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VHA Research Compliance Reporting Requirements

VHA Research Compliance Reporting Requirements. ORD Accreditation Conference Call December 15, 2011. Research Compliance Reporting Requirements ( VHA Handbook 1058.01).

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VHA Research Compliance Reporting Requirements

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  1. VHA Research Compliance Reporting Requirements ORD Accreditation Conference Call December 15, 2011

  2. Research Compliance Reporting Requirements (VHA Handbook 1058.01) • Set forth requirements for reporting research compliance events to VHA facility officials, relevant research review committees and ORO • Define serious noncompliance, serious problem, apparent serious or continuing noncompliance, etc. • VHA reporting requirements differ from those of OHRP, FDA, etc.

  3. Serious Noncompliance (§4.x) Failure to adhere to the laws, regulations, or policies governing human research that may reasonably be regarded as: • Involving substantive harm, or a genuine risk of substantive harm, to the safety, rights, or welfare of human subjects, research staff, or others; or • Substantively compromising the effectiveness of a facility’s human research protection or human research oversight programs

  4. Serious Problem (§4.y) A problem in human research that may reasonably be regarded as: • Involving substantive harm, or a genuine risk of substantive harm, to the safety, rights, or welfare of human subjects, research staff, or others; or • Substantively compromising the effectiveness of a facility’s human research protection or human research oversight programs

  5. Continuing Noncompliance A persistent failure to adhere to the laws, regulations, or policies governing human Research (§4.e) [Examples provided in (§7.g)]

  6. Reporting serious or continuing noncompliance (1) Apparent serious or continuing noncompliance identified by RCO based on RCO audits: • RCO reports to Facility Director, IRB, ACOS/R&D, R&DC and other relevant committees within 5 business days • Facility Director reports to ORO, Network Office, and ORD within 5 business days [Reporting to OHRP, FDA, sponsor, etc., is not required at this point]

  7. Reporting serious or continuing noncompliance (2) Apparent serious or continuing noncompliance identified by RCO based on RCO audits (continued) Convened IRB determines whether serious or continuing noncompliance has occurred based on the VHA definitions/criteria in 30-45 days. If yes: • IRB chair reports to Facility Director, ACOS/R&D, R&DC and other relevant committees within 5 business days • Facility Director reports to ORO within 5 business days • Report to OHRP (38 CFR 16.103(b)(5)(1)), FDA (21 CFR 56.108(b)(2), the sponsor, etc. as required

  8. Reporting serious or continuing noncompliance (3) Apparent serious or continuing noncompliance identified other than from RCO audits: Report to IRB within 5 business days Convened IRB determines whether serious or continuing noncompliance has occurred based on the VHA definitions/criteria in 30-45 days. If yes: • IRB chair reports to Facility Director, ACOS/R&D, R&DC and other relevant committees within 5 business days • Facility Director reports to ORO within 5 business days • Report to OHRP (38 CFR 16.103(b)(5)(i)), FDA (21 CFR 56.108(b)(2), the sponsor, etc. as required

  9. Reporting serious unanticipated problems or Local Serious Adverse Events (SAEs) Report to IRB within 5 business days Convened IRB or a qualified IRB member-reviewer determines whether the problem or the local AE is serious, unanticipated, and related (caused by or probably caused by research) within 5 business days. If yes: • IRB chair or designee notifies ORO via telephone or e-mail within 48 hours and reports to Facility Director, ACOS/R&D, and R&DC within 5 business days • Facility Director reports to ORO within 5 business days • Report to OHRP (38 CFR 16.103(b)(5)(i)), FDA (21 CFR 56.108(b)(1), the sponsor, etc. as required

  10. ORO Common Findings(Research Compliance Reporting) (1) Facility policies and procedures inconsistent with current VHA policies (i.e., VHA Handbook 1058.01) • Facility definition of serious or continuing noncompliance was inconsistent with that of VHA Handbook 1058.01 (§4.e & 4.x) • Facility allowed IRB to use expedited review procedures to review and make determination on the reported apparent serious or continuing noncompliance (§7.i) • Facility compliance reporting timeline (i.e., more than 5 business days) was inconsistent with VHA Handbook 1058.01

  11. ORO Common Findings(Research Compliance Reporting) (2) Facility policies and procedures inconsistent with current VHA policies (i.e., VHA Handbook 1058.01) • Facility allowed use of similar procedures for reporting all apparent serious and continuing noncompliance (whether they are identified by RCO based on RCO audits) (§7.e & h) • Facility did not maintain SOPs for reporting research information protection incidents (§6.a & §11)

  12. ORO Common Findings(Research Compliance Reporting) (3) Facility operations: • Facility IRB did not use VHA definition to make determination whether the reported apparent serious noncompliance is serious (§4.x) • Facility IRB (particularly affiliated IRB) did not report serious or continuing noncompliance to the Facility Director (only reported to ACOS/R&D and R&DC) (§7.i(1)) • Facility did not report change in HRPP accreditation status (reaccreditation-pending) to ORO (§7.k(4))

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