March 31, 2021 update on cayuse irB/Human ethics implementation
The UNH Research Office is implementing comprehensive grants management and research compliance cloud-based software called Cayuse. One module (Cayuse IRB/Human Ethics) is for managing protocols submitted to the UNH Institutional Review Board (IRB) for research involving human subjects. With Cayuse IRB/Human Ethics, researchers will be able to streamline IRB submissions and have online access to their IRB protocol records. Some benefits of Cayuse IRB for researchers include:
- Easy to use electronic forms with autofill features
- Ability to submit and certify protocols from their computer or device
- Real-time online submission tracking
- Centralized IRB record management from initial submission through study closure
The UNH IRB will begin using Cayuse IRB/Human Ethics on June 1, 2021. Please read the following carefully as there will be disruptions in the IRB review process in May and implications for current studies.
Disruptions in UNH IRB Operations
- The UNH IRB operations will be closed from Monday, May 17 through Monday, May 31, 2021 in order to switch to the new software. During this time, the IRB will not be accepting new applications, requests for modifications, or requests for continuing review.
- The IRB will review on Tuesday, May 18, 2021 applications requiring Full Board review submitted by the deadline of Tuesday, May 4, 2021. The summer IRB meeting schedule has not been set yet but as in years past, the IRB will meet once a month in June, July and August. The IRB website will be updated in May with the summer meeting dates.
- UNH IRB operations will resume on Tuesday, June 1, 2021 using the new Cayuse IRB/Human Ethics software.
- Effective this date, researchers with new applications will need to develop them in Cayuse IRB/Human Ethics; the IRB staff will not accept new applications submitted via any other means (e.g., email, hard copy).
- Researchers who want to request an extension of the IRB approval for an existing study that expires on or after June 1, 2021 and who did not submit the completed continuing review request to the IRB office before Friday, May 17 will need to submit the request via Cayuse IRB/Human Ethics on or after June 1, 2021. Please ensure that you do not let your study’s IRB approval lapse. If your study expires, it will be closed in Cayuse.
- Researchers who need to request after June 1, 2021 modifications for existing studies should contact the IRB office (see below).
Existing (Legacy) Studies with IRB Approval
- Researchers who have existing Exempt* or Expedited with no annual continuing review* level studies that are ongoing, where the study is anticipated to continue for more than a year or require modifications in the future, should plan to submit a new application in Cayuse IRB/Human Ethics after June 1, 2021 to replace the existing study. Doing so will allow researchers to take advantage of the many features of Cayuse IRB/Human Ethics to not only have online access to the information about their studies, but also to submit modifications via Cayuse IRB/Human Ethics. Once approved, the IRB will close the existing (legacy) IRB protocol.
- Researchers who have Expedited with annual continuing review* or Full Board* level studies:
- For those studies in data analysis or interpretation and where there will not be any further data collection or future modifications to the protocol, researchers should submit continuing review requests via Cayuse IRB/Human Ethics for the existing (legacy) study.
- For studies that are in the recruitment or data collection stages or where PIs anticipate submitting modifications in the future, researchers should complete a new application in Cayuse IRB/Human Ethics for the study before the study’s current IRB approval expiration date. The IRB will treat it as a new application and give it a new IRB number but, unless the PI indicates there are changes from the prior version, will perform a confirmatory review at the previous study’s review level. The new study will receive a new expiration date based on its new approval date. At that time, the IRB will close the existing (legacy) study.
*If you are unsure of your study’s protocol review level, please email IRB staff with the protocol #.
In preparation for the move to the Cayuse IRB/Human Ethics software, the IRB staff will post training videos on this website and hold a couple of training sessions via Zoom in the week prior to closure. After June 1, the IRB staff will hold weekly training sessions for a couple of months, and then a session each month. Researchers will need to pre-register for sessions, and the Zoom link will be sent to them the day before the session. Information about the sessions will be posted below. While researchers may find the training helpful in getting familiar with the new platform, attending a session is not a prerequisite to submitting an IRB protocol in the system.
Cayuse IRB/Human Ethics Training
Recording ~ will be posted here when available
Live sessions (via Zoom) ~ dates TBA