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.
Table of Contents
|1 Introduction, Background, and Definitions||23-44|
|2 Models of Accreditation||45-62|
|3 Standards for Accreditation||63-88|
|4 Evaluating HRPPP Pilot Accreditation Programs||89-94|
|Appendix A: Data Sources and Methods||103-114|
|Appendix B: PRIM&R Accreditation Standards||115-134|
|Appendix C: VA Human Research Protection Accreditation Program Draft Accreditation Standards||135-196|
|Appendix D: Committee, Expert Adviser, and Staff Biographies||197-208|
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