The Revised Common Rule, slated to take effect Jan. 21, 2019, will bring some significant changes to our UAMS/ACH policies and procedures related to human subject research. Note that we can’t accuse the federal Office for Human Research Protections (OHRP) of rushing through this rule-making process; this is the first major revision since the original rule took effect in 1991, and this revision has been in the works since 2011. The changes, in OHRP’s words, are designed “to modernize, strengthen, and make more effective the regulations for protecting human subjects in research.” Our general thoughts on the rule is that, in many significant ways, e.g., eliminating the annual continuing review requirement for some research, expansion of some exempt status research categories, the revised rule lightens the oversight burden for both PIs and IRBs. Other changes, such as the requirement that informed consent documents start with a “concise and focused” summary, will require a steeper learning and work curve.
As you can imagine, many, many words have been written about the revisions since they were first proposed 7 long years ago. (The words that have yet to be written, alas, include the guidance that OHRP has been promising on some rule provisions.) Here are some resources to help you get more familiar with the changes we expect to see in January.
First, please plan to attend our planned Revised Common Rule Overview on Tuesday, Oct. 30, 1:30-3 p.m., Sam Walton Auditorium, Cancer Institute, tenth floor. Organizers say the Skype Meeting will be available to those off-campus. (1.5 hours CRS elective credits available too!)
Straight from the horse’s mouth (not that our OHRP friends are, you know, livestock or anything like that) — The people who wrote the Revised Common Rule have also compiled some videos and other educational resources all about the RCR. They’re the experts and a good place to take a deep dive into the changes.
An online course about the Revised Common Rule is now available via the UAMS affiliation at citiprogram.org.
The Final Rule text and its preamble can be accessed here. Note that the rule itself is not that long; it begins on page 7259 of the linked document. The preamble explains the process behind each rule provision and OHRP’s rationale for incorporating (or not) the proposed changes. While the preamble provides the context for why OHRP did what it did, we’re telling you now that it’s a pretty involved read (everyone at the IRB office waded through it, though). The full saga about revised rule’s tortured route to completion can be found here. [To summarize: Advanced Notice; Notice; The Final Rule (which dropped the last possible day it could have dropped); The First Delay (which dropped the day before the final rule was to take effect); The Second Delay (which we are pretty sure will be the last delay)]
OHRP leadership covered some of the revised rule highlights in a New England Journal of Medicine article published in February 2017.
For a deep dive into some of the words written about the Revised Common Rule, take a look at PRIM&R’s compilation of articles on the rule.
Additional helpful recaps appeared in Health Affairs and Science. We recognize the names of several of these authors from conferences we’ve attended about human research protections — they know their stuff.