Revised Common Rule
Effective January 21, 2019, the MHC IRB will begin implementing the new requirements of the Revised Federal Policy for the Protection of Human Subjects, also known as the Common Rule found in the Code of Federal Regulations at 45 CFR 46. The Final Rule is intended to add flexibility and to reduce regulatory burden. MHC applies the Common Rule to all human subject research, regardless of funding, unless the funding source has different human subject regulations or the project comes under another agency's jurisdiction. In those cases, the appropriate organization's regulations would be applied. The Common Rule regulations are separate from FDA regulations. The FDA regulations have NOT changed.
To ensure that all research approved on or after 1/21/19 is fully compliant with the Revised Common Rule changes will occur with the following:
- iRIS & IRB applications
- Informed consent template (NEW Version Available)
- HRPP Operation Manual
- HRPP/IRB policies will be revised to reflect the Revised Common Rule. Until the time revision to policies are complete, the addendum SOP “Transition and IRB Review of Research Subject to the Revised 2018 Common Rule” will serve as intermediate information on MHC’s response to the newly Revised Common Rule.
As under the current Common Rule, our institution will still hold research that is not funded by a Common Rule agency (and not subject to FDA regulations) to the same standards that we do research funded and therefore subject to the Common Rule. That hasn’t changed. However, there are a few areas in the human research protection program where you, as a researcher, may be affected.
What does this mean for my research reviewed before January 21, 2019?
All human subject research reviewed on or after January 21, 2019, regardless of submission date, will be reviewed in accordance with the Revised Common Rule. IRB applications submitted shortly before January 21, 2019 may not be reviewed in time to qualify under the current human subject protections regulations. Applications undergoing the review process at the time of transition may be returned to the study team to update the informed consent elements.
If a study is approved prior to the 1/21/2019 effective date of the new rule, it will remain on the old rule until its next Continuing Review. At that point, it will transition to the new rule. If a study is approved on or after 1/21/2019, it will automatically be governed by the new rule.
As under the current Common Rule, our institution will still hold research that is not funded by a Common Rule agency (and not subject to FDA regulations) to the same standards that we do research funded and therefore subject to the Common Rule. That hasn’t changed.
However, there are a few areas in the human research protection program where you, as a researcher, may be affected.
How will the changes to the Common Rule affect my current studies at McLaren?
-
Existing Full Board Protocols
Existing full board protocols open to enrollment or still in the interventional phase will see the fewest changes under the Revised Common Rule.
- Existing Expedited Protocols
Studies that are currently under an expedited protocol status may see changes in requirement for continuing reviews. The exempt categories have been expanded to be more inclusive of standard research methodologies to the extent so that some research studies that are now reviewed as expedited will qualify for exempt status at continuing review.
- Existing Exempt Protocols
Existing exempt studies will experience no changes. Exempt categories will change for future exempt studies.
- Informed Consent
After 1/21/20 19, at the time of the next continuing review or significant modification affecting the informed consent form you will be requested to update the informed consent form to meet the Revised Common Rule requirement.
What assistance will be provided to researcher on the transition to the Revised Common Rule?
Educating our research community is primary in assisting our researchers with this transition process. While there are a number of revisions that are included in the Revised Common Rule, the most notable are outlined below along with an explanation of transitioning MHC research studies from the old to Revised Common Rule In addition, during the month of January, educational sessions will be held on the Revised Common Rule and Impact on Researchers. Updated policies and updated ICF template will be posted to our website. For additional information, a list of resources is available. Of course, if you have any questions or concerns, contact the Research Integrity office at (248) 484-4950.