On January 19, 2017, the Department of Health and Human Services issued revisions to the regulations governing human subjects research (called the Common Rule). The Revised Common Rule will take effect on studies starting on or after January 21, 2019.
Researchers can expect minor changes to review processes, Cayuse IRB forms, and informed consent templates when preparing study submissions. We strongly recommend that you familiarize yourself with the regulatory changes in order to understand how they may or may not impact your current or future human subjects research projects. Key changes include:
- Revision to Exempt Research Categories
- Revision to Continuing Review Requirements for Minimal Risk Research
- New Requirements for Informed Consent Forms
- Single IRB Review to Assist Multi-Center NIH-Funded Studies
- New and Revised Definitions of Research Terms