The Johns Hopkins Medicine IRBs
Join the Johns Hopkins Institutional Stem Cell Oversight (ISCRO) administrator and Interim ISCRO Co-Chairs for a discussion of the updated Stem Cell Research Guidelines published by the International Society for Stem Cell Research in 2021 and the revisions made to JHU ISCRO policy and procedures to align with these new guidelines. An overview of the revised ISSCR guidelines will be presented and updates to the ISCRO policy, website, and training related to these new guidelines will be shared. Researchers who submit applications subject to ISCRO review or who may do so in the future are encouraged to attend. Each session will feature a live Q&A session.
All sessions will be held virtually (Zoom information below). Attendees may attend either of the available sessions. For more information...
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.
On June 1, 2022, the new Johns Hopkins University policy on investigator-held INDs/IDEs will take effect, requiring institutional approval to serve as sponsor-investigator and submit an application for a new IND or IDE to the FDA.
The policy does not apply to IND/IDE applications submitted to the FDA before the effective date, IND/IDE exempt studies, or emergency/compassionate use requests for single patients.
Detailed guidance for the process to secure institutional approval from the Office of Clinical Trials (OCT) Investigational New Drug (IND)/Investigational Device Exemption (IDE) Regulatory Program is here.
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