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 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
New categories for exemption have been created and some of the existing categories have been modified or clarified. [§46.104]
Continuing Review (Renewal)
Continuing Review 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
HRPO will make determinations on whether continuing review is required at the next review of either a modification or submitted continuing review. Modifications cannot be submitted solely to convert to a "no renewal" statuts.
A system-generated annual notice will be sent to investigators as a reminder that modifications, reportable events and termination reports still need to be submitted to the IRB. [§46.109(f)(1)]
Consent Process and Forms
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)].
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 approved after January 21, 2019. HRPO will encourage 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. [§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)]
Single IRB Review
Use of a Single IRB for review of multi-site research for NIH funded studies will be required on January 25, 2018. This effective date has not changed. The policy will apply to all competing grant applications for due dates on or after January 25, 2018. Use of a Single IRB for review of multi-site research for studies funded by other Common Rule agencies will be required by January 20, 2020. [§46.114(b)]. Contact email@example.com for all questions related to use of a sIRB.