Common Rule and Other Regulatory Changes
The revised Common Rule applying to research supported by DHHS and many other federal agencies (excluding FDA and DOJ), goes into effect on January 21, 2019. This site provides an overview of the major changes and how the UT IRB will implement them. Other information on recent related regulation is also provided.
Major Regulatory Changes
Categories have been updated, mostly to expand the type of research qualifying for exemption. New categories have been added. See the Exempt Changes PowerPoint for specific details.Continuing review is no longer required for minimal risk research, including research originally reviewed by the convened IRB that now qualifies for expedited categories 8 or 9. See the Minimal Risk Research Continuing Review PowerPoint for specific details.Consent forms are now required to include a “Key Elements” section and new elements of informed consent are required in some circumstances. UT IRB consent form templates have been updated to reflect the regulatory changes. See the Informed Consent PowerPoint for specific details.Beginning January 20, 2020, most federally-funded multi-site/collaborative research projects occurring in the U.S. will be required to use a single IRB.
Minor Regulatory Changes
In order to approve a waiver of informed consent, in addition to previously existing waiver criteria, the IRB must now also determine: If the research involves using identifiable private information or identifiable biospecimens, the research could not practicably be carried out without using such information or biospecimens in an identifiable format. See the Informed Consent PowerPoint for specific details.For each clinical trial supported by a Federal department or agency, one IRB-approved informed consent form used to enroll subjects has to be posted by the PI on a publicly available Federal website that will be established as a repository for such forms. The form must be posted on the Federal website after the clinical trial is closed to recruitment, and no later than 60 days after the last study visit by any subject.
Implementation of Regulatory Changes at UT
- IRB forms updates have been released.
- Informed consent templates have been revised.
- IRB Policies & Procedures manual is being updated.
- The UT IRB has decided not to implement Broad Consent or Exempt categories 7 & 8 at this time.
New Studies approved January 21, 2019 and later
- Studies approved after January 21, 2019 will be approved in compliance with the New Common Rule.
- The UT IRB will consider serving as a single IRB in limited circumstances until a new electronic system is implemented. Consult with IRB staff prior to submitting an application in these cases.
Studies approved before January 21, 2019
- Studies approved prior to January 21, 2019 will continue to follow the old Common Rule until these studies convert to a new electronic system at some time in the future.
- Existing exempt studies will remain unchanged unless an amendment submission requires a recategorization.
- Studies currently approved via Expedited or Full Board review will be considered for reclassification to an Exempt category at the time of continuing review, if applicable.