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Preparing for AAHRPP Accreditation Everything you need to know

Preparing for AAHRPP Accreditation Everything you need to know. Joseph Andrews, MA, CIP Director, Institutional Review Board Wake Forest University Health Sciences. Outline. AAHRPP Accreditation What is it? Why is it important? What’s the process? How might you be involved?

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Preparing for AAHRPP Accreditation Everything you need to know

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  1. Preparing for AAHRPP AccreditationEverything you need to know Joseph Andrews, MA, CIP Director, Institutional Review Board Wake Forest University Health Sciences

  2. Outline • AAHRPP Accreditation • What is it? • Why is it important? • What’s the process? • How might you be involved? • Question/Answers

  3. AAHRPP Accreditation • Accreditation from the Association for the Accreditation of Human Research Protection Programs (AAHRPP) covers the entire HRPP • 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 • participant/community outreach

  4. AAHRPP Accreditation 4 • Accreditation from the Association for the Accreditation of Human Research Protection Programs (AAHRPP) covers the entire HRPP • HISTORY • AAHRPP was founded by 7 non-profit organizations: • Association of American Medical Colleges • Association of American Universities • Association of Public and Land Grant Universities • Consortium of Social Science Associations • Federation of American Societies of Experimental Biology • National Health Council • Public Responsibility in Medicine and Research

  5. AAHRPP Accreditation • AAHRPP began accrediting programs in 2001 • There are now 200 institutions accredited, representing over percent of all medical schools in the country! • To be competitive we other premier institutions, we need to demonstrate our commitment to human subject protection through this accreditation as well. 5

  6. Why is Accreditation important? Evidence of a quality research program Indicates institutional commitment to continuous quality improvement Provides a ‘stamp of approval’ to external Institutions (NIH, DOD) and investigators Means for reducing Institutional exposure It may soon become a condition for IRB Authorization Agreements and/or research support

  7. The Accreditation Process: Step 1 IRB Office Tasks: • Application Preparation/Submission • Conduct Self-Evaluation and make necessary improvements to meet Accreditation standards • Submit Application: two-page application form, a program overview (10 page maximum), copies of documents used by Organization, such as SOPs and Application forms, index to those documents • Initial Application – Mar. 2010 • (Anticipated) Revised Application – Aug. 2010

  8. The Accreditation Process: Step 2 • Evaluation/Site Visit • A team of experts reviews the application and conducts an on-site visit evaluation • Visit lasts 2-4 days • Access to all facilities and relevant records (confidentiality agreements signed) • Site visitors will interview (1) OR/IRB staff, (2) IRB board members, and (3) members of the WFUHS research community • YOU may be asked to meet with the AAHRPP site visitors

  9. If You are Selected: Role of Research Community: • Check the IRB website for updates • Revised SOPs/Forms/Checklists/Templates • New eIRB functionalities and formats • Starting NOW!!! • Notification of those selected by AAHRPP • Oct. 2010 • Preparation • Practice mock interview questions with IRB staff • Focused training sessions • Review key WHUHS IRB Policies and Procedures

  10. IRB Policies and Procedures • What ? • Policies and procedures that Inform investigators and study staff regarding conduct of Human Research at WFUHS are available • Currently under extensive revision • Where are they? • They will be posted on a revamped OR/IRB website • How will they help you? • Better explain the IRB review process • Outline human subjects training requirements • Describe how to prepare IRB Submissions • Describes what new information to report • Provides resources/services to contact

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