The Regs They Are A’Changin’: Important information for All Researchers
Here is what you need to know about recent changes in January 2019 to the federal regulations for human subjects research.
On January 18, 2017, the Federal Policy for the Protection of Human Subjects (known as the “Common Rule”) was updated for the first time since 1991. The update aims to better protect research subjects in the context of the modern world (e.g., online research, issues involving electronic data security) and to reduce administrative burden. Due to changes in the federal government, the implementation was delayed. The implementation date for most provisions of the revised rule is now January 21, 2019.
Because the initial implementation date was supposed to be 2018, things are listed and referred to on federal websites as “pre-2018 requirements” (the old rules) and “2018 requirements” (the ones to be adopted by 1/21/19). Some IRBs adopted three burden-reducing regulations in July 2018, but the Fairfield University IRB decided to follow what many other IRBs were doing and wait to adopt all the regulations in one fell swoop for the January 21, 2019 implementation date.
Fairfield University Key Dates
- All research already approved before January 21, 2019 will continue to follow the regulations that existed when the study was initially reviewed. These already approved protocols will follow those regulations for the lifespan of the protocol.
- All new research submitted after January 21, 2019 will follow the new regulations (the 2018 requirements of the Revised Common Rule).
We have updated the website and submission system to reflect the new regulations and to better educate Fairfield University researchers. Look for the following new additions:
- Resources to Learn More About the New Regulations
- Researcher’s Roles and Responsibilities
- Ethics Training for Human Subjects