The Johns Hopkins Medicine IRBs
Announcements
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Join our IRB monthly Office Hours on July 24th at 2pm as we discuss conflicts of interests. The Office of Outside Interests will join along with our Sr. Human Research Compliance Associate, Eunhae Gohng and will provide an overview of their office and what researchers should know when submitting their conflict. Register here. Registration ends on July 22nd.
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The Electronic Regulatory Management System (eReg) is an electronic regulatory binder designed to streamline regulatory workflows, enhance compliance, and improve overall efficiency across Johns Hopkins University (JHU). JHU requires the use of eReg for managing study documents associated with faculty-held INDs and IDEs. The eReg is fully compliant with 21 CFR Part 11, ensuring data integrity and security. Effective October 1, 2025, the use of eReg is mandatory for all studies conducted under a JHU faculty-held IND or IDE.
To get started with a new protocol in eReg, you must first contact the eReg team by completing a brief (< 5 minutes) survey using REDCap. Once the survey is submitted, the central eReg Team will create the protocol in eReg on your behalf. The creation of a new protocol centrally is necessary to minimize errors and improve the efficiency of regulatory workflows. More information about eReg and the new protocol creation process is available on the eReg home page , under the JHM Research IT Hub.
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Effective May 1st, 2025, Advarra IRB has updated their JHM organizational processing rules. The internal changes will apply to studies where JHM relies on Advarra IRB with a goal to improve efficiency of reviews for site applications and site-specific consent forms. Please review the addendum for more information.
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The JHM IRB Guidance: FAQs on Data Sharing are provided as a resource to help guide research teams on responsible data sharing. These FAQs aim to help study teams in the JHM research community think proactively about data sharing as they develop their study plans.
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The myLearning 2.0 project has chosen Cornerstone OnDemand to replace the current learning system, myLearning. The platform change will require a blackout period when the new system launches. The blackout period will start February 28th and continue until Cornerstone goes live on March 3rd. During the blackout period, no training courses can be accessed through myLearning and no training dates will be updated in the system. For questions, contact our JHM IRB Help Desk.
For project details and contact information, visit the myLearning 2.0 SharePoint site
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The JHM Office of Human Subjects Research (OHSR) is expanding its existing consult service to offer a new consult service designed for research teams with projects that involve Artificial Intelligence (AI). The consult service is available to research teams that may be developing AI or that intend to use existing AI tools to support the conduct of their study.
Study teams are encouraged to utilize the consult service in the planning phase of their study but may also be referred for an AI consult by the IRB or its associated ancillary review committees.
The consult team includes experts from the IRB and Data Trust and faculty consultants representing diverse disciplines including medicine and engineering. We hope to help researchers anticipate and mitigate issues that may arise during the IRB and ancillary review processes and aim to make the process more efficient for all involved. The consult service will also inform the development of tools and resources to help improve the review process.
AI consult meetings will be held every Tuesday from 12pm-1230pm and there will be a limited number of reviews assigned to each meeting. To sign-up for a consult, please email Kat Jeter at kjeter1@jhmi.edu.
If unable to attend a consult during one of the pre-arranged consult times listed below, please contact Kat Jeter to arrange an alternate consult time.
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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...
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
