The Johns Hopkins Medicine IRBs
Announcements
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The Compliance Monitoring Program is offering an education seminar on September 11, 2024. This virtual seminar, “Research Record Retention,” can be accessed in MyLearning at: The JHM OHSR Compliance Monitoring Program Educational Seminar Series. The sessions are open to all research staff and will count towards the in-person requirements for Investigator HSR recertification. Please contact Suzanna Roettger ([email protected]) with any questions.
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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! October’s session will explore the Johns Hopkins Medicine (JHM) Biospecimen Transfer Policy and Committee Review Process. The Biospecimen Transfer Committee (BTC) staff will provide an overview of the policy’s rationale and what types of research with biospecimens fall under the policy’s purview. They will also discuss special considerations made by the Committee when determining if a transfer is approvable, and provide techniques to assist researchers in streamlining the BTC process. This session will be held on October 30th at 1pm. Our Biospecimen Program Administrator, Jessica Williams, and Biospecimen Program Analyst, Andrew Tomer, will lead the presentation. Megan Singleton, Associate Dean of Human Research Protections and Director of the Human Research Protections Program, will also join the discussion. Register Here or search “IRB Office Hours” in MyLearning.Registration ends October 27th.
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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
