Preserving Public Trust: Accreditation and Human Research Participant Protection Programs (2001)
Chapter: What Is Missing
meeting the PRIM&R standards. Data collection from even a sample of investigators at an accreditation site would be overwhelming, and sample bias would be a very serious concern. The committee therefore had a difficult time conceiving of how these standards could be effectively enforced, even if a useful measurement approach could be devised.
On the other hand, several standards do indeed seem measurable but appear to depend on the production or appropriate filing of pieces of paper (or other bits of data) and may have little to do with the quality of research or protecting the rights and interests of participants. For example, standards for IRB minutes and record keeping are fairly prescriptive and provide some measure of activity for individuals inspecting or accrediting a site. 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. However, the NCQA program is based on the assumption that an institutional quality improvement program exists at the organization seeking accreditation (in this case VA facilities). The quality improvement documentation is an important source of data for the accreditation body, serving as a measure of performance at a particular point in time but also as a measure of change over time. This strategy provides the opportunity within the NCQA HRPP accreditation standards to become less reliant on documentation and more reliant on performance (Recommendation 7).
The NCQA standards clearly articulate the data source and measurement method to be used by the accreditation organization. As noted above, this is a real strength because clear indications of the data source to be tapped and an unambiguous method for the measurement of compliance with the standards must be developed in conjunction with the standards if they are to be workable.
In contrast, evaluation of the level of compliance with the PRIM&R standards has not been thoroughly described in the materials reviewed by the committee. It is not enough for the institution to just have policies. It must also follow them. In the absence of clear guidance on how outcomes should be measured, determination of whether an institution meets these standards could be daunting for both accreditors and the organizations that they are accrediting.
What Is Missing
The committee identified a few topics that do not appear to be explicitly included in the current drafts of the PRIM&R and the NCQA standards. Both lack standards for improving participant involvement in the local research review and decision-making processes. There is little to no mention of the rights and responsibilities of research participants or the need for subject participation in the functions of the HRPP (except for those that are required by regulation). In addition, the standards might better address some procedural ap-
