The Five Domains of the Current Accreditation Standards
This page provides a commentary on each Domain of the Current Accreditation Standards.
- Organization
- Research Review Unit, including IRBs
- Investigator
- Sponsor Research
- Participant Outreach
Organization
The Organization domain describes structural characteristics of the entity that assumes responsibility for the Human Research Protection Program and that applies for accreditation. The organizational structure is the means by which organizations meet the responsibilities of the Human Research Protection Program. These broad responsibilities are met by establishing a formal process to monitor, evaluate, and continually improve the protection of human research participants; dedicating resources sufficient to do so; exercising oversight of research protection; educating investigators and research staff about their ethical responsibility to protect research participants; and, when appropriate, providing a mechanism to intervene in research and to respond directly to concerns of research participants. The Organization applies its Human Research Protection Program to all research conducted domestically or internationally.
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Research Review Unit, Including IRBs
Within a Human Research Protection Program, responsibilities must be delegated for providing ethical review and oversight of research. These responsibilities may be distributed differently in different organizations; in many organizations, the Institutional Review Board (IRB) along with the support personnel and systems provide these functions. In more complex organizations, there might be multiple IRBs, a general oversight office, or individual organizational officials with oversight responsibilities. The term "Research Review Unit" refers to the structures and individuals within an organization who carry out oversight responsibilities; in some cases a Research Review Unit consists of a single IRB, while in other cases it includes IRBs and other entities. This domain of standards sets forth requirements for the ethical oversight of research, including the IRB review process. An IRB is a body established under federal regulations to protect the rights and welfare of human research participants. The Human Research Protection Program must have mechanisms in place to ensure the independence of its ethical review and oversight functions from other units within the organization, particularly with respect to decision-making regarding the ethics of research involving human participants. IRB structure, composition, operations, and review standards are set forth in federal regulations. A major IRB responsibility is to determine that the risks of proposed research are reasonable in relation to the potential benefits to the participants and to society, and that risks are minimized to the extent possible consistent with sound research design. In addition, the IRB must determine that the risks of research do not fall disproportionately on one group while the potential benefits accrue to another. IRBs must approve a consent process that is voluntary and fully informs the prospective participant about the research study. Individuals who are particularly vulnerable or whose capacity to consent may be in doubt require additional protections. IRBs must determine that the research is designed to respect individual privacy and preserve the confidentiality of identifiable information. Finally, IRBs have ongoing responsibility for approved research to oversee that the welfare of the participants is protected and to determine that the risks and potential benefits remain reasonable. In carrying out its obligations, an IRB may approve, disapprove, or require modifications to research protocols. It also may suspend or terminate its approval of ongoing (previously approved) research.
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Investigator
The environment in which Investigators conduct research and the type of research they conduct influence their roles and responsibilities. Competent, informed, conscientious, compassionate and responsible Investigators provide the best possible protection for research participants. This domain of standards sets forth requirements for Investigators and other research staff involved in research involving human participants. As part of its Human Research Protection Program, an Organization can improve its protection of research participants if it has arrangements for ascertaining and enhancing the competence of its Investigators.
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Sponsor Research
A sponsor is the company, institution, individual donor, or organization responsible for the initiation, management or financing of a research study. Sponsors may enter into agreements with intermediaries that act as agents, such as contract research organizations or coordinating centers. In this domain, the term “sponsor” refers to the sponsor or its agents. Sponsors enter into arrangements with organizations to conduct research, here referred to as sponsored research. In sponsored research, both the sponsor and the Organization have obligations to protect research participants. In this domain, the focus is on the obligations of the Organization. The Organization seeking accreditation must identify and address human research protection requirements with all sponsors. In general these requirements might include, but are not limited to, the ethical conduct of research, dissemination of knowledge gained from research, and the availability of health care to injured research participants. The Organization applies its human research protection program to all sponsored research.
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Participant Outreach
The involvement of research participants at every stage of the research endeavor 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. Organizations and investigators should have channels for receiving and responding to participant and community concerns and questions about research and conduct outreach and education activities with participants and their communities. Encouraging the involvement of the research participant and the public in building research programs should enhance trust in the conduct of research and the desire to help investigators pursue sound, ethical science.
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