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