Revised Common Rule
Implementation Date: January 21, 2019
Major Areas of Change
Public posting of Informed Consent documents (Clinical trials)
New categories for exemption have been created and some of the existing categories have been modified or clarified [§46.104]. See our comprehensive guidance on the revised Common Rule Exemption categories here!
NIH also created a helpful infographic that illustrates the new categories for exemption and gives concrete examples of what does and does not meet each of the new categories. Additional information can be found in the Exemption FAQs. Also, you may watch OHRP's video, "Overview of Changes to Exemptions in the Revised Common Rule: Focusing on Exemptions 1, 2, 3 & 5."
Continuing Review (Progress Reports)
Continuing Review will no longer be required for studies eligible for expedited review (minimal risk research) and studies that underwent Full Board review for which ongoing activity is limited to data analysis, including analysis of identifiable data/biospecimens OR involve accessing follow-up clinical data from procedures that subjects would undergo as part of clinical care. Continuing review will still be required for FDA regulated research studies.
Studies released from continuing review requirements will undergo quality assurance monitoring efforts to confirm if the study is still ongoing, remind investigators to continue to submit amendments and Reportable Events related to the research, and to prompt investigators to close the study if human subject research activities are complete.
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 [ see §46.116(a)]. Guidance and templates are provided on the HRPP's Forms & Templates page in the Consent table.
Elements of Informed Consent
New language is required as applicable to a study based on the study's design, related to future use of identifiable information or specimens, use of the specimens, commercialization, return of results and whole genome sequencing [see §46.116(b)(c)]. Guidance is provided in the HRPP's "Investigator Self-Evaluation Checklist" available here.
Waiver of Informed Consent
An additional criterion has been added that requires investigators to justify the use of identifiable private information or identifiable biospecimens [see §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 [see §46.116(g)].
Public Posting of Informed Consent documents
Researchers conducting clinical trials will now be required to post clinical trial consent forms on a federal website “after the clinical trial is closed to recruitment, and no later than 60 days after the last study visit by any subject, as required by the protocol.” For a multi-site study, only a single consent form from the entire study is required to satisfy the posting requirement – not a consent form from each participating site.
OHRP has identified “two publicly available federal websites that will satisfy the consent form posting requirement” in the revised Common Rule: http://ClinicalTrials.gov and a docket folder on http://Regulations.gov.(Docket ID: HHS-OPHS-2018-0021). Further instructions and guidance from HHS and other federal agencies will follow, and additional federal websites that satisfy the posting requirement may be identified in the future.
Single IRB Review
Use of a Single IRB for review of multi-site research for NIH funded studies was required as of January 25, 2018. This effective date has not changed. The policy applies 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 [see §46.114(b)].
Elimination of IRB Review of Funding Proposals
The revised Common Rule eliminates the requirement for the IRB to review grant applications or proposals for the purpose of assuring "congruency" with the corresponding IRB protocol. Experience suggests that review and approval of the grant application or proposal is not a productive use of IRB time. Thus, this change focuses the HRPP's and IRB's review and attention on the actual IRB protocol. (We can all applaud this welcomed change!)
Brown must still certify to the HHS sponsor [per 45 CFR 46.103(d)] that each proposed non-Exempt research study has been reviewed and approved by the IRB. Such certification must be submitted as prescribed by the federal department or agency component supporting the research. As such, the onus is placed on the Principal Investigator to notify the HRPP when a new funding source supports an active or new IRB protocol.