VHA Research Compliance Reporting Requirements - PowerPoint PPT Presentation

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VHA Research Compliance Reporting Requirements

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Title: VHA Research Compliance Reporting Requirements


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
    facilitys 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
    facilitys 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/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

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/RD,
    RDC 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/RD,
    RDC 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/RD, and RDC 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/RD
    and RDC) (7.i(1))
  • Facility did not report change in HRPP
    accreditation status (reaccreditation-pending) to
    ORO (7.k(4))
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