/Institutions/United-States-University/json/2023-2024/Policy-and-Procedure-Manual-local.json

/Institutions/United-States-University/json/2023-2024/Policy-and-Procedure-Manual.json

700-27-Length of Approval Period

Title:	Length of Approval Period
Owner:	IRB
Last Update/Revised:	05/01/2024

Policy: The length of the approval period for any project or study conducted at USU is one year.

The expiration date is the date by which continuing review must occur if the project/study is to continue.  This date is calculated one day earlier in the following year than the date the research was approved/determination was given (e.g., if the approval/determination date was 1/5/2023, then the expiration date is 1/4/2024).

Review of a change in a protocol (i.e., modification or amendment) does not alter the expiration date because continuing review is the review of the full protocol, not simply a change to it.

Investigators (or chairs of doctoral students) are notified of the need to apply for continuing review before the expiration date. There is no grace period extending the conduct of the project or research beyond the expiration date; extensions beyond the expiration date will not be granted. A continuing review form must be submitted and reviewed by the IRB prior to the expiration date.

If the investigator (or the chair of a doctoral student) fails to submit a continuing review form prior to the expiration date, the project/study will be administratively closed by the IRB Chair or designee (see also 700-30: Final Reports). Once closed, the investigator (or chair of a doctoral student) must submit a new IRB Review Form for initial review and wait for approval/determination to continue with the study.

For projects/research which is expired and is reviewed after the expiration date, a new expiration date will be calculated as described above. The lapse due to the expiration is documented in the IRB Google Drive. If required by the IRB, the investigator (or the chair of a doctoral student) will provide the IRB with an action plan to prevent any future lapses.

All activities must cease upon expiration of IRB approval/determination or study closure as described in 700-30: Final Reports (whichever comes first).

Purpose: This policy outlines how the expiration dates are calculated and how compliance is maintained.

Procedures:

1. Assignment of Expiration Dates
   1. The IRB Chair or designee calculates the expiration date as 1 day minus the approval date (or in the case of not human subjects research or exempt research the date of determination, rather than approval, is used).
   2. Expiration dates appear on the approval/determination letter and are maintained on a spreadsheet in the IRB Google Drive.
2. Notification of the Need to Apply for Continuing Review
   1. The IRB Chair or designee will send two emails prior to the expiration data (two months and one month prior to the expiration date notifying the investigator (and chair of a doctoral student) of the need to apply for continuing review.
3. Notification of Expiration

1. Once IRB determination/approval for a project/study expires, an expiration notice is sent from the IRB Chair or designee. The expiration notice informs the investigator (and chair of a doctoral student) the project/research has expired and no activity may continue until the application for continuing review is received and accepted by the IRB. The notice also states hat no new participants may be enrolled.
2. In order to conduct any project- or study-related procedures after the expiration, investigators (or a chair of a doctoral student) must make a request in writing via email to the IRB Chair at IRB@usuniversity.edu. If the IRB Chair determines that subjects participating in an expired study would suffer a hardship because research procedures must be discontinued, appropriate research procedures may continue beyond the expiration date for a reasonable amount of time. Prospective research data cannot be collected until a continuing review form is reviewed and approved. The IRB Chair will notify the investigator (or chair of a doctoral student) of the decision by way of written documentation and this documentation will be attached permanently to the continuing review form, accessible by all IRB members. Documentation will be retained in the IRB Google Drive.

Scope: This policy applies to all projects and research reviewed by the USU IRB.

Documents and Forms:

Continuing Review Form