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Preserving Public Trust: Accreditation and Human Research Participant Protection Programs
ICH-GCP represents an “international ethical and scientific quality standard for designing, conducting, recording, and reporting trials that involve the participation of human subjects” (International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use, 1996, p. 1). In addition to being widely accepted in the clinical trials community, the ICH-GCP standards are recognized by the Office for Human Research Protections (OHRP) and included within the Food and Drug Administration (FDA) guidance document for clinical trials. Although these are guidelines for investigators and research sponsors conducting or supporting clinical trials, they specifically address the roles and responsibilities of these parties at a level of detail not found in either the PRIM&R or NCQA standards and are thus directly relevant to the assessment of HRPPPs.
As the committee struggled in a short period of time to develop a “theory” on which the standards for accreditation of HRPPPs could be based, the challenges and perhaps impossibility of developing a “one-size-fits-all ” approach became apparent. The three sets of standards were reminders of the vastness of the research enterprise and the distinctive nature of certain types of research and research settings. For example, the PRIM&R standards appear to focus on research conducted in traditional academic health care settings, the NCQA standards encompass research conducted by the VA in its own self-contained health care system, and the ICH-GCP guidelines are specific to investigators and sponsors conducting clinical trials, a specialized type of research with human participants.
Even so, the three distinct research situations described above all pertain to biomedical research environments. As discussed in Chapter 1, this does not adequately represent the multiple contexts in which human research occurs. The breadth of these research contexts creates layers of complexity that are not easily absorbed when a single set of standards is being developed for the assessment of performance. An organization's scope of activities should define which standards apply. Moreover, the accreditation body must consider the degree to which an HRPPP must comply with the standards. That is, must an organization be in full compliance with every standard to become accredited? Or should the organization demonstrate overall compliance with the full set of applicable standards? The answers to these questions might dictate the magnitude and scope of a set of standards and the level of detail that is necessary to support them. If the goal is to develop a single set of standards, such standards must accommodate several types of organizations engaged in the review and conduct of research with human participants.
STANDARDS FOR STANDARDS
At a minimum, standards should address an organization's level of performance in specific areas and, some would argue, not just what the organization is capable of doing but what it actually does (JCAHO, 2000). In theory, stan-