AAHRPP accredits high-quality human research protection programs in order to promote excellent, ethically sound research. Through partnerships with research organizations, researchers, sponsors, and the public, AAHRPP encourages effective, efficient, and innovative systems of protection for human research participants.

AAHRPP, through accredited research programs worldwide, will ensure that all human research participants are respected and are protected from unnecessary harm.

All of us at AAHRPP are accountable to our clients, our colleagues, and the public for setting high standards for human research protection. We share our knowledge and provide encouragement through our enthusiasm, responsiveness, and personal attention to each other and the people we serve.

We operate under high ethical standards to earn and sustain the trust and respect of the public, research participants, and the research community.

We constantly improve the accreditation process, so that it remains independent, unbiased and confidential, and responds to the needs of our clients and the public.

We include and partner with organizations and research participants and their communities to encourage best practices and set effective, reasonable standards that add value to human research protection programs around the world.

AAHRPP has adopted nine principles for accreditation. These nine principles serve as the foundation for the structure and content of the AAHRPP Accreditation Standards.

Principles for Accreditation of Human Research Protection Programs

What AAHRPP expects from Organizations

1. Protecting the rights and welfare of research participants must be an Organization's first priority. An Organization should promote a research environment where ethical, productive investigation is valued.
2. Protecting research participants is the responsibility of everyone within an Organization and is not limited to the Institutional Review Board (IRB). Accreditation examines whether the policies and procedures of the Organization as a whole result in a coherent, effective system to protect research participants and that all individuals know their roles and responsibilities.
3. Striving to exceed the federal requirements and continually seeking new safeguards for protecting research participants while advancing scientific progress must be integrated into an Organization’s mission.

What Organizations can expect from AAHRPP

1. The standards for protecting participants in human research will be clear, specific, and applicable to research across the full range of settings (e.g., university-based biomedical, behavioral and social science research, independent review boards, hospitals, government agencies, and others). Standards will address any special concerns (e.g., the use of vulnerable populations or heightened risk to privacy and confidentiality) that may arise in each setting.
2. The standards will identify outcome measures that Organizations can use to assess and demonstrate quality improvement over time.
3. The standards will be performance-based using objective criteria and measurable outcomes to evaluate whether a Human Research Protection Program effectively implements the standards. The evaluation will result in a grade of pass or fail for each standard and, where appropriate, will also include commendations or recommendations for meeting the standards.
4. The accreditation process will provide a clear, understandable pathway to accreditation, along with equally clear pathways for appeal and the remediation of identified shortcomings.
5. The accreditation process will be educational involving collegial discussion and constructive feedback. The accreditation process will identify areas in which the Human Research Protection Program does not yet meet the standards and give organizations the opportunity to discuss potential program improvements.
6. The accreditation process will be responsive to changes in federal regulations and to standards that will evolve based on what AAHRPP learns from accrediting Organizations from research settings.

This page provides a commentary on the AAHRPP Accreditation Standards for each Domain, followed by a link to the specific Standards.

Domain I: Organization

This Domain describes the structural characteristics of the entity that assumes responsibility for the 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, Institutional Review Boards (IRBs) or Ethics Committees (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 contract 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 applies its HRPP to all sponsored research.

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Domain II: Institutional Review Board or Ethics Committee

Within a HRPP, responsibilities must be delegated for providing ethical review and oversight of research. These responsibilities are distributed differently in different organizations; in many organizations, the IRB or EC along with the support personnel and systems provide these functions. In more complex organizations, there might be multiple IRBs and a general oversight office. This Domain of Standards sets forth requirements for the ethical oversight of research.

An IRB or EC is a body established generally under laws, regulations, codes, and guidance to protect the rights and welfare of human research participants. The HRPP must have mechanisms in place to ensure the independence of its ethics 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 or EC structure, composition, operations, and review Standards are set forth in laws, regulations, codes, and guidance.

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Domain III: Researcher and Research Staff

The environment in which Researchers and Research Staff conduct research and the type of research they conduct influence their roles and responsibilities. Competent, informed, conscientious, compassionate, and responsible Researchers and Research Staff provide the best possible protection for human research participants. This Domain of Standards sets forth requirements for Researchers and Research Staff involved in research involving human participants. As part of its HRPP, an Organization can improve its protection of research participants if it has arrangements ascertaining and enhancing the competence of Researchers and Research Staff.

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