National Academies Press: OpenBook

Preserving Public Trust: Accreditation and Human Research Participant Protection Programs (2001)

Chapter: APPLYING THE MODELS TO HUMAN RESEARCH OVERSIGHT

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Suggested Citation:"APPLYING THE MODELS TO HUMAN RESEARCH OVERSIGHT." Institute of Medicine. 2001. Preserving Public Trust: Accreditation and Human Research Participant Protection Programs. Washington, DC: The National Academies Press. doi: 10.17226/10085.
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Page 53
Suggested Citation:"APPLYING THE MODELS TO HUMAN RESEARCH OVERSIGHT." Institute of Medicine. 2001. Preserving Public Trust: Accreditation and Human Research Participant Protection Programs. Washington, DC: The National Academies Press. doi: 10.17226/10085.
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Page 54
Suggested Citation:"APPLYING THE MODELS TO HUMAN RESEARCH OVERSIGHT." Institute of Medicine. 2001. Preserving Public Trust: Accreditation and Human Research Participant Protection Programs. Washington, DC: The National Academies Press. doi: 10.17226/10085.
×
Page 55
Suggested Citation:"APPLYING THE MODELS TO HUMAN RESEARCH OVERSIGHT." Institute of Medicine. 2001. Preserving Public Trust: Accreditation and Human Research Participant Protection Programs. Washington, DC: The National Academies Press. doi: 10.17226/10085.
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Page 56

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MODELS OF ACCREDITATION 53 Appeals Process Institutions that fail to get accredited or that are given probationary status will need a credible appeals process. This may be through the accreditation body itself or may require some involvement of FDA or OHRP.6 The NCQA standards include a standard for an appeals process by the applicant institution; the PRIM&R standards do not. Repeat Accreditation Accreditation is not permanent. The models of accreditation reviewed by the Lewin Group in 1998 involved accreditation terms of 3 to 5 years. The NCQA program plans a 3-year accreditation cycle. The AAHRPP accreditation term has not yet been firmly specified, but it is expected to be 3 to 5 years. The process for reapplication might or might not differ from that for initial accreditation. It is likely that accredited organizations with few untoward events would face a more abbreviated process, but this is likely to be decided in light of experience. APPLYING THE MODELS TO HUMAN RESEARCH OVERSIGHT Recommendation 1: Pursue Accreditation Through Pilot Testing as One Approach. Accreditation of HRPPPs should be pursued as one promising approach to improving the human participant protection system. The first step is implementation of pilot programs to test standards, establish accreditation processes, and build confidence in accreditation organizations. This effort should be evaluated for its impact on protecting the rights and interests of participants in 3 to 5 years. 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). 6 For example, mammography accreditation entails a two-layer appeals process, first to the private body, but if it is denied, then the private body's decision can be appealed directly to FDA (Lewin Group, 1998).

MODELS OF ACCREDITATION 54 Accreditation might also serve as an important educational tool. The process of preparing for accreditation would force institutions to attend to their HRPPPs, and that attention would necessarily entail education about the importance of protection of human participants in research. Accreditation could raise the median performance (average middle performance) of HRPPPs. It might offer HRPPPs located within research institutions, both public and private, a potent argument when asking their administrative supervisors for additional resources. (This is a major role played by accreditation of academic units within a university and is used as a tool to effect changes in, for example, library services, curricula, and services.) Accreditation could not serve these ends, however, until it became widely accepted as a mark of excellence. 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-starus model) could have several attractive features. Both OHRP and FDA have signaled that they might consider accreditation by a nongovernmental accreditation organization presumptive evidence of compliance with regulations. In the case of research institutions under OHRP oversight, accreditation could serve as a partial substitute for the assurance and compliance functions, reducing FDA and OHRP scrutiny of accredited organizations (allowing them to concentrate their scrutiny on nonaccredited organizations). FDA and OHRP would necessarily retain independent oversight authority (e.g., inspections “for cause”) and independent investigation and enforcement capacity if violations are alleged or documented and would periodically need to ”accredit the accreditors,“ as in other deemedstarus accreditation models. However, before the usefulness of this approach can be assessed in the case of HRPPP accreditation, an accreditation program(s) will need to be much further along in its development. The regulatory enforcement model is also worth considering, particularly as a starting point. It might be wise to start, as NCQA apparently proposes to do under its contract with the VA, with a focus on innovative or more effective means of evaluating regulatory compliance before moving on to a program that raises standards above the regulatory minimum. This approach could, however, have the effect of inundating HRPPPs with further paperwork if additional requirements are imposed on current ones. If the goal is to shift from a focus on such paper compliance to a focus on more meaningful performance measures, 7 Some accreditation programs fail to take root and flourish. An AMA physician certification program was announced with great fanfare in late 1996, but AMA discontinued the program in April 2000 because it had not been widely adopted. JCAHO implemented an accreditation program for managed care in 1987 but stopped in 1990, until a new managed care accreditation program was put in place in 1995 (BNA, 1996, 2000; Dimmitt, 1995).

MODELS OF ACCREDITATION 55 then a strategy that assumes that current oversight is the baseline will not accomplish it and any additional measures will add to the regulatory burden. Again, it is important to look carefully at what value accreditation adds to the regulatory program that already exists and whether this added value justifies the added costs (financial and personnel) of such a program. Testimony that the committee heard from representatives of the FDA and OHRP left it uncertain about whether the draft accreditation standards are seen as supplementing a regulatory program that will continue largely as is or as providing an alternative means of oversight, with federal agencies “deeming” accredited HRPPPs to be in compliance and thus reducing federal inspections and audits of accredited institutions. A voluntary national accreditation system, however, could decrease the burden currently experienced by regulators, allowing them to refocus their efforts where they are most needed, and it could also increase flexibility for entities attempting regulatory compliance. An independent accreditation organization(s) could more readily modify and improve its standards than federal agencies carrying out mandatory programs. Federal agencies attempting to modify their regulatory approach are less flexible because they must follow formal rule-making procedures to do so. 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 barrier, 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. The need to shift from paper compliance to measures that more meaningfully prevent unnecessary risks, promote sound scientific design, and ensure autonomous choice has been a consensus direction for improvement since regulations were first implemented. The call for better measures was articulated by the President's Commission for the Study of Ethical Problems in Medicine and Biomedical and 8 OPRR noted three agencies that appeared to sponsor research with human participants but that were not signatories to the Common Rule: the National Endowment for the Humanities, the U.S. Department of Labor, and the Nuclear Regulatory Commission, as cited in a report forthcoming from NBAC (NBAC, forthcoming-b). 9 The rigidity of the current regulatory framework, entailing the consensus of 18 agencies, is one major argument that NBAC offers to support its recommendation for new legislation to create a single federal agency with oversight authority for protection of human participants in research. This topic is beyond the scope of this committee's first report but will likely be taken up in its subsequent report.

MODELS OF ACCREDITATION 56 Behavioral Research (the President's Commission) in reviewing regulations created in the wake of the National Commission and echoed in reports of the Advisory Committee on Human Radiation Experiments (ACHRE) in 1995 and the Office of the Inspector General (OIG) of DHHS in 1998 and 2000 (ACHRE, 1995; DHHS OIG, 1998a,b,c,d, 2000a,b,c; President's Commission, 1981, 1983). Recommendation 2: Establish a Nongovernmental Accreditation Organization (s). Organizations formulating accreditation standards and carrying out the accreditation process should be independent, nongovernmental organizations. These organizations should include within their programmatic leaderships the perspective of the relevant stakeholders in the applicant HRPPP community (i.e., institutions, investigators, sponsors, and participants). As discussed above, one of the chief virtues of a nongovernmental accreditation system is that it can evolve over time without requiring new federal regulations at each step. 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).10 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. The parallel evolution of accreditation standards and HRPPP operations should be an iterative process, with the formulation of standards efficiently informed by knowledge acquired in the accreditation process. The formulation of standards, the conduct of accreditation site visits, and external evaluation must therefore be intimately linked and appropriately responsive to feedback. Organizations formulating standards and conducting the accreditation process should 1. be national in scope; 2. be familiar with the operations of institutions that apply for accreditation; and 3. incorporate the perspectives of research participants within their programmatic leaderships. 10 Circular A-119 was intended mainly for technical standards pertaining to products, but it also contemplates “related management systems practices” (see http://www.whitehouse.gov/omb/ circulars/a119/a119.html).

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Amid increasing concern for patient safety and the shutdown of prominent research operations, the need to improve protections for individuals who volunteer to participate in research has become critical. Preserving Public Trust: Accreditation and Human Research Participant Protection Programs considers the possible impact of creating an accreditation system to raise the performance of local protection mechanisms. In the United States, the system for human research participant protections has centered on the Institutional Review Board (IRB); however, this report envisions a broader system with multiple functional elements.

In this context, two draft sets of accreditation standards are reviewed (authored by Public Responsibility in Medicine & Research and the National Committee for Quality Assurance) for their specific content in core areas, as well as their objectivity and validity as measurement tools. The recommendations in the report support the concept of accreditation as a quality improvement strategy, suggesting that the model should be initially pursued through pilot testing of the proposed accreditation programs.

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