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.
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