Revised Human Subjects Regulations (Common Rule) Wednesday, June 20th 2018
The regulations that human subjects researchers must adhere to (referred to as the Common Rule Regulations) were established in 1991. In 2011, federal agencies began the long-awaited process to revise these regulations and, on January 18, 2017, the final revisions to the Common Rule (Final Rule) were posted in the federal register. The effective and implementation dates have recently changed. As posted in the federal register on June 18, 2018, the revised final Common Rule is both effective and to be implemented on January 21, 2019 with the option of implementing 3 burden-reducing provisions before January 21, 2019.
Human Subjects Protection Training Requirements
All Principal Investigators (PIs) and Co-PIs on human subjects research protocols must complete human subjects protection training. The IRB strongly recommends that anyone else associated with the research team who will be interacting with the participants or have access to the data also take complete human subjects protection training. At this time, this training must be fulfilled by completing the CITI online training.
Training must be renewed every three (3) years. The IRB strongly recommends that anyone else associated with the research team who will be interacting with the participants or having access to the data take one of the training options. For more information about CSU’s Human Subjects Protection Training, please see the CSU Human Subjects Protection Training Requirements or contact the IRB or RICRO.
Training Status in eProtocol
When creating your protocol on the eProtocol system, you will need to know your training status. All PIs and Co-PIs must have up-to-date training.
If a protocol is NIH funded, all key personnel (as defined by NIH) must complete the training.