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The Association for Accreditation of Human Research
Participant Protection Programs (AAHRPP)

The Association for Accreditation of Human Research Participant Protection Programs (AAHRPP) was incorporated as a not-for-profit organization in April, 2001, to offer accreditation to institutions engaged in research involving human participants. AAHRPP is the first organization of its kind in the field of human participant protection.

AAHRPP was created by seven member organizations representing the leadership of universities, medical schools and teaching hospitals; biomedical, behavioral, and social scientists; IRB experts and bioethicists; and patient and disease advocacy organizations:


"Responding to increased public and political scrutiny, AAHRPP seeks not only to ensure compliance, but to raise the bar in human research protection by helping institutions reach performance standards that surpass the threshold of state and federal requirements".

"By establishing a "gold seal" signifying adherence to a rigorous set of human protection standards, accreditation by AAHRPP will help ensure consistency and uniformity among all institutions conducting biomedical, behavioral and social sciences."

The mission of AAHRPP is to work "to protect the rights and welfare of research participants and promote scientifically meritorious and ethically sound research by fostering and advancing the ethical and professional conduct of persons and organizations that engage in research with human participants. AAHRPP achieves its mission by using an accreditation process based on self-assessment, peer review, and education" (from About us: http://www.aahrpp.org/www.aspx?PageID=5).

Dr. Marjorie Speers, Executive Director, talked with the NCDDR about the organization and some of its goals (Marjorie Speers, personal communication, December 12, 2001). Dr. Speers was on assignment from the Centers for Disease Control for two years to serve as project director with the National Bioethics Advisory Committee (NBAC). The NBAC was established by President Clinton to examine and make recommendations on bioethical issues related to research on human biology and behavior. She was Acting Executive Director during the NBAC's final months, and became Executive Director of AAHRPP in October, 2001.

Who will be accredited by AAHRPP?

The goal of AAHRPP is to serve all researchers, from large university research centers to small and independent programs. Universities and colleges, hospitals, for-profit and non-profit organizations, government agencies, independent IRBs--all types of research settings are envisioned as benefiting from this effort to scrutinize the quality of programs to protect research participants.

AAHRPP does not believe there is one "right" model, but wants the standards to be broad enough and flexible enough to be useful in a range of settings.
Several of the founding organizations of AAHRPP represent colleges and universities, and many institutions of higher education are expected to participate in the accreditation program.

NOTE: Who is eligible for accreditation? is available on the AAHRPP Website:
http://www.aahrpp.org/www.aspx?PageID=15

What is the accreditation process, and how much does it cost?

Organizations that apply for accreditation will be asked to conduct a self-assessment to provide a program description to the AAHRPP staff. Then an on-site assessment will be conducted. Both the self-assessment and on-site accreditation visit will use the Accreditation Standards and Procedures developed by AAHRPP. If the standards are met, the organization will be accredited for a period of three years. Pilot testing began in December, with the National Institutes of Health.

Accreditation will be offered once the pilot test and revision of the Interim Standards have been completed. The fees have not yet been set but will be determined following the pilot testing experience, which includes accreditation visits to five varied sites. Fees will be on a sliding scale based on the size of the organization and its research program, the clinical or non-clinical nature of the research program, as well as the number of IRBs affiliated with the organization.

NOTE: Accreditation step-by-step is available on the AAHRPP Web site:
http://www.aahrpp.org/www.aspx?PageID=95

NOTE: Information on fees is available on the AAHRPP Web site:
http://www.aahrpp.org/www.aspx?PageID=17

When will the Accreditation Standards and Procedures be released?

The Interim Accreditation Standards and Procedures were released in September, 2001. AAHRPP accepted comments through December 3, 2001. A substantial number of comments were received, and are still being reviewed in preparation for analysis. Many of the comments have been supportive. The analysis of the comments will be used to make changes and revisions to the Standards.

The development of the Interim Standards was initiated by the group Public Responsibility in Medicine and Research (PRIM&R). Findings from Preserving the Public Trust, a report from the Institute of Medicine on accreditation of human research protection programs, are also incorporated into the Interim Standard. The pilot test is using the Interim Standards for both the self-assessment and accreditation visits.

NOTE: The Accreditation Standards are available on the AAHRPP Web site: http://www.aahrpp.org/www.aspx?PageID=24

NOTE: The Principles for Accreditation of Human Research Protection Programs are available on the AAHRPP Web site:
http://www.aahrpp.org/www.aspx?PageID=22

Does the AAHRPP plan to offer training or other activities?

At this time, AAHRPP has no plans to provide specific training to its accredited clients. However, AAHRPP will gather information about a wide range of programs and will make it available to its clients. New ideas and ways to deal with problems will also be shared.

As a non-profit agency, AAHRPP is not a political organization. Its founding members came together to provide a response from within the research community to the need to improve the process and oversight of human research participant protection. The pursuit of accreditation reflects a serious commitment to protecting participants by setting the bar higher than the standards required by law. AAHRPP will affect policy by blazing the way to developing higher quality programs at accredited research institutions to protect research participants.

Dr. Speers or her designate representing the AAHRPP may be invited to serve on one or more of the various committees working to improve human research participant protection. There are a number of federal agencies and organizations examining this issue. At this time, there is no one "leader" or coordinating body. Recommendation 2.2 of the report on Ethics and Policy Issues in Research Involving Human Participants, the 2001 report of the NBAC, was "to create a single independent federal office….to lead and coordinate the oversight system." "This office should be responsible for policy development, regulatory reform (see Recommendation 2.3), research review and monitoring, research ethics education, and enforcement."

Would the Director of AAHRPP like to share anything else with the community of NIDRR researchers?

Dr. Speers said she believes it is important for researchers to know about the new accreditation process, and to inquire if their institutions will seek accreditation. AAHRPP accreditation is available to all organizations engaged in research, regardless of whether or not they are based in a university. Researchers can benefit because institutions that obtain accreditation are committed to providing a high level of protection for research participants. Such institutions support their researchers and convey to the public that they are dedicated to protecting their local citizens who enroll in research studies.

The Accreditation Standards and Accreditation Procedures are designed to be comprehensive and flexible, and to be applied to different types of research and settings. Dr. Speers emphasized that this organization is the result of an initiative from within the community of researchers, and will be responsive to what researchers need. Those institutions that are accredited will demonstrate that their research programs include exemplary provisions for protecting the participants in that research.

The AAHRPP is located in Washington, DC.

The Web site is http://www.aahrpp.org/

Dr. Marjorie Speers, PhD, Executive Director
AAHRPP
915 15th Street, NW, Suite 400
Washington, DC 20005
202-783-1112
202-783-1113 (fax)
accredit@aahrpp.org


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