The 2018 Final Common Rule for Human Subjects Research – Effective January 19, 2019

The 2018 Final Common Rule for Human Subjects Research – Effective January 19, 2019
January 19, 2019 dmock2015

After  being delayed twice since January of 2018, the general compliance provisions of the 2018 Final Common Rule finally become effective on January 19, 2019.  During the delay period, institutions could choose to comply with the “burden-reducing provisions”: (1) the revised definition of “research”; (2) permissible waiver of the annual continuing review requirement for certain categories of research; and (3) elimination of the requirement for the IRB to review grant applications or funding proposals related to the research.  But in deciding to do so, these research studies now have to comply with the 2018 Common Rule, as applicable, beginning on January 19, 2019.  For more information the Office for Human Research Protections of the Department of Health and Human Services has issued “Revised Common Rule Q&As” on their website.


Legal Disclaimer:

This content of this blog is provided for informational purposes only and does not constitute legal advice. The transmission of information on this blog is not intended to establish, and receipt of such information does not establish or constitute, an attorney-client relationship. You should not act or rely on any information contained on this blog without first seeking the advice of an attorney.
This blog is not intended to be advertising, and Delfino Madden O’Malley Coyle & Koewler LLP does not desire to represent anyone desiring representation based upon viewing this blog or any articles contained on this blog in a jurisdiction where this email fails to comply with all laws and ethical rules of that jurisdiction.