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NEWS and Policy Updates:

April 2017

NIH Single IRB Review Policy
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 Homewood IRB, the School of Medicine (SOM) IRB, and the Johns Hopkins School of Public Health (JHSPH) 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. 
 
Reviewers will evaluate and act on the request.  SOM faculty will use the same portal for applications seeking to rely on an external sIRB.

 

  • Homewood and JHSPH investigators preparing grant submissions and new applications that propose relying on an external sIRB should contact the JHSPH (jhsph.irboffice@jhu.edu ) or Homewood IRB (hirb@jhu.edu ) 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. 

 

December 2016:

NIH-Funded Human Subjects Research

As of January 1, 2017, NIH-funded investigators and their research staff who are involved in the conduct of clinical trials (both FDA regulated drug or device studies, as well as behavioral interventions), as defined by the NIH, must complete Good Clinical Practice (“GCP”) training. 

This policy is effective and applies to both new applications, and on-going programs. 

The NIH definition of a clinical trial is “A research study in which one or more human subjects are prospectively assigned to one or more interventions (which may include placebo or other control) to evaluate the effects of those interventions on health-related biomedical or behavioral outcomes.”  

This definition encompasses trials that do not involve drugs or devices, and investigators should review the NIH definition for more detail:  https://grants.nih.gov/grants/guide/notice-files/NOT-OD-15-015.html 

JHU investigators and their research staff who may be subject to this NIH requirement should complete the CITI GCP training module in myLearning, or demonstrate compliance through providing a certificate of other acceptable GCP training to ORA and/or the JHM IRB.


October 2016:

Data Use Agreements (DUA): 

Faculty-led research, all DUAs should be reviewed and signed by JHURA or BARA.

Student-led research involving DUAs are NOT subject to JHURA/BARA signature unless the research is sponsored. Faculty PIs must sign.


HIRB Policies & Procedures

HIRB Standard Operating Policies & Procedures manual contains guidelines for the operation of HIRB. HIRB is the central component of the Human Research Protection Program (HRPP) for those divisions within Johns Hopkins served by HIRB. The manual is an important resource for HIRB and HRPP members, investigators, and HIRB staff.  See also the Glossary of IRB-Related Terminology . 

Cooperative Amendment for FWA 00005834 – The Johns Hopkins University Homewood Institutional Review Board – and FWA 00005752 – The Johns Hopkins University School of Medicine