James Riddle

by James Riddle

Race to the Finish: The Common Rule Deadline Looms Large

As we wrap up 2018 and look forward to taking a short break for the holidays, those of us in the IRB community have another gift to look forward to after the first of the year. New federal regulations concerning the protection of human subjects (aka the New Common Rule) will be effective January 21, 2019. This is truly a New Year’s gift for those who were prepared last year and have been longing for this moment since the original Advanced Notice of Proposed Rule Making in 2011! However, for those maybe just getting started with preparations the deadline is looming large; and now is the time to sprint to the finish.

Much has been written about the nature of the changes. There are resources, webinars, and blogs aplenty. In this last Common Rule-related blog before the big day I would like to pass on a few tips for last-minute shoppers. You know who you are—out there shopping on Christmas Eve, and just now preparing for Common Rule changes. But sometimes good things come to those who wait: Condensing your preparations also means condensing the duration you spend stressing about how to finish all the preparations! The following are a few last-minute shopping—I mean preparation—tips.

Prioritize Updates to Critical Documents Necessary for Compliance!

  1. Consent Templates: Your investigators are writing consent forms today that will likely be reviewed after the new rule is in effect. If you haven’t updated your institution’s consent templates to reflect the new requirements of 45 CFR 46.116, start now and get that new language out to your investigators!
    So, what does this new consent form that must “begin with” a “concise summary” containing “sufficient detail” and “organized to facilitate understanding” of a “reasonable person” look like?
    There are a number of good consent template examples available to our community through the PRIM&R Common Rule Resources page. A special thank you to PRIM&R for making these resources available.
  2. IRB Written Procedures: If you have time to conduct a comprehensive update of your IRB’s written procedures, great. Don’t forget to methodically go through all of your written procedures to update definitions, exempt determinations, informed consent requirements, waiver criteria, changing regulatory citation locations (the exemptions are not at 45 CFR 46.101(b) anymore), etc.   While the changes may seem easy, they can represent a significant number of edits. It is a good idea to have someone proof your work to make sure you didn’t miss anything. Oh, and don’t forget to call out the specific differences between Common Rule requirements and FDA requirements, which are now more prolific (e.g., the new Common Rule has five criteria the IRB must consider for waiver of consent, while the FDA only has four).
  3. Critical IRB Documentation: At a minimum, make sure your key templates are updated and ready for January 21. Expedited and exempt reviewer determinations checklists, minutes templates, and template IRB letters should all be ready to reflect the new requirements, definitions, regulatory citations, etc. For instance, if you are considering a waiver of consent as part of a new project on January 22, there will now be five waiver criteria to consider, not four like under the old rule; and the citations have moved to a new home (now at 45 CFR 46.116(f)(3) rather than their old address of 116(d)).
  4. Put a Plan into Place for In-Flight Transactions: You will need to think about how to handle projects submitted on IRB forms, templates, etc. that reflect the old rule requirements. Will you make the investigator update the materials and re-submit? Will the IRB office do the updates? And how will that work exactly if the IRB forms or eIRB system haven’t been updated to reflect the new Common Rule requirements yet? While not a compliance issue, if you don’t have a cutover plan developed at this point, I would put that on the list of must-dos.

These are the last-minute bare-bones critical areas. More changes are necessary. To get a comprehensive picture, check out our webinar on how to prepare.

What You Can Conceivably Leave for Later, But Not Too Much Later…

Just like gift cards are a good last minute standby if you run out of holiday shopping time, there are some items you can leave until later if there simply is not enough time. A short list:

  • IRB forms or eIRB systems—ad-hoc questions and custom documentation can be used as a stopgap to get needed additional information until forms and systems are updated;
  • website instructions for investigators;
  • staff checklists and other practice documents;
  • guidelines;
  • education materials; and
  • all your other documentation!

While not ideal to be living with manual workarounds, these items are not required by regulation, so if they are not up to date on Day 1 (or Day 22 as the case may be) you will not be out of compliance.

And Wait, There’s More!

Just when you thought our regulatory gifts could not get any better, on December 4 the FDA posted notice to the OMB register announcing their intent to publish proposed rules in what is undoubtedly the opening salvo in harmonizing the 21 CFR 50 & 56 regulations with the new Common Rule.

More changes coming soon!

Open your gifts here:

Happy Holidays from the Team at Kinetiq!


Still need help getting ready for Common Rule? Kinetiq has resources standing by to assist. 

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