WASHINGTONMedicine and other sciences need to move
beyond institutional review boards (IRBs) and adapt a broader focus for
protecting participants in human research studies, according to a new Institute
of Medicine (IOM) report. It recommends a vigorous accreditation system to
oversee what it terms "human research participant protection
programs," or HRPPPs.
"The need to improve protections has become more apparent
as report after report has highlighted mounting concerns about the ability of
the participant protection system to keep up with the evolving research
enterprise," the report stated.
HRPPPs exist in the nation today in many forms, although not
generally under that name and not as a single recognized entity, the committee
that wrote the IOM report concluded. Essentially, four principal functions
comprise an HRPPP, it said:
To ensure a sound study design and to ensure that its
potential for advancing knowledge justifies the use of human participants.
To provide an assessment of a study’s risks and benefits
independent of the researchers involved.
To ensure that a person’s participation is voluntary and
To ensure that participants are recruited equitably, and
that risks and benefits are distributed fairly.
These four basic responsibilities need to be considered as a
whole and subject to accreditation procedures, the report argued.
Committee chair Daniel D. Federman, MD, professor of medicine
and medical education, Harvard University, said that "accreditation does,
indeed, possess strong potential as a mechanism to strengthen the participant
protection system." He said that this approach should be pursued as soon
as possible and called pilot testing of any accreditation program critical to
the eventual success of the effort.
Accreditation, when viewed as a mark of excellence, might offer
"a competitive advantage over nonaccredited competitors in seeking support
from sponsors or access to participants, researchers, or students," the
Incidents Raise Concerns
The IOM committee began a two-part study of participant
protection issues in human trials last year at the request of the Department of
Health and Human Services, after several incidents in 1999 raised concerns
about the adequacy of measures to ensure protection of study participants.
First, the former federal Office of Protection from Research
Risks and the Food and Drug Administration suspended human research programs at
several major universities for noncompliance with federal regulations.
Second, an 18-year-old volunteer in a University of
Pennsylvania gene therapy experiment died as the result of his treatment. A
follow-up investigation found "that the system intended to protect him
from unacceptable research risks instead failed him," the IOM report
The new report, Preserving the Public Trust: Accreditation and
Human Research Participant Protection Programs, is focused solely on
The committee is continuing with a more comprehensive
assessment of the overall system for protecting human research volunteers,
which it will issue next year. That study will examine ways to improve the
informed consent process, ease the burdens on IRBs, and ensure that
investigators are educated about the ethics and practices of conducting
In its review, the panel examined two draft standards and
accepted one developed by the private National Committee for Quality Assurance
(NCQA) for the Department of Veterans Affairs as a framework for other groups
wanting to initiate accreditation programs.
The report cited the NCQA standards because they "include
specific attention to quality improvement, provide flexibility in achieving
performance goals (eg, increased protection of research participants), and are
explicit in their grounding in current regulations."
In expanding the draft NCQA standards for use beyond VA
facilities, the committee recommends that the standards be strengthened in
several specific ways, including how investigators will be reviewed (beyond the
review of protocols by IRBs); how sponsors will be assessed; how participants
will be involved in setting performance standards; and how oversight mechanisms
can ensure participants’ safety.
"Any set of standards must be flexible enough to be
applicable to a variety of institutions yet rigorous enough to ensure that
their enactment enhances protection of participants in human research,"
the committee said.
The committee further recommended that research participants
should be included in the formulation of accreditation standards, the
accreditation process, and all HRPPP operations.
It also advised that the accreditation process "should
accommodate organizations involved in research beyond the traditional research
organization models involved in academic health centers and VA
facilities." And it recommended that accreditation standards be developed
for all research programs involving humans, including behavioral and social
"Whether it is a demographic survey used to develop
marketing ads or a clinical trial testing the efficacy of a new therapy,
research involving humans is touching all of our lives with increasing
frequency," Dr. Federman said.
He indicated that the cornerstone of this research is trust:
"Trust between the individual participating in a research study and the
investigator, the university, the hospital, or the private company conducting
To preserve this trust, he said, the research system and the
specific mechanisms for protecting human research participants "must be
credible and accountable to the public."