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Human Subjects Research (HSR) Training
Required Training for New PI and New Study Team Members
There are two types of Compliance training required for New PIs and Study Team Members to perform human subjects research:
IRB Compliance Training – Principal Investigators (PIs) and study team members are required to complete IRB compliance training prior to submission of a human subjects research eIRB application. IRB Compliance Training includes: Human Subjects Research (HSR), Conflict of Interest (COI), and HIPAA for Research (HFR). For more information on IRB compliance training…
**In Addition to Compliance Training, first time Principal Investigators (PIs) are required to take REWards Training**
REWards – Required for PIs and Fellows. PIs must complete REWards training within 1 year from the date of their first eIRB submission of a human subjects research application. Fellows must complete REWards training by the end of their fellowship. For more information on REWards…
Recertification Training Requirements
Recertification – Required for all PIs and study team members engaged in human subjects research. PI’s and study team members must complete recertification every three years. For more information on Recertification…
Good Clinical Practice (GCP) Training - NIH leadership released a new policy requiring GCP training as of January 1, 2017. For more information on GCP training...
Required Training for External IRB Studies
All new (NIH) grant applications and competitive renewals for multi-site research require a plan for use of a single IRB. The JHM IRB routinely serves as the single IRB, but there are also cases where Johns Hopkins will be asked to rely on an external IRB.
For external IRB applications submitted on or after January 1, 2019, any PI named on an external IRB application will be required to complete an online training course: Relying on an External IRB. The training will review the initial steps to request reliance on an external IRB, outline how to submit an external IRB application to the JHM IRB and review the roles and responsibilities of local site PIs and study teams when relying on an external IRB.
The training must only be completed once. While required for PIs, completion of the training is also encouraged for investigators and other study team members who will be working with external IRBs. A copy of the completion certificate must be uploaded with the external IRB application [Section 2 – Study Team Compliance Training, Question 2].
eIRB Training Tools:
The OHSR also offers voluntary technical training consisting of online tutorials and in-person classes for those who may be new to the eIRB system or who want a refresher course. For more information on eIRB training…