Updates to the Common Rule for the Protection of Human Subjects Research

Brownstein Hyatt Farber Schreck
Contact

On Sept. 8, 2015, the U.S. Department of Health and Human Services (HHS) issued a Notice of Proposed Rule Making (NPRM) to seek input on changes to the Federal Policy for the Protection of Human Subjects, otherwise known as the “Common Rule” as set forth under 45 CFR Part 46, Subpart A. From the NPRM, it appeared as though human subject protections would be considerably tightened and that conducting research, especially with biospecimens, was going to be an administrative nightmare. Alas, it was not so. On Jan. 19, 2017, HHS and 15 other federal agencies issued a Final Rule to update the Common Rule. Revisions to the Common Rule are intended to enhance protections for research participants and minimize the administrative and regulatory burden for researchers by providing flexibility in the ever-changing human subjects research landscape. The majority of the Final Rule is expected to go into effect Jan. 19, 2018.

Please see full publication below for more information.

LOADING PDF: If there are any problems, click here to download the file.

DISCLAIMER: Because of the generality of this update, the information provided herein may not be applicable in all situations and should not be acted upon without specific legal advice based on particular situations.

© Brownstein Hyatt Farber Schreck | Attorney Advertising

Written by:

Brownstein Hyatt Farber Schreck
Contact
more
less

PUBLISH YOUR CONTENT ON JD SUPRA NOW

  • Increased visibility
  • Actionable analytics
  • Ongoing guidance

Brownstein Hyatt Farber Schreck on:

Reporters on Deadline

"My best business intelligence, in one easy email…"

Your first step to building a free, personalized, morning email brief covering pertinent authors and topics on JD Supra:
*By using the service, you signify your acceptance of JD Supra's Privacy Policy.
Custom Email Digest
- hide
- hide