JHM IRB Serving as the sIRB
- JHM sIRB Review for JHSPH and Homewood Investigators
- sIRB Review Fees
- Grant Submission Planning
- Satisfying Just-in-Time Requirements
- Individual Investigator Agreement
- Continuing Review Package
- Helpful Instructions and Forms
Johns Hopkins has three separate IRBs [JHM, School of Public Health, Homewood Schools]. Where JHU single IRB services are needed, only JHM IRB will serve as the single IRB, as JHM IRB is the only accredited IRB.
JHSPH and Homewood investigators preparing grant submissions and new applications that propose relying on an external sIRB should contact the JHSPH ([email protected]) or Homewood IRB ([email protected]) for further guidance.
sIRB studies are subject to review fees. A tailored estimate of sIRB review fees is provided at the time of grant submission based on the following factors:
- Anticipated # of participating sites
- Expected duration of the study [e.g., how many continuing reviews might occur]
- Estimated # of study-wide amendments that might be anticipated (e.g., introducing a new study procedure that could affect the conduct of the research at relying sites]
- Risk level of the research
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 serve as the sIRB, investigators are provided with the following package of information for inclusion in the grant submission:
- Letter of Support from JHM IRB to serve as the sIRB
- Template Letters of Support [for participating sites]
- sIRB grant language, describing JHM IRB’s experience in serving as a sIRB
- FWA and SMART IRB instructions for participating sites
- sIRB review fee estimate
Planning Phase Survey [for non-JH PIs] when the JHM IRB is the sIRB
In cases where JHU SOM IRB will serve as the Single IRB, 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.
Planning Phase eIRB application [for JH PIs] when the JHM IRB is the sIRB
In cases where JHU SOM IRB will serve as the Single IRB, Johns Hopkins is engaged in the research, and documentation of IRB approval for is needed to satisfy Just-in-Time requirements/permit release of funds, you are required to submit a Planning Phase application in eIRB2.
- Login to eIRB2 and select “Create New Application” on the left navigator bar.
- In Section 1- General Information, Question 7, select “Planning Phase” and follow the prompts.
- If you’ve previously received a letter of support confirming JHM IRB’s willingness to serve as the sIRB for your study, you should also upload a copy of your letter of support
If an individual is engaged in human subjects research and is not affiliated with an organization that can provide IRB oversight, JHM IRB can provide oversight by executing an Independent Investigator Agreement [IIA]. The study-specific IIA must be completed and returned to the JHMIRB Reliance Team. In addition, the following must be completed before the investigator can began research activities:
- Provide documentation of human subjects training
- JH PI must submit Change in Research, uploading a copy of the fully-executed IIA and HSR training certificates in Section 2 [Study Team Compliance Training], Question 2.
- Add the investigator as an “Other Non-Hopkins Site” in Section 10 [Study Location]
- The non-affiliated investigator should not obtain an ADHOC JHED or be added as a study team member.
- sIRB Continuing Review Guidelines
- JHM IRB Continuing Review Summary Sheet for Relying Sites
- sIRB Continuing Review p-Site Summary Sheet
- Form RF3 Adverse Event Report Summary Sheet
- Form RF4 Protocol Deviation Summary Sheet
- Participating Site and sIRB Tracking Log Toolkit
- FWA Information Sheet
- Participating Site Worksheet
- Single IRB Submission Checklist
- Adding a Participating Site [pSite]
- Submit a pSite Modification
- Submit a pSite Termination Report
- Submit a pSite Progress Report
- Submit a pSite Problem Event Report
- Single IRB Review Workflow
- Local Context Questionnaire Template
- pSite Local Context Tip Sheet
- Site-Specific Consent Information Template
- Sample pSite Application
- SIRB Frequently Asked Questions
- sIRB Presentation – Understanding sIRB Requirements
- pSite Submission Workflow
Interested in setting up a sIRB consult or in sIRB training? Contact Us at [email protected]