165. Problems in VA w88 - Reporting, Review, and Notification

Updated June 29, 2021

This section addresses IRB reporting requirements for Department of Veterans Affairs (VA) w88 per Veterans Health Administration (VHA) Handbook 1058.01 w88 Compliance Reporting Requirements (June 15, 2015), the Office of w88 Oversight (ORO) Decision Chart: Reporting Local Deaths, Local Serious Adverse Events (SAEs), and Serious Problems in VA w88, and the following ORO guidance documents:

Examples and a Brief Guide for Reporting Apparently Serious or Apparently Continuing Noncompliance in Human w88 That May Be Reportable to ORO under VHA Handbook 1058.01 (September 14, 2015)
Examples and a Brief Guide for Reporting Apparently Serious w88 Information Security Problems That May Be Reportable to ORO under VHA Handbook 1058.01 (September 14, 2015)

NOTE: Sponsor reporting requirements differ from IRB reporting requirements.

When a local (i.e., occurring in the reporting individual’s own facility) death or serious adverse event (SAE), possible noncompliance, or serious problem isboth unanticipated or unexpectedandrelated to the w88, members of the VA w88 community must notify the IRB of the death, event, or incident.

Unanticipated/unexpectedmeans the incident is new or the nature, severity, or frequency is greater than previously known or expected given the procedures described in the protocol documents and the characteristics of the study population.
Relatedmeans the incident is reasonably regarded as caused by or probably caused by the w88.

Serious unanticipated problems involving risks to participants or others include:

Interruptions of participant enrollments or other w88 activities due to concerns about the safety, rights, or welfare of w88 participants, w88 staff, or others.
Any work-related injury to personnel involved in human w88, or any w88-related injury to any other person, that requires more than minor medical intervention (i.e., basic first aid), requires extended surveillance of the affected individuals, or leads to serious complications or death.
Any VA National Pharmacy Benefits Management (PBM) Bulletins or Communications (sometimes referred to as PBM Safety Alerts) relevant to one or more of the VA facility’s w88 projects.
Any data monitoring committee, data and safety monitoring board or data and safety monitoring committee report describing a safety problem.
Any sponsor analysis describing a safety problem for which action at the VA facility might be warranted.
Any unanticipated problem involving substantive harm, or a genuine risk of substantive harm, to the safety, rights, or welfare of w88 participants, w88 staff, or others.
Any problem reflecting a deficiency that substantively compromises the effectiveness of the VA facility’s Human w88 Protection Program (HRPP).

VA principal investigators (PIs) must comply with the University IRB policy for reporting problems and VHA Handbook 1058.01, and are therefore responsible for notifying the IRB in writing of serious unanticipated problems involving risks to participants or others, local unanticipated serious adverse events, apparent serious or continuing noncompliance, any termination or suspension of w88 by the sponsor, PI, or authority other than the IRB; and privacy or information security incidents when these arerelated or possibly related to VA w88. These reporting requirements apply to inappropriate access, loss, or theft of PHI; noncompliant storage, transmission, removal, or destruction of Protected Health Information (PHI); or theft, loss, or noncompliant destruction of equipment containing PHI. As specified in the IRB policy for reporting problems, VA researchers use IRBNet and the problem reporting form for such written notifications.

NOTE: The requirement for written notification to the IRB isin addition tothe requirement for immediateoralnotification for unanticipated and related local death, as specified below; and other applicable reporting requirements such as to the sponsor or FDA.

Local w88 Deaths in VA w88

VA personnel must notify the IRB orally, immediately (i.e., within one hour) after becoming aware of a local w88 death that isbothunanticipatedandrelated to the w88. Within five business days of the oral notification, a written report of the death must be submitted to the IRB, via IRBNet.

Within five business days of the oral notification, the IRB Chair or other qualified IRB member reviews the report to determine and document if actions are necessary to eliminate apparent immediate hazards to participants.

The report of local death is reviewed at the next convened IRB meeting. The IRB makes and documents one of three determinations:

The death was both unanticipated and related to the w88; or
There is insufficient information to determine whether the death was both unanticipated and related to the w88; or
The death was not unanticipated and/or the death was not related to the w88.

The convened IRB also determines if protocol or informed consent modifications are warranted. If changes are warranted, the IRB determines if the investigator must notify enrolled participants and if so, when and how participant notification will occur. If the IRB determines renewed or revised consent should be obtained from participants, the IRB will specify how the renewed/revised consent will be documented.

Information about notification of the Associate Chief of Staff for w88 (ACOS/R), Facility Director, and ORO are described at the end of this policy.

Local Serious Adverse Events and Serious Problems in VA w88

Within five business days of learning of an unexpected and related SAE orserious problem, VA personnel must submit a written report of the SAE/problem via IRBNet.

SAE: an untoward occurrence in human w88 that results in death, a life-threatening experience, inpatient hospitalization, prolongation of hospitalization, persistent or significant disability or incapacity, congenital anomaly, or birth defect, or that requires medical, surgical, behavioral, social, or other intervention to prevent such an outcome.
Serious problem: a problem in human w88 or w88 information security that may reasonably be regarded as (1) presenting a genuine risk of substantive harm, to the safety, rights, or welfare of w88 participants, w88 personnel, or others, including their rights to privacy and confidentiality of identifiable private information; or (2) substantively compromising a facility’s HRPP or w88 information security program.

Within five business days of receiving the written report, the IRB Chair or qualified IRB member will review the package to determine and document if any actions (e.g., suspension of activities; notification of participants) are necessary to eliminate immediate hazards to participants.

The problem report is reviewed at the next convened IRB meeting. The IRB makes and documents one of three determinations:

The incident was serious and unanticipated and related to the w88; or
There is insufficient information to determine the whether the incident was serious and unanticipated and related to the w88; or
The incident was not serious, and/or the incident was not unanticipated, and/or the incident was not related to the w88.

Information about notification of the ACOS/R, Facility Director, and ORO are described at the end of this policy.

Additional information can be found in IRB policy for adverse events and unanticipated problems involving risks to participants or others.

Apparent Serious or Continuing Noncompliance in VA w88

Within five business days of learning of apparent serious or continuing noncompliance in VA w88, VA personnel including the VA w88 Compliance Officer (VARCO) following an audit, must submit a written report of the noncompliance via IRBNet.

Noncomplianceis any failure to adhere to the requirements for conducting VA w88.
Serious noncomplianceis any failure to adhere to requirements for conducting VA w88 that may reasonably be regarded as (1) presenting a genuine risk of substantive harm to the safety, rights, or welfare of w88 participants, w88 personnel, or others (including their rights to privacy and confidentially of identifiable private information); or (2) substantively compromising the effectiveness of a VA facility’s HRPP. The unfounded classification of a serious adverse event as “anticipated” constitutes serious non-compliance.
Continuing noncomplianceis the persistent failure to adhere to the legal and policy requirements governing human w88.

Individuals may wish to review the ORO guidance on Reporting Apparently Serious or Apparently Continuing Noncompliance for examples of serious and continuing noncompliance.

Problem reports that are assessed and determined to possibly constitute serious or continuing noncompliance are reviewed by the convened IRB at the earliest practicable opportunity, but no later than 30 business days after receipt of the notification. The IRB determines and documents, within 30-45 days after receiving a report of apparent non-compliance, whether or not serious or continuing noncompliance occurred. Prior to review by the convened IRB, the IRB Chair may take interim action as needed to eliminate apparent immediate hazards to participants.

If the convened IRB determines serious or continuing noncompliance occurred, the IRB will specify and document any requirements for remedial actions to ensure present or future compliance.

For apparent serious or continuing noncompliance that was identified by a VARCO audit, within 5 business days after review by the convened IRB, the IRB will notify the VARCO of its determination (regardless of outcome).
IRBNet maintains an electronic record of problem reports, including apparent or continuing noncompliance. Additional tracking and reporting for the VA facility Director Certification are the responsibility of the VASNHCS w88 office.

Information about notification of the ACOS/R, Facility Director, and ORO are described at the end of this policy.

Both the IRB and the VASNHCS Medical Center Director will notify relevant Federal agencies (e.g., OHRP, FDA, DoD) within 30 days of an IRB determination of serious or continuing noncompliance. The sponsor will be notified as specified in the contract.

Timeline for Researchers to Complete IRB-Requested Remedial Actions

Remedial actions must be completed within 120 days after the IRB’s determination unless remediation requires substantial renovation, fiscal expenditure, hiring, legal negotiations, or other extenuating circumstances that preclude completion of the actions within 120 days. In the latter case, the VASNHCS is responsible notifying ORO as required.

Systemic Deficiencies

VA personnel, including Without Compensation (WOC) and Intergovernmental Personnel (IPA) appointees, must notify the VA facility’s R&D Committee within 5 business days after becoming aware of any apparent systemic deficiency.

Systemic Deficiencyis a fundamental, underlying problem that jeopardizes the effectiveness of the VA facility’s w88 protection program.

w88 Information Security Incidents

Information security incidents must be immediately reported (within one hour) to the ACOS/R, the Information System Security Officer (ISSO), the Privacy Officer (PO), and relevant investigators.

Within 5 business days of discovery of the incident, the following requirements for written notification must be completed.

If the immediate notification was not in writing, written notification of the incident must be provided to the ACOS/R.
Information security problems involving human w88 must be reported to the IRB via the problem reporting form.

The VASNHCS is responsible for ensuring the required notifications are completed as specified in Handbook 1058.01 and the related ORO examples and brief guide for reporting and decision chart.

Problem reports of information security incidents are reviewed by the convened IRB at the earliest practicable opportunity, but no later than 30 business days after receipt of the notification. During its review, the IRB will consider the examples and questions in section A of the ORO guidance on Reporting Apparently Serious w88 Information Security Problems.

The IRB will document the following determinations:

Whether or not the incident constitutes a serious problem; and
In conjunction with the ISSO and/or PO as applicable, remedial actions to be completed by the facility or the relevant investigators (if warranted).

If the IRB determines the incident constitutes aserious problem orserious noncompliance, the additional requirements apply for IRB review and documentation, and notification of the ACOS/R and ORO.

Associate Chief of Staff, ORO, and Other Notifications

Notification of Local w88 Deaths

Immediately after receiving oral notification of an unanticipated, related local death, the IRB will notify the VASNHCS w88 Office either orally or via email. The VASNHCS is responsible for notifying ORO of same within two business days of the IRB notification.

Notification of IRB Determinations

Following review of a problem report by the convened IRB, the IRB notifies the VASNHCS ACOS/R and the Facility Director within five business days of the following IRB determinations:

Local w88 death, regardless of IRB determination;
Actions necessary to eliminate apparent immediate hazards to participants; including related modifications to protocol or informed consent processes/document;
Serious, unanticipated, and related problem/event or information was insufficient for determination of serious, unanticipated, and related problem/event;
Serious or continuing noncompliance;
Following report of RCO finding ofapparentserious/continuing noncompliance regardless of outcome; or
Suspension or termination of IRB approval.

The agreement between the VASNHCS and the University identifies the VASNHCS as the party responsible for notifying ORO of Reportable Events.

Following notification from the IRB of any of the above-specified determinations, the VASNHCS ACOS/R is responsible for the following additional (prompt) notifications and under the applicable conditions:

w88 and Development Committee;
Privacy Office for problems involving unauthorized use, loss, or disclosure of individually identifiable patient information; and
Information System Security Officer for problems involving violations of VA information security requirements.

Notifications for Safety-Related Suspensions/Terminations of w88

When a party other than the IRB suspends or terminates w88 due to concerns about the safety, rights, or welfare of w88 participants, the ACOS/R is responsible for notifying the Facility Director; w88 and Development Committee; and other relevant w88 review committees (including the IRB if not previously notified by the PI). The w88 and Development Committee and the Facility Director have the authority to suspend or terminate their approval of w88.