Preserving Public Trust Accreditation and Human Research Participant Protection Programs (2001) / Chapter Skim
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2 Models of Accreditation
2 Models of Accreditation
Pages 45-62
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From page 45... ...
" The present committee will spend another year thinking about the design and implementation of an improved system of human research protection, so it has not had the opportunity to consider the value of accreditation compared with other strategies to ensure the ethical conduct of research. However, even if one begins with the current system rather than a reconstructed one, accreditation should not be evaluated in a vacuum it is still necessary to have a theory of accreditation and a process for carrying it out.
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From page 46... ...
Another variant of nongovernmental voluntary accreditation is seen under Medicare's "deemed-status" program, in which the Joint Commission on Accreditation of Healthcare Organizations (JCAHO) hospital accreditation program serves as an alternative to state certification, which uses Medicare's own federal regulatory standards as a basis for hospital participation in Medicare (Jost, 19941.
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From page 47... ...
This strategy will improve research oversight only if noncompliance is one of the system's major problems. The same model could, however, also be used to augment regulatory standards if some accreditation standards exceed the regulatory minimum.
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From page 48... ...
a set of standards by which HRPPPs can be measured. The central focus of this report and the following chapter is accreditation standards, the benchmarks by which accreditation programs measure achievement.
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From page 49... ...
AAHRPP is designed to bring together diverse stakeholder organizations with the intent of implementing a voluntary accreditation process. AAHRPP was originally incorporated in Massachusetts in March 2000, but it is expected to be incorporated in Maryland in spring 2001 as a private nonprofit corporation to 'provide a process of voluntary peer review and education among organizations concerned with research involving human subjects, in order to promote preservation of rights and welfare of subjects in research and 2 For more information, see http://www.primr.org.
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From page 50... ...
, the Association of American Universities, the Federation of American Societies for Experimental Biology, the National Health Council, the National Association of State Universities and Land Grant Colleges, and the Consortium of Social Science Organizations (Accrediting Body for Human Subjects Research Nears Reality, 2001~. The VA and NCQA Accreditation Process In March 1999, clinical research at the West Los Angeles VA Medical Facility was suspended because of noncompliance with the Common Rule (see Chapter 1~.
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From page 51... ...
. 4 Multi-Center Academic Clinical Research Organization, or MACRO, brings together five major academic health centers Baylor College of Medicine, Harvard Clinical Research Institute, the University of Pennsylvania School of Medicine, Vanderbilt University, and Washington University School of Medicine under a collaborative agreement that includes an agreed upon system for protocol review by IRBs among the institutions (for more information, see http://www.mc.vanderbilt.edu/ctc/macro.html)
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From page 52... ...
This pool is limited, however, and it would be unrealistic to expect a new accreditation organization to manage more than one or two site visits per week, on average, during its first year. The minimum of potential applicants can be estimated by the 165 institutions that registered their IRBs with the Office for Human Research Protections (OHRP)
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From page 53... ...
Accreditation as a mark of excellence of achievement well beyond regulatory compliance might offer an HRPPP a competitive advantage over nonaccredited competitors in seeking support from sponsors or access to participants, researchers, or students. That is, NIH or other funding review committees might look more favorably on research proposals from accredited institutions than on those from nonaccredited ones, those recruiting participants might advertise accreditation as a hallmark of quality and safety, or private drug and device firms might preferentially site clinical trials that they sponsor at accredited research institutions (or have them reviewed by accredited IRBs)
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From page 54... ...
Any accreditation program seeking to establish its value on the basis of these terms would first need to achieve broad recognition as a credible program. All previous accreditation programs faced a similar dilemma when they were initiated, and some have succeeded in attaining credibility, but others have not.7 Accreditation that would supplant regulation (the deemed-status model)
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From page 55... ...
It took a decade to reach agreement on the federal Common Rule, and at least three agencies that conduct research with human participants did not adopt the rule,8 leaving all agencies loathe to reopen the process used to modify the regulations. The current need for multiagency concurrence is a tremendous barner, and so short-term improvements are more likely to come from other approaches, such as nongovernmental accreditation, that do not require major regulatory overhaul.9 The most compelling argument in favor of an independent accreditation system, however, is that, if it is done right, it could move the focus of oversight from simple administrative documentation to focusing on processes and outcomes that more directly threaten the rights and interests of participants.
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From page 56... ...
The regulations are demonstrably unresponsive to dramatic changes in how research is conducted; a nongovernmental accreditation system may be more responsive by comparison and would comport with Circular A-119 of the Office of Management and Budget, which urges the use of nongovernmental "voluntary consensus standards" where possible (OMB, 1998~.~° The committee envisions an accreditation process that will continually evolve to update standards over time and to incorporate the variety of organizational structures through which human research programs are reviewed and carried out. The operations of organizations seeking accreditation will also evolve.
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From page 57... ...
Monitoring, investigation, and enforcement are necessary to augment an accreditation system, and under the current regulatory framework these will remain functions of OHRP and the FDA. ~ The main cause of error in many prominent controversies in research ethics lies with investigators who diverge from an agreed-upon protocol.
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From page 58... ...
and the death of Jesse Gelsinger in gene transfer experiments at the University of Pennsylvania in 1999, for example~2 appear to be attributable to the conduct of principal investigators and their collaborators or to institutional decisions unrelated to the IRB, so it is not clear how accreditation of an HRPPP could prevent such cases. An accreditation body should not be expected to be the original source responsible for uncovering violations or the main body responsible for investigating or sanctioning them.
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From page 59... ...
In a background paper written for NBAC, Charles McCarthy, drawing on two decades of direct experience with federal oversight of protection of human participants in research, argued that the measure most important to improving the ethical conduct of research is education—of investigators, IRB members, IRB staff, and those working at research institutions (McCarthy, forthcoming)
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From page 60... ...
Research monitoring may be the more important function of the system, but effective monitoring is much harder to measure. The current HRPPP system attends to the functional equivalent of maintenance records by documenting informed-consent forms and IRB deliberations, but it appears to be less adept at identifying and investigating serious breaches or systematically detecting danger signals in ongoing research.
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From page 61... ...
These monitoring boards receive reports of study outcomes, including both intended effects and adverse events. They pool findings from multiple centers (findings which the individual centers often do not receive and to which only research sponsors would otherwise have access)
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From page 62... ...
The federal regulatory system is indeed rigid and focused on documentation rather than performance (see discussion under Applying the Models to Human Research Oversight)
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