Preserving Public Trust: Accreditation and Human Research Participant Protection Programs (2001)
Chapter: PRIM&R Standards
good as the guidelines and measures used to assess compliance with them. Thus, many questions that arise from review of the drafts might be resolved only when they are considered in the context of the guidelines that will accompany them and experience gained through pilot testing.
In reviewing the PRIM&R and NCQA standards the committee found it useful to assess them according to the following general criteria: (1) their scope and focus; (2) their relationship to the existing regulatory standards; and (3) the extent to which the standards can be consistently implemented, measured, and enforced, as well as their inclusion of various key elements (see Table 3-1).
In addition to the two sets of proposed accreditation standards examined, the committee considered the ICH-GCP guidelines on the basis of their inclusion of widely accepted guidelines (internationally and domestically) for research sponsors and investigators involved in clinical trials.
Scope and Focus of the Standards
PRIM&R Standards
The PRIM&R standards (Appendix B) appropriately imply that the ethical principles described in The Belmont Report (National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research, 1979) should serve as the fundamental inspiration for institutions seeking to promote research while protecting those who participate in it. However, they appear to be written mainly with academic medical centers that house one or more IRBs in mind. The PRIM&R document states that accreditation applies to the human research protection program (HRPP). Outside traditional academic health centers, it is not clear what entity would be responsible for the HRPP and hence for seeking accreditation.
One test of the broader utility of the PRIM&R standards (and those of NCQA) is whether they could be easily applied in other research settings, such as private industry, institutions that rely on independent IRBs, survey organizations, community hospitals, and teaching institutions with largely undergraduate student populations, or even in instances of multisite trials or collaborative IRB review. As discussed earlier in this chapter, all accreditation programs must be adaptable to a broad range of research environments, methods, and review mechanisms (Recommendation 5).
An additional observation relates to the apparent focus on the IRB as the central arbiter of the protection of human participants. If, in fact, the activities surrounding the protection of human participants in research are evolving into a system, then this focus seems too narrow. Although the standards mention the
TABLE 3-1 Elements in Three Sets of Standards and Guidelines
|
Organization Developing the Standard or Guideline |
|||
|
Key Elements |
PRIM&R |
NCQA |
ICH |
|
Intended use |
Standards |
Standards |
Guidelines |
|
Targeted sites or bodies |
Research institutions (U.S.) |
VA facilities |
Organizations conducting clinical trials of drugs |
|
Foundational principles |
The Belmont Reporta |
The Belmont Report |
Declaration of Helsinkib |
|
Regulatory relevance |
Implied |
45 CFR46, 21 CFR 50 and 56, and VA regulations are the starting points (cross-referenced) |
Drug approval regulations in the European Union, Japan, and the United States |
|
Components affected |
|
|
|
|
Link to quality improvement program? |
No |
Yes |
No |
|
Standards for participant involvement (beyond consent)? |
No |
No |
No |
|
Standards for sponsors? |
No |
Noc |
Yes |
|
Standards for monitoring? |
Limited, one mention in one documentation standard |
Yes |
Yes |
