Final revisions to the Federal Policy for the Protection of Human Subjects were issued by the Department of Health and Human Services and will be effective on January 21, 2019. In order for UM to implement the New Rule, a revised New Protocol Exempt Form will be published by January 18th. There are also new consent templates that include updated consent regulations. While we will begin to accept new Exempt forms on January 18th, review and approval for new protocols submitted in January may be placed “on hold” until the new rules go into effect on the 21st.
During January, the IRB will concentrate on completing pending studies and finalizing the new protocol submission system that reflects changes to the common rule. Therefore, please be aware that this will most likely affect your review time in January. Also, if your study is one of those that is already in pre-review or IRB review in late early January, please reply promptly to any IRB requests.