Revised Common Rule
UPDATE: Changes to the Common Rule, the primary rule regulating human subjects research, will go into effect January 21, 2019.
Important Note: The U.S. Department of Health and Human Services and 16 other federal departments and agencies have announced that the Final Revisions to the Common Rule will go into effect on January 21, 2019.
Implementation and Transition to the Revised Rule
All studies approved on and after January 21, 2019 will be required to comply with the Revised Common Rule. The Revised Rule allows the IRB to make certain determinations regarding compliance with the Pre-2018 Rule and the Revised Rule.
Major Areas of Change
Continuing Review (Renewal)
Continuing Review for studies submitted on or after 1/21/19 may not be required in the following circumstances:
- Studies approved through an expedited mechanism
- Studies approved by the full board once subject interaction is completed
If Continuing Review is determined to not be required, an abbreviated Annual Check-In process will still be required. A system-generated annual notice will be sent to investigators as an instruction to complete the Annual Check-In and will include a reminder that modifications, reportable events and closure reports still need to be submitted to the IRB. [§46.109(f)(1)]
The IRB will make the final determination on the need for ongoing Continuing Review. Issues that may prohibit release from Continuing Review for expedited studies include but are not limited to the following situations:
- Require additional regulatory or ancillary oversight (e.g. RDRC, COI)
- FDA regulated
- Include international or non-local sites
- New findings require additional oversight
- History of non-compliance
Note that release from the requirement for Continuing Review does not release the Investigator from other regulatory requirements such as submitting modifications and amendments for review and approval prior to implementation and submission of reportable events. Failure to do so may result in a finding of non-compliance. Investigators are also required to submit a Closure Report upon completion of the study.
Continuing Review for Existing Studies Initially Approved Prior to 1/21/19
Due to the complexity and considerations required for transitioning existing studies, the Carilion IRB has determined that expedited studies that were initially approved prior to 1/21/19 will remain under the Original Common Rule and therefore will continue to require Annual Continuing Review.
This decision will be assessed again within a few months of the implementation of the 1/21/19 Revised Rule.
Exempt Studies
New categories for exemption have been created and some of the existing categories have been modified or clarified. [§46.104] The new exempt categories are listed in PRIS3M.
Key Information in Consent Forms
The Revised Common Rule states that informed consent must begin with a "concise and focused presentation of the key information" that would assist subjects in deciding why they may or may not want to participate in the research. It needs to be organized and presented in a way that facilitates comprehension. [§46.116(a)]. Refer to the Biomedical Informed Consent Template for more information. Please be sure to use the most current version of the Consent Template on the website.
Elements of Informed Consent
Items have been added to the required and additional elements of informed consent. These new elements will be expected in consent forms submitted on or after January 21, 2019. IRB encourages use of the elements in advance of that date. The new language relates to future use of identifiable information or specimens, use of the specimens, commercialization, return of results and whole genome sequencing. [§46.116(b)(c)]
Waiver of Informed Consent
An additional criterion has been added that requires investigators to justify the use of identifiable private information or identifiable biospecimens, and the IRB must now find that it would be impracticable to use de-identified data. [§46.116(f)]
A waiver of informed consent is no longer necessary for screening or recruitment procedures as long as the IRB approves the procedures as a part of the protocol. [§46.116(g)]. A HIPAA Authorization Waiver is still required for recruitment purposes if access to PHI will be needed.
A comprehensive description of how Carilion will implement the Revised Common Rule and other resources can be found below:
1.0 IRB Addendum Regarding Review of Research Subject to the Revised Common Rule (v.1/5/19)
Consent Form Concise Summary Examples
