155. Additional Requirements - IRB Review and Documentation for VA Research

Updated August 8, 2022

VASNHCS refers to VA Sierra Nevada Health Care System.

VASNHCS Review of Requests for Not Human Research Determinations

The VASNHCS internally reviews VA researcher requests for determinations of human research (i.e., VASNHCS Research Form 130 – Determination of Research). The Determination Official (DO) will review the submitted form to determine if the activity is human research per VHA ORD Program Guide 1200.21 – Determining when Operations Activities Constitute Research. If the DO determines the project is human research, the DO will submit Research Form 130 to the ACOS/R for final determination. The investigator will be informed they must complete a new research submission that must be submitted to the IRB.

University IRB Review of Protocol Amendments

There are no additional requirements for IRB review of amendments to VA research. See IRB policies for amendment reviews by Full Committee and amendment reviews by Expedited Review.

University IRB Review of Continuing Reviews

There are no additional requirements for continuing review of VA research. See IRB policies for continuing reviews by Full Committee and continuing reviews by Expedited Review.

Actions that Must Occur if IRB Approval Expires

The VASNHCS Research Office is responsible for promptly notifying PIs of expiration of IRB approval.

If an investigator does not provide continuing review information to the IRB or the IRB has not approved a continuing review package by the expiration date, the IRB informs the researcher that all research activities must stop including but not limited to, enrollment of new participants and continuation of research interventions or interactions with currently enrolled participants, and data analysis.

If enrolled participants may be harmed by stopping study procedures, the PI must immediately submit to the IRB chair a list of these research participants. The IRB Chair, with appropriate consultation with the VA Chief of Staff, must determine within two business days whether participants on the list may continue participating in the research interventions or interactions.

Once study approval has expired, a University IRB must re-review and re-approve the research before the study can resume. The IRB cannot retrospectively grant approval to cover a period of lapsed IRB approval.

Additional Requirements for Documentation of IRB Review of VA Research

The VASNHCS Research Office is responsible for ensuring the required IRB records for each project (e.g., applications, amendment and continuing review requests, recruitment and consent materials, research instruments/assessment materials, IRB correspondence, problem reports with IRB determinations, investigator's research records, and correspondence between the IRB and the Research and Development Committee); and IRB member CVs, membership rosters, and meeting minutes are maintained in accordance with VA requirements. Specifically, the VASNHCS maintains the required records until disposition (six years after close of study, may retain longer if required by other Federal regulations) instructions are approved by the National Archives and Records Administration and are published in VHA's Records Control Schedule (RCS 10-1).

Codes or keys linking participant data to identifiers must be retained as part of the research record for at least six years. If a protocol is cancelled without participant enrollment, IRB records are maintained for at least five years after cancellation.

Researchers inform the IRB of their agreement to comply with VA requirements for disposition of records by selecting the related option in the data confidentiality sections of the Part II applications.