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))