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INTRODUCTION, BACKGROUND, AND DEFINITIONS 38 intrusive but equally valid methods for obtaining informed consent for research involving more than minimal risk. Such methods could, in turn, produce measures of informed consent that are more effective and less bureaucratic and that might eventually enable a shift in accreditation standards from documentation to assessment of genuine informed consent. The Rise of Clinical Trials and Privately Funded Research Clinical trials constitute only a subset of research, but they are an important subset. Clinical trials comprise a sizeable fraction of the studies that entail medical risks to participants and are a large and growing fraction of medical research. Also, on the basis of the growth of organizations dedicated to managing clinical trials and other evidence, it appears that the number of privately financed clinical trials has grown dramatically over the past decade (Rettig, 2000). Those trials conducted at a research institution with an HRPPP can be accommodated by attending explicitly to the roles and responsibilities of research sponsors. Many trials, however, are âmulticenter trialsâ involving participants drawn from academic medical centers, private physicians' practices, community hospitals, clinics, and other institutions. Some of these may, in fact, lack an IRB. In some cases, organizations that manage multicenter trials have developed, and these present a particular challenge to determination of the appropriate HRPPP unit. In cancer research, for example, several âoncology cooperative groupsâ have existed for decades to organize such trials, so that today 1,400 institutions participate. Community hospitals are also engaged in research through the Community Clinical Oncology Program, which includes 52 centers in 30 states (NCI, 1997). The National Cancer Institute is forming a central IRB and is revamping its support structure for clinical trials. This is driven in large part by the need to increase the scope and scale of clinical trials (NCI, 2001). For multicenter trials, research sponsors are often very large organizations for which clinical trials are only a small fraction of their work (e.g., pharmaceutical firms or NIH institutes), and so the sponsor may not be the appropriate unit for HRPPP accreditation. When large organizations sponsor and conduct trials, however, they have organizational units that are responsible for trial oversight and that could apply for accreditation. In large multicenter trials, individual research institutions are at too low a level for meaningful accreditation because many such institutions are involved in the trial and none has meaningful control over the study design and overall safety. The appropriate locus of accreditation for multicenter clinical trials might prove to be different from that for research in general and might be focused on the organizations that have developed to manage the research, such as contract research organizations for privately funded trials or cooperative groups for both private and publicly funded trials. Accreditation bodies might devise a special set or subset of standards for such organizations.
