Changes to the Common Rule

The New Revised Common Rule

The Common Rule governs all research involving human subjects conducted, supported, or otherwise subject to regulation by any Federal department or agency that chooses to implement these regulations.  The Common Rule is published in the U.S. Code of Federal Regulations in Title 45 Part 46.

In 2017, the Common Rule was revised with an implementation date of January 21, 2019.  

Summary of Major Changes

  • Informed Consent: New standards and organizational formats are required in the informed consent document.
  • Continuing Review: New studies approved by the IRB for the first time will not be subject to continuing review if they pose no more than minimal risk; ongoing studies that have progressed to the point that they only are analyzing data or using follow-data from clinical care also will not be subject to continuing review.
  • Single IRB: Any multi-site study must rely upon approval by a single IRB at all study sites in the United States unless otherwise required by law or exempted from this requirement by the federal department or agency supporting that research.
  • Exemptions: New exemption categories have been added.

CWRU Implementation

  • Informed Consent: The CWRU IRB has prepared a new informed consent template that is available online in the Sparta IRB system.
  • Continuing Review:  For eligible new studies approved on or after January 21, 2019, continuing review will no longer be required. Modifications to these studies will still require IRB review and approval prior to implementation.  This includes changes to study staff, study site, and study protocol. For ongoing studies that have progressed to the point that they only are analyzing data or using follow-up data from clinical care, please consult with the IRB office to determine whether continuing review may be necessary.
  • Single IRB: CWRU has a long-standing policy of allowing reliance on other institutions for IRB review and of serving as the IRB of record for studies conducted at other performance sites.  There are no plans to change this practice, and all reliance requests will continue to be reviewed according to CWRU policy.
  • Exemptions: As of January 21, 2019, CWRU IRB will validate exemption from IRB review new studies that meet the regulatory criteria for benign behavioral interventions that do not include identifiable information.

How Will CWRU Studies Be Affected?

  • Already approved studies:  The revised Common Rule allows for studies approved by an IRB before January 21, 2019 to continue unchanged.  These studies will be subject to the pre-2018 version of the Common Rule until they are closed unless the CWRU IRB has approved a transition from the pre-2018 Common Rule to the revised Common Rule.
  • Studies under review: Studies reviewed by the CWRU IRB on or after January 21, 2019 will be reviewed and approved under the criteria put forth in the revised Common Rule except as described above under CWRU implementation.
  • Studies approved on or after January 21, 2019 will be subject to the revised Common Rule.

 

Questions?  Please contact Kim Volarcik at kimberly.volarcik@case.edu.