Important Note: The U.S. Department of Health and Human Services and 15 other federal departments and agencies have announced a six month delay of the effective date and general compliance date of the revisions of the Final Revisions to the Common Rule. Most provisions in the revised Common Rule were scheduled to go into effect on January 19, 2018. They will now go into effect on July 19, 2018
All studies approved after July 19, 2018 will be required to comply with the New Rule. The New Rule allows the IRB to make certain determinations regarding compliance with the Pre-2018 Rule and the New Rule. Also visit the Implementation and Transition page for more information. Refer to to the following documents to aid in decision making.
Major Areas of Change
(click on titles to link to additional information)
New categories for exemption have been created and some of the exisiting categories have been modified or clarified. [§46.104]
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)]
Key Information in Consent Forms
The new rule states that the informed consent must begin with a "concise and focused presentation of the key information" that would help assist subjects in undersatnd the reason why they may or may not participate in the resarch. It needs to be organized and presented in a way that facilitates comprehension. [§46.116(a)]. Guidance on the summary is available.
Elements of Informed Consent
Additional items have been added to the required and additional elements of informed consent. These new elements will be expected in consent forms approved after July 19, 2018. 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)]
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)]