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The Johns Hopkins Medicine IRBs
IMPORTANT INFORMATION REGARDING THE CORONAVIRUS:
For the most up-to-date information for research teams about COVID-19 please visit - Essential information for Human Subjects Research Teams Related to COVID-19
ATTENTION EIRB Update: An update is being finalized for eIRB that will affect continuing review and progress report applications not submitted by the time the update is launched. The update is expected to be launched on 8/14/2020, and includes new and modified questions.
When the update is launched, continuing reviews and progress reports that are in Researcher Prep, will be converted to the new applications automatically. This will require the study team to answer new/modified questions before submitting.
Any continuing review or progress report that has been submitted at least once prior to the update, will retain the current questions. This includes applications that are submitted and returned on pre-review and those that have undergone IRB review and had an outcome recorded [e.g. tabled, approved with administrative changes, etc.].
If you have a continuing review or progress report application currently in Researcher Prep, you are encouraged to submit the application prior to the launch to avoid receiving an error if you submit without answering the new/revised questions.
Changes in Research Consent Scanning Workflow
Effective 9/1/2020 study teams will be responsible for ensuring a copy of clinical research consents are placed in Epic. Study teams will also be responsible for setting the Certificate of Confidentiality (COC) flag in Epic, where it applies. For more information on Expectations for Registering Research Participants in CRMS and Research Consent Form Availability please click HERE.
IRB Virtual Office Hours related to Resuming In-Person Research Activities and New Enrollment
The IRB staff will be holding virtual office hours via zoom twice weekly to help answer questions from study teams related to resuming in-person research activities and new enrollment. To sign up submit an email request to the IRB’s Help Desk at firstname.lastname@example.org. Sessions are capped at 15 attendees. Dates and times for upcoming sessions can be found HERE.
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. Daniel E. Ford.
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/
Guiding Principles of Institutional Review Boards (IRB)
Johns Hopkins experts discuss the critical role of Institutional Review Boards in research involving human subjects and the guiding principles they operate by:
- respect for persons
- risk and benefit analysis
- justice and fairness.
General IRB Questions