On January 18, 2017, the Department of Health and Human Services issued the final revisions to the Federal Policy for the Protection of Human Research (The Common Rule). The effective date for most provisions is Friday, January 19, 2018*.
Summary of major changes that affect the research community:
- Changes to the informed consent policy and minor changes to the templates
- Continuing review for certain minimal risk research (Expedited studies and Full Board studies in data analysis only) may no longer be required
- Various clarifications and the addition of new categories of Exempt research
- Single IRB of Record (sIRB) requirements for multi-site studies (effective January 25, 2020 – for NIH studies, effective date is January 25, 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 for implementation of 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.
Studies approved January 19, 2018, and beyond must meet the updated requirements of the “2018 Rule”, and are subject to the updated consent, continuing review, and exemption regulations. Studies approved before January 19, 2018, will be transitioned to the updated regulations at the time of their next continuing review. Exempt studies will remain under the previous Common Rule requirements.
More information will be provided on the HRPP/IRB website as it becomes available. Please let us know if you have any questions or concerns!
*On October 7, 2017, HHS proposed a one-year delay of the implementation date of the revised Common Rule. The proposed delay is currently pending review.