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 before January 8th, 2019 will be reviewed using the pre-2018 requirements. This gives time for the IRB to process these new protocols before the IRB meeting later that week. However, if any of these protocols require revisions that are not made before the IRB meeting on January 11, 2019, the researcher will have to submit the protocol after January 21st, 2019 and the protocol will be subject to the new regulations (the 2018 requirements of the Revised Common Rule).
- No new submissions will be accepted between January 8th and January 20th, 2019 to allow time to prepare and test the online submission portal. All new research submitted after January 21, 2019 will follow the new regulations (the 2018 requirements of the Revised Common Rule).
Resources to Learn More About the New Regulations
Several organizations have put together summaries of what they consider to be especially important changes in the regulations:
- PRIM&R Quick Reference Guide (PDF)
- ASCO Common Rule Summary (PDF)
- The Council on Governmental Relations
Read the complete Revised Common Rule (PDF)
Learn more about the new regulations from the Health and Human Services government website.
The CITI Program has free resources for people wanting to better understand the changes in the new regulations (note: this is very extensive).
The CITI Program also has a tutorial course you can take: “Revised Common Rule Course: Comprehensive training covering the Final Rule updates to the Common Rule.” You need to register for the course by creating an account (and selecting Fairfield University as your affiliation). Fairfield University has a yearly subscription to the CITI program, thus you do NOT have to pay to take this course.
Training Certificate for Conducting Human Subjects Research
The upgraded submission portal will prompt researchers to upload their training credentials (NIH or CITI), so if you have not completed human subjects training within the past 3 years, you should plan on doing so prior to submitting any new research after January 21, 2019. Researchers conducting research that involves expedited or full board review are expected to complete ongoing human subjects research training, and we strongly encourage ALL researchers – including those conducting research reviewed under exempt categories or healthcare quality improvement (QI) projects – to complete the CITI training. CITI plans to update their human subjects research courses with additional information about the 2018 Final Common Rule sometime over the weekend of January 19th. You can complete the already existing courses or wait until after this update.
There are different courses for different types of research. For many of you, the “Social-Behavioral-Educational (SBE) Basic Course” will be the most useful. Others will find the “Biomedical (Biomed) Basic Course” more relevant. These and other courses are available to you – and to any of your students – through the University’s subscription to the CITI Program, so please use it and encourage your students to do the same if it is relevant to their course of study. Create an account and access the courses Fairfield University has subscribed to at CITI Program.