As you are likely aware, new human subjects regulations go into place for all new protocols submitted on or after Saturday, January 19, 2019. The full text of the updated Common Rule can be found here. A brief summary of the changes is located on the IRB website.
The RIO office has updated applicable standard operating procedures, review tools (checklists and worksheets), and investigator-facing materials.
- IMPORTANT: The templates for informed consent have changed to be compliant with the new rule and must be used for all new submissions. These can be accessed in the ICON library and on the IRB website. If a protocol has received a “deferred” decision by the convened IRB, updated consent documents are also required.
- Aside from informed consent documentation, the majority of these changes will not affect the information you provide to the IRB in a new protocol submission. Changes primarily affect IRB review categorization and internal processes for review. In many cases, the revisions reduce burden and/or turnaround time for the investigator.
- Protocols already approved under the previous version of the Common Rule will remain under the previous rule. Should investigators wish to transition their study to the new rule (for example, to eliminate the continuing review requirement for studies in an exempt or expedited review category), a transition process will be made available to you no later than March 1, 2019.
- RIO will offer in-person training sessions in the upcoming weeks; these will be announced through DOR and on the IRB website soon; they can also be scheduled for Departmental meetings upon request.
RIO is here to answer your questions! The IRB team may be reached at CPHS@central.uh.edu or 713-743-9204, or you may reach out to your committee-specific coordinator.