Preserving Public Trust: Accreditation and Human Research Participant Protection Programs (2001)
Chapter: INTERNATIONAL CONFERENCE ON HARMONISATION GUIDELINE FOR GOOD CLINICAL PRACTICE
proaches to the inclusion of research participants in the HRPP (see discussion following Recommendation 8). However, members of the Program Advisory Committee for the NCQA accreditation system will be selected from research stakeholder groups, including participant advocates, and will consider programmatic issues to advise the Program Accreditation Committee (the decision-making group for this program).
As mentioned earlier, the roles and responsibilities of research sponsors are important omissions from both sets of standards that should be addressed. In the case of the NCQA draft standards, it is possible that VA headquarters, through ORCA, is developing standard operating procedures that establish standards when the VA is the sole sponsor. However, for externally sponsored research conducted at VA facilities, HRPP standards or assurance that sponsors are abiding by ICH-GCP or other accepted external standards is needed.
INTERNATIONAL CONFERENCE ON HARMONISATION GUIDELINE FOR GOOD CLINICAL PRACTICE
The ICH-GCP was developed as a handbook for researchers conducting clinical trials, particularly drug trials conducted by sponsors and researchers from more than one country (International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use, 1996, 1997). Although the guidelines presented in the ICH-GCP are not actually standards, they provide a clear and explicit set of best practices for those conducting clinical trials (see Box 3-1). The committee looked to the ICH-GCP because it includes defined goals for sponsors and investigators. However, it does not address, per se, the institutions or the setting in which the research will be conducted. As such, the ICH-GCP is “portable” and is therefore an important contribution to enhancing the protection of research participants, wherever the clinical trial is conducted. Aspects of the ICH-GCP serve as clearly delineated models for investigator and sponsor behavior, and, thus, the responsibilities contained within these models should be included in the development of guidelines for HRPPPs. The ideals or norms that the document espouses, however, would need to be translated into standards, and such standards would have to be applicable beyond clinical trials and biomedical research methods.
