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JHM IRB is willing to review requests for reliance on an external IRB as well as requests for JHM to act as the IRB of record. Typically, requests for reliance are submitted to our IRB at two time points:
a) when studies are in their planning stages, and
b) when studies are ready to be submitted for IRB review
For more information see Single IRB FAQs.
Reliance Request Instructions
The first step in the reliance agreement process is to complete a Reliance Request. The JHM IRB reliance team will review the information provided in the reliance request and will contact you with next steps.
For studies that are in the planning stage [e.g. you are preparing a grant submission or have just been awarded grant funds but are not yet ready to submit your protocol for IRB review], the JHM IRB will review your reliance request to determine whether we are willing to enter into a reliance agreement.
For studies that are ready to be submitted for IRB review; once the JHM IRB has agreed to enter into a reliance agreement, please following the instructions provided below:
- Request for JHM IRB to serve as the single/central IRB – The JHM IRB reliance team will provide tailored instructions to the lead site study team, which will include submission of an eIRB2 application and instructions to on-board relying sites.
- Request for JHM IRB to rely on an External IRB – Click Here for instructions on what to include in your external IRB application.
- For external IRB applications submitted on or after January 1, 2019, any PI named on an external IRB application will be required to complete an online training course: 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.
Request for Planning Phase Review
In cases where JHU SOM IRB will serve as the Single IRB and Johns Hopkins is not otherwise engaged in the research, and documentation of IRB approval for is needed to satisfy Just-in-Time requirements/permit release of funds, external investigators should complete the Planning Phase Request Tool.
Use the applicable flowchart below to track the submission and outcome of your reliance request:
- JHM IRB Reliance Requests: Planning Stage
- JHM IRB Reliance Requests: Request to Rely on External IRB
- JHM IRB Reliance Requests: Request to Rely on JHM IRB – New Application Submission
- JHM IRB Reliance Requests: Request to Rely on JHM IRB – Change in Research Submission
Johns Hopkins University School of Medicine IRB is a signatory to the SMART IRB reliance agreement platform. Interested in learning more about SMART IRB? Click Here!
JHSPH and Homewood investigators preparing grant submissions and new applications that propose relying on an external sIRB should contact the JHSPH (email@example.com) or Homewood IRB (firstname.lastname@example.org) for further guidance.
All other reliance requests will be managed by the IRB associated with the PI’s division.
Please contact JHMIRBreliance@jhmi.edu with questions about the SOM IRB sIRB process.