers toward these goals, and include:
- emphasizing the central responsibility of the IRB in
reviewing the ethics of human research protection and
delegating scientific and financial conflict of interest
reviews to other bodies;
- streamlining multi-site trial reviews through the use
of one identified lead review committee;
- refocusing the informed consent process so that it
is an ongoing series of dialogues that continually ascertains
the understanding of the participant about the research
project;
- compensating through a no-fault system for which sponsors
and institutions would be responsible for injury that
results from participation in research;
- including an accreditation standard to establish accountability
for specific protection functions; and
- harmonizing and strengthening practices for safety
monitoring and adverse event reporting.
The IOM concludes that medical progress relies on ensuring
that "the interests and dignity of every research participant
are diligently protected throughout the research process."
Information:
Eva Loh, Staff Associate
AAMC Biomedical Health Sciences Research
eloh@aamc.org
(202) 828-0485
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