to participate in research. The rapid growth in the size and breadth of the research enterprise in the United States makes it imperative to determine how improvements can be made in the system of protections to ensure that, given the volume and sometimes complex nature of research, institutions and investigators fulfill their ethical responsibilities to research participants.

CONTEXT FOR THIS REPORT

In October 2000, the Department of Health and Human Services (DHHS) asked the Institute of Medicine (IOM) to conduct a two-phase study to address concerns about protecting the rights and interests of research participants. The first-phase report, Preserving Public Trust: Accreditation and Human Research Participant Protection Programs, was released in April 2001 (IOM, 2001a). In that report, the Committee on Assessing the System for Protecting Human Research Participants (“the committee”) developed terminology to describe a set of activities and functions critical to protecting research participants. The term “Human Research Participant Protection Program” (HRPPP), although perhaps unwieldy, reflects the committee’s vision of a system of components, functions, and accountability that should exist, at a minimum, when human research is conducted.

In its first report, the committee addressed the potential for accreditation of HRPPPs to enhance the function of the current protection system. The committee also outlined the basic elements of an HRPPP, envisioning a system with appropriate functions within which roles and accountability would be articulated. The committee suggested that HRPPPs are the appropriate units for accreditation, that human research participant protection should be integral to every aspect of the research effort, and that it can most effectively be provided through an HRPPP. However, it will be critical to evaluate the effects of accreditation to determine whether it actually improves protections.

In this second-phase report, the committee broadens its focus, refining the concept of an HRPPP and examining the overall system of protections within which accreditation is merely one factor. The two primary questions addressed in this phase are, “What should be the functioning units of the protection system?” and “How can performance be assessed to ensure the public safety and effectively maintain public trust?”

It should be noted that the current system is a moving target, and the committee acknowledges that a number of individuals and groups are working within this framework to improve protections for human research participants. It could be said that many institutions already have an HRPPP in place, some more fully developed than others and perhaps applying different names and functions while seeking to achieve the same goals.



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