Preparing the IRB and Investigators for an External Audit/Site Visit Cynthia Monahan, MBA, CIP IRB Director Boston University Charles River Campus IRB.

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<ul><li><p>Preparing the IRB and Investigators for an External Audit/Site VisitCynthia Monahan, MBA, CIPIRB DirectorBoston University Charles River Campus IRB</p></li><li><p>Table of ContentsOffice for Human Research Protections (OHRP) Compliance Oversight EvaluationsFood and Drug Administration (FDA) InspectionsAssociation for the Accreditation of Human Research Protection Programs (AAHRPP) Site VisitPreparing and Navigating the Inspection/Visit</p></li><li><p>OHRP Compliance Oversight Evaluation Division of Compliance Oversight (DCO) evaluates, at OHRPs discretion, written substantive indications of noncompliance with HHS regulationsDCO also conducts a program of not-for-cause surveillance evaluations of institutions, and receives, reviews, and responds to incident reports from Assured institutions</p></li><li><p>OHRP Not-for-cause EvaluationVisit is not initiated by a complaint or report of possible non-complianceInstitutions are selected based on:VolumeHistory of low level of reporting to OHRPNeed to evaluate that corrective actions from a previous for-cause evaluation have been implementedGeographic locationAccreditation statusResults of recent evaluations/audits by other regulatory agencies</p></li><li><p>OHRP Not-for-cause EvaluationOHRP notifies Institutional Officials in writing of evaluationNotice will include whether interviews will be conducted and if an on-site visit will be conductedInstitutional officials, IRB members, and investigatorsOHRP requests the following information by a specified date:Policies and proceduresRecent meeting minutesList of active IRB protocols</p></li><li><p>OHRP For-Cause EvaluationEvaluation is in response to an allegation of non-complianceSources of non-compliance include: research subjects, investigators, research staff, and Institutional Officials</p></li><li><p>OHRP For-Cause EvaluationOHRP notifies institutional officials in writing of evaluation Initial letter includes:Description of the allegationRequest for the institution to conduct an investigationRequest for written response by a specified dateCorrective action plan if investigation reveals any non-complianceExplanation of OHRP evaluation procedures </p></li><li><p>OHRP On-Site VisitIn most cases, on-site visits are not required; however, visit will be required if concerns cannot be resolved through correspondenceMajority of on-site visits are for-causeMost on-site visits are announced 1-2 weeks in advance; however, there is no requirement that visit must be announced</p></li><li><p>OHRP On-Site VisitVisits are conducted by a team of 2-5 OHRP professionals and 2-5 external consultantsVisits are usually announced by telephone and in writingOHRP is informing the institution that the visit will occur NOT inquiring about scheduling an appointmentOHRP provides agenda for visit</p></li><li><p>OHRP On-Site VisitOHRP will request list of human subjects research3-5 days in advance of visit, OHRP will identify 50-100 specific protocols and request that they be available for review; medical records may also be requestedMinutes from the past 3 years will be reviewedVisit usually lasts 3-5 days</p></li><li><p>OHRP On-Site VisitVisit begins with an introductory meeting with the institutional officials and other appropriate officials1 hour/day devoted to on-site review of the IRB1 day devoted to meetings with IRB chairs, IRB members, administrators, investigators, and research staffExit interview at the end of the visit</p></li><li><p>OHRP On-Site VisitExit interview:Determinations and required corrective actions are presentedIf immediate action is required, determination letter may be issued at exit interviewOHRP determination letters are publicly available and are posted on the OHRP website</p></li><li><p>Evaluation OutcomesOHRP does not identify any areas of non-complianceOHRP recommends improvementsInstitution is free to implement the recommendations or not</p></li><li><p>Evaluation Outcomes (contd)OHRP determines that there is non-complianceInstitution is required to develop and implement corrective actionsRestricts or attaches conditions to its approval of the institutions FWASuspends its approval of the institutions FWATemporarily suspend or permanently remove an institution or investigator from specific projectsNotify scientific peer groups of non-complianceInstitution and/or investigator is debarredRefer the matter to another Federal agency</p></li><li><p>FDA Inspections</p></li><li><p>Bioresearch Monitoring (BIMO) ProgramFDA developed BIMO to ensure:The protection of the rights, safety, and welfare of human research subjects The quality and integrity of data submitted to the AgencyBIMO Program involves site visits to clinical investigators, sponsors, monitors, contract research organizations, IRBs, nonclinical (animal) laboratories, and bioequivalence analytical laboratories</p></li><li><p>FDA InspectionsRoutine InspectionsEvery 5 yearsDirected InspectionsFDA receives information that calls an IRBs practices into question</p></li><li><p>FDA InspectionsFDA inspector will contact the institution with the notification of intent to inspectFDA inspector is not calling to schedule an appointment; this is a notification that you will be inspected</p></li><li><p>FDA InspectionsThe PI or his/her representatives should meet the inspector and receive and sign the FDA form 482 Notice of Inspection.Request to see the inspectors identification if he/she does not present it to youWrite down the inspectors identification informationyou cannot make a copy of the inspectors badge!!</p></li><li><p>FDA InspectionsWhat does the FDA inspect?IRB written proceduresIRB membershipIRB meeting minutesConsent formsCorrespondence between the IRB and PICorrespondence regarding unanticipated problems and serious and/or continuing non-compliance</p></li><li><p>FDA InspectionsWhat does the FDA inspect (contd)Non-significant risk (NSR)/Significant Risk (SR) device determinationsStudy filesDocumentation of approvals and waiversHumanitarian use Devices (HUD)Pediatric findings</p></li><li><p>After the FDA InspectionThe FDA inspector will hold an exit interview at the conclusion of the audit to discuss findings and deficienciesDocument the interview, specifically noting observations, comments, and commitmentsAny deficiencies will be noted on the FDA form 483 and given to the PIIRB should respond to the 483 in writing (within 15 days)</p></li><li><p>After the FDA InspectionAfter the inspection, the inspector will write an Establishment Inspection Report (EIR) and submit it to FDA headquartersAfter the report has been evaluated you will receive one of three letters:No action indicated (NAI): No objectionable conditions or practices were found during the inspection, or the significance of the objectionable conditions does not justify further FDA action</p></li><li><p>After the FDA InspectionPost-inspection letters (contd)Voluntary Action Indicated (VAI): Objectionable conditions were found and documented, but the FDA is not prepared to take or recommend further regulatory action because the objectionable conditions are few and do not seriously impact subject safety or data integrityOfficial Action Indicated (OAI): Regulatory violations uncovered during the inspection are repeated or deliberate and/or involve submission of false information to FDA or to the sponsor</p></li><li><p>FDA Actions for Non-ComplianceAdministrative ActionsRe-inspect to verify corrective actionsWithhold approval of new studiesNo new subjects can be enrolled into ongoing studiesTerminate ongoing studiesDisqualification</p></li><li><p>2013 BIMO MetricsIRB Inspections: 174Clinical Investigator Investigations: 664</p></li><li><p>Most Common IRB DeficienciesInadequate initial and/or continuing reviewInadequate SOPsInadequate membership rostersInadequate meeting minutesQuorum issuesSubpart D issuesInadequate communication with CI/institutionLack of or incorrect SR/NSR determination</p></li><li><p>Most Common Clinical Investigator DeficienciesFailure to follow the investigational plan and/or regulationsProtocol deviationsInadequate recordkeepingInadequate accountability for the investigational productInadequate communication with the IRBInadequate subject protection-- failure to report AEs and informed consent issues</p></li><li><p>Association for the Accreditation for Human Research Protection Programs (AAHRPP)</p></li><li><p>Who is AAHRPP?Independent non-profit accrediting bodyVoluntary, peer-driven, educational modelSite VisitorsCouncil MembersEnsures that HRPP meet rigorous standards for quality and protectionTangible evidence of commitment to ethical research and continuous improvementPolicies, procedures, and practicesProvides assurance that HRPP is focused on excellenceResearch subjects, researchers, sponsors, federal regulators</p></li><li><p>Why AAHRPP Accreditation?Earn respect and meet expectations of peersOver 60% of US research-intensive universities and over 65% of US medical schools have or are in the process of AAHRPP AccreditationLeadership role in collaborative effortsExternal IRB reviewsCompetitive edge with sponsors/fundersReduce the risk of non-complianceStreamlined policiesEnhance standing with US federal agenciesBenefit from a common commitment to continuous quality improvement</p></li><li><p>Goals, Principles, and StandardsAAHRPP has adopted nine overarching principles for protecting human research participants, which serve as the foundation for the AAHRPP Accreditation Standards for Human Research Protection Programs. The AAHRPP Accreditation Standards themselves describe what Organizations can do to consistently act on these principles by applying them to the diverse organizational and cultural contexts in which research is conducted and reviewed</p></li><li><p>AAHRPP Accreditation StandardsDomain I: OrganizationStructural characteristics of the OrganizationDomain II: Institutional Review Board/Ethics CommitteeReview and oversight of researchEnsure independence of ethics reviewDomain III: Researcher and Research StaffRequirements for researchers and research staff involved in human subjects researchhttp://www.aahrpp.org/apply/process-overview/standards</p></li><li><p>Accreditation ProcessApplication preparation (Step 1)Submit Application to AAHRPP for reviewOn-site evaluation (Step 2)Site visitors conduct on-site visitCouncil ReviewCouncil reviews the Application, Draft Site Visit Report, and response and determines accreditation statusNotification of accreditation statusReport sent to Organization detailing the status of the accreditation</p></li><li><p>Preparing for AccreditationConduct a self-assessmentAllows the Organization to review its HRPP and evaluate its compliance with the AAHRPP Accreditation StandardsCreate list of supporting documents (forms, policies, checklists, etc.) and make copies (this becomes part of your Application)Draft an element-by-element index to the supporting documents (this becomes part of your Application)Use Evaluation Instrument for AccreditationProvides direction on the meaning of each Standard and Element</p></li><li><p>Application StepsStep 1 (Application Review)Submit Application including: 1) program overview, 2) copies of supporting documents (policies/procedures, checklists, forms, etc.), and 3) an index for the supporting documentsAAHRPP will review Application and provide feedback within 45 daysAddress any issues with feedback</p></li><li><p>Application Steps (contd)Step 2 (Site Visit)Once all issues have been resolved, AAHRPP will schedule the site visitSite visits are typically scheduled within 3 months after Application is considered to be complete</p></li><li><p>On-site VisitDepending on size of the Organization, the visit will last 2-4 daysFour-Eight Weeks Before the Visit, AAHRPP will send the following:Draft agendaList of people to be interviewedExplanation of the types of visitsList of the AAHRPP site visitorsRequest for logistical and travel informationRequest to set aside rooms to be used by site visitorsRequest for additional info (e.g. electronic system, etc.)</p></li><li><p>On-site Visit One week before the Visit, AAHRPP will send the following:Final agendaLogistical detailsList of records and documents that must be readyProtocol filesAverage is 20-30 files</p></li><li><p>On-Site VisitDuring the Visit:Introduction SessionAAHRPP site visitors, lead contact from Organization, Organizational Official, other staff membersAAHRPP site team leader will describe the accreditation processProgram OverviewOpportunity for site visitors to ask questionsOrganization provides overview of ProgramFile ReviewSite visitors will review requested files</p></li><li><p>On-Site VisitDuring the Visit (contd)InterviewsConfidential and limited to individuals on the agendaCloseout SessionSite team leader will provide high-level overview and specific observations about each StandardOrganization is provided with the comments that will be in the reportSite visitors may provide suggestions but they will not be included in the reportOrganization attendees usually the same as Introduction session</p></li><li><p>After the VisitAAHRPP will provide a Draft Site Visit Report to Organization within 30 days of the site visitOrganization must respond within 30 daysOnce response has been completed and accepted, it is sent to Council for review</p></li><li><p>Council ReviewCouncil on Accreditation makes the decision about accreditation Accreditation StatusNew ApplicantsFull AccreditationQualified AccreditationAccreditation PendingAccreditation Withheld</p></li><li><p>Preparing and Navigating for the Inspection/Visit</p></li><li><p>Preparing for the Inspection/VisitEnsure that all study documentation is available for review for the inspector/visitorReview study documentation for:Comprehensiveness, accuracy, and complianceWeakness/gaps; correct those that can be corrected (i.e. file violations, notes-to-file, locate missing documents, etc.)Unresolved or outstanding issuesOrganize documents</p></li><li><p>Preparing for the Inspection/VisitNotify all appropriate officials/individualsPrepare work space for the inspector/visitorAccess to copy machineAccess to electronic systemsInvolve IT DepartmentIssue Temporary passwordsTraining session</p></li><li><p>During the Inspection/VisitThe Institutional representatives should meet the inspector/visitor Arrive on timeAsk for identification</p></li><li><p>During the Inspection/VisitIf the inspector/visitor requests copies of documents:Remove subject identifiers from the copies given to the inspector/visitorMake a copy for yourself The inspectors/visitors copies should be stamped Confidential and your copies should be stamped Copy.Set aside time each day to talk with the inspector/visitor</p></li><li><p>During the Inspection/VisitHow to answer questions from the inspector/visitor:Be concise; answer only the question that is askedAlways be clear with answers to questionsAnswer honestly and openlyDO NOT volunteer informationDO NOT guess or speculateDO NOT argueIf you dont know the answer, write down the question and refer it to the appropriate personKeep a log of questions asked by the inspector</p></li><li><p>Ongoing Preparation ProcessInternal auditsReview FDA/OHRP determination lettersAdequate IRB StaffingContinuing education for IRB members, IRB staff, and researchersMaintain and update IRB policies</p></li><li><p>ResourcesBIMO http://www.fda.gov/ICECI/EnforcementActions/BioresearchMonitoring/default.htm</p><p>OHRP: Compliance Oversighthttp://www.hhs.gov/ohrp/compliance/index.html</p><p>AAHRPPhttp://www.aahrpp.org/</p><p>*</p></li></ul>

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