As many of you know, most of the provisions of the Final Rule updating the Common Rule (“2018 Common Rule“) will go into effect, and compliance is required, on January 19, 2018. Notwithstanding some uncertainty with respect to the current Administration’s regulatory plans, as of now institutions should be taking stock of what needs to be done to bring IRBs and human research protection programs into timely compliance with the revised regulations.
To assist clients and friends in assessing high priority areas for compliance preparedness, we have attached a 2018 Common Rule Implementation Checklist.
Also, in case you missed it, we have created a redline of HHS’s current Common Rule regulations at 45 C.F.R Part 46, Subpart A against the Final Rule. You can find and download a copy of this redline here.
Members of our Academic and Clinical Research Group (ACRG) have been busy presenting on the 2018 Common Rule and its practical implications at various conferences and webinars. Stay tuned for additional ACRG commentary on the 2018 Common Rule in the coming weeks.