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The Johns Hopkins Medicine IRBs
New policy for JHU faculty serving as Sponsor-Investigator for Investigational New Drug (IND) or Investigational Device Exemption (IDE) clinical trials
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.
Updates to the Human Subjects Research Compliance Training Registration Process
Starting January 10th, 2022, improvements will be implemented to the registration process for Human Subjects Research (HSR) Compliance Training. Investigators and Study Team Members will be able to enroll in required training courses (initial training, ICH GCP and recertification) by selecting one “bundle” in myLearning. Please review this guide on how to get started. For additional questions, please contact the IRB Help Desk at email@example.com.
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
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/
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