VHA Handbook 1058.01“Research Compliance Reporting

Requirements”

Version: June 15, 2015

ORO Presentation: July 14 and 16, 2015

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All documents related to VHA Handbook 1058.01 can be found at:

• ORO’s Web Site:http://www.va.gov/ORO/oropubs.asp

• ORO’s SharePoint Site:https://vaww.vha.vaco.portal.va.gov/sites/ORO/RCO/Shared%20Documents/Forms/AllItems.aspx?RootFolder=%2Fsites%2FORO%2FRCO%2FShared%20Documents%2FVHA%20Handbooks%2F1058%2E01%20Research%20Compliance%20Reporting%20Requirements%20%28June%2015%2C%202015%29

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2. SUMMARY OF MAJOR CHANGES: This revised VHA Handbook clarifies and simplifies research compliance reporting requirements.

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• became effective immediately upon publication (June 15, 2015)

• ORO recognizes that research facilities need a reasonable period of time to update their standard operating procedures (SOPs) to comply with the revised requirements. ORO strongly recommends that all such revisions be completed and fully implemented no later than October 1, 2015.

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facilities are free to retain local requirements that exceed those required by the revised Handbook where such requirements are working well and serve the needs of the local research oversight program.

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3. SCOPE: This Handbook describes requirements for reporting compliance events in VA research to research review committees, VHA officials, and ORO.

These requirements do not alter or replace any additional requirements for reporting such events to other internal or external entities as mandated by law, regulation, policy, or agreement.

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§5.b. Reports to ORO. The VA facility Director must report to ORO within 5 business days (except as otherwise specified below) after receiving notification of any situation that is reportable to ORO under this Handbook.

§5.b(2). The VA facility Director must ensure that ORO is notified by e-mail or telephone as soon as possible, but no longer than 2 business days, after becoming aware of:

(a) Any research-related citation or determination of regulatory noncompliance issued by any State or Federal agency; or

(b) Any situation covered by this Handbook that has generated media attention or Congressional interest.

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§5.c. Remedial Actions. The VA facility Director must ensure timely implementation of remedial actions in response to identified noncompliance or as otherwise found warranted by ORO.

(1) Except where remediation requires substantial renovation or fiscal expenditure, hiring, legal negotiations, or other extenuating circumstances, remedial actions must be completed within 120 calendar days after any determination of noncompliance.

(2) Where remedial actions cannot be completed in 120 calendar days, the VA facility Director must provide ORO with an acceptable written justification and an acceptable timeline for completion.

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§5.h. Systemic Deficiencies. VA personnel, including WOC and IPA appointees, must ensure written notification of the VA facility’s R&D Committee within 5 business days after becoming aware of any apparent systemic deficiency that has a reasonable likelihood of substantially compromising the facility’s research protection programs, including persistent failure by any subcommittee of the R&D Committee to adhere to the requirements governing VA research.

§5.i. R&D Committee Responsibilities [for reviewing reports of systemic deficiencies].

§4.x. A systemic deficiency is a fundamental, underlying problem that jeopardizes the effectiveness of the facility’s research protection system(s).

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§5.j. Voluntary Alerts to ORO. In addition to the required reporting described in this Handbook, ORO welcomes voluntary “preliminary” alerts about incidents that are unusual or likely to result in reportable events, as well as voluntary “near miss” alerts about incidents that could have resulted in a reportable event had the facility not taken timely action. Voluntary “preliminary” alerts facilitate efficient review and effective mitigation, while voluntary “near miss” alerts validate local oversight mechanisms and help identify emerging compliance challenges.

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§5.k. Research Misconduct. ORO must be notified within 1 business day of any Research Misconduct allegations received by the facility.

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An individual becomes aware of a LOCAL DEATH, LOCAL SAE, or SERIOUS

PROBLEM in VA research that appears to be both UNANTICIPATED

and RELATED to the research.

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The unanticipated related incident involves a

LOCAL DEATH.

· The individual must ensure IMMEDIATE ORAL NOTIFICATION OF THE IRB and WRITTEN NOTIFICATION WITHIN 5 BUSINESS DAYS.

· The IRB MUST ALERT ORO (by e-mail or telephone) within 2 BUSINESS DAYS AFTER RECEIVING ORAL NOTIFICATION.

· The Facility Director and ACOS/R&D must receive notification concurrent with ORO.

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The unanticipated related incident involves a

LOCAL SAE or a SERIOUS PROBLEM.

· The individual must ensure WRITTEN NOTIFICATION OF THE IRB WITHIN 5 BUSINESS DAYS.

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· WITHIN 5 BUSINESS DAYS after receiving written notification, the IRB Chair or a qualified IRB member reviewer‑ must DETERMINE and DOCUMENT whether any actions are warranted to eliminate apparent IMMEDIATE HAZARDS to subjects.

The unanticipated related incident involves a

LOCAL DEATH.

The unanticipated related incident involves a

LOCAL SAE or a SERIOUS PROBLEM.

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• The IRB MUST REVIEW the incident and the determination of the IRB Chair or qualified IRB member-reviewer at its next CONVENED MEETING and must DETERMINE and DOCUMENT that:

a) The incident was SERIOUS AND UNANTICIPATED AND RELATED to the research; or

b)There is INSUFFICIENT INFORMATION to determine whether the incident was serious and unanticipated and related ; or

c) The incident was NOT SERIOUS and/or the incident was NOT UNANTICIPATED and/or the incident was NOT RELATED.

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• The convened IRB MUST also DETERMINE and DOCUMENT:

a) Whether any PROTOCOL OR INFORMED CONSENT MODIFICATIONS are warranted, and if so,

b)Whether investigators must NOTIFY or SOLICIT RENEWED/REVISED CONSENT from previously enrolled subjects, and if so, WHEN and HOW consent is to be DOCUMENTED.

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The unanticipated related incident involves a

LOCAL DEATH.

· For DEATHs, the IRB must notify the FACILITY DIRECTOR and ACOS/R&D OF ALL ITS DETERMINATIONS WITHIN 5 BUSINESS DAYS.

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The unanticipated related incident involves a

LOCAL SAE or a SERIOUS PROBLEM.

· For SAEs or PROBLEMS, the IRB must notify the FACILITY DIRECTOR and ACOS/R&D WITHIN 5 BUSINESS DAYS after its meeting if (a) actions were taken to eliminate hazards to subjects, (b) the incident was serious and unanticipated and related to

the research or there was insufficient information to make the determination, or

(c) protocol or informed consent changes were warranted.

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The unanticipated related incident involves a

LOCAL DEATH.

The unanticipated related incident involves a

LOCAL SAE or a SERIOUS PROBLEM.

The FACILITY DIRECTOR MUST REPORT the incident to ORO WITHIN 5 BUSINESS DAYS after notification.

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An individual becomes aware of

APPARENT SERIOUS or CONTINUING NONCOMPLIANCE

with IRB or Human Research Protection requirements.

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Examples of Possibly Reportable Serious Noncompliance in Human Research: (1) Initiation of human research without required IRB approval. (2) Initiation of human research without R&D Committee approval. (3) Initiation of human research without ACOS/R notification that the research may begin. (4) Failure to obtain informed consent for one or more subjects (where required, unless waived by the IRB). (5) Failure to obtain HIPAA authorization for one or more subjects (where required, unless waived by the IRB). (6) Modification of a protocol without IRB approval (except to prevent immediate hazards to subjects). (7) Failure to notify the IRB of a death, SAE, or problem as required. (8) Unfounded labeling of a death, SAE, or problem as “anticipated” or “not related” to the research. (9) Conduct of research without required credentialing, privileging, or initial training. (10) Conduct of research involving women known to be pregnant, prisoners, or children, or of international

research, without required approvals from the Facility Director or Chief Research and Development Officer, as applicable.

(11) Failure to implement, in a timely fashion, any protocol or informed consent modifications, or other changes required by the IRB.

(12) Failure to remediate any noncompliance in a timely fashion as required by the IRB. (13) Continuation of human research beyond the specified IRB approval period (except where in subjects’ best

interests as determined by the IRB Chair). (14) Substantive informed consent or HIPAA authorization deficiencies. (15) Failure to obtain documentation of informed consent (where required, unless waived by the IRB). (16) Substantive deviations from IRB-approved protocols, including substantive violations of inclusion or exclusion

criteria. (17) Any finding by any entity, including clinical trial monitors, of apparent serious noncompliance as listed here. (18) Programmatic noncompliance (e.g., violation of IRB quorum requirements; improper approval or

documentation of exemptions or waivers; failure to ensure review of proposed research sufficient to identify and address privacy or data security concerns).

(19) Any combination of noncompliant actions that collectively present a genuine risk of substantive harm to the safety, rights, or welfare of human research subjects, research personnel, or others, or substantively compromise a facility’s HRPP.

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An individual becomes aware of

APPARENT SERIOUS or CONTINUING NONCOMPLIANCE

with IRB or Human Research Protection requirements.

· The individual must ensure WRITTEN NOTIFICATION OF THE IRB WITHIN 5 BUSINESS DAYS.

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• The IRB MUST REVIEW the incident at its next CONVENED MEETING, not to exceed 30 BUSINESS DAYS, and must DETERMINE and DOCUMENT:

a) Whether or not SERIOUS or CONTINUING NONCOMPLIANCE actually occurred; and

b)If so, whether REMEDIAL ACTIONS are needed to ensure present and/or future compliance.

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· If it determines SERIOUS or CONTINUING NONCOMPLIANCE occurred, the IRB MUST NOTIFY the FACILITY DIRECTOR and ACOS/R&D WITHIN 5 BUSINESS DAYS.

The FACILITY DIRECTOR MUST REPORT the determination to ORO WITHIN 5 BUSINESS DAYS after notification.

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• The IRB MUST ALSO TRACK ITS DETERMINATIONS of SERIOUS or CONTINUING NONCOMPLIANCE for use in the VA FACILITY DIRECTOR CERTIFICATION

Additional Clarification:

Reporting of this information will begin with the Facility Director Certification (FDC) submitted in CY2016 (i.e., the reporting period from June 1, 2015, to May 31, 2016).

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NOTE ALSO that the following requirement from the prior version of VHA Handbook 1058.01 (§7.h) has been REMOVED from the current (June 15, 2015) version:

“Within 5 business days of identifying apparent serious or continuing noncompliance based on an informed consent audit, regulatory audit, or other systematic audit of VA research, an RCO must report the apparent noncompliance directly (without intermediaries) to the facility Director.”

Current Requirement: As with any other “VA personnel” the RCO must follow the steps indicated earlier (copied again, below):

An individual becomes aware of APPARENT SERIOUS or CONTINUING NONCOMPLIANCEwith IRB or Human Research Protection requirements.

· The individual must ensure WRITTEN NOTIFICATION OF THE IRB WITHIN 5 BUSINESS DAYS.

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