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NIH requirement for sIRB
Effective September 25, 2017, the NIH requires that all grant applications for domestic, multi-site, non-exempt human subject research studies include a proposal for the use of a single IRB (“sIRB”) to review the research for all participating domestic sites. The JHSPH IRB, the SOM IRB, and the Homewood IRB are working together to address the new NIH requirement for sIRB. When sIRB services are required by a Sponsor, and a JHU PI wants JHU to serve as the study’s sIRB, the SOM IRB will review all requests for sIRB services, and if approved, will serve as the University’s sIRB for all divisions. JHU has signed on to the SMART IRB Reliance agreement, and investigators are urged to make sure that their collaborators have either signed on to this form of reliance agreement, or are willing to sign on.
- All Planning Phase and New Applications that involve Hopkins as the reviewing sIRB must submit a “Reliance Request” through an on-line SOM IRB query portal available on this page: http://www.hopkinsmedicine.org/institutional_review_board/about/reliance_agreement.html. Reviewers will evaluate and act on the request. SOM faculty will use the same portal for applications seeking to rely on an external sIRB.
- JHSPH and Homewood investigators preparing grant submissions and new applications that propose relying on an external sIRB should contact the JHSPH (email@example.com) or Homewood IRB (firstname.lastname@example.org) for further guidance.
All other reliance requests will be managed by the IRB associated with the PI’s division.
Please contact JHMIRBreliance@jhmi.edu with questions about the SOM IRB sIRB process.
Final Rule: Federal Policy on Protection of Human Subjects (Revisions to the Common Rule)
The U.S. government has published its changes to the regulation known as “The Common Rule” governing Human Subjects Research. The IRB office is reviewing the new rule and will communicate information about the changes, including statements about what these changes mean for researchers at Johns Hopkins University in the next few months.
The rule goes into effect in 2018. A version of the final rule was made available on January 18, 2017, by the Office of the Federal Register and can be accessed at: https://www.federalregister.gov/documents/2017/01/19/2017-01058/federal-policy-for-protection-of-human-subjects. It is expected that the final rule will be published in the Federal Register on January 19, 2017.
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.