Senate Panel Reviews Adequacy
of Human Research Subjects Protections
April 26, 2002- The Senate Health, Education Labor,
and Pensions Subcommittee on Public Health held a hearing
April 23 on the adequacy of protections for human research
subjects. Characterizing the current situation as a "crisis
in confidence that imperils medical progress," Subcommittee
Chairman Edward Kennedy (D-Mass.) said that if patients fear
for their safety, future cures will be put in jeopardy. He
noted the changes in clinical research, including increasing
financial ties on the part of investigators, require modifications
to the oversight protections that have served well in the
past.
Senator Bill Frist (R-Tenn.), the subcommittee's ranking
member, echoed the concern that recent tragedies have shaken
the public's confidence and trust in research and joined with
Senator Kennedy in calling for bipartisan legislation to address
the gaps in federal oversight.
Marjorie Speers, Ph.D., executive director, Association for
the Accreditation of Human Research Protection Programs (AAHRPP),
described three major recommendations of the report - "Ethical
and Policy Issues in Research Involving Human Participants"
- for which she was project director while serving as Acting
Executive Director of the National Bioethics Advisory Commission.
First, federal legislation should be enacted to provide protections
to participants in both publicly and privately sponsored research.
Second, a single, independent federal office for human research
oversight should be created to issue a unified comprehensive
federal policy embodied in a single set of regulations and
guidance that would apply to all research involving human
participants. Finally, the research community must create
a culture of concern and respect. The federal government and
professional organizations should promote educational training
in human research protection, certification for individuals
and accreditation for institutions.
Dr. Speers also explained the purpose of AAHRPP, noting it
uses a "voluntary, peer-driven, educational model of
accreditation." By requiring institutions to meet an
explicit set of standards, which in some cases exceed federal
regulatory requirements, she said accreditation can raise
the level of protection beyond the minimal level set by the
government. She told the subcommittee that protecting research
participants is not the sole responsibility of the Institutional
Review Board (IRB) but "a duty shared by everyone who
conducts research." In response to a question from Senator
Frist, Dr. Speers said that AAHRPP can accredit different
types of institutions, including community hospitals, independent
IRBs, government agencies, and companies that conduct research.
Charles A. Johnson, MBChB, associate director of biotherapeutics,
Genetech, Inc., testifying on behalf of the Biotechnology
Industry Organization (BIO), told the subcommittee that although
industry-supported research is already heavily regulated,
some have called for additional restrictions. He noted that
BIO companies have spent considerable time evaluating the
existing system of research oversight and have identified
several key concerns and areas for improvement:
- Congress should eliminate the multiple and overlapping
layers of review, which lead to confusion and inefficiency
for participants as well as research sponsors;
- New regulations, such as the HIPAA privacy rule, will
increase the burden on an already overwhelmed IRB system;
- Regulatory oversight should be commensurate with the
risk to the research participants, with separate requirements
for interventional research and for research using medical
records or tissue archives;
- Consideration should be given to creating one national,
uniform set of rules governing research to eliminate differing
state laws that complicate the form of research review and
format of consent required in each state; and
- Ensure that research protocols are independently reviewed
and that all financial interests are disclosed to counteract
the strong and persistent perception that the presence of
private money in the health care setting creates conflicts
of interest in researchers that may affect results and the
quality of care provided to research participants.
P. David Charles, M.D., assistant professor of neurology,
Vanderbilt University Medical Center, testified on behalf
of the National Alliance of Medical Researchers and Teaching
Physicians, a coalition that advocates for the benefits of
technology to the health care system. Dr. Charles told the
subcommittee, "The challenge for the medical profession
and public policy makers is to strengthen safeguards without
creating new regulations so burdensome that they make it impossible
to complete vital research." The Alliance supports the
following principles for any new federal legislation:
- A comprehensive and uniform set of federal protections;
- Strong, informed, and independent oversight by IRBs;
- Effective privacy protections that do not prevent important
archival research; and
- Strong guidelines governing conflicts of interest that
require full disclosure of such arrangements.
Cherlynn Mathias, R.N., manager, Clinical Trials Department,
Harris Methodist Fort Worth Hospital, described alleged abuses
of human subjects protections she observed while employed
as a clinical trials manager at the University of Oklahoma,
including enrollment of ineligible patients in a clinical
trial, use of non-IRB approved protocols and informed consent
processes, and the absence of adverse event reporting. She
noted that the university, under the direction of President
David Boren, has now adopted many changes to its human subjects
protections.
Information:
Dave Moore, Senior Associate Vice President
AAMC Government Relations
dbmoore@aamc.org
(202) 828-0525
Get Washington Highlights
in your Inbox!
|
