National Academies Press: OpenBook

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

Chapter: STANDARDS FOR QUALITY IMPROVEMENT AND SELF-STUDY

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Suggested Citation:"STANDARDS FOR QUALITY IMPROVEMENT AND SELF-STUDY." 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 72

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STANDARDS FOR ACCREDITATION 72 federal regulatory process does not possess the sensitivity and responsiveness to maintain pace with opportunities for improvement. STANDARDS FOR QUALITY IMPROVEMENT AND SELF- STUDY Recommendation 7: Incorporate Continuous Quality Improvement Mechanisms into Standards Accreditation organizations should emphasize the process of self-study, evaluation, and continuous quality improvement among applicants. They should move beyond documentation of informed consent and protocol review, which, although essential, do not of themselves protect the rights and interests of research participants. Standards provide an HRPPP with the opportunity for benchmarking, a continuous, systematic process used to make improvements. By periodically examining activities, policies, procedures, support functions, organizational performance, and the status of data collection and processing, an HRPPP can develop an approach to quality improvement. A sound system of self-assessment can identify the best practices in an organization and target areas in need of improvement. Compliance with regulatory requirements, in contrast, provides an important but irregular approach to ensuring that protections are in place. Thus, standards not only provide the basis for a system of self-study and improvement but also should incorporate the expectation of such a quality improvement system. This is not to say that self-study alone is sufficient. To maintain the integrity of the accreditation process, an HRPPP must conduct self-study as well as be subjected to external review (whether by an accreditation body or a regulatory agency). Standards should aim to improve outcomes and should not overly prescribe how to achieve the specified objectives. Rather, they should focus on the core standards that apply across programs and that are essential to a quality HRPPP. Current proposed standards generally reinforce the documentation practices required by federal regulations but do not yet go beyond the regulations. In general, both entities seeking accreditation and accreditation bodies should identify exemplary performance and best practices, providing benchmarks for the research community at large and making information on organization performance openly available to the public and policy makers. In this way, for example, an HRPPP demonstrating a particularly reliable system for the monitoring of participant safety or the reporting of problems in ongoing research, might have an advantage over nonaccredited competitors in seeking support from sponsors or having access to participants, researchers, or students.

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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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