VHA Research Compliance Reporting Requirements

ORD Accreditation Conference CallDecember 15, 2011

VETERANS HEALTH ADMINISTRATION

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.

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VETERANS HEALTH ADMINISTRATION

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

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VETERANS HEALTH ADMINISTRATION

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

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VETERANS HEALTH ADMINISTRATION

Continuing Noncompliance

A persistent failure to adhere to the laws,regulations, or policies governing human Research (§4.e)

[Examples provided in (§7.g)]

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VETERANS HEALTH ADMINISTRATION

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]

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VETERANS HEALTH ADMINISTRATION

Reporting serious or

continuing noncompliance (2)

Apparent serious or continuing noncomplianceidentified 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

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VETERANS HEALTH ADMINISTRATION

Reporting serious or

continuing noncompliance (3)

Apparent serious or continuing noncomplianceidentified 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

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VETERANS HEALTH ADMINISTRATION

Reporting serious unanticipated

problems or Local Serious Adverse

Events (SAEs)

Report to IRB within 5 business days

Convened IRB or a qualified IRB member-reviewerdetermines whether the problem or the local AE isserious, unanticipated, and related (caused by orprobably caused by research) within 5 businessdays. 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

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VETERANS HEALTH ADMINISTRATION

ORO Common Findings

(Research Compliance Reporting) (1)

Facility policies and procedures inconsistent withcurrent 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

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VETERANS HEALTH ADMINISTRATION

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)

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VETERANS HEALTH ADMINISTRATION

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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