Conducting research with human participants is a privilege granted by willing volunteers. Such research is central to the translation of scientific knowledge into societal goods and should be encouraged. However, in doing so, it should be realized that we have a solemn responsibility to protect research participants and to ensure that this protection is integral to every aspect of the research process.

Our current system of protection, however, is not functioning as intended, a message that this committee as well as a long line of analysts and observers have delivered. The committee believes that the system should be adapted to overcome its current constraints in order to ensure that the oversight of comprehensive participant safety occurs in a manner that does not curb the quality of research. Previous groups have made recommendations to the federal government, to IRBs, and to investigators. This committee also offers recommendations to those entities, but in addition it seeks to emphasize a systems approach (i.e., the HRPPP) for protecting research participants.

The envisioned HRPPP should strive to prevent research harms through systematic and interlocking protection functions within which discrete roles and accountability are clearly articulated; the program should be buttressed by an infrastructure that is adequately funded and embraced by its leadership; and the level of protection it provides should be commensurate with the anticipated risks of the research. To achieve these goals, each research entity should develop processes and procedures that are clear, efficient, and effective. Finally, clear and open communication among those who are involved in protecting research participants should be established and maintained.

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