Institutional Review Board
Revised Common Rule Regulations for Human Subjects Research
Revised Common Rule regulations for human subjects research will take effect on January 21, 2019. Many of the changes associated with these regulations will impact policies and processes associated with the HRPP/IRB office that will not be a direct impact on researchers. However, the following are areas that will have a direct impact on our researchers.
- The eCompliance system will not be accepting new applications after midnight on December 24, 2018 until 6:00 am on January 7, 2019 to allow for the transition of review of studies to incorporate the new rule which take effect January 21, 2019.
- For full board studies this timeline is in alignment with our current guidelines
- For exempt and expedited studies, this timeline may have a small impact on your expected timeline for approval
- If you have an existing study submitted in the system that is in a “returned” or “pending” status prior to December 25, our staff will be working with you to have all items complete in order to avoid any delays in approval or need to meet new requirements.
- If you have started a study but not yet submitted (status is New), please submit with required items by midnight on December 24, 2018 or plan to work with a new application beginning January 7, 2019.
After January 21, 2019, the following types of studies will be required to follow the Revised Common Rule for initial review and will be required to transition existing studies at the time of Continuous Review of Research (CRR) which are still open to enrollment:
- Federally funded research (unless funded by Department of Justice or Consumer Product Safety Commission)
- Clinical trials
- For federally funded studies: Informed Consent form must be posted on ClinicalTrials.gov after the trial is closed (no later than 60 days after last study visit for any subject)
- Greater than Minimal Risk Studies
At this time, the University of Missouri has elected not to adopt broad consent for biospecimens.
Our eCompliance application system will include links to new templates and guidance within the application beginning January 7 to help guide researchers through those items that require new elements and our staff will be available to assist you with the process. Specifically, a new informed consent template will be provided which captures the new requirements for “reasonable person”; “key information”; and “facilitates subject’s….understanding”. This was discussed at our December 10, 2018 monthly seminar and a recording is available by contacting our office at firstname.lastname@example.org or 573-882-3181.
We will have the ability to pull in-process items from the archives if you work with our staff after January 7, but submission prior to December 24 at 11:59 pm will avoid any delays in accessing your information. You may contact our main IRB email at email@example.com after January 7, 2019 if you need assistance retrieving archived information.
We will be providing an in-person as well as remote Zoom accessible meeting on February 11 from 2:00-3:00 pm in SON Room 342 to discuss specific changes related to the Revised Common Rule. Zoom information will be provided via the listserv in January and recorded sessions will be available by contacting our office.