1.21 Post-Approval Monitoring of Research

• 4.2.2.1. It is expected that at least twelve non-exempt studies will be selected for “Not-For-Cause” audit per year, however the actual number of audits will be contingent on available manpower
• 4.2.2.2. The Post Approval Monitoring visit will be scheduled at a time mutually acceptable tomonitoring, the PI and theresearch designated IRB Administrator. Unannounced visitsteam will nothave occur.
the
• 4.2.2.3. Prioropportunity to the Post Approval Monitoring visit, the PI will be informed, in writing, thatdo a Post Approval Monitoring visit has been scheduled, including the date, time, place, and protocol(s) selected for review. The PI will also be provided a descriptionself-review of the auditprotocol. processThe andself-report criteria,may asbe wellused as a copyfocus of the ChecklistPAM.
for
• 3.2.2. PostThe ApprovalPAM Monitoringmay include observation of On-Goingthe Researchprocess of informed consent or interviews with subjects if required by the IO, IRB Executive Chair or the IRB. If so, potential subjects must provide their consent to be completedobserved byor the designated IRB Administrator during the visit.interviewed.
• 4.3.2.2.4. The PI will be asked to complete the Investigator Assessment Checklist for Regulatory Documentation and submit it to the ORA prior to conduct of the Post Approval Monitoring visit.
• 4.2.2.5. Visits must occur within 30 days of notification, unless delay is approved by the IRB Executive Chair.
• 4.2.2.6.3. Failure to comply with the Post Approval Monitoring RequestRequest, constitutesor failure to cooperate with PAM, or interference with the PAM process may represent serious non-compliance subject to HRPP policy 8.4 (Review of Noncompliance Involving the PI and Study Personnel)Personnel …).
• 3.2.4. 4.2.2.7.As The designated IRB Administrator will utilize the Checklist for Post Approval Monitoring of On-Going Research during review of investigator records.
• 4.2.2.8. If the assessment visit will include observation of the process of informed consent or interviews with subjects, the PI will be asked to arrange this in advance with one or more subjects. All subjects who have agreed must give written informed consent in advance by signing the Consent for IRB Observation of the Informed Consent Process. The designated IRB Administrator will utilizeappropriate, the IRB Observationanalyst of Consent Process Form to evaluateperforming the process of consent.
• 4.2.2.9. Failure of the investigator or the research staff to cooperate with PAM, or interference with PAM by the investigator or the research staff, constitutes serious noncompliance subject to HRPP policy 8.4 (Review of Noncompliance Involving the PI and Study Personnel).
• 4.2.2.10. Following completion of the Post Approval Monitoring visit, the designated IRB Administrator will present preliminary findings to the investigator and/or staff,PI, obtain additional clarifications and corrections, and provide education concerning IRB requirements as needed.
• 3.2.5. 4.2.2.11.If ThePAM designatedsuggests IRBnoncompliance, Administratoror will preparesuggests a written report ofUP, the PAM visit, including, as needed, a request for a corrective action plan. The written reportinvestigator will be giveninstructed to thesubmit investigator,an theIncident IRB Executive Chair,Report and theCorrective IO.
Action
• Plan 4.2.2.12.as Theappropriate. designatedSuch IRB Administrator, in consultation with the IO and the IRB Executive Chair, will evaluate the PAM report and the investigator’s corrective action plan, if provided.
  • 4.2.2.12.1. Reports which suggest serious noncompliance or other concernsIR will be referredhandled toas the IRB for review in accordance withper HRPP policy 8.4 (Review of Noncompliance Involving the PI and Study Personnel).
  Personnel
  • 4.2.2.12.2. Reports which demonstrate few…) or noHRPP deficiencies,policy and/or8.3 (Review of Unanticipated Problems Involving Risk to the useSubject ofor “bestOthers). practices”
    • 3.2.5.1. PAM that suggests subjects or other may be placed at unacceptable risk will be reportedreferred immediately to the IRB Executive Chair and to the ORA, and may justify suspension or termination of the research in accordance HRPP policy 8.6 (Study Hold, Suspension, and Termination).
  • 3.2.6. After resolution of all issues related to PAM, the IRB Analyst performing the PAM will present a written report of findings and resolution to the PI, the Institutional Official, the IRB Executive Chair and the convened IRB as a notification item,item.
  • 3.2.7. Based on the evaluation of the PAM report, and will(as be communicated toappropriate) the investigator.
  Corrective
  Action
Plan
• 4.2.2.13. The Post Approval Monitoring Program will include appropriate follow-up to ensure that deficiencies are corrected in a timely manner. This follow-up may include only a written report of corrective action(s) implementedsubmitted by the PI,Investigator orin itresponse to findings of the PAM, the IRB may require additional follow-up monitoring by the IRB. In some cases, the PI and/or other study personnel may be required to undergo specific training in order to assist in achieving the desired level of compliance.

4.2.3. “For-Cause” Audit

“For-Cause” audits will follow the same procedure as above, except that unannounced visits may occur if authorized by the IO, and all PAM reports will be reviewed by the convened IRB.