Association for the Association for the Accreditation Accreditation

of Human Research of Human Research Protection Programs (AAHRPP)Protection Programs (AAHRPP)

Presentation/Discussion for IRB Presentation/Discussion for IRB MembersMembers

What is AAHRPP?What is AAHRPP?• Association for the Accreditation of Human Association for the Accreditation of Human

Research Protection ProgramsResearch Protection Programs

• AAHRPP works to protect the rights and AAHRPP works to protect the rights and welfare of research participants by fostering welfare of research participants by fostering and advancing the ethical and professional and advancing the ethical and professional conduct of persons and organizations that conduct of persons and organizations that engage in research with human participants. engage in research with human participants.

• AAHRPP achieves its mission by using an AAHRPP achieves its mission by using an accreditation process based on self-accreditation process based on self-assessment, peer review, and education.assessment, peer review, and education.

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

• 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?

Benefits of AccreditationBenefits of Accreditation

• Makes UCI’s research programs more Makes UCI’s research programs more competitivecompetitive

• 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

AAHRPP AAHRPP Five Domains of StandardsFive Domains of Standards

• AAHRPPAAHRPP®® divides the criteria for divides the criteria for accrediting programs into the accrediting programs into the following five domains:following five domains:

OrganizationOrganization Research Review Unit, including IRBsResearch Review Unit, including IRBs InvestigatorsInvestigators Sponsored ResearchSponsored Research Participant OutreachParticipant Outreach

Each Domain:Each Domain:

• Divided into Divided into STANDARDSSTANDARDS– Each STANDARDEach STANDARD

Divided into Divided into ELEMENTSELEMENTS

For each For each STANDARDSTANDARD andand each each ELEMENTELEMENT, , UCI’s Human Research Protection Program UCI’s Human Research Protection Program needs a written statement attached to needs a written statement attached to policy/procedure/item to demonstrate that policy/procedure/item to demonstrate that our program meets standard/element.our program meets standard/element.

AAHRPP Accreditation AAHRPP Accreditation StandardsStandards

• Based on U.S. federal regulations for Based on U.S. federal regulations for conducting human researchconducting human research Department of Health and Human Department of Health and Human

Services Services – 45 CFR 4645 CFR 46

Food and Drug AdministrationFood and Drug Administration– 21 CFR 50, 5621 CFR 50, 56

• ICH Good Clinical Practice GuidelinesICH Good Clinical Practice Guidelines• Common SenseCommon Sense

What do the standards What do the standards evaluate?evaluate?

• StructureStructure– What we haveWhat we have

• ProcessProcess– How we do itHow we do it

• OutcomeOutcome– What we achieveWhat we achieve

Focus on outcomesFocus on outcomes

• Look to the outcomesLook to the outcomes

• Do we meet the outcome described Do we meet the outcome described or implied by the element?or implied by the element?

• AAHRPP is flexible on the processAAHRPP is flexible on the process

AAHRPP does not…AAHRPP does not…

• ““Audit” decisions Audit” decisions made by the IRBmade by the IRB

• Critique researcher’s Critique researcher’s proposalsproposals

• Report “findings” to Report “findings” to regulatory agenciesregulatory agencies

• The entire The entire accreditation accreditation process is process is confidential!confidential!

Accreditation ProcessAccreditation Process• Self-assessmentSelf-assessment Evaluation and improvement of UCI’s Human Evaluation and improvement of UCI’s Human

Research Protection Program Research Protection Program

• On-site evaluationOn-site evaluationA team of experts reviews UCI’s materials and A team of experts reviews UCI’s materials and schedules an on-site visit. schedules an on-site visit.

• Council reviewCouncil reviewAAHRPP's Council of Accreditation reviews the AAHRPP's Council of Accreditation reviews the report, deliberates on the team's findings and report, deliberates on the team's findings and determines your accreditation status. determines your accreditation status.

• Notification of accreditation statusNotification of accreditation statusOrganizations that achieve accreditation must be re-Organizations that achieve accreditation must be re-evaluated every three years in order to remain evaluated every three years in order to remain accredited.accredited.

Typical site visitTypical site visit• 2 to 6 site visitors over 2-4 days2 to 6 site visitors over 2-4 days

• Representation from stakeholdersRepresentation from stakeholders IRBIRB InstitutionInstitution InvestigatorsInvestigators ParticipantsParticipants

• Interviews with…Interviews with… OfficialsOfficials Administrators—various unitsAdministrators—various units Staff: Research Protections and allied units (Sponsored Staff: Research Protections and allied units (Sponsored

Projects, Conflict of Interest)Projects, Conflict of Interest) IRB membersIRB members ResearchersResearchers Allied research support and other committees (CTPRMC, Allied research support and other committees (CTPRMC,

DSRC, GAC, Research Pharmacists)DSRC, GAC, Research Pharmacists)

What happens after site What happens after site visit ?visit ?

• UCI receives written reportUCI receives written report

• Thirty day response period to address Thirty day response period to address questions or gapsquestions or gaps

• Site Visit Team Report and UCI Site Visit Team Report and UCI response submitted to AAHRPP response submitted to AAHRPP Council on AccreditationCouncil on Accreditation

• AAHRPP Council renders a decisionAAHRPP Council renders a decision

What IRB members What IRB members should knowshould know

• Basic principles of human subjects Basic principles of human subjects protectionprotection

• Regulations/Policies/Assurance: Regulations/Policies/Assurance: what what they mean, where to find them, how to apply themthey mean, where to find them, how to apply them

• IRB Review ProcessIRB Review Process

• How to read minutes/expedited review How to read minutes/expedited review reports and where to go for more reports and where to go for more informationinformation

How to prepare for site How to prepare for site visitvisit

• Re-read Belmont ReportRe-read Belmont Report

• Complete on-line training modules using Complete on-line training modules using UCI Net ID loginUCI Net ID login

• familiarize yourself with the familiarize yourself with the IRB IRB MembersMembers website website

• Attend IRB meetings and participate in Attend IRB meetings and participate in discussionsdiscussions

• Participate in annual educational Participate in annual educational offeringoffering

Where to get more Where to get more informationinformation

http://aahrpp.org/index.html