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

Chapter: RECOMMENDATION FOR INITIAL STANDARDS TO BEGIN PILOT TESTING

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Suggested Citation:"RECOMMENDATION FOR INITIAL STANDARDS TO BEGIN PILOT TESTING." 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 84
Suggested Citation:"RECOMMENDATION FOR INITIAL STANDARDS TO BEGIN PILOT TESTING." 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 85
Suggested Citation:"RECOMMENDATION FOR INITIAL STANDARDS TO BEGIN PILOT TESTING." 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 86
Suggested Citation:"RECOMMENDATION FOR INITIAL STANDARDS TO BEGIN PILOT TESTING." 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 87
Suggested Citation:"RECOMMENDATION FOR INITIAL STANDARDS TO BEGIN PILOT TESTING." 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 88

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STANDARDS FOR ACCREDITATION 84 RECOMMENDATION FOR INITIAL STANDARDS TO BEGIN PILOT TESTING Recommendation 9: Use Modified NCQA Standards to Initiate Pilot Programs Pilot accreditation programs should start from the accreditation standards and processes proposed by NCQA for VA facilities, as adapted for use in other organizational contexts. In expanding the draft NCQA accreditation standards for use beyond VA facilities, the standards should be strengthened in six specific ways as pilot testing commences. The PRIM&R standards were prepared for a broad set of potential applicant organizations, which would include but not be restricted to academic health centers. The NCQA standards were explicitly prepared for accreditation of VA medical facilities. In this instance, the applicant pool is defined, and, in fact, pilot tests that will use those standards are being planned as this report goes to press. As noted throughout this discussion of report recommendations, the committee regards the NCQA standards as an excellent starting point for accreditation of VA facilities. The committee recommends, however, that the NCQA standards be strengthened in six areas, to specify (1) how investigators will be reviewed beyond the review of the protocols that they submit for IRB approval;8 (2) whether and how research sponsors will be assessed in the accreditation process;9 (3) how participants will be involved in setting standards and accrediting HRPPPs;10 (4) how oversight mechanisms can ensure participants' safety in ongoing research;11 (5) the steps that research institutions and their leadership can take to cultivate a culture that puts the safety and interests of research participants foremost;12 and (6) mechanisms by which research institutions and, where applicable, research sponsors can be held accountable for ensuring sufficient funding, structural support, and professional rewards for HRPPPs.13 8 For research programs involving only a small set of investigators, accreditors might contact all of them; for most programs, however, accreditors would need to sample investigators in a way that is independent of control by the IRB or the institution's research administration. How to do this will likely vary by institution and will have to be specified in advance by the accreditation body. The sampling procedure is likely to evolve during the pilot testing phase. 9 Some organizations do little or no externally sponsored research so they would be exempt from this aspect of accreditation review. Organizations that do sponsored research will vary widely in the number of protocols and the kinds and numbers of sponsors. For programs with extensive externally sponsored research portfolios, accreditation bodies will need to develop sampling methods that are credible and independent of the organization's IRBs and research administration. Standards for this aspect of review could initially start from the ICH-GCP guidelines noted in Table 3.1. 10 Accreditation bodies will need to develop methods to sample participants in a manner that is credible and independent of IRBs and research administrators of the organizations seeking accreditation. Participants were not surveyed in the 1998 survey of IRBs and investigators commissioned by National Institutes of Health (Bell et al., 1998), yet the committee believes that participant perspectives are essential to judging whether an HRPPP is operating effectively.

STANDARDS FOR ACCREDITATION 85 BOX 3-1 THE INTERNATIONAL CONFERENCE ON HARMONISATION OF TECHNICAL REQUIREMENTS FOR REGISTRATION OF PHARMACEUTICALS FOR HUMAN USE The International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use is a project that brings together the regulatory authorities of Europe, Japan, and the United States and experts from the pharmaceutical industry in the three regions to discuss scientific and technical aspects of product registration (or, in the United States, approval for marketing). The purpose is to make recommendations on ways to achieve greater harmonization in the interpretation and application of technical guidelines and requirements for product registration to reduce or obviate the need to duplicate tests carried out during the research and development process for new medicines. The objectives of such harmonization are the more economical use of human, animal, and material resources and the elimination of unnecessary delay in the global development and availability of new medicines while maintaining safeguards on quality, safety and efficacy, and regulatory obligations to protect public health. The Guideline for Good Clinical Practice is an international ethical and scientific quality standard for the design, conduct, recording, and reporting of trials that involve the participation of human subjects. Compliance with this standard provides public assurance that the rights, safety, and well- being of trial subjects are protected, consistent with the principles that have their origin in the Declaration of Helsinki, and that the clinical trial data are credible. The objective of the International Conference on Harmonisation Guideline for Good Clinical Practice (ICH-GCP) is to provide a unified standard by which the European Union, Japan, and the United States can facilitate the mutual acceptance of clinical data by their respective regulatory authorities. The guideline was developed with consideration of the current good clinical practices of the European Union, Japan, and the United States, as well as those of Australia, Canada, the Nordic countries, and the World Health Organization. Investigators should follow this guideline when they are generating clinical trial data that are intended to be submitted to regulatory authorities. The principles established in ICH-GCP may also be applied to other clinical investigations that may have an impact on the safety and well-being of human subjects. SOURCE: http://www.ifpma.org/ich5.html.

STANDARDS FOR ACCREDITATION 86 The NCQA standards, if improved as recommended, could also be used—by NCQA, the Association for the Accreditation for Human Research Protection Programs (AAHRPP), or other accreditation organizations—as the basis for the development of accreditation standards for non-VA research organizations. Accreditation will not be successful until it is widely accepted as a mark of excellence. To accomplish this, it should serve as an educational tool to raise the median overall performance of an accredited organization. To do this, accreditation standards and the processes in which they will be used must incorporate consistent feedback from the parties involved in the various aspects of an HRPPP. As discussed above, the local aspects of this issue (i.e., aspects that apply to individual applicant institutions) should be enhanced in the NCQA standards. The committee is encouraged that both NCQA and AAHRPP include stakeholder representatives in their programmatic leaderships (see Recommendation 2). Those who encounter problems in the research protection system, irrespective of the perspective that they represent in that system, need simple, con 11 Chapter 3 describes some options for research monitoring and feedback. When organizations applying for accreditation conduct research that is monitored by DSMBs, for example, details of how those boards interact with investigators, IRBs, and research administrators would need to be evaluated for all or a representative sample of DSMBs. Reporting mechanisms for severe or unanticipated adverse events would similarly be necessary to evaluate all protocols or a representative sample of protocols. Ombudsman programs and reporting mechanisms for concerns, complaints, and other feedback mechanisms would be included. Pilot testing will likely reveal a wide variety of monitoring and feedback methods that will have to be accommodated in the accreditation process. 12 PRIM&R's Standard 1.16 calls for assessment of quality improvement programs, and NCQA's standards presented in Table C-3(B) do so with even more specificity. The committee believes that procedures for evaluating the informed-consent process in particular deserve special attention and will be both the foundation of effective protections and the best hope of shifting from documentation to performance measures. 13 Budget and staffing for IRB operations, monitoring and ombudsman programs, and other HRPPP components are not sufficient to evaluate quality and effectiveness. Insufficient budgets and staffing, however, would be clear indications of deficiencies. The committee sought information about budgets and staffing, but found few data. (The 1998 report by Bell and colleagues contains some data on IRBs and investigators at 491 institutions; it does not, however, include data on IRBs regulated only by the FDA, monitoring bodies, or administrative costs.) Extant data were insufficient for the committee to develop benchmarks for different kinds of organizations seeking accreditation. Such benchmarks will thus have to be established in light of experience from pilot testing.

STANDARDS FOR ACCREDITATION 87 sistent ways to bring their concerns to light and to bring relevant information into the procedure for the review of the process at the level of both the HRPPP and the accreditation process. It is the committee's understanding that the NCQA standards will be tested in a pilot study beginning in the spring of 2001.14 This is an important step in gauging the feasibility of the use of these standards for the accreditation process, and the committee encourages similar pilot testing with appropriately modified standards in non-VA research environments. 14 As this report went to press, NCQA made their draft standards available for public comment. See http://www.ncqa.org/Pages/Programs/QSG/VAHRPAP/vahrpapdraftstds.htm for further information.

STANDARDS FOR ACCREDITATION 88

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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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