Skip to content

Menu

Epstein Becker & Green, P.C. logo
HomeAboutServicesContact
RSS YouTube Join the Discussion on Facebook Follow on Twitter View LinkedIn Profile

Health Law Advisor

Thought Leaders on Laws and Regulations Affecting Health Care and Life Sciences

Common Rule

Subscribe to Common Rule

FDA Loosens the Reins on Informed Consent Requirements for Certain Clinical Studies

By Bonnie Odom on November 20, 2018
Posted in FDA
FDA-Developments-MEME

Following up on its July 2017 guidance on the same topic (discussed in a previous blog post), FDA issued a proposed rule on November 15, 2018 to amend Agency regulations to allow Institutional Review Boards (“IRBs”) to waive or alter certain informed consent elements (or in some cases, waive the informed consent requirement altogether)…

Recent Posts

  • Podcast: Impact of COVID-19 on Pharmacist Scope of Practice: Before and After the PREP Act – Diagnosing Health Care
  • Biden Administration Seeks to Clarify Patient Privacy Protections Post-Dobbs, Though Questions Remain
  • Podcast: Owner’s Outlook: Renovating and Expanding Critical Access Hospitals in a Volatile Market – Diagnosing Health Care
  • Unpacking Averages: Assessing Whether FDA’s Breakthrough Device Designation Is Helpful
  • Podcast: Interoperability: Health Care’s Next Disruptor Is openEHR – Diagnosing Health Care

Topics

Archives

Epstein Becker Green Blogs

  • Commercial Litigation Update
  • Health Employment and Labor
  • Management Memo
  • Trade Secrets & Employee Mobility
  • Wage & Hour Defense
  • Workforce Bulletin

Health Law Advisor

Epstein Becker & Green, P.C. logo
RSS YouTube Join the Discussion on Facebook Follow on Twitter View LinkedIn Profile
Privacy PolicyDisclaimer

ABOUT EPSTEIN BECKER & GREEN, P.C.

Epstein Becker & Green, P.C., is a national law firm with a primary focus on health care and life sciences; employment, labor, and workforce management; and litigation and business disputes. Founded in 1973 as an industry-focused firm, Epstein Becker Green has decades of experience serving clients in health care, financial services, retail, hospitality, and technology, among other industries, representing entities from startups to Fortune 100 companies. Operating in locations throughout the United States and supporting domestic and multinational clients, the firm’s attorneys are committed to uncompromising client service and legal excellence. For more information, visit www.ebglaw.com and subscribe to our email lists. Follow the firm on Twitter, Facebook, Instagram, YouTube, and LinkedIn.

Copyright © 2022, Epstein Becker & Green, P.C. All Rights Reserved.
Law blog design & platform by LexBlog LexBlog Logo

We use cookies on this website to enhance your browser experience. By continuing to use this site or by clicking the button below, you are providing us with your consent to our use of cookies on the site. To learn more about cookies and how we use them, please review our privacy policy.

I Understand