Ultimate responsibility for the adequacy of an HRPPP resides at the highest level of an organization. An effective protection program requires the unequivocal support of the leaders of the relevant research organizations and the research sponsors. These leaders should engender an institutional culture that facilitates and improves the ethical and scientific quality of research within their purview. Four specific conditions should undergird the establishment of such a culture:
accountability—to assure the quality and performance of the protection program,
adequate resources—to assure that sufficiently robust protection activities are in place,
ethics education programs—to provide research personnel and oversight committees with the knowledge necessary to carry out their obligation to conduct or oversee ethically sound research, and
transparency—to ensure open communication and interaction with the local community, research participants, investigators, and other stakeholders in the research enterprise.
Each organization should tailor these pre-requisite conditions to its mission, the breadth and substance of its program, and the context of its community. When multiple organizations are involved in a research project, at least one of them should assume responsibility for obtaining appropriate and documented assurances from the other participating organizations that a robust protection program is in place at each site.
Recommendation: 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. (Recommendation 2.2)
Establishing the appropriate research culture will require ongoing efforts to educate researchers, research administrators, IRB members, and participants about research ethics and participant protection issues, as well as continuous QI activities. The Office for Human Research Protections (OHRP), with input from a variety of scholars in science and ethics, should coordinate the development and dissemination of core education elements and practices for human research ethics for those conducting and those overseeing such research. The individual research organization is responsible for ensuring that its personnel are educated about their responsibilities