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Reporting Adverse Events to the IRB

Reporting Adverse Events to the IRB. IRB Responsibilities. Ensure that local management of unanticipated problems in research Assure maximal protection for research participants Comply fully with all laws, regulations, and standards. Purpose of IRB Review of AEs.

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Reporting Adverse Events to the IRB

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  1. Reporting Adverse Events to the IRB

  2. IRB Responsibilities • Ensure that local management of unanticipated problems in research • Assure maximal protection for research participants • Comply fully with all laws, regulations, and standards

  3. Purpose of IRB Review of AEs • Are there any changes in the risk/benefit ratio? • Should the consent form be changed? • Do subjects need to be re-consented?

  4. Local Management • PI initiated change • Revision of inclusion/exclusion criteria • Closer monitoring • Suspension of enrollment • Suspension of certain procedures • Modification of the Consent Form • Contacting previously enrolled subjects

  5. Is AE an Unanticipated Problem? OHRP Algorithm: OHRP Guidance Topic III

  6. Non-compliance • Failure to follow the regulations, or the requirements or the determinations of the IRB • Applies to anyone: investigators, staff, IRB members, IRB office

  7. Requirements • Written procedures for ensuring prompt reporting to the IRB…any serious or continuing non-compliance • Reporting promptly to the IRB regarding non-compliance by study personnel • Notifying medical center officials and VA Central Office of any instance of serious or continuing non-compliance 38 CFR 16.103(b)(5)(i) VHA Handbook 1200.5, p. 13-14

  8. Policies and Procedures • Define serious, continuing, minor, sporadic non-compliance • Report everything to IRB, determine what needs to be reviewed by the IRB • IRB decides whether non-compliance is serious or continuing • Describe the materials that should be provided to and reviewed by IRB members in its determination

  9. Suspension or termination of IRB approval (38 CFR part 16.113) • IRB has authority to suspend or terminate a project not being conducted in accordance with its requirements or is associated with unexpected harms to subjects • Must be reported

  10. Reporting Policy • Who drafts the report • Who approves the report • The distribution of the report • The maximum time allowed between the recognition of a reportable event and fulfilling reporting requirements • Coordination with reporting by the affiliate IRB (when appropriate)

  11. Report distribution • The Institutional Official • The ACOS/R&D • The Chair of the R&D Committee • The IRB • The VISN Director • The Regional VA Office of Research Oversight • The Office of Research and Development • FDA, if the study is subject to FDA regulations • OHRP, if the study is subject to DHHS regulations • Any “Common Rule” Federal Agency that is supporting research • Principal Investigator • Sponsor, if the study is sponsored • Contract research organization (CRO), if the study is overseen by a CRO • The VA Privacy Officer if the event involved unauthorized use, loss, or disclosure of individually-identifiable patient information • The VA Information Security Officer if the event involved violations of information security requirements • Office of Risk Management • Regional Counsel

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