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Fw: IOM Press Release: Reforms Needed...Human Research
The word "radiation" does not appear in this article, but much of this kind
of research involves ionizing radiation, and so any changes could be
relevant to some listmembers.
Michael G. Stabin, PhD, CHP
Assistant Professor of Radiology and Radiological Sciences
Department of Radiology and Radiological Sciences
Vanderbilt University
1161 21st Avenue South
Nashville, TN 37232-2675
Phone (615) 343-0068
Fax (615) 322-3764
e-mail michael.g.stabin@vanderbilt.edu
internet www.doseinfo-radar.com
> Date: Oct. 3, 2002
> Contacts: Christine Stencel, Media Relations Officer
> Chris Dobbins, Media Relations Assistant
> (202) 334-2138; e-mail <news@nas.edu>
>
> FOR IMMEDIATE RELEASE
>
> Broader Federal Protections, Other Reforms Needed
> To Ensure Safety of Human Research Participants
>
> WASHINGTON -- Broader federal oversight is needed to ensure that the
health
> and well-being of people who are enrolled in research studies, whether
> publicly or privately funded, are better-protected, says a new report from
> the Institute of Medicine (IOM) of the National Academies.
>
> Congress should require every organization conducting research with human
> subjects to do so under the authority of a research participant protection
> program, which would be subject to federal oversight. However, ultimate
> responsibility for ensuring that the essential protections are in place
and
> followed must rest with the highest levels of the research organization's
> leadership, said the committee that wrote the report.
>
> "It is understandable that the public has come to perceive that research
> institutions put more emphasis on insulating themselves from liability
than
> on protecting people from harm," said committee chair Daniel Federman,
> senior dean for alumni relations and clinical teaching and professor of
> medicine and medical education, Harvard Medical School, Boston. "There is
no
> single cause for the errors and mishaps that unfortunately have resulted
in
> the deaths of some research participants in recent years. Rather, a
> combination of stresses, weaknesses, and lack of accountability have
> strained the current hodgepodge of protections to the point that
fundamental
> changes are needed to protect all participants and keep public trust from
> being irrevocably eroded."
>
> The IOM report was commissioned following the death of 18-year-old Jesse
> Gelsinger during a 1999 clinical study at the University of Pennsylvania.
> This case, along with incidents at other research centers, highlighted
> growing problems, such as conflicts of interest, inadequate monitoring and
> oversight, and insufficient communication with participants.
>
> Federal agencies that conduct studies on humans follow a set of principles
> for protecting research participants known as the "Common Rule." But
> jurisdiction of this rule does not extend to non-federally funded
research,
> although a bill has been proposed to make it law. Private-sector research
to
> develop drugs, biologics, or medical devices is held to similar protection
> standards overseen by the Food and Drug Administration (FDA). However,
other
> privately sponsored research that is outside FDA's authority is not
required
> to follow specific protection standards, although many private
organizations
> have developed their own guidelines. Without universal standards, though,
> participants may not be consistently afforded basic protections, such as
> adequate information about risks or assurance that researchers do not have
> conflicts of interest, the committee said. Moreover, improvements must be
> made in the organization, funding, and oversight of these programs in both
> the public and private sectors.
>
> The participant protection program proposed by the committee is a system
of
> interdependent elements -- the investigators, the institution, the staff
> that monitors safety and data collection, the boards that review the
> scientific and ethical integrity of proposed research, and the research
> sponsor -- linked through explicit responsibilities for participant
> protection. Many of the functions recommended for the protection program
> currently are carried out by institutional review boards (IRBs), the
groups
> originally created by research institutions to review the ethics of
proposed
> research involving human subjects. However, as the number of studies
> performed each year has increased and demands on the research oversight
> system have intensified, IRBs have been called on to handle an ever-wider
> array of tasks, including institutional risk management, regulatory
> compliance, evaluation of increasingly complex scientific issues, and
> assessments of conflicts of interest.
>
> IRBs must return to the focused role they were originally intended to
serve
> -- reviewing the ethical issues of proposed protocols -- because the
boards
> do not necessarily have the expertise, authority, or resources to carry
out
> all of these additional tasks on their own, the committee said. Issues
> pertaining to institutional interests, such as compliance with rules and
> regulations, should be managed by other entities within the protection
> program. In most cases, existing offices or departments, such as an
> organization's compliance office and risk counsel staff, should be able to
> assume these responsibilities. Assessments of potential conflicts of
> interest should be the responsibility of research organizations'
> conflict-of-interest oversight bodies. Review of the scientific merits of
> proposed research should be carried out separately from the ethical
review,
> either by a subcommittee of the IRB or by a different group of experts.
>
> To ensure that the entire protection system receives credible, expert
> advice, Congress should establish an independent, multidisciplinary,
> nonpartisan advisory body. Its membership should include individuals who
can
> provide the perspective of the research participant. Since 2000, the
> National Human Research Protections Advisory Committee, created by the
U.S.
> Department of Health and Human Services, has provided expert advice to
> federal agencies on issues of participant protections. However, it was
> recently disbanded, although the administration has signaled that a new
> committee likely will be formed.
>
> In addition, reasonable compensation should be provided to people who are
> harmed as a result of their participation in studies, the committee said.
> Currently, the only recourse for such participants is to file lawsuits.
> While suits may be the appropriate avenue in cases where injuries result
> from negligence, misconduct, or product defect, research is never a
> risk-free enterprise and injuries may occur through no fault of the
> researchers or institutions. No-fault cases add to the judicial system's
> burden and compound the injured parties' aggravation.
>
> Acknowledging that more data are needed on the extent to which illness and
> injury happen in studies, the committee recommended the immediate creation
> of a no-fault compensation system to provide injured participants or their
> survivors quicker resolution of claims and relieve some of the burden on
the
> courts. Compensation should include at least the costs of medical care and
> rehabilitation and could be paid for either by the research organizations
or
> potentially through a federal compensation program. In addition, an
> examination of the burden of lost wages, and whether these should be
> compensated, should be undertaken. In cases where fault can be proved,
> participants could still seek redress through lawsuits.
>
> The report calls for a number of changes in the way institutions inform
and
> solicit input from research participants. The process of informed consent
> should focus on informing volunteers, not on protecting institutions, the
> committee said. Informed consent should entail an ongoing series of
> conversations between the investigators and the participants, rather than
a
> single conversation or signing of a document at the beginning of the
> process. These conversations should not only clearly communicate any
changes
> in the nature of the study, but also reiterate the risks, benefits, and
> other details necessary for individuals to make informed decisions about
> their ongoing participation.
>
> The study was sponsored by the U.S. Department of Health and Human
Services
> and the Greenwall Foundation. The Institute of Medicine is a private,
> nonprofit institution that provides health policy advice under a
> congressional charter granted to the National Academy of Sciences. A
> committee roster follows.
>
>
> Read the full text of Responsible Research: A Systems Approach to
Protecting
> Research Participants
> <http://www.nap.edu/catalog/10508.html?onpi_newsdoc100302> for free from
the
> National Academies at
> <http://www.nap.edu/catalog/10508.html?onpi_newsdoc100302>. Printed copies
> are available for purchase from the National Academies Press website or by
> calling (202) 334-3313 or 1-800-624-6242. Reporters may obtain a
> pre-publication copy from the Office of News and Public Information
> (contacts listed above).
>
>
> INSTITUTE OF MEDICINE
> Board on Health Sciences Policy
>
> Committee on Assessing the System for Protecting Human Research
Participants
>
> Daniel D. Federman, M.D.* (chair)
> Senior Dean for Alumni Relations and Clinical Teaching, and
> Carl W. Walter Distinguished Professor of Medicine and Medical Education
> Harvard Medical School
> Boston
>
> Daniel L. Azarnoff, M.D.*
> President
> D.L. Azarnoff Associates, and
> Senior Vice President of Clinical and Regulatory Affairs
> Cellegy Pharmaceuticals
> San Francisco
>
> Tom Beauchamp, Ph.D.
> Professor
> Kennedy Institute of Ethics
> Georgetown University
> Washington, D.C.
>
> Timothy Stoltzfus Jost, J.D.
> Robert L. Willett Family Professor of Law
> Washington and Lee University School of Law
> Lexington, Va.
>
> Patricia A. King, J.D.*
> Carmack Waterhouse Professor of Law, Medicine, Ethics, and Public Policy
> Georgetown University Law Center
> Washington, D.C.
>
> Roderick J.A. Little, Ph.D.
> Chair
> Department of Biostatistics
> School of Public Health
> University of Michigan
> Ann Arbor
>
> James McNulty
> President
> National Alliance for the Mentally Ill, and
> President, Depressive/Manic Depressive Association of Rhode Island
> Bristol
>
> Anne Petersen, Ph.D.*
> Senior Vice President for Programs
> Kellogg Foundation
> Battle Creek, Mich.
>
> Bonnie W. Ramsey, M.D.
> Professor
> Department of Pediatrics
> School of Medicine
> University of Washington
> Seattle
>
> Lydia Villa-Komaroff, Ph.D.
> Vice President for Research
> Northwestern University
> Evanston, Ill.
>
> Fran Visco, J.D.
> President
> The National Breast Cancer Coalition
> Washington, D.C.
>
> INSTITUTE STAFF
>
> Laura Lyman Rodriquez, Ph.D.
> Study Director
>
>
>
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