Preserving Public Trust: Accreditation and Human Research Participant Protection Programs (2001)
Chapter: 3 Standards for Accreditation
3
Standards for Accreditation
Any set of standards used by accreditation organizations responsible for the protection of research participants must be flexible enough to be applicable to a variety of institutions yet rigorous enough to ensure that their enactment enhances protection of human research participants. In addition, they must be clearly written, relatively straightforward to execute, consistently applicable, and measurable. These are not easy goals.
In response to a request from the U.S. Department of Health and Human Services (DHHS), the Institute of Medicine was asked to address accreditation standards for human research participant protection programs (HRPPPs). To accomplish this task, the committee reviewed draft versions of proposed standards developed by Public Responsibility in Medicine and Research (PRIM&R) and the National Committee for Quality Assurance (NCQA), as well as the International Conference on Harmonisation Guidelines for Good Clinical Practice (ICH-GCP).
The PRIM&R standards were drafted to be used as measurement criteria for a new voluntary program for research protection. 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.
NCQA is an independent, nonprofit organization under contract with the U.S. Department of Veterans Affairs (VA) to operate an accreditation program to ensure that VA medical centers are complying with VA and other relevant federal regulations designed to protect human participants in research.
