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IRB Inspections. Melody Lin, Ph.D. Deputy Director, Office for Human Research Protections Director, International Activities Melody.Lin@hhs.gov Santiago, Chile August 2006. Objectives. Inspections Program OHRP FDA Tips for Preparation Common Deficiency Behavioral Guidelines. - PowerPoint PPT Presentation

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  • IRB InspectionsMelody Lin, Ph.D.Deputy Director, Office for Human Research ProtectionsDirector, International ActivitiesMelody.Lin@hhs.gov

    Santiago, Chile

    August 2006

  • ObjectivesInspections ProgramOHRPFDATips for PreparationCommon DeficiencyBehavioral Guidelines

  • JurisdictionOHRP45 CFR 46OHRP approved assuranceFDA21 CFR 5621 CFR 50

  • Inspections ProgramOHRPFor cause site visitNot for cause site visitFDARoutine surveillance inspectionDirected inspection

  • OHRP Compliance Oversight InvestigationReceive allegation of noncomplianceDetermine OHRP jurisdiction Written inquiry to appropriate institutional officialsReview of institutions report and relevant IRB documentsAdditional correspondence/telephone interview/site visit as neededIssue final determinations

  • OHRP For-Cause Site VisitsWhen does OHRP conduct a site visit?Base on:Nature and severity of the allegationsEvidence of systemic problemsAppropriateness of any corrective actions takenPerceived need for more in-depth discussions with institution staff

  • OHRP For-Cause Site VisitsInterview with:Institutional administrator(s)IRB Chairperson(s)IRB membersIRB staffInvestigators who conduct human subjects researchOthers as appropriate

  • OHRP For-Cause Site VisitsRecord ReviewsSelect 50-75 active protocols for review of entire IRB record on-siteLast 25 protocols approved by the IRB under an expedited review proceduresLast 25 amendments approved by the IRB under an expedited review procedureProtocols determined to be exempt during the past 6 monthsMinutes for all IRB meetings for last 4 years

  • OHRP For-Cause Site VisitsFindingsMeet with the signatory officials on the Assurance, or their designees on last day to describe OHRPs findings

  • OHRP Not-For-Cause Compliance Oversight Evaluations

  • Purpose of OHRP Not-for Cause EvaluationsTo assess institutional compliance with 45 CFR 46In absence of specific allegationsSomewhat proactiveSome evaluations are partially for cause previous compliance problems

  • OHRP Compliance Oversight Investigation Possible Determinations/Outcomes (1)Protections under an institutions Assurance are in compliancein compliance, but recommended improvements have been identifiedNoncompliance identified, and corrective actions required Assurance restricted pending required corrective actionsOHRP approval of Assurance withdrawn

  • OHRP Compliance Oversight Investigation Possible Determinations/Outcomes (2)OHRP may recommend that HHS Officials suspend terminate

  • Compliance Oversight Investigation Possible Determinations/Outcomes (3)OHRP may recommend:Debarment ofInstitutionsInvestigations(ineligible for HHS research support)

  • FDA IRB InspectionsSelection CriteriaPast inspection historyFrequency Compliance statusActivity of IRBNew IRBsComplaints

  • FDA IRB InspectionsRoutineInspections assigned on cyclic basis for surveillanceDirectedComplaints to FDAFDA, other agenciesSponsor/monitorSubjects/Public

  • FDA IRB InspectionsInspections are announced and scheduled in advanceConsist of interviews with responsible IRB staffIn-depth review of SOPs , files and records Active FDA regulated studies

  • Scope of FDA IRB Inspections

    IRB membershipWritten procedures Initial review and approval of studiesContinuing review of research

  • Scope of FDA IRB Inspections

    IRB reporting to investigator and institutionExpeditedI.C.Emergency review

  • FDA IRB InspectionsDiscuss IRB administration and proceduresIndividual responsibility and authorityMembershipOperationsRecord keeping requirementsReview and approval of informed consent

  • FDA IRB InspectionsRecord ReviewSOPsMust have written procedures as required by 21 CFR 58.108Should agree with procedures described during interview

  • FDA IRB InspectionsInspection of IRB files-FDA regulated study filesMinutes of meetingsList of IRB members Documents submitted to IRB to obtain study approvalCorrespondence between IRB and investigatorRecords of continuing reviewAny other records

  • Conclusion of FDA IRB InspectionExit interview with managementDiscussion of inspection findingsIssuance of an FDA 483

  • Post FDA IRB Inspection

    Detailed Narrative Report PreparedSubmitted to HQ BIMO Staff for Evaluation

  • FDA Compliance Inspection Classification(1)NAI No Action IndicatedVAI Voluntary Action IndicateObjectionable conditions or practices were found, but FDA is not prepared to take or recommend any administrative of regulatory action

  • FDA Compliance Inspection Classification(2)OAI Official Action IndicatedRegulatory and/or Administrative actions will be recommended due to significant objectionable observations

  • Tips Prior to Inspection(1)Know what the regulatory requirements are for your operations21 CFR 50 and 56 IRBs and informed consent21 CFR 312 Clinical Investigators and Sponsors of Drugs and biologics21 CFR 812 Clinical Investigators of Medical Devices

  • Tips Prior to Inspection(2)Obtain and be familiar with the Compliance Program covering your operationRetain all records necessary to completely reconstruct activities and findings

  • Tips During the Inspection (1)

    Have the most responsible personnel available IRB ChairIRB administrator/Exec. Sec.Institutional official

  • Tips During the Inspection(2)Have all records readily available and organizedBe available throughout the inspection to answer questions

  • Tips During Inspection (3)Update records, organized and be availableInventory of ongoing research and current statusIRB SOPs covering current practicesIRB membership rosters, current and pastIRB meeting minutesRecords of tracked studiesProtocol, consent forms, IRB correspondence, etc.

  • Post FDA IRB InspectionCorrespondenceSent to IRB Chair Describes which practices or conditions, were determined to be objectionableLetters are sent for serious noncompliance and require a response

  • Recurrent Compliance Problems(1)IRB failure to review grant applicationsIRB lacks sufficient information to make determinations Inadequate continuing review, or longer than 1 yearInadequate IRB review at convened meetings

  • Recurrent Compliance Problems(2)Contingent approval without subsequent re-reviewIRB meetings without a quorumIRB members with conflicts of interestInadequate records, minutes, files, documentation, policies and procedures

  • Inappropriate use of expedited review for new, continuing, and changesFailure to report unanticipated problems to IRB, IO, OHRPFailure or inadequate review of protocol changesInappropriate use of exempt categoriesRecurrent Compliance Problems(3)

  • Recurrent Compliance Problems(4)Deficient or inadequate informed consent documentsLack of diversity, expertise of IRB membershipOverburdened IRBInadequate IRB resources

  • Common IRB Deficiencies (FDA)Written proceduresIncomplete inadequate not followedExpedited reviewDevice SR/NSRInadequate continuing reviewsMinutes insufficientVote not recorded by number of votesAdverse events not adequately reviewed

  • Common IRB Deficiencies (FDA)Majority of members not at meeting Majority of members not present for voteNon-scientific member not presentFail to report to FDA when study is suspended or terminated

  • Behavioral Guidelines

  • Rules to Follow During InspectionKnow the contents of your job descriptionBe aware of your body languageNever remain in the room to chat with a inspector after you have answered all inspection related questions.

  • More to dosBe yourselfRemain focusedAnswer only the question asked

  • More to dosThink before you answer. There are no bonus points for being fastRemain calm, remember you do your job every day, and no one knows your job as well as you

  • What is Redacting?Redacting is the act of selecting or adapting for publication or releaseRemove all information that the inspector is not legally entitled to see

  • Use Caution During InspectionDont fill in the silencesDont allow yourself to become irritated. Maintain a professional demeanor at all times

  • More cautionsAnswer all yes or no questions with yes" or noDo not editorialize or volunteer information

  • More cautionsNever hand a document directly to a inspector - - - always pass documents to the inspection team leaders

  • More cautionsNever volunteer information on any subjectNever refer to another topic, area, or procedure when answering a question

  • Body LanguageDo not sit on the edge of your chair, Make eye contactDo not play with your hair, twirl your thumbs, click your ink pin, or tap your fingers

  • Body LanguageDo not watch the doorNever cross your arms over your chest or slouch in your chair

  • Statement to AvoidIts supposed to do (fill in the blank).Wow, it usually never does it right the first time!Do you want to know how it is supposed to happen or how it really happens?

  • Statement to AvoidI didnt even know we had an SOP for that!I didnt even know the SOP said that.I dont know (with no follow-up).

  • Statement to AvoidLet me show you what we do for Pfizer (or any other client).Would you like to see all our metrics?Well, I can try to do that for you, but Ive never really been trained.

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