FIGURE 2.3 Effective Human Research Participant Protection Programs Require Four Necessary Conditions

In order to establish and operate a sufficiently robust Human Research Participant Protection Program (HRPPP), four necessary conditions should be pervasive throughout a research culture. These conditions include accountability for all participant protection activities; sufficient resources to carry out those activities (monetary and non-monetary); ethics education programs for those who conduct and those who oversee research with humans; and transparency, in terms of open communication with the public and other stakeholders regarding HRPPP policies and procedures.

tailored to its mission, the breadth and substance of its research program, and the specific context of its community.

Accountability

Recommendation 2.2: The authority and responsibility for research participant protections should reside within the highest level of the research organization. Leaders of public and private research organizations should establish a culture of research excellence that is pervasive and that includes clear lines of authority and responsibility for participant protection.

Administrative responsibility for the program may reside within a designated office of the organization (perhaps called “Office for the Protection of Research Participants”), but ultimate responsibility for the adequacy of the program resides at the highest level of the research organization. In private organizations, the Chief Executive Officer (CEO) is ultimately responsible for participant protection; in an institutional academic setting,



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