Update: Revised Common Rule (45 CFR 46, Subpart A) - Important Dates

On January 18, 2017, the Department of Health and Human Services issued the final revisions to the Federal Policy for the Protection of Human Subjects (the Common Rule). The effective date for most provisions is January 19, 2018*. 

The University’s Human Research Participant Protection (HRPP) offices are developing a transition plan to implement these revised regulations.  To this end we want to alert you that the HRPP will need to take down iRIS for one week to upgrade the system to implement these regulatory changes.  Therefore, the current plan is to take iRIS down the week of January 15 – 21, then re-open on Monday, January 22, 2018.  Below is the planned timeline of events based on the implementation date:

• January 3, 2018:  iRIS will be closed to new study submissions at 4:00pm. Continuing Reviews, Modifications, and other submissions will continue to be accepted.
• January 4-14, 2018: Time needed for IRB to review new study submissions, get responses for stipulations, and grant final IRB approval. 
• January 15, 2018: iRIS down for upgrade and testing.
• January 22, 2018: iRIS up to accept all submissions. 
• January 2018: Education sessions for research community (dates to be determined); update and publish guidance, new consent templates, and transition details. 

NOTE: The above schedule should allow enough time for the HRPP / IRB to complete its review of anything submitted prior to January 19^th to remain under the “pre-2018 Rule.”  Research approved January 19, 2018 and beyond must meet the updated requirements of the “2018 Rule”, and is subject to the updated consent and exemption requirements. Any exceptions to the above schedule or urgent submissions will be considered for acceptance on a case-by-case basis.