AAHRPP President & CEO Clarifies
Coast Accreditation Status
After a Congressional hearing last spring—and the eventual liquidation of Coast IRB—some organizations developed the misperception that Coast was accredited by AAHRPP.
In the following letter to industry sponsors and other key decision-makers, AAHRPP President and CEO Marjorie A. Speers, Ph.D., clarified the issue: Coast IRB did not earn accreditation.
August 18, 2009
Dear Colleague:
We are writing to clarify the accreditation status of Coast IRB, which announced in April 2009 that it would cease operation. Coast IRB did not earn accreditation.
Applying for accreditation is not indicative of an organization’s ability to earn accreditation. Organizations must meet a total of 98 standards and elements. These standards and elements meet or exceed the U.S. federal requirements and are consistent with ICH-GCP guidelines for protecting human research subjects. Organizations initiate the accreditation process by submitting an application for accreditation—Step 1 application. AAHRPP staff reviews the written documents for consistency with the accreditation standards and elements and requests revisions, if needed. When the written documents are satisfactory, the organization submits a Step 2 application that includes the revised documents and a site visit is arranged. The purpose of the site visit is to confirm that the written documents are implemented and to evaluate the practices of the organization. Following the site visit, the organization receives a draft site visit report and may respond to any errors of fact or report any corrective actions that have been taken since the site visit. The application, draft site visit report, and response to the draft site visit report are then evaluated by the Council on Accreditation, which makes a determination regarding accreditation status.
An organization can earn full or qualified accreditation. Both categories of accreditation are valid for three years. At the end of the accreditation period, the organization must reapply and repeat the same process.
At the end of each quarterly meeting of the Council, AAHRPP announces any new organizations that have earned accreditation. AAHRPP publishes the names of accredited organizations on its Website at www.aahrpp.org. Media outlets are informed of the Council’s decision within seven days of the meeting and the new accreditations are published in the next issue of AAHRPP’s newsletter, AAHRPP Advance.
While the AAHRPP accreditation process is rigorous and permits accredited research organizations, including independent IRBs, to assure the public that they have met and, in some instances, even exceeded federal regulations designed to protect research participants, the burden remains on accredited organizations to maintain their procedures and follow their written procedures during the three-year accreditation period.
AAHRPP publishes on its Web site a series of questions that sponsors and others should ask an organization about its accreditation status. In addition, I encourage you to contact me if you have questions about accreditation.
Sincerely,
Marjorie A. Speers, Ph.D.
President and CEO
Association for the Accreditation of Human Research Protection Programs (AAHRPP)
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