Revised Human Subject’s Training Requirements

Revised Human Subject’s Training Requirements

The Institutional Review Board (IRB) is pleased to announce the following revision to current expectations regarding human subjects’ training.

Effective April 2, 2019, the IRB will no longer require refresher training for human subjects’ research. The requirement to complete initial training appropriate for the type of research you conduct will remain. This revision to the training requirement aligns with external funding training requirements as they relate to human subjects’ training (this includes the NIH, Department of Defense, etc.) and given that refresher training is not required to receive funding, the training requirements at Penn are now being revised to remove this additional element of burden after initial training is established.

Please note: this revised requirement is specific to human subjects’ training only; this will not affect other training requirements for the conduct of research with human participants (i.e. HIPAA, GCP, Sponsor requirements, etc.).

If you are engaged in the process of review/approval/oversight of research involving human participants and have any questions about this revised requirement, or if you have any general questions regarding this updated requirement, please contact Tracy Ziolek (ziolekt@upenn.edu or 215-746-6272).

If you need an updated CITI certificate (for proof of training for parties external to Penn) to show completion of training with no expiration date (especially if the expiration date is in the past), please go here for instruction for how to download an updated certificate.

If you have current training, no action is necessary. Knowledge Link has been updated to no longer send you warning of upcoming expirations. Should this occur, please contact IRBCITISupport@lists.upenn.edu. Effective April 2, 2019 the IRB will not request updated training certificates.

In addition to this training requirement revision, the following burden reduction efforts are already occurring:

• Assessment of incoming submissions for minimal risk research studies to determine if they qualify for no continuing review required going forward
• Applying expanded exemption categories to avoid further regulatory submissions for research not requiring it

Assessment for burden reduction eligibility is part of the IRB screening process and does not need to be requested by the submitting Principal Investigator and/or study team. If you wish to seek guidance on whether an existing study will qualify, please contact any member of the IRB staff.

For an overview of the revised Common Rule, please go here.