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Suggested Citation:"WILL ACCREDITATION ENHANCE PERFORMANCE?." 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 61
Suggested Citation:"WILL ACCREDITATION ENHANCE PERFORMANCE?." 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 62

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MODELS OF ACCREDITATION 61 The emergence of accreditation bodies will introduce new organizations with important roles to play in learning from lapses in the system to ensure continuous improvement, making it all the more important to spell out the roles and responsibilities of different parties when serious infractions come to light. Large multicenter clinical trials now routinely include formal data safety and monitoring boards (DSMBs). DSMBs were initially established to assist research sponsors with analysis of their data, but their importance in assessing risk and monitoring safety has become apparent. Such boards are typically composed of researchers with expertise similar to that of the principal investigators, but they come from independent research institutions and are augmented by statisticians, bioethicists, and sometimes lawyers and consumers. The only personnel requirements for NIH DSMBs are that they include expert clinicians and experts in biometrics or statistics. 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). DSMBs may stop a trial if it appears to be causing harm or if its study objective is met early. A DSMB can also become the locus for receiving reports of mishaps and complaints, as well as adverse events and research outcomes. NIH has recently mandated that any NIH-sponsored clinical trial have a research monitoring plan and that the plan take into account the level of risk (NIH, 2000). The National Cancer Institute has mandated that any phase III trial (a large trial, typically conducted at many centers, intended to demonstrate the efficacy of an intervention) have a DSMB (NCI, 1999). The inclusion of such boards has been standard practice in most trials sponsored by private industry to test new drugs, devices, or biologics. The Good Clinical Practice portion of the International Conference on Harmonisation guidelines that govern clinical trials has an entire section (section 5.18) devoted to monitoring (International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use, 1996, pp. 26–29). The connections between DSMBs and IRBs are not completely consistent, however. Although all DSMBs are accountable to research sponsors for the integrity of the data, their role in ensuring safety and in protecting research participants is less well articulated. They are not always clearly accountable to IRBs, and their responsibilities to research participants or groups representing the interests of research participants are sometimes not explicit. WILL ACCREDITATION ENHANCE PERFORMANCE? The interaction between accreditation bodies and the organizations that they accredit can indicate new strategies for improving performance. Over the past three decades the constant lament of dozens of reports from a half dozen knowl

MODELS OF ACCREDITATION 62 edgeable commissions has been that the current HRPPP system emphasizes administrative compliance when it would do better to focus on the rights and interests of research participants, the risks that they face, and whether their choices are fully autonomous. Yet, the federal regulations governing the protection of human research subjects have been largely the same for 25 years, and it took a decade to get agreement on the federal Common Rule among 18 agencies. The arduousness of that task has itself become an argument for leaving the regulations intact, but that is a recipe for stagnation in a research enterprise that is rapidly growing and changing. Even an experiment to have a “central IRB” at the National Cancer Institute took 2 years to launch. The federal regulatory system is indeed rigid and focused on documentation rather than performance (see discussion under Applying the Models to Human Research Oversight). An accreditation process should “emphasize outcomes or performance rather than structure, process, and procedures,” and “successful accreditation bodies are flexible, future-oriented, and constantly looking at changes taking place in their fields to make sure the standards and review process are relevant to the needs of the accredited entities” (Hamm, 1997, pp. 72–73). For the first time in decades, the HRPPP system is in flux with the elevation of OHRP out of NIH and a recent shift to an IRB registration process linked to a streamlined assurance process by OHRP (OHRP, 2000b) along the lines of a recommendation by C. K. Gunsalus in a report to NBAC (Gunsalus, forthcoming). These changes were possible without a revamping of federal regulations, but flexibility beyond this will be more difficult to achieve. If a nongovernmental accreditation system could fulfill the promise of flexibility, provide an orientation toward performance, and provide adaptability, it could measurably improve the HRPPP system over time. In the immediate future, the emphasis on HRPPP accreditation, based on the draft standards and procedures proposed, appears to be bringing existing HRPPPs into compliance with existing federal regulations. The aspiration, however, is higher, and that may be possible, but the problem is difficult. In congressional testimony in 1994, Robyn Nishimi of the Office of Technology Assessment observed: The current system, while changing incrementally, has fallen short of implementing, or did not implement at all, recommendations made between 1973 and 1982 by an ad hoc committee of DHEW, a congressional report and two congressionally mandated commissions (Nishimi, 1994, p. 149). Since Nishimi made that statement, the nation has had reports from ACHRE (ACHRE, 1995), the General Accounting Office (GAO, 1996), and DHHS OIG (DHHS OIG, 1998a,b,c,d,e, 2000a,b,c). NBAC's report on those with mental disabilities and two forthcoming NBAC reports also contain many recommendations that warrant action (NBAC, 1998, forthcoming-a,b). An independent voluntary accreditation system appears to be one element that could improve the system as part of a long-term strategy and, thus, should be pilot tested and evaluated over the next several years.

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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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