If you're reading this, you’re likely well prepared for the impending changes to the Common Rule, which finally go into effect on Monday, January 21. Still, no matter how prepared you are, you may be facing some last-minute anxiety. After all, this change is years in the making, and there are a lot of moving parts to coordinate! That’s why we’ve rounded up a few last-minute resources to help reassure you: you got this.
Read on for three tips for navigating last-minute anxieties about Common Rule compliance.
1. Review guidance documents
On January 10, the OHRP released a draft guidance document: The Revised Common Rule Compliance Dates and Transition Provision. This document “discusses the regulatory implications of institutional decisions to voluntarily transition research studies initiated before January 21, 2019 to the 2018 Requirements.” The default is to apply the pre-2018 Requirements (or the “old Common Rule”) to studies that were ongoing prior to January 21. However, you do have the option to implement parts of the 2018 Requirements (or “revised Common Rule”), and that’s what this new draft guidance document explains.
As reported by Bloomberg Law, the latest provision is one of four draft documents released to help guide the way. There aren’t any final guidance documents on the rule changes available, and it probably would have been helpful to have more guidance sooner! But research administrators have been preparing for months, even years, training PIs and IRB members to ensure compliance and sharing information with colleagues at other institutions. In other words: don’t worry, you got this.
2. Understand how the partial government shutdown may affect the Common Rule compliance date and related issues
The partial government shuttdown, ongoing at of time of publishing, impacts several Federal agencies that are important to research institutions. The good news is, the shutdown doesn’t directly impact the Common Rule compliance date (source). However, it may impact timely communication and updates to related resources. For example:
Federal agencies affected by the shutdown have limited operations, so questions or requests sent to agency representatives during the shutdown likely won't be answered
Affected agency websites may not be updated with current info on funding opportunities and proposal submission deadline
Panel reviews and grants/funding increments may be postponed
Thankfully, for most research institutions, ongoing studies can continue as planned, and funding that’s already been received can be spent. Check with your institutional leadership for speficic instruction, and keep doing the job you do so well.
3. Take a moment to breathe…and celebrate!
After months of preparation within an already-loaded schedule, you’re ready for the Common Rule compliance date. Pause to catch your breath, and acknowledge a job well done. Whether you bring donuts to the office next Monday morning, take the team out for happy hour, or mark the occasion in a more creative way, the important thing is that you take some time to celebrate.
Looking for ways to effectively and efficiently maintain compliance moving forward?
Bad Rabbit’s team of RA system experts can help–let’s talk.