OHRA is in the Process of Seeking AAHRPP Accreditation!
What is AAHRPP?
The Association for the Accreditation of Human Research Protection Programs, Inc. (AAHRPP) is an independent, non-profit accrediting body, which uses a voluntary, peer-driven, educational model to ensure that Human Research Protection Programs (HRPPs) meet rigorous standards for quality and protection. To earn accreditation, organizations must provide tangible evidence-through policies, procedures, and practices-of their commitment to scientifically and ethically sound research and to continuous improvement. Nearly 200 institutions have received full accreditation status from AAHRPP.
What is AAHRPP Accreditation?
Although frequently referred to as IRB accreditation, accreditation from AAHRPP covers the entire Human Research Protection Program (HRPP). To achieve accreditation requires meeting performance standards in following five Domains: organizational/institutional commitment, research review unit including IRB operations, Investigators' understanding and fulfilling of their responsibilities, sponsored research oversight and management, and participant/community outreach. Altogether, there are 20 AAHRPP Standards within five Domains, and 77 Elements under 20 Standards.
What is AAHRPP Accreditation Process?
AAHRPP accreditation is a two-step process, namely self-assessment and AAHRPP on-site visit. Starting August 2008, the Office for Human Research Administration (OHRA) has embarked on the Step 1 self-assessment process, which is intended to strengthen HSPH's HRPP, as well as to meet AAHRPP accreditation standards. The self-assessment included reviewing, revising and developing policies and procedures for HSPH's Human Research Protection Program, which is comprised of IRB Operations, Quality Improvement Program (QIP), and relevant key individuals, departments, and units.
The Step 2 on-site visit occurs 3 - 4 months after AAHRPP receives our application. The purpose for the site visit is to evaluate the implementation of our policies and procedures. The AAHRPP site visitors will interview institutional and organizational officials, IRB Chairs and Members, Investigators, research assistants/coordinators. To fully evaluate our HRPP, the site visitors will also be permitted and have access to all study-related records such as protocols, consent forms, recruitment materials, IRB meeting minutes, and audit reports. Accreditation occurs following a successful site visit and evaluation, usually 3-6 months after the completion of AAHRPP on-site visit.
AAHRPP Accreditation Related Changes - How will accreditation process affect the HSPH research community?
Meeting the AAHRPP appreciation standards requires changes/improvements to existing policies and procedures including relevant forms, templates, and checklists. The newly developed Investigator Manual will be posted to OHRA website by the end of September, along with applicable forms. A series of live education sessions for investigators and coordinators are scheduled to explain these changes. In addition, small group educational sessions, as well as one-on-one questions-and-answers will be offered through OHRA's Quality Improvement Program (QIP). To learn more about OHRA's education offers, please contact QA/QI Education Specialist Alyssa Speier, or HRPP Coordinator, Justin Fendo.
Tentative Timeline:
August/September 2009: Finalizing AAHRPP application to AAHRPP
October/November 2009: OHRA receiving draft agenda for the site visit including protocols to be reviewed and persons to be interviewed during on-site visit.
December 2009/January 2010: On-site visit/evaluation
March or June 2010: AAHRPP Council Review - determining accreditation status
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