Overview of AAHRPP Accreditation Process for NYU SoM (August 2007)
Elan Czeisler IRB Director
NYU School of MedicineNYU School of Medicine
INSTITUTIONAL REVIEW BOARDINSTITUTIONAL REVIEW BOARD
www.med.nyu.edu/irb
Founders of AAHRPPFounders of AAHRPP Association of American Medical CollegesAssociation of American Medical Colleges Association of American UniversitiesAssociation of American Universities Consortium of Social Science AssociationsConsortium of Social Science Associations Federation of American Societies for Federation of American Societies for
Experimental BiologyExperimental Biology National Association of State Universities National Association of State Universities
and Land-Grant Collegesand Land-Grant Colleges National Health CouncilNational Health Council Public Responsibility in Medicine and Public Responsibility in Medicine and
ResearchResearch
What is AAHRPP?What is AAHRPP?
Accreditation conducted by Accreditation conducted by Association for Accreditation of Association for Accreditation of Human Research Protection Programs Human Research Protection Programs (AAHRPP)(AAHRPP)
AAHRPP is a non-profit organization AAHRPP is a non-profit organization founded in 2001 to ensure research founded in 2001 to ensure research compliance and promote uniform compliance and promote uniform standards for the protection of human standards for the protection of human research subjectsresearch subjects
Why Pursue AccreditationWhy Pursue Accreditation
NYU SoM and affiliates:NYU SoM and affiliates: aspire to the highest level of research conductaspire to the highest level of research conduct
proud of program and recent historyproud of program and recent history
want to demonstrate to the public and sponsors want to demonstrate to the public and sponsors that the program meets or exceeds national that the program meets or exceeds national standardsstandards
Why Do We Need Accreditation ?
Human Subject Protections Programs are currently under intense scrutiny—legislative attention, media attention
Numerous evaluations of IRBs reveal lack of investigator, IRB member, and administrative staff understanding
Loss of public confidence in research
Benefits of accreditation toBenefits of accreditation toorganizationsorganizations
Improves human research protection Improves human research protection programprogram
Assists in achieving complianceAssists in achieving compliance Improves research qualityImproves research quality Facilitates research and recruitment of Facilitates research and recruitment of
subjectssubjects Builds public trustBuilds public trust Instills confidence in sponsorsInstills confidence in sponsors
Benefits of accreditation toBenefits of accreditation toorganizationsorganizations
Elevates human research protection operations Elevates human research protection operations from a single review unit to a from a single review unit to a programprogram
Validates the strengths and highlights the Validates the strengths and highlights the weaknessesweaknesses
Focuses accountability within the human Focuses accountability within the human research protection programresearch protection program
Provides opportunity to develop mechanisms to Provides opportunity to develop mechanisms to address related issuesaddress related issues
Benefits of Accreditation to the Benefits of Accreditation to the Research CommunityResearch Community
Congressional interest in legislating is still highCongressional interest in legislating is still high Seeking accreditation will clearly demonstrate Seeking accreditation will clearly demonstrate
the research community’s commitment to do the the research community’s commitment to do the right thing – conduct ethically sound and safe right thing – conduct ethically sound and safe researchresearch
Government action may be averted if the Government action may be averted if the research community respondsresearch community responds
Focus on the WHOLE Human Research Protection Program:
•Organization
•IRB (s)
•Investigators
•Sponsors
•Participants
…all parts of the “whole” (NOT accreditation of the IRB)
AAHRPP Accreditation “Domains”AAHRPP Accreditation “Domains”
Program description divided into:Program description divided into:
Domain I: OrganizationDomain I: Organization Domain II: Research Review UnitDomain II: Research Review Unit Domain III: InvestigatorDomain III: Investigator Domain IV: SponsorDomain IV: Sponsor Domain V: ParticipantDomain V: Participant
What do the Standards evaluate?What do the Standards evaluate?
StructureStructure What we haveWhat we have
ProcessProcess What we doWhat we do
OutcomeOutcome What we achieveWhat we achieve
How Does Accreditation Work?How Does Accreditation Work?
On-site evaluationExpert site visitors
Tailored to organizational setting
Self-assessmentSelf Evaluation
Program Description
Council on Accreditation
Determines accreditation category
What AAHRPP doesn’t do:
“Audit” decisions made by the IRBnot a “second guessing” exercise
Critique researcher’s proposals
Report “findings” to regulatory agencies
Where we are now:Where we are now: Completed initial self assessmentCompleted initial self assessment (18 month process of review,evaluation, surveys, improvements, (18 month process of review,evaluation, surveys, improvements,
reallocation of resources, etc.)reallocation of resources, etc.)
Continue to make improvementsContinue to make improvements-Upgraded Policies, Forms, Review -Upgraded Policies, Forms, Review
ProcessProcess Submitted written application to AAHRPP Submitted written application to AAHRPP
(April 2007)(April 2007) Completed revisions to application suggested by Completed revisions to application suggested by
AAHRPP AAHRPP (May 2007)(May 2007)
Site Visit: August 7, 8 and 9, 2007Site Visit: August 7, 8 and 9, 2007
What happens next?What happens next?
Site visit (week long/system wide)Site visit (week long/system wide) Interviews with:Interviews with:
Officials-Dean, Vice-Deans, CMOOfficials-Dean, Vice-Deans, CMO Administrators—OCT, SPA, BHC, ComplianceAdministrators—OCT, SPA, BHC, Compliance StaffStaff IRB membersIRB members ResearchersResearchers
SITE VISIT DAYSSITE VISIT DAYS
3 days 3 days
August 7th – 9thAugust 7th – 9th
The Site VisitorsThe Site Visitors John M. Falletta, M.D. John M. Falletta, M.D.
Professor of Pediatrics Professor of Pediatrics Senior IRB Chairman Senior IRB Chairman Duke University Medical Center Duke University Medical Center
Karen Blackwell, MS Karen Blackwell, MS Director, Human Research Protection Program - Privacy Official Director, Human Research Protection Program - Privacy Official University of Kansas Medical CenterUniversity of Kansas Medical Center
Eugene A. Gallagher, MSPH Eugene A. Gallagher, MSPH IRB Compliance Officer IRB Compliance Officer Vanderbilt University Vanderbilt University
Bruce Gordon, M.D. Bruce Gordon, M.D. IRB Co-Chairman, Professor IRB Co-Chairman, Professor Pediatrics and Preventive and Societal Medicine University of Pediatrics and Preventive and Societal Medicine University of Nebraska Medical Center Nebraska Medical Center
Key concepts:Key concepts: Accreditation is voluntaryAccreditation is voluntary NYU SoM wants accreditationNYU SoM wants accreditation AAHRPP wants NYU SoM to be accreditedAAHRPP wants NYU SoM to be accredited Compliance and achievement as an Compliance and achievement as an
integrated integrated organizationorganization NotNot accreditation of the IRB accreditation of the IRB ProtectionProtection, not Perfection is the focus, not Perfection is the focus Institutional Support for the HRPP must be Institutional Support for the HRPP must be
demonstrated, not personal commitment of demonstrated, not personal commitment of a few peoplea few people
What happens after that ?What happens after that ?
Exit Interview with Officials (written report)Exit Interview with Officials (written report)
Thirty day response period to address questions or Thirty day response period to address questions or gaps-Septembergaps-September
Site Visit Team Report and NYU SoM response Site Visit Team Report and NYU SoM response submitted to AAHRPP Council on submitted to AAHRPP Council on AccreditationAccreditation
AAHRPP Council renders a decision-AAHRPP Council renders a decision-DecemberDecember
How does this affect how we How does this affect how we operate NOW?operate NOW?
Upgraded Submission FormsUpgraded Submission Forms Enhanced Education & Training Enhanced Education & Training
ProgramProgram Pooled Resources-QA/QI ConsortiumPooled Resources-QA/QI Consortium Administrative Efficiencies-Electronic Administrative Efficiencies-Electronic
Submissions-Elimination of Paper Submissions-Elimination of Paper (finally!)(finally!)
Growth of Research Program-FundingGrowth of Research Program-Funding
NIH Awards to All Institutions by Rank - Fiscal Year NIH Awards to All Institutions by Rank - Fiscal Year 20042004
RankRank OrganizationOrganization # # awardsawards
Award amtAward amt
11 Johns HopkinsJohns Hopkins 1,3061,306 $555,875,515$555,875,515
22 University of WashingtonUniversity of Washington 1,0021,002 $440,877.371$440,877.371
33 University of PennsylvaniaUniversity of Pennsylvania 1,1661,166 $434,456,754$434,456,754
44 University of California San University of California San FranciscoFrancisco
926926 $420,731,695$420,731,695
55 Science Applications Science Applications International CorpInternational Corp
33 $417,351,396$417,351,396
66 Washington UniversityWashington University 834834 $383,225,085$383,225,085
77 University of MichiganUniversity of Michigan 920920 $362,149,790$362,149,790
88 University of PittsburghUniversity of Pittsburgh 864864 $348,225,811$348,225,811
Where to get More Where to get More Information:Information:
http://aahrpp.org/index.html