The Johns Hopkins Medicine IRBs
Announcements
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To increase efficiency, the JHM IRB has introduced a new Study Team Member Only Change In Research (STMO CIR). The STMO CIR can be used to add new study team members, make updates to existing study team members, and remove existing study team members. Using the STMO CIR, these updates can be administratively reviewed and approved through the eIRB system. For more information...
Training and information sessions on the new Study Team Member Only Change in Research (STMO CIR) will be offered twice monthly starting in November 2024 and will run through February 2025. For a list of dates and times as well as registration information CLICK HERE.
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The BTI form for external biospecimen transfer requests has been updated and use of the new version will be required effective September 15, 2024. The revised form can be found HERE.
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The following forms have been updated and use of the new versions will be required effective 7/1/2024.
- eFormE: Applications submitted on or after 7/1/2024 will be returned to use the revised eForm E, version 2, dated 3/2024.
- eFormR: Applications submitted on or after 7/1/2024 will be returned to use the revised eForm R, version 3, dated 3/2024.
- eFormS: Applications submitted on or after 7/1/2024 will be returned to use the revised eForm S, version 7, dated 3/21/2024.
These forms can be found HERE.
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Effective July 1, 2024 there will be new IRB fee schedule for research studies subject to either standard or sIRB billing. The threshold for standard billing for studies with commercial funding has been increased from >$10,000 to >$15,000 to assist study teams with small commercial funding support. The new fee schedule will apply to new applications submitted on or after 7/1/2024. For more information and to see the new fee schedule go to https://www.hopkinsmedicine.org/institutional-review-board/about/fees
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Join us for JHM IRB’s Monthly Office Hours! November’s session will be held on November 25th at 10am and will explore the Johns Hopkins Hospital Investigational Drug Services (IDS). The IDS PGY2 Pharmacy Resident, Emma Meyer, will lead the presentation and provide a brief overview of services offered by the IDS as well as how to collaborate with the IDS throughout the clinical trial process. Register here or search “IRB Office Hours” in MyLearning.
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The investigational drug data sheet (IDDS) has been revised. As of 1/2/2024, new submissions that involve drugs and require an IDDS will need to use the revised IDDS template located here. Any studies submitted before 1/2/2024, can continue to use the prior IDDS template. However, for studies submitted before 1/2/2024 that add drugs for the first time via a Change in Research, the new IDDS template must be used.
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About the IRB
The Institutional Official who has authority over the JHM Human Subjects Protection Program is the Vice Dean for Clinical Investigation. The current Vice Dean for Clinical Investigation is Dr. Gail Daumit, MD, MHS.
The Johns Hopkins Medicine Institutional Review Boards (JHM IRBs) are responsible for protecting the rights and welfare of the human subjects of research conducted by faculty and staff at the Institutions. The JHM IRBs review all human subjects research projects conducted by Hopkins faculty and staff. To fulfill the agreement underlying the assurances, and to satisfy institutional policy, all faculty and staff at the Institutions must submit for JHM IRB review any human subject research project, regardless of funding source (or lack thereof) and/or location at which the research will be conducted.
Please Note: Part-time faculty are obliged to obtain JHM IRB approval of all human subjects activities conducted under the auspices of their Hopkins’ appointment ( which means “use of Hopkins’ personnel or space or the use of the faculty appointment in correspondence, agreements with sponsors, etc…”).
The Institutions operate under Federal-Wide Assurances associated with each of the organizations linked to the JHM IRBs. List of JHM FWAs
For more information on the federal guidelines that determine the kind of research the JHM IRB is required to approve please visit http://www.hhs.gov/
General IRB Questions
Phone: 410-955-3008
