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Seeking To ImproveSeeking To ImproveHuman ResearchHuman Research

Protections throughProtections throughAccreditationAccreditation

John H. Mather MDJohn H. Mather MDDirector, ORCR, OVPRDirector, ORCR, OVPR

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What will be discussed?What will be discussed?

The University’s commitment to The University’s commitment to accreditation of its Human Research accreditation of its Human Research Participant Protection Program (HRPPP)Participant Protection Program (HRPPP)

Present information on the current status Present information on the current status of development and the present schedule.of development and the present schedule.

Provide an opportunity for questions.Provide an opportunity for questions.

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What has been the impetus for What has been the impetus for accreditation of human subject accreditation of human subject

(participant) protection programs?(participant) protection programs? Increased vigilance of adherence to regulatory Increased vigilance of adherence to regulatory

compliance at OHRP and FDA since 1998.compliance at OHRP and FDA since 1998. ““Shut-downs” of human subject research at Shut-downs” of human subject research at

several major academic institutions by OHRP several major academic institutions by OHRP through summer 2001. [e.g. University of through summer 2001. [e.g. University of Pennsylvania, Duke, Johns Hopkins etc.]Pennsylvania, Duke, Johns Hopkins etc.]

Development of a “Plan for Insuring Adequate Development of a “Plan for Insuring Adequate Protection of Participants in Clinical Trials”.Protection of Participants in Clinical Trials”.Issued Spring 2002. University of Michigan.Issued Spring 2002. University of Michigan.

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What is theWhat is the“Plan for Insuring “Plan for Insuring Adequate Protection of Adequate Protection of

Participants in Clinical Trials”?Participants in Clinical Trials”?

Human Research Coordinating CouncilHuman Research Coordinating Council Significant enhancements of IRBsSignificant enhancements of IRBs Optimization of CACROptimization of CACR Organization of PEERRS ProgramOrganization of PEERRS Program Establishment of ORCREstablishment of ORCR Development of M-PRIMEDevelopment of M-PRIME Seek Accreditation for the HRPPPSeek Accreditation for the HRPPP

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Who will accredit?Who will accredit?

Association for Accreditation of HumanAssociation for Accreditation of Human Research Protection Programs (AAHRPPResearch Protection Programs (AAHRPP))

AAHRPP works to protect the rights and welfare AAHRPP works to protect the rights and welfare of research participants by fostering and of research participants by fostering and advancing the ethical and professional conduct advancing the ethical and professional conduct of persons and organizations that engage in of persons and organizations that engage in research with human participants. AAHRPP research with human participants. AAHRPP achieves its mission by using an accreditation achieves its mission by using an accreditation process based on self assessment, peer process based on self assessment, peer review, and education.review, and education.

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What are the origins of AAHRPP?What are the origins of AAHRPP? Initiated by Public Responsibility in Medicine and Initiated by Public Responsibility in Medicine and

Research [PRIM&R]Research [PRIM&R]

PRIM&R and AAMC partner with five other PRIM&R and AAMC partner with five other Founding Members.Founding Members.

Founding and Incorporated April 2001Founding and Incorporated April 2001

Number Accredited Institutions May 2004Number Accredited Institutions May 2004

For More Information: For More Information: hhttp://aahrpp.org/index.htmlttp://aahrpp.org/index.html

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Who are the founding Who are the founding organizations?organizations?

Association of American Medical CollegesAssociation of American Medical Colleges Association of American UniversitiesAssociation of American Universities Consortium of Social Science OrganizationsConsortium of Social Science Organizations Federation of American Societies for Federation of American Societies for

Experimental BiologyExperimental Biology National Association of State Universities and National Association of State Universities and

Land-Grant CollegesLand-Grant Colleges National Health CouncilNational Health Council Public Responsibility in Medicine and ResearchPublic Responsibility in Medicine and Research

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What are some Accreditation What are some Accreditation Principles?Principles?

Research participants protection is foremostResearch participants protection is foremost Compliance is the minimum requirementCompliance is the minimum requirement The whole institution, not just the IRBsThe whole institution, not just the IRBs Coverage of all disciplines under FWACoverage of all disciplines under FWA Educational and collegial Educational and collegial Peer Driven: “Expert” ReviewPeer Driven: “Expert” Review Performance based: Not an auditPerformance based: Not an audit Confidential and VoluntaryConfidential and Voluntary No reports to Regulatory AgenciesNo reports to Regulatory Agencies

(AAHRPP modeled on AAALAC)(AAHRPP modeled on AAALAC)

Human Subjects Protection is a Human Subjects Protection is a Shared ResponsibilityShared Responsibility

Investigator/

Researcher

Institution

IRB

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What are the accreditation What are the accreditation standards?standards?

•• Based on U.S. federal regulations for conducting Based on U.S. federal regulations for conducting human researchhuman research

- Department of Health and Human Services- Department of Health and Human Services

• • 45 CFR 4645 CFR 46

- Food and Drug Administration- Food and Drug Administration

• • 21 CFR 50, 56 [and 11,312,812, as 21 CFR 50, 56 [and 11,312,812, as appropriate] appropriate]

•• ICH Good Clinical Practice GuidelinesICH Good Clinical Practice Guidelines

• “• “Common Sense”Common Sense” and “Best Practices” and “Best Practices”

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What do the Standards evaluate?What do the Standards evaluate?

•• StructureStructure - What we have - What we have

• • ProcessProcess - What we do- What we do

• • OutcomeOutcome - What we achieve- What we achieve

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What are the Five Domains for What are the Five Domains for accreditation by AAHRPP?accreditation by AAHRPP?

Domain Domain II The OrganizationThe Organization Domain Domain IIII Review Bodies Review Bodies (not just the IRB)(not just the IRB)

Domain Domain IIIIII InvestigatorsInvestigators Domain Domain IVIV SponsorsSponsors Domain Domain VV ParticipantsParticipants

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What is involved in Each Domain?What is involved in Each Domain?

Domains Divided into Domains Divided into STANDARDSSTANDARDS

STANDARDS STANDARDS Divided into Divided into ELEMENTSELEMENTS

For each For each STANDARDSTANDARD andand each each ELEMENTELEMENT

AAHRPP needs a written statement attached AAHRPP needs a written statement attached to a policy/procedure/item to demonstrateto a policy/procedure/item to demonstrate

HRPP meets standard/element.HRPP meets standard/element.

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What is the process sequence?What is the process sequence?

Self-assessmentSelf-assessment

On-site evaluationOn-site evaluation

Council on AccreditationCouncil on Accreditation

Self EvaluationSelf Evaluation Program Description Program Description

Expert site visitorsExpert site visitors

Tailored to organizationalTailored to organizational settingsetting

DeterminesDetermines

Accreditation categoryAccreditation category

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What is going on What is going on NowNow??

Complete initial Self Assessment in 2004Complete initial Self Assessment in 2004

(18 month process of review, evaluation, (18 month process of review, evaluation, surveys, improvements, reallocation of surveys, improvements, reallocation of resources, etc.)resources, etc.)

Continue to make HRPPP improvementsContinue to make HRPPP improvements Submit written application to AAHRPPSubmit written application to AAHRPP Provide additional input and documentsProvide additional input and documents AAHRPP Site visitAAHRPP Site visit

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What happens on a Site Visit?What happens on a Site Visit?

Site visit (week long/system wide)Site visit (week long/system wide) Interviews with:Interviews with:

- Officials- Officials

- Administrators – various units- Administrators – various units

- Staff: RSPP and allied units- Staff: RSPP and allied units

- IRB members- IRB members

- Researchers- Researchers

- Allied research support [e.g. Pharmacy]- Allied research support [e.g. Pharmacy]

- and other committees [e.g. COI, IBC]- and other committees [e.g. COI, IBC]

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What do IRB members need to What do IRB members need to know?know?

ExamplesExamples

Basic principles of human subjects protectionBasic principles of human subjects protection Regulations/Policies/Assurance: what they Regulations/Policies/Assurance: what they

mean, where to find them, how to apply themmean, where to find them, how to apply them Process of review: meeting protocolProcess of review: meeting protocol How to read minutes/expedited review reportsHow to read minutes/expedited review reports Where to go for more informationWhere to go for more information

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How do investigators prepare? How do investigators prepare? ExamplesExamples

(Re-) Read Belmont Report(Re-) Read Belmont Report (Re-) Read UM Human Subjects Guide(Re-) Read UM Human Subjects Guide Fully comprehend the IRB processesFully comprehend the IRB processes Familiarity with M-PRIME systemFamiliarity with M-PRIME system Complete on-line training modules [ e.g. Complete on-line training modules [ e.g.

PEERRS] and document completionPEERRS] and document completion

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What happens after that?What happens after that?

•• Exit Interview with Officials Exit Interview with Officials

•• Receipt of written reportReceipt of written report

•• Thirty day response period to address Thirty day response period to address

questions or gapsquestions or gaps

•• Site Visit Team Report and UM response Site Visit Team Report and UM response submitted to AAHRPP Council on submitted to AAHRPP Council on AccreditationAccreditation

•• AAHRPP Council renders a decisionAAHRPP Council renders a decision

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Summary of Summary of TimetableTimetable for Initial for InitialAccreditation Accreditation

Self AssessmentSelf Assessment → → UNDERWAYUNDERWAY

Necessary system adjustments Necessary system adjustments →→ ONGOINGONGOING

Preparation of application and program descriptionPreparation of application and program description

Submission of application Submission of application → → AIMING FOR JAN 2005AIMING FOR JAN 2005

Preparation for on-site evaluationPreparation for on-site evaluation

Hosting of on-site evaluation-preliminary feedbackHosting of on-site evaluation-preliminary feedback →→(Est) MARCH (Est) MARCH 20052005

Notification and “negotiation” on accreditation Notification and “negotiation” on accreditation → → (Est) JUNE 2005(Est) JUNE 2005

Receipt of Accreditation Receipt of Accreditation → → (Est) JULY 2005(Est) JULY 2005

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What are the potential What are the potential BenefitsBenefits of accreditation? of accreditation?

Improves protection program (HRPPP)Improves protection program (HRPPP) Assists in achieving complianceAssists in achieving compliance Facilitates research integrityFacilitates research integrity Improves research qualityImproves research quality Instills confidence in sponsorsInstills confidence in sponsors Builds public trustBuilds public trust

““Protection not Perfection is the Focus”Protection not Perfection is the Focus”

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Audience QuestionAudience Question

““You said that they are going to randomly select You said that they are going to randomly select investigators to interview during this process. investigators to interview during this process. We’re off to a good start with you beginning to We’re off to a good start with you beginning to do these road shows and this session today. do these road shows and this session today. How do we get the word out and let our many How do we get the word out and let our many hundreds of investigators on this campus hundreds of investigators on this campus know about the potential of them being know about the potential of them being interviewed during this process?”interviewed during this process?”

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Audience QuestionAudience Question

““Do you see a need to come back and Do you see a need to come back and give updates to faculty when you have a give updates to faculty when you have a better idea of what they need to know? I better idea of what they need to know? I think I share Erich’s concern that unless think I share Erich’s concern that unless we have a very targeted message and we we have a very targeted message and we know exactly who to target to we are not know exactly who to target to we are not going to get a lot of interest from the going to get a lot of interest from the faculty.”faculty.”