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

Chapter: DEVELOPING MEASURES TO ACCOMPANY STANDARDS

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Suggested Citation:"DEVELOPING MEASURES TO ACCOMPANY STANDARDS." 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 67
Suggested Citation:"DEVELOPING MEASURES TO ACCOMPANY STANDARDS." 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 68

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STANDARDS FOR ACCREDITATION 67 2. They should be flexible and adapted to different kinds of research and different research institutions. 3. They should encourage accredited organizations to shift from a culture that relies on external compliance checks to a culture that puts safety and voluntary participation foremost. 4. They should facilitate compliance with federal regulations but should aim to move an organization toward having stronger protection of human research participants. 5. To the extent possible, they should focus on the use of meaningful measures of how well the rights and interests of research participants are being protected rather than simple determination of whether informed-consent statements have been signed or IRB meetings were duly constituted. Measurement of an organization's compliance with the procedural requirements set forth by standards serves as a proxy for ascertainment of the organization's level of compliance with the ethical principles that underlie the standards. In its early discussions, the committee noted that beyond the primary aspiration of protecting those who participate in research, institutions seeking accreditation will be motivated by other aims as well, for example, enhancing the qualities and reputations of their research programs (and, as a result, potentially improving their financial status or prestige), attracting faculty and students to their graduate research training programs, and facilitating the recruitment of individuals as research participants. A successful system of accreditation must offer incentives for participation, such as enhancing the likelihood that a program in compliance with the standards will attract these resources. In addition, a successful accreditation system must have realistic and enforceable mechanisms by which to deter noncompliance with the standards (e.g., suspension from the program or loss of accreditation). DEVELOPING MEASURES TO ACCOMPANY STANDARDS Standards must be developed with consideration of the measures that will be used to evaluate an organization's level of compliance. The processes of developing standards and designing a set of tools that can be used to measure compliance (i.e., accreditation) cannot generally be uncoupled. The measures must address areas in which performance is likely to have a significant impact on the protection of human research populations. In addition, they must be precisely defined and specified, that is, standardized with explicit predefined requirements for data collection and for calculation of the value of the measure or the score for the measure. Furthermore, for the purpose of accreditation, there must be documentation for the measure that includes defined data elements,

STANDARDS FOR ACCREDITATION 68 corresponding data sources, and allowable values. Such measures must be reliable— that is, the measurement should be able to identify consistently the events that it was designed to identify across multiple HRPPPs over time—and they must be valid, that is, they must capture what they were intended to measure. The tools used to measure compliance with standards should be easily interpreted by those who use the resulting data, including accreditors, research participants, and those conducting or overseeing the research. Finally, determinations of the levels of compliance with the standards must be based on data. HRPPPs seeking accreditation will be required to provide evidence of compliance. This evidence must be supported by a reasonable data collection effort. In the development of standards, accreditation bodies must be mindful of the availability and accessibility of the required data elements and the effort and cost of abstracting and collecting data. In general, standards should help HRPPPs and accreditation bodies identify exemplary performance and best practices, thus serving as a benchmarking service for the organizations seeking accreditation. In addition, ideal standards would provide the content for publicly available comparative reports on the performance of the accredited organization. This view of accreditation standards is reflected in Understanding Accreditation (Young et al., 1983), which notes four trends in the accreditation process: (1) it has moved from a more quantitative to a more qualitative system of assessment, with more general rather than specific standards; (2) it has placed less emphasis on making institutions look alike and more emphasis on a stance of recognizing and encouraging individuality; (3) it has evolved from a system based more on external review to a system of self-evaluation and self-regulation; and (4) it has moved from a focus on the institution to a focus on encouraging and assisting the organization in its efforts to improve quality. In this light, standards should describe important functions related to the protection of research participants, and they should be framed as performance objectives that are unlikely to change substantially over time. Because standards aim to improve outcomes, they should place minimal emphasis on how to achieve these objectives. In addition any set of standards should make clear which standards are cores, that is, those that must be applied across programs and that are essential to an HRPPP. Some standards, such as those that directly relate to the protection of human research participants, should carry more weight than others. It is especially important that clear measurement tools be available for core standards and that guidance on how the measurement will be interpreted is available.

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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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