VHA Research Compliance Reporting RequirementsVHA研究合规报告的要求.pptVIP

VETERANS HEALTH ADMINISTRATION VETERANS HEALTH ADMINISTRATION VHA Research Compliance Reporting Requirements ORD Accreditation Conference Call December 15, 2011 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. * 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 * 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 * Continuing Noncompliance A persistent failure to adhere to the laws, regulations, or policies governing human Research (§4.e) [Examples provided in (§7.g)] * 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/RD, RDC 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] * Reporting serious or continuing noncompliance (2) Apparent serious or continuing noncom