Winthrop University: Grants and Sponsored Research Development - Revised Common Rule

Revised Common Rule / Final Rule

The U.S. Department of Health and Human Services and fifteen other Federal Departments and Agencies have issued final revisions to the Federal Policy for the Protection of Human Subjects (the Common Rule). The Final Rule was published in the Federal Register on January 19, 2017. It implements new steps to better protect human subjects involved in research, while facilitating valuable research and reducing burden, delay, and ambiguity for investigators. The Final Rule is scheduled to go into effect on January 21, 2019.

Key areas of change include:

  • Revised Definitions
  • Changes to Informed Consent documents
  • New Exemption Categories (1-6 only)
  • Changes to Continuing Review
  • Limited IRB Review Process

Implementation Dates
January 6, 2019
Last day to submit a protocol using the current IRB forms.

January 7, 2019
All new protocols must be submitted using the new IRB Request for Review form and Informed Consent documents (available online January 2, 2019.)

January 21, 2019
Protocols on new forms will be reviewed under new Final Rule processes and procedures.

Required CITI Training
To prepare for the implementation of the Final Rule, GSRD has added a new course to the CITI offerings. This new course is called "Revised Common Rule." This course is available to all faculty and staff. Completion of this course is required for all faculty and staff who submit or serve as the faculty advisor on an IRB Request for Review after the January 21, 2019 effective date. Instructions to set up an account and log into the CITI site can be found here.
***Please allow up to 3 hours to complete the course.

Additional Resources
Here are a few resources to help you navigate the Final Rule revisions.

Final Rule Presentation (PDF - 708 KB)

US Department of Health and Human Services
Office for Human Research Protections (OHRP)
Revised Common Rule Resources

Full Text of Revised Common Rule
Code of Federal Regulations

For specific training and/or protocol submission questions, please contact Michele Smith at ext. 2460 or

Last Updated: 9/4/19