Preserving Public Trust: Accreditation and Human Research Participant Protection Programs (2001)
Chapter: Extent to Which the Standards Can Be Implemented, Measured, and Enforced
Relation to Existing Regulatory Requirements
As suggested in Recommendation 6, both the PRIM&R and the NCQA draft standards use the current regulatory standards as the “starting point” for the development of their accreditation programs (Chodosh, 2000; Goldschmidt, 2001). In fact, Standards 1.2 and 1.3 in the PRIM &R standards state that “the organization must uphold ethical principles underlying the protection of individuals studied in research” and that “the organization must assure compliance with applicable legal requirements, including state and local laws ” (see Appendix B). However, in the PRIM&R document, there are some instances in which consistency with the federal regulations could be more explicit and concise, such as the reporting of adverse events to the National Institutes of Health, research sponsors, the FDA, IRBs, and institutional biosafety committees. 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. This is a useful approach and one that will be welcomed by administrators facing competing guidelines, regulations, and standards. In addition, because they rely on the regulations to establish which research must be reviewed by an IRB and which research requires retrieval of informed consent, they provide the flexibility that is needed to exclude some types of minimal-risk research from full review and also possibly the requirement to obtain informed consent.
Extent to Which the Standards Can Be Implemented, Measured, and Enforced
To be measurable, there must be some objective means through which the extent to which a program is in compliance with accreditation standards can be gauged. Put another way, if an institution was denied accreditation or had its accreditation revoked, are the standards sufficiently well defined and consistently applied that the accreditor could defend its decision in court? The need for objective measurement tools is critical to ensuring consistency and diminishing arbitrary subjectivity in the accreditation system. What is considered independent and credible in one institution might not be considered so in another.
In the material provided by PRIM&R, some of the standards seem largely hortatory.7 Some committee members found it difficult to envision how these standards could be implemented, measured, or enforced (except perhaps retrospectively, after egregious noncompliance). For instance, the language directed toward investigators in Standard 3.1 and 3.2 ( Appendix B) is very important, as investigator conduct is essential to the realization of ethical research. It is not clear, however, how one would ensure in an objective way that investigators are
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For example, Standards 1.1, 1.7, 3.1, and 3.2 (Appendix B). Documentation standards are more specific, but many other standards are similarly hortatory. |
