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

Updated Oct. 2, 2020

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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. Note: if determined by the DO to be Research but exempt from IRB, then full application will be submitted to Research and Development Committee (RDC). If the DO determines that the project does not constitute human research, DO will submit Research Form 130 to ACOS/R for final determination to be signed and provided to the investigator. Note: Once signed determination form is received, may initiate project.

VASNHCS Review of Exemptions

Per VHA Directive 1200.05 (1), item 10 research that meets the exempt categories is not subject to IRB review but must be reviewed by the RDC. Ensuring the latter occurs is the responsibility of the VASNHCS Research Office.

VA qualified staff may review applications for exempt research; Associate Chief of Staff makes the final decision. The designated reviewer

  • determines whether or not a study meets the criteria for exempt review; and
  • completes the exempt review checklist to document her/his determination and specify the exempt category.

Exempt VA studies involving protected health information must comply with VASNHCS policy related to the use and disclosure of protected health information for research purposes. Investigators must submit a VA HIPAA authorization form or a request for a waiver of HIPAA authorization with the exemption application. The IRB does not approve the HIPAA authorization form. The IRB is responsible for review and approval of all HIPAA waivers of authorization.

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 or not 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).

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.