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The Johns Hopkins Medicine IRBs
ACTION REQUIRED FOR NEW APPLICATIONS RELATED TO THE REVISED COMMON RULE
1. New applications that are in a status of Tabled or Approved with Administrative Changes
If your new application was reviewed by the IRB and is in either a Tabled or Approved with Administrative Changes state, we encourage you to submit your response as quickly as possible so it can be processed under the existing rule. We will make every effort to review responses submitted on or before 12/15/2018 prior to the 1/21/2019 rule change.
- If your response is not approved before 1/21/2019, the new rule will apply and you will be required to make additional changes to bring the application into compliance with the new rule. The application will be returned to you after 1/21/2019 to make these changes.
- If your response is not received by 12/15/2018, the application will not be processed before 1/21/2019 and you will be required to address the new rule changes as they pertain to your study. Your application will be returned to you after 1/21/2019 to make these changes.
2. New applications not yet submitted for IRB review
All new applications initially submitted on or after 12/15/2018 will be held and returned after 1/21/2019. At that time you will be required to answer additional questions as needed for compliance with the new common rule. No new applications will be processed between 12/15/2018-1/21/2019 with the exception of compassionate or emergency use applications, which will be accepted and processed as needed during this period.
New applications approved before 1/21/2019 will continue to follow the requirements of the current Common Rule. New applications approved after 1/21/2019 must comply with the new Common Rule.
Please Note: Due to the winter holidays, the JHM IRBs will not have any convened IRB meetings the week of 12/24/2018. In addition, several convened IRB meetings will be cancelled the week of 12/31/2018.
For more information about the New Common Rule please click HERE.
Please click HERE for information about the new JHM IRB Combined Informed Consent/HIPAA Authorization Template, required for studies approved on or after January 21, 2019.
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