There are new elements of consent, as well as changes to how and when consent information is presented. These changes are reflected in the updated consent form templates and guidance and have been incorporated into the application and protocol form.

In most cases, minimal risk studies approved on or after January 21, 2019 will be given a 5-year, non-renewable determination and will no longer require continuing review. This change will be reflected in the expiration date for each study and will not apply to FDA-regulated studies. Researchers must continue to submit reports of unanticipated events, requests for project revisions, and final reports. Refer to the additional requirements and guidance provided for Post Approval activities.

There are new and revised categories of exemption. Restrictions have been added to some categories, while others have been expanded or replaced. The changes have been incorporated into the application and protocol form available through iRIS in January 2019.