News & Announcements Archive

Notice of New NIH Policy on Issuing Certificates of Confidentiality

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. Identifiable, sensitive information is information about an individual, gathered… Read more »

Preparing for the NIH’s Single IRB Review Requirement

As of January 2018*, all competing National Institutes of Health (NIH) grant applications for multi-site research require a plan for use of a single IRB. This training will review NIH’s new policy for single IRB review and its implications; discuss how JHU will address the single IRB review requirement; provide advice on how to continue to provide… Read more »

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… Read more »

NIH-Funded Human Subjects Research

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… Read more »

Data Use Agreements

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 or BARA signature unless the research is sponsored. Faculty PIs must review and sign off on these agreements.

CITI Training Expires After 5 Years

Friendly Reminder: Has it been 5 years since you last completed Human Subjects Research training? Please regularly check your HSR training dates! All HIRB study team members and other key personnel are required complete the Johns Hopkins University computer-based human participant research training program, provided through the Collaborative Institutional Training Initiative . Training of Johns… Read more »