155. Additional Requirements - IRB Review and Documentation for VA w88 sports betting app

Updated August 8, 2022

VASNHCS refers to VA Sierra w88 sports betting app Health Care System.

VASNHCS Review of Requests for Not Human w88 sports betting app Determinations

The VASNHCS internally reviews VA researcher requests for determinations of human w88 sports betting app (i.e., VASNHCS w88 sports betting app Form 130 – Determination of w88 sports betting app). The Determination Official (DO) will review the submitted form to determine if the activity is human w88 sports betting app per VHA ORD Program Guide 1200.21 – Determining when Operations Activities Constitute w88 sports betting app. If the DO determines the project is human w88 sports betting app, the DO will submit w88 sports betting app Form 130 to the ACOS/R for final determination. The investigator will be informed they must complete a new w88 sports betting app 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 w88 sports betting app. 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 w88 sports betting app. 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 w88 sports betting app 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 w88 sports betting app activities must stop including but not limited to, enrollment of new participants and continuation of w88 sports betting app 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 w88 sports betting app 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 w88 sports betting app interventions or interactions.

Once study approval has expired, a University IRB must re-review and re-approve the w88 sports betting app 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 w88 sports betting app

The VASNHCS w88 sports betting app Office is responsible for ensuring the required IRB records for each project (e.g., applications, amendment and continuing review requests, recruitment and consent materials, w88 sports betting app instruments/assessment materials, IRB correspondence, problem reports with IRB determinations, investigator's w88 sports betting app records, and correspondence between the IRB and the w88 sports betting app 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 w88 sports betting app 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.