Preserving Public Trust Accreditation and Human Research Participant Protection Programs (2001) / Chapter Skim
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3 Standards for Accreditation
3 Standards for Accreditation
Pages 63-88
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From page 63... ...
The standards are intended to guide organizations seeking private voluntary accreditation in the assessment of their human research protection programs (HRPPs) and to be used by independent site visitors during the accreditation process.
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From page 64... ...
The three sets of standards were reminders of the vastness of the research enterprise and the distinctive nature of certain types of research and research settings. For example, the PRIM&R standards appear to focus on research conducted in traditional academic health care settings, the NCQA standards encompass research conducted by the VA in its own self-contained health care system, and the ICH-GCP guidelines are specific to investigators and sponsors conducting clinical trials, a specialized type of research with human participants.
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From page 65... ...
In the United States, the principles embodied in The Belmont Report have served as the foundation for the ethical requirements in human research (National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research, 1979~. The three basic ethical principles in The Belmont Report are (1)
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From page 66... ...
They should be based on sound and widely accepted ethical principles.2 ., ~ The committee does not mean that any member who could have a conflict with any conceivable protocol coming to an IRB for review should be excluded from service on an IRB but, rather, that the individual should recuse himself or herself from reviewing such protocols. 2 The principles laid out in The Belmont Report are one foundation (National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research, 1979~.
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From page 67... ...
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)
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From page 68... ...
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.
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From page 69... ...
. One of the virtues of a nongovernmental voluntary accreditation process is its flexibility, and nongovernmental accreditation bodies should not find it difficult to accommodate disparate organizational structures.
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From page 70... ...
Accreditation pilot programs can begin by focusing on the research institutions for which they were designed, but they might evolve in many different ways. In the future, there could be one or a few accreditation bodies and one or a few sets of accreditation standards, and many different kinds of organizations will certainly be involved in research with human participants.
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From page 71... ...
Accreditation standards should start from the base of regulations governing research with humans. These regulations, in turn, are based on a set of principles for the ethical conduct of research (see Recommendation 4~.
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From page 72... ...
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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From page 73... ...
IRBs, DSMBs, research design teams, and merit review committees should increase their level of attention to the involvement of research participants or those who genuinely represent participants' perspectives in the design, selection, review, and monitoring of research involving human participants. In 73 3 By "participants," the committee refers to those whose background and expertise are credible to a lay constituency external to the research institution and who are knowledgeable about the research process and research protections.
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From page 74... ...
Hundreds of private voluntary health organizations are directly involved in advocacy for health research, and they often play decisive roles in decisions about research budgets and priorities, which is perhaps their bestknown function. Their concerns do not stop at funding, however, but extend to the ethical conduct of research not only to encourage high-quality research to meet participants' health needs but also to protect the perspective of their constituents.
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From page 75... ...
in specifying the desired outcomes to be incorporated into accreditation standards. Accreditation bodies could invite private voluntary health organizations and other organizations representing research participantsS to help formulate points to be considered in the development of accreditation standards and modification of the standards as they evolve.
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From page 76... ...
For clinical trials of drugs, devices, and other products subject to FDA regulation, FDA staff would continue to hold sponsors accountable by site visits, audits, investigation, enforcement, and other activities already performed by agency staff. Sponsors may continue to be liable if they do not make reasonable efforts to determine whether participant protection systems are in place at research institutions where they are conducting research.
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From page 77... ...
In addition to the two sets of proposed accreditation standards examined, the committee considered the ICH-GCP guidelines on the basis of their inclusio-n of widely accepted guidelines (internationally and domestically) for research sponsors and investigators involved in clinical trials.
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From page 80... ...
to support the field operations in protecting human participants and to assess their compliance with regulations that protect human research participants. The standards will be applied to VA hospitals and VA employees.
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From page 81... ...
The relationship of the standards to additional regulatory requirements, such as DSMBs and emerging medical privacy regulations, should be considered and made clear. A notable aspect of the NCQA standards is that they cross-reference the federal regulations.
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From page 82... ...
Although the ability to keep accurate records is necessary, it is insufficient to guarantee an effective human research protection program. Similarly, the NCQA standards also possess a reliance on documentation already called for in federal regulations.
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From page 83... ...
INTERNATIONAL CONFERENCE ON HARMONISATION GUIDELINE FOR GOOD CLINICAL PRACTICE The ICH-GCP was developed as a handbook for researchers conducting clinical trials, particularly drug trials conducted by sponsors and researchers from more than one country (International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use, 1996, 1997~. Although the guidelines presented in the ICH-GCP are not actually standards, they provide a clear and explicit set of best practices for those conducting clinical trials (see Box 3-1~.
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From page 84... ...
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.
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From page 86... ...
the steps that research institutions and their leadership can take to cultivate a culture that puts the safety and interests of research participants foremost; and (6) mechanisms by which research institutions and, where applicable, research sponsors can be held accountable for ensuring sufficient Finding, structural support, and professional rewards for HRPPPs.~3 The NCQA standards, if improved as recommended, could also be used by NCQA, the Association for the Accreditation for Human Research Protection Programs (AAHRPP)
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From page 87... ...
i4 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.
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