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STANDARDS FOR ACCREDITATION 75 some conditions, however, are less well organized and may require funding from research sponsors, both public and private, to build the capacity for research oversight. Accreditation programs can systematically solicit desired outcomes from research participants. In his book on accreditation, Michael Hamm (Hamm, 1997) alluded several times to the desirability of having a focus on outcomes and performance rather than process and structure. The outcomes most desired in an HRPPP are an independent review of risks and benefits and a genuine process of informed consent. Participants are directly relevant to the informedconsent process in particular. The literature on empirical studies of the informed-consent process suggests that investigators often do not know what participants hear, and investigators are poor judges of what participants understand. Those who develop accreditation standards would do well to directly involve focus groups, consent monitors, and participant representatives (e.g., those who themselves have been involved in past studies or who are educated about the research process and ethical standards but who are also familiar with the interests of a constituency) in specifying the desired outcomes to be incorporated into accreditation standards. Accreditation bodies could invite private voluntary health organizations and other organizations representing research participants5 to help formulate points to be considered in the development of accreditation standards and modification of the standards as they evolve. NEED FOR STANDARDS REGARDING ROLES AND RESPONSIBILITIES OF RESEARCH SPONSORS Neither the PRIM&R nor the NCQA draft standards address standards for sponsors. The PRIM&R document defines sponsor as, âAny entity that provides funds or other resources to support the research. This entity could be a federal agency, corporation, foundation, institution or an individualâ (see Appendix B, Glossary). It is noteworthy that in most cases it will not be the sponsor that is seeking accreditation as an HRPPP. However, there will be some examples in which the research institution that conducts and reviews the studies is also paying for a particular research project. In addition, when the sponsor is a federal agency, the assurance process results in an agreement between the sponsor and the research institution that federal regulatory requirements will be met. The committee recognizes that it would be difficult to incorporate such standards into the accreditation programs for HRPPPs; however, it believes that such standards should exist. These standards would provide research institutions, investigators, and IRBs with a set of expectations that should be met when 5 For research not on a particular medical condition, the constituency may be, for example, veterans at VA facilities or representatives of the general public familiar with research methods and ethical canons for general population studies.