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The Johns Hopkins Medicine IRBs

UPDATE: Delay in Changes to the Federal Policy on Protection of Human Subjects (the Common Rule): A revised version of the federal rule governing Human Subjects Research (i.e. the Common Rule) was scheduled to go into effect on January 19, 2018. On January 17, 2018 an Interim Final Rule was released delaying the effective date of the rule changes until at least July 19, 2018. The Interim Final Rule can be accessed at the following link: https://www.federalregister.gov/documents/2018/01/22/2018-00997/federal-policy-for-the-protection-of-human-subjects-delay-of-the-revisions-to-the-federal-policy-for.

Until the Final Rule becomes effective, all human subjects research must continue to comply with the existing Common Rule. The OHSR will keep study teams apprised of any changes to the federal requirements for human subjects protections. Please check the OHSR website frequently for any updates. Training sessions outlining the planned rule changes and the status of the rule will still be held in January 2018. Please click here to register: http://lms14.learnshare.com/l.aspx?CID=89&A=2&T=734689   For more information about the changes generated by the new rule, including information about forthcoming training sessions...

NIH Announces New Changes Regarding Certificates of Confidentiality for NIH-funded Research: Effective October 1, 2017, all ongoing or new research funded wholly or in part by NIH as of December 13, 2016 that is collecting or using identifiable, sensitive information is automatically issued a Certificate of Confidentiality (Certificate) as a term and condition of NIH grant awards. For more information...

FWA Changes: By November 1, 2017 we will make changes to streamline the number of FWAs held by the institution and ensure that each legal entity has one FWA. This will require closing out some existing FWAs assigned to organizations that are components under either the Johns Hopkins School of Medicine FWA number or The Johns Hopkins Health System FWA number.  For more information...

Training Sessions:

Relying on an External IRB (JHM IRB): This training will review website tools and instructions available to support requests to rely on an External IRB; provide guidance about the local institutional review required when JH relies on an external IRB. (both initial and ongoing); and review the roles and responsibilities of local site PIs and study teams when relying on an external IRB. For more information and to register...

NIH's Single IRB Review Requirement: Effective January 25th 2018, 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. For more information and to register 

 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