AAHRPP Accreditation Standards Issued

Tip Sheets

CONTACT:           David Ward, (202) 783-1112 dward@aahrpp.org

Strengthening Trust in Human Research with Effective, Consistent Protections Worldwide

WASHINGTON, D.C., October 1, 2009—The Association for the Accreditation of Human Research Protection Programs (AAHRPP) today issued the final version of the first major revision of its standards in its eight-year history.

AAHRPP streamlined the number of standards and increased flexibility in how to interpret them, even as it added or strengthened standards on global research, conflict of interest, community-based research, and data and safety monitoring.

As part of AAHRPP’s own quality improvement initiative, it undertook a comprehensive review of the standards, something that is planned to occur regularly. With government scrutiny of human research increasing, the urging of behavioral and social scientists to make human research protection meaningful to their research, and industry moving more clinical trials into the developing countries, AAHRPP responded by strengthening, updating and streamlining its standards.

While none of the new standards or revisions reflect major changes in the requirements for accreditation, the revisions do reflect a major regrouping of the standards, providing a more logical framework for a human research protection program (HRPP) and better definition of the primary roles and responsibilities of the entities that comprise an HRPP, according the Marjorie A. Speers, Ph.D., President and CEO of AAHRPP.

Overall, AAHRPP has reduced the number of standards from 22 to 15, and the number of elements, from 77 to 60.

AAHRPP began developing a set of Proposed Revised Accreditation Standards at the end of 2008, and presented them for public comment on June 1, 2009. When the comment period ended on July 30, 2009, AAHRPP used those comments to develop the Final Revised Accreditation Standards issued today.

Organizations wishing to apply for accreditation from now through February 28, 2010, may follow either the Final Revised Accreditation Standards or the Current Accreditation Standards in effect before October 1, 2009. Beginning March 1, 2010, all new applicants will follow the Final Revised Accreditation Standards, which will then be referred to simply as the AAHRPP Accreditation Standards.

Readers will find the Final Revised Accreditation Standards and be able to compare them with the current accreditation standards on the Web at aahrpp.org. A version of the Evaluation Instrument for Accreditation based on the Final Revised Accreditation Standards, which organizations use to apply the standards to their own HRPPs, is also available on the Web site.

About the Association for the Accreditation of Human Research Protection Programs, Inc.

AAHRPP is a non-profit organization that works with organizations that conduct human research to raise the level of protection for research participants. Available to organizations worldwide that conduct biomedical, behavioral or social sciences research involving human participants, the accreditation program utilizes a voluntary, peer-driven educational model.

Organizations must demonstrate that they have built extensive safeguards into every level of their research operation and that they adhere to the high ethical standards. For organizations interested in learning more about accreditation, visit aahrpp.org.