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The Johns Hopkins Medicine IRBs

IMPORTANT INFORMATION REGARDING THE CORONAVIRUS:

As we make decisions on how to respond to the COVID-19 infections we want to begin by stating that our primary concern is the safety of our research participants and the research team members who work for Johns Hopkins University and Health System. Our secondary goal is to preserve the scientific integrity of the research protocols. For the most up-to-date information visit - Essential information for Human Subjects Research Teams Related to COVID-19

Changes in Research Consent Scanning Workflow

Effective September 1, 2020 the Office of Clinical Research Billing Compliance (CRBC) will no longer be uploading the faxed/scanned clinical research consent documents in the Epic patient record or placing the Certificate of Confidentiality (COC) flag in Epic. This will become the responsibility of the study team. Study teams must identify and assign resources to support this required task. Clinical trials with a Prospective Reimbursement Analysis (PRA) must ensure a scanned copy of the consent is placed into the Epic electronic patient record. Lack of a consent document in Epic may delay patient care and protocol conduct. Zoom sessions for the Epic “Integrated Scanning 100” course, reserved solely for study team staff, are available in July and August. For more information and registration details…


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. It is vital resources are identified to support these requirements. Participant activities and protocol conduct may be interrupted if the consent form is not available in Epic. For more information and training registration details click here: https://ictr.johnshopkins.edu/coronavirus/announcement-from-the-vice-dean-for-clinical-investigation-june-30/ 
 

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 the first phase of resuming in-person research activities and new enrollment. The virtual office hours will begin the week of 6/22/2020 and are currently planned to run through the week of 7/27/2020 with additional sessions added if needed. Study team members interested in joining a virtual office hour session may submit an email request to the IRB’s Help Desk at jhmeirb@jhmi.edu. Study team members may sign up for one time slot. Sessions are capped at 15 attendees. Once you have registered, an email confirming zoom details will be provided. 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

Phone: 410-955-3008