- Reliance Determinations
- Training Requirements
- IRB Review Fees [Local Context Application]
- Grant Submission Planning
- Helpful Instructions and Forms
JHM IRB is willing to consider all requests to rely on External IRBs. We are required to rely for studies subject to the Single IRB Policy for Multi-Site Research and subsequent expansion of the sIRB policy to cooperative research conducted or supported by a Federal department or agency. In other cases, we may recommend local IRB review when reliance on a sIRB is not a regulatory requirement [e.g., study is commercially-funded]. Upon agreement to rely, we will issue a cede documentation, confirming JHM’s agreement to rely on the designated sIRB; however, we retain authority to decide to participate or not in the study as part of our local context review.
Effective January 1, 2019, any PI named on an external IRB application is required to complete an online training course: Understanding Reliance: Roles and Responsibilities when Relying on an External IRB. The training will review the initial steps to request reliance on an external IRB, outline how to submit an external IRB application to the JHM IRB and review the roles and responsibilities of local site PIs and study teams when relying on an external IRB. You are required to upload a copy of the training certificate of completion in your External IRB application [Section 2 - Study Team Compliance Training, question 2].
IRB Review Fees [Local Context Application]
JHM IRB charges review fees for commercially funded studies with financial support in excess of $10,000. This includes a local context review fee when JHM relies on an External IRB [e.g., JHM is not the IRB of Record]. Please refer to the Fees for JHM IRB Review guidance for more information.
We encourage investigators to communicate with us as soon as possible prior to the grant application deadline. You are required to submit a Reliance Request at least 2-3 weeks prior to your grant application deadline.
If JH agrees to rely on the designated External IRB, investigators are provided with the following package of information for inclusion in the grant submission:
- Letter of Support from JHM IRB to relying on the External IRB
- Instructions to submit a local context application should the grant be funded
- Local Context Review Workflow
- External IRB Submission Checklist – Investigators
- External IRB Submission Checklist – Investigators NCI CIRB Studies
- JHM Consent/Assent Template Language – External IRB
- Statement of PI Responsibilities when Relying on an External IRB
- Sample Local Context Application
- External IRB Frequently Asked Questions
- Guideline for JHM PIs when Relying on an External IRB
- sIRB Presentation – Relying on an External IRB
Interesting in External IRB training? Contact Us at email@example.com