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VHA Handbook 1058.01 Research Compliance Reporting Requirements Revised May 21, 2010 (Presentation prepared 05/27/2010)

VHA Handbook 1058.01 Research Compliance Reporting Requirements Revised May 21, 2010 (Presentation prepared 05/27/2010). Highlights (New Requirements in Red – Previous Requirements in Blue ) Requirements for Designation of Facility RCO [1058.01 §6c]

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VHA Handbook 1058.01 Research Compliance Reporting Requirements Revised May 21, 2010 (Presentation prepared 05/27/2010)

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  1. VHA Handbook 1058.01 Research Compliance Reporting Requirements Revised May 21, 2010 (Presentation prepared 05/27/2010)

  2. Highlights (New Requirements in Red – Previous Requirements in Blue) Requirements for Designation of Facility RCO [1058.01 §6c] Requirements to Conduct Annual and Triennial Audits as Specified by ORO [1058.01 §6c] Facility Director Reporting Requirements [1058.01 §6f] Annual Facility Director Certification of Research Oversight [1058.01 §6g] RCO Role as Consultant to Review Committees [1058.01 §4t] Requires Reporting of All RCO Audit Findings to Relevant Review Committees and R&DC [1058.01 §§6d, 6e] Time Periods for Implementing Remedial Actions [1058.01 §5d] Requires Providing ORO Compliance Reports to ACOS/R, RCO, Relevant Review Committees and R&DC [1058.01 §6g]

  3. Highlights (New Requirements in Red – Codification of Previous Guidance in Blue) Distinguishes Rapid Reporting Requirements for Serious Adverse Events and Unanticipated Problems Involving Risks to Subjects or Others from Reporting Requirements Under Local SOPs Clarifies Definitions of Serious or Continuing Noncompliance [1058.01 §§4e, 4x] Limits Special Rapid Reporting Requirements for Serious or Continuing Noncompliance to Human Research [1058.01 §§4e, 4x] Distinguishes Apparent Serious or Continuing Noncompliance from IRB-Determined Serious or Continuing Noncompliance and Provides Specific Examples[1058.01 §7i] Defines “Reportable Events” for Non-Human of Research [1058.01 §§8-11]

  4. Role of the RCO RCO’s primary responsibility = auditing and reviewing research projects relative to VA research requirements RCO may also serve as a nonvoting consultant, as needed, to the facility’s R&D Committee, IRB, IACUC, Subcommittee on Research Safety (SRS), and other research review committees The RCO may not serve as a voting or nonvoting member of these committees -- may attend meetings of these committees when requested by the committee or as specified in local committee SOPs [1058.01 §4t]

  5. The IRB is responsible for determining: Whether or not apparent noncompliance is serious or continuing Remedial action(s) in response to identified noncompliance Verifying that the remediation is implemented as required. [1058.01 §7i]

  6. Remedial Actions Remedial actions related to specific research projects should typically be completed within 90-120 days of the research review committee’s determination of noncompliance. Except where remediation requires substantial renovation, fiscal expenditure, hiring, legal negotiations, or other extenuating circumstances, remedial actions related to programmatic noncompliance should typically be completed within 120-180 daysof the noncompliance determination. Where completion of remedial actions extends beyond the periods described in the preceding subparagraphs, the facility must provide ORO with a written justification for the delay and an acceptable timeline for completion. [1058.01 §5d]

  7. Serious or Continuing Noncompliance vs Apparent Serious or Continuing Noncompliance Serious Noncompliance: Involves substantive harm (or genuine risk of substantive harm) to the safety, rights, welfare of human subjects, research staff or others in human research Substantively compromises the effectiveness of the facility’s human research protection/oversight programs Continuing Noncompliance: Reflects a persistent failure to adhere to the laws, regulations, or policies governing VA human research [1058.01 §§4e,4x,7e, 7f, 7g]

  8. Serious or Continuing Noncompliance vs Apparent Serious or Continuing Noncompliance Apparent Serious or Continuing Noncompliance = a situation that, in the judgment of the individual observing it: Satisfies the Handbook’s definition of Serious Noncompliance Satisfies the Handbook’s definition of Continuing Noncompliance Reflects one or more of the examples provided in the Handbook [1058.01 §§4e,4x,7e, 7f, 7g]

  9. Apparent Serious or Continuing Noncompliance Observed by an RCO in an Informed Consent, Regulatory, or Other Systematic Audit of Human Subjects Research Must be reported to the Facility Director, IRB, ACOS/R, R&D Committee, etc. within 5 business days Facility Director must report to ORO Regional Office within 5 business days of being notified (even if disposition complete) Facility Director must provide follow-up reports as specified by ORO Regional Office Convened IRB determines whether: Serious or Continuing Noncompliance occurred Remedial Actions are warranted [1058.01 §7h]

  10. Apparent Serious or Continuing Noncompliance in Human Subject Research Observed by anyone in the Research Community (including RCO in context other than audit) Must be reported to the IRB within 5 business days Convened IRB determines whether: Serious or Continuing Noncompliance occurred Remedial Actions are warranted If Serious of Continuing Noncompliance, IRB must report to Facility Director, ACOS/R, R&D Committee, etc, within 5 business days Facility Director must report to ORO Regional Office within 5 business days of being notified [1058.01 §7i]

  11. Serious Adverse Event (SAE) Reporting Investigator (or other person) must report local AE that is Serious and Unanticipated to the IRB within 5 business days: Serious = untoward physical or psychological occurrence in a human subject resulting in death, life-threatening experience, impatient hospitalization, persistent or significant disability or incapacity, congenital anomaly or birth defect, or that requires medical, surgical, behavioral, social, or other intervention to prevent such an outcome Unanticipated = reflects a risk that is new or greater than previously known Special review by IRB (or qualified IRB member) within 5 business day after the report to categorize the event [1058.01 §§ 4b,4p,4x,4y,4bb,7c, 7d]

  12. Serious Adverse Event (SAE) Reporting IRB must report Unanticipated, Related, Local SAE to Facility Director within 5 business days of categorization Related = event may reasonably be regarded as caused by, or as probably caused by, the research Facility Director must report to ORO Regional Office within 5 business days of being notified IRB (or qualified IRB member) must also document whether or not action is needed to prevent immediate hazard to subjects If consent or protocol modifications are required, convened IRB must determine whether previously enrolled subjects must be notified, and if so when, how, and how documented [1058.01 §§ 4b,4p,4x,4y,4bb,7c,7d]

  13. Unanticipated Problem Reporting Investigator (or other person) must report any unanticipated problem involving risks to subjects or others in human research to the IRB within 5 business days if it: May reasonably be regarded to involve substantive harm, or a genuine risk of substantive, to safety, rights, or welfare, or Substantively compromises the effectiveness of the facility’s human research protection or human research oversight programs Special review by IRB (or qualified IRB member) within 5 business days after the report to categorize the event Investigator (or other person) must report any other unanticipated problems involving risks to subjects or others in human research to the IRB promptly per local SOPs [1058.01 §§ 4y,4bb,7a,7b,7d]

  14. Unanticipated Problem Reporting IRB must report Related, Serious, Unanticipated Problems involving risk to subjects or others to Facility Director within 5 business days of categorization Related = event may reasonably regarded as caused by, or as probably caused by, the research Facility Director must report to ORO Regional Office within 5 business days of being notified IRB (or qualified IRB member) must also document whether or not action is needed to prevent immediate hazard to subjects If consent or protocol modifications are required, convened IRB must determine whether previously enrolled subjects must be notified, and if so when, how, and how documented [1058.01 §§ 4b,4p,4x,4y,4bb,7c,7d]

  15. Animal Research, Research Safety, Research Laboratory Security, Research Information Protection, Research Misconduct No “Special Rapid Reporting” Requirements No “Serious or Continuing Noncompliance” Reporting Defines “Reportable Events” for Each Type of Research The terms “Serious or Continuing Noncompliance” and “Serious Adverse Event” are used only for human research

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