Important Update
On April 14, the NIH sent Harvard University a Stop Work Order of the SMART IRB federal funding contract.
From the beginning, SMART IRB has been a collaborative, grassroots effort: SMART IRB was built by and for the community. It is not owned by Harvard, NIH, HHS, or any other entity.  At this time, Harvard is supporting the core team to maintain the Agreement and assist Participating Institutions to the best of our abilities. It is our intention to continue to provide this vital support to advance collaborative research. Please contact us for assistance.
Read Full Statement

Training Materials

Reliance Decision Making

1. “Select “All Requests” from left hand navigation. 

2. Click on the expand button under the action column, of the request 

3.If you are a the point of contact/ site admin of the home institution, select “reliance pre-check” and mark your institution’s decision.

4.If the request is appropriate to proceed, select the radio button for “Eligible for reliance”. Otherwise, choose “Not eligible for reliance”.

5. Click “Continue” to change the status to “Eligible”. 

6. Click “Submit”.

7.Once pre-check is complete, a Site Admin (Point of Contact) for the Proposed Reviewing IRB will be prompted to indicate their willingness to serve in this capacity. Click on “Reviewing IRB” 

8. By default, if the home institution has an IRB, they will be asked if they are willing to serve as the reviewing IRB. This is called the ‘Right of First Refusal’, which is afforded to home institutions. If so, select “Yes”. 

9. Click “Make Decision”.

10. Click “Submit” on the confirmation pop-up.

11. Once the reviewing IRB has been identified, the “sites reliance” page open up for involved sites. The reliance request is currently listed as reviewing IRB identified.  

12. The POC/site admin of an involved site navigates to their reliance dashboard and expands the request that is pending the involved site decision. 

13. POC/Site admin expands to view the request summary page. Request Activity page displays overall request status with corresponding graphic. 

14. Select your institution’s name under sites reliance.

15. Mark your site’s reliance decision. 

16. If you are ready to confirm you decision, select “submit”.  

17. Reliance Request status is listed as “reliance forms submitted” when at least one involved site on a request has submitted their site’s reliance decision. 

18. The Reviewing IRB will log in, find a request that is in the “reliance forms submitted” status, and click the expand button. 

Reliance Pre-Check and Reviewing IRB Decision
Issuing a Determination Letter