This Domain describes the structural characteristics of the entity that assumes responsibility for the Human Research Protection Program (HRPP) and applies for accreditation. The organizational structure is the means by which the organization meets the range of responsibilities of the HRPP.

The organization applies its HRPP to all research regardless of funding source, type of research, or place of conduct of the research. The organization exercises these responsibilities through relationships with researchers and research staff, IRBs or ECs, sponsors, participants, and the community.

An organization has the responsibility not only to protect the rights and welfare of human research participants but also to involve research participants in the research enterprise. The involvement of research participants at every stage of the research enterprise helps everyone to achieve the ethical principle of respect for persons. In addition to enhancing the appropriate safeguards and protecting the rights and welfare of research participants, involving research participants in the research process can improve recruitment and retention of participants and also improve the overall quality of research.

The conduct of research is highly dependent upon the partnership between organizations and sponsors. A sponsor is the company, institution, individual donor, or government agency responsible for the initiation, management, or financing of a research study. Sponsors may enter into agreements with intermediaries that act as agents, such as clinical research organizations or coordinating centers. In sponsored research, both the sponsor and the organization have obligations to protect human research participants. In this Domain, the focus is on the obligations of the organization. In seeking accreditation, the organization must address human research protection requirements with all sponsors and apply its HRPP to all sponsored research.