Join us for JHM IRB’s monthly Office Hours on June 29th at 10am. We review the process for investigator qualification to serve as an IND/IDE holder and the planning phase approval process to submit an IND or IDE to the FDA. Register by Fri, Jun 26, 2026, 10:00 AM EST. Register here!

The JHM IRB has recently updated the Version 15 and 17 written consent form templates. The new templates include updates to tax reporting requirements and minor revisions to template language related to incidental findings and conflicts of interest. The new Version 17.4 consent template will become mandatory for all new studies with consent forms as of September 8, 2026.

Effective January 1, 2026, the U.S. IRS reporting threshold for research participant compensation has increased from $600 to $2,000 per calendar year. While the institutional reporting threshold to the IRS has increased, research participant compensation remains subject to taxation and is reportable. Reimbursement for documented participant expenses related to participation is not taxable.

To facilitate informing research participants of these responsibilities the IRB has created the following guidance. For more information...

The Compliance Monitoring Program is offering an education seminar, “Informed Consent: Requirement for Those with Limited English Proficiency". This virtual seminar will  be on June 17 at 1pm. These sessions are open to all research staff. Please contact Suzanna Roettger ([email protected])  with any questions.

There are three JHM IRB Listservs available for the research community to receive information on topics of interest. These communications will provide eIRB2 announcements, human subject research training announcements and general JHM IRB announcements.   Click on the links below to sign up for any listservs of interest. You must subscribe to each listserv individually.

• EIRB-Updates - This listserv will be used to provide updates about our eIRB system including notification of system downtime and any changes made to the system including new or revised application questions. Notices will be sent through this listserv on an as-needed basis.
• IRB-Training  - This listserv will include a monthly update about upcoming JHM IRB trainings and other research-related trainings.
• IRB-Updates - This listserv will include a monthly update featuring the latest information from the JHM IRB. Updates shared through this listserv may include links to new guidelines and FAQs, revisions to IRB forms/templates, new resources, and reminders.

New to Conducting Research at Johns Hopkins? The investigator toolkit connects you to resources you may need for research at Johns Hopkins Medicine (JHM) in one convenient location. Research staff and coordinators who are involved with the development of research protocols and submissions to the IRB are encouraged to utilize this resource as it pertains to their respective studies. For more information...

We’re excited to introduce our new Request a Training feature! This option makes it easier for groups to schedule customized training sessions. You can select from a list of pre-approved topics or request a session tailored to your specific needs. To start your request, please click here and complete the quick survey. 

The Electronic Regulatory Management System (eReg) is a 21 CFR Part 11 compliant electronic regulatory binder designed to streamline regulatory workflows, enhance compliance, and improve overall efficiency across Johns Hopkins University (JHU). Effective October 1, 2025, eReg will serve as the mandatory, institutionally supported system for managing documentation for all studies conducted under an IND or IDE at JHU, ensuring data integrity and security.  Please consult the Use of JHM Clinical Research Electronic Regulatory Management System (eReg) Policy for further information.

 

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.

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 [email protected]. 

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.