1. Association for the Accreditation of Human Research Protection Programs (AAHRPP) Presentation/Discussion for IRB Members

2. What is AAHRPP? Association for the Accreditation of Human Research Protection ProgramsAssociation for the Accreditation of Human Research Protection Programs AAHRPP works to protect the rights and welfare of research participants by fostering and advancing the ethical and professional conduct of persons and organizations that engage in research with human participants.AAHRPP works to protect the rights and welfare of research participants by fostering and advancing the ethical and professional conduct of persons and organizations that engage in research with human participants. AAHRPP achieves its mission by using an accreditation process based on self-assessment, peer review, and education.AAHRPP achieves its mission by using an accreditation process based on self-assessment, peer review, and education.

3. Founders 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 Experimental BiologyFederation of American Societies for Experimental Biology National Association of State Universities and Land-Grant CollegesNational Association of State Universities and Land-Grant Colleges National Health CouncilNational Health Council Public Responsibility in Medicine and ResearchPublic Responsibility in Medicine and Research

4. Mandated by the Chancellor To ensure that scientific research can continue to grow and flourish in an environment where the best interests of research participants will be protected. Recent federal shutdowns of research programs around the country underscore the need to ensure consistency in meeting high standards for the protection for human research participants. Self accreditation rather than additional federal oversight Why do we need accreditation?

5. Benefits of Accreditation Makes UCI’s research programs more competitiveMakes UCI’s research programs more competitive Improves research qualityImproves research quality Builds public trustBuilds public trust Assures regulatory complianceAssures regulatory compliance Credibility - helps in recruiting participantsCredibility - helps in recruiting participants Gauges over-interpretation of regulationsGauges over-interpretation of regulations

6. AAHRPP Five Domains of Standards AAHRPP ® divides the criteria for accrediting programs into the following five domains:AAHRPP ® divides the criteria for accrediting programs into the following five domains:  Organization  Research Review Unit, including IRBs  Investigators  Sponsored Research  Participant Outreach

7. Each Domain: Divided into STANDARDSDivided into STANDARDS –Each STANDARD  Divided into ELEMENTS For each STANDARD and each ELEMENT, UCI’s Human Research Protection Program needs a written statement attached to policy/procedure/item to demonstrate that our program meets standard/element.

8. AAHRPP Accreditation Standards Based on U.S. federal regulations for conducting human researchBased on U.S. federal regulations for conducting human research  Department of Health and Human Services – 45 CFR 46  Food and Drug Administration – 21 CFR 50, 56 ICH Good Clinical Practice GuidelinesICH Good Clinical Practice Guidelines Common SenseCommon Sense

9. What do the standards evaluate? StructureStructure –What we have ProcessProcess –How we do it OutcomeOutcome –What we achieve

10. Focus on outcomes Look to the outcomesLook to the outcomes Do we meet the outcome described or implied by the element?Do we meet the outcome described or implied by the element? AAHRPP is flexible on the processAAHRPP is flexible on the process

11. AAHRPP does not… “Audit” decisions made by the IRB“Audit” decisions made by the IRB Critique researcher’s proposalsCritique researcher’s proposals Report “findings” to regulatory agenciesReport “findings” to regulatory agencies The entire accreditation process is confidential!The entire accreditation process is confidential!

12. Accreditation Process Self-assessmentSelf-assessment Evaluation and improvement of UCI’s Human Research Protection Program Evaluation and improvement of UCI’s Human Research Protection Program On-site evaluation A team of experts reviews UCI’s materials and schedules an on-site visit.On-site evaluation A team of experts reviews UCI’s materials and schedules an on-site visit. Council review AAHRPP's Council of Accreditation reviews the report, deliberates on the team's findings and determines your accreditation status.Council review AAHRPP's Council of Accreditation reviews the report, deliberates on the team's findings and determines your accreditation status. Notification of accreditation status Organizations that achieve accreditation must be re- evaluated every three years in order to remain accredited.Notification of accreditation status Organizations that achieve accreditation must be re- evaluated every three years in order to remain accredited.

13. Typical site visit 2 to 6 site visitors over 2-4 days2 to 6 site visitors over 2-4 days Representation from stakeholdersRepresentation from stakeholders  IRB  Institution  Investigators  Participants Interviews with…Interviews with…  Officials  Administrators—various units  Staff: Research Protections and allied units (Sponsored Projects, Conflict of Interest)  IRB members  Researchers  Allied research support and other committees (CTPRMC, DSRC, GAC, Research Pharmacists)

14. What happens after site visit ? UCI receives written reportUCI receives written report Thirty day response period to address questions or gapsThirty day response period to address questions or gaps Site Visit Team Report and UCI response submitted to AAHRPP Council on AccreditationSite Visit Team Report and UCI response submitted to AAHRPP Council on Accreditation AAHRPP Council renders a decisionAAHRPP Council renders a decision

15. What IRB members should know Basic principles of human subjects protectionBasic principles of human subjects protection Regulations/Policies/Assurance: what they mean, where to find them, how to apply themRegulations/Policies/Assurance: what they mean, where to find them, how to apply them IRB Review ProcessIRB Review Process How to read minutes/expedited review reports and where to go for more informationHow to read minutes/expedited review reports and where to go for more information

16. How to prepare for site visit Re-read Belmont ReportRe-read Belmont Report Complete on-line training modules using UCI Net ID loginComplete on-line training modules using UCI Net ID login familiarize yourself with the IRB Members websitefamiliarize yourself with the IRB Members website Attend IRB meetings and participate in discussionsAttend IRB meetings and participate in discussions Participate in annual educational offeringParticipate in annual educational offering

17. Where to get more information http://aahrpp.org/index.html