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