Transcript IC_AAHRPP Overview Presentation(2)

Joseph Andrews, MA, CIP
Director, Institutional Review Board
Wake Forest University Health Sciences
 AAHRPP
Accreditation
• What is it?
• Why is it important?
• What’s the process?
• How might you be involved?
 Question/Answers
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
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
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
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
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•
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.
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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
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IRB Office Tasks:
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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
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Initial Application – Mar. 2010

(Anticipated) Revised Application – Aug. 2010
 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
Role of Research Community:
 Check the IRB website for updates
• Revised SOPs/Forms/Checklists/Templates
• New eIRB functionalities and formats
• Starting NOW!!!
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Notification of those selected by AAHRPP
• Oct. 2010
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Preparation
• Practice mock interview questions with IRB staff
• Focused training sessions
• Review key WHUHS IRB Policies and Procedures
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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
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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