FIGURE 2.1 A Schematic Illustration of Roles and Interactions of HRPPPs in a Typical, Multisite Clinical Trial

Multiple HRPPP modules often collaborate to form the HRPPP for a specific protocol. In this situation, the sponsor’s HRPPP is ultimately accountable for the entire trial. For participants enrolled by the community physicians, the sponsor’s HRPPP bears direct responsibility for all of the protection functions except the protocol ethics review conducted by the independent IRB under contract with the sponsor. For participants enrolled by the academic investigator and the hospital specialist, it is likely that the sponsor will contract, respectively, with the academic medical center and the community hospital to carry out many (though perhaps not all—data and safety monitoring may be retained, for example) of the protection functions, including science and ethical review (which may be ceded to a lead IRB); education of investigators, board members, participants, etc.; conflict of interest review; and quality improvement for their portions of the study.

employ a set of processes conducted by IRBs and a few other entities within an organization—e.g., regulatory compliance.

The committee acknowledges that the research process itself is a complex and adaptive one and that efforts to integrate an additional complex system within it will be challenging and could create bureaucratic and administrative distractions rather than contribute value and enhance performance. However, the committee has concluded that appropriate participant protection can best be assured through a systemic approach that utilizes diversified and distributed elements with clearly defined and articulated responsibilities. A similar systems-based approach to ensuring patient safety has been recommended by panels that have examined the quality of health

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