Calling All McFlys: A Checklist for Going Back to the Future on the Revised Common Rule
After taking a month off to channel our inner Doc Browns and find perspective on the federal rule delaying implementation of the revised Common Rule (RCR), now may be a good time to jump on our hoverboards and go back to the future to unravel updates that were a year in the making.
Many of us took the release of the RCR as a catalyst to update our processes, procedures, forms, and checklists beyond strictly RCR revisions—possibly even upgrading from a DeLorean to a Tesla by:
- Tightening local policies,
- Integrating U.S. Food and Drug Administration (FDA) regulatory changes such as waiver of informed consent for certain minimal risk studies and IRB chair concurrence for single patient expanded access INDs,
- Weaving in NIH policy for issuing Certificates of Confidentiality, and
- Addressing 21st Century Cures Act
However, it is likely we were not using extra gigawatts to track which revisions corresponded with the RCR and which went beyond.
Since working from redlined versions may feel as dizzying as time travel, Kinetiq is providing a high-level checklist to get you started in rolling back your RCR updates.
Checklist for Rolling Back Common Rule Changes
- Update any documents that refer to RCR citations (e.g., SOPs, forms, checklists, agreements).
- Definitions – Change the definitions of the following back to what they were before:
- Clinical trial
- Generalizable knowledge
- Human subject
- Identifiable private information/identifiable biospecimen
- Legally authorized representative
- Tribal law
- Vulnerable populations
- (Some RCR definitions also add “agency,” “institution,” or “department” when referring to federal entities. You can either leave these in or remove them for consistency.)
- Common Rule Standards
- Update all effective and compliance dates in your documents so the dates are consistent with current regulations.
- “Check the Box” is back! If you do not apply Common Rule to all your studies, revise your policies back to what they were.
- Revise any policies regarding research begun prior to January 19, 2018 that specifically address transitioning the research to the RCR.
- You should still submit grant applications for federally funded research to the IRB.
- IRB Composition
- Add in gender requirements for IRB composition.
- Continue reporting IRB rosters to the Office of Human Research Protections (OHRP) (including roster updates).
- (You may consider removing language relating to IRB member expertise on research subjects with “impaired decision-making capacity or economically or educationally disadvantaged persons.”)
- Continuing Review
- Undo RCR-related changes to continuing review processes for minimal risk studies and studies in data analysis or accessing follow-up clinical data.
- If you added an “administrative check-in or review” in place of continuing review for impacted studies under the RCR, you should hold off on implementing this alternate process.
- Limited IRB Review
- While privacy and confidentiality safeguards should be part of your review processes, no concept of “limited IRB review” was present before the RCR.
- Remove any specific process standards for conducting limited IRB review (e.g., via expedited review procedures).
- Change back to the six prior categories, including updated citations.
- Remove references to broad consent and limited IRB review.
- Informed Consent – The Federal Rule on the delay to the RCR does allow implementation of the RCR’s new informed consent requirements, perhaps because they were mainly additive. However, this is a section of the rule that many were waiting for OHRP guidance on, so it is a choose-your-own-adventure! Nevertheless, some suggestions for rollbacks are below.
- Remove basic and additional elements of informed consent relating to whole genome sequencing, commercial profit, return of individual results, and whether individually identifiable or de-identified information is to be shared with other researchers.
- No key information or concise summary is needed for now, and the nebulous “reasonable person” standard for human subjects research can wait.
- No need to post informed consent forms publically.
- Broad Consent
- Perhaps one of the more challenging components of the RCR to digest and implement, broad consent can hibernate for now, with hope that guidance is forthcoming.
- Waiver of Informed Consent
- Relating back to the definition for a human subject: Remove any criteria explicitly referring to “identifiable information or identifiable biospecimens.”
- Consent for Screening, Identification, and Recruitment
- Consent for these activities is still a requirement under the Common Rule, so any screening consent templates and the like should go back into circulation.
- Documentation of Informed Consent – Think about revisiting policies for obtaining documentation of informed consent from distinct cultural groups, where signing the consent form is not the norm. This population was part of the RCR’s waiver of documentation criteria.
Some may have decided all this time travel is too confusing and went ahead and applied the RCR to non-federally funded studies. While this seems logical based on the impending effective and compliance dates for the RCR, Kinetiq reminds you to be in compliance with existing regulation.
Given all the recent activity, it may be worthwhile to inform your research community about current regulatory criteria and standards for human subjects research at your institution. Whether you are attempting to address the RCR for the first time or turning back time to revisit impacted processes and documents, Kinetiq is here to assist you with your research needs and navigate the road to the future!