155. Additional Requirements: IRB Review and Documentation for VA Research
Updated July 1, 2019
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Review of Requests for Not Human Subjects Determinations
The VASNHCS internally reviews VA researcher requests for determinations of human subject research (i.e., VASNHCS Form 130) and engages RI in the decision-making process as follows:
- After concluding a project likely does not constitute human subject research, the VASNHCS Research Office will forward a copy of VASNHCS Form-130 or summary of the project to the RI Director.
- The RI Director will administratively review the submission and will notify the VA Research Office of
- confirmation of Not Human Subject Research determination, or
b. determination that exempt or IRB review is required.
- The VA Research Office will notify the researcher of the outcome of the administrative review.
NOTE: The VASNHCS Research Office is responsible for ensuring that projects determined to not constitute human subject research are reviewed by the R&D committee.
Review of Exemptions
Per VHA Handbook 1200.05, item 5.c. research that meets the exempt categories is not subject to IRB review but must be reviewed by the R&D Committee. Ensuring the latter occurs is the responsibility of the VASNHCS Research Office.
Through exclusive authority granted by the University to RI for review and approval of exempt research, qualified RI staff may review applications for exempt research although most exempt reviews are completed by experienced RI staff who are also voting members of the IRB. 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.
RI staff generating the Exempt Determination letter will key in the exempt category which auto-generates in the letter. Exempt determination letters are signed by the IRB Chairs, in accordance with requirements in VHA Handbook 1200.01, item 4.d., which specifies written documentation of IRB approval (or that of other such entities) be signed by a voting member for the committee.
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.
Review of Protocol Amendments
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.