transcript   Transcript

Clinical Research Law and Compliance: 2017-2018 Regulatory and Enforcement Review

Recorded on: May. 31, 2018
Running Time: 01:03:32

Full Transcript:



If you are a Privileged Member, just log in and start reading now! If you are not a Privileged Member, please click here to learn how unlimited access to PLI programs may be right for you and your firm.

To access the streaming media of this presentation, please purchase the corresponding seminar segment.

Taken from the Web Program Clinical Research Law and Compliance: 2017-2018 Regulatory and Enforcement Review Recorded May 2018 in New York
Clinical Research Law and Compliance: 2017-2018 Regulatory and Enforcement Review [01:03:32]

While federal funding for clinical research is allegedly decreasing, federal agencies having oversight for research have been extremely active in providing new laws, regulations and in providing industry guidance as to government expectations for the application and conduct of clinical research.  The 21st Century Cures Act has provided an influx of funding for the hastening of scientific discoveries and the Office for Human Research Protections and the FDA are outlining ways of streamlining the informed consent process and creating more transparency around the conduct and outcomes of clinical research studies.  At the same time, federal enforcement agencies have been active in pursuing false claim cases related to federal grants, research misconduct, and violations of the human research protection regulations.

This session will discuss the salient regulatory, legal and enforcement developments which have occurred throughout 2017 and the first quarter of 2018.  The presenter will reflect on her 30 years of experience working as a healthcare and research attorney, chief compliance officer, and consultant and will make recommendations for appropriate enhancements to academic and research organizations in light of the current regulatory and enforcement environment.

Specifically, this session will cover:
  • The 21st Century Cures Act
  • FDA Regulatory and Guidance Documents
  • NIH Regulatory Updates
  • Office for Human Research Protection Updates
  • Office of Inspector General Updates Related to Research
  • Office for Civil Rights (HIPAA) Updates
  • Department of Justice Research Related Updates
  • Office for Research Integrity Updates
Presentation Material
  • 2017 Research Compliance Year in Review
    F. Lisa Murtha
  • Share
    Email
    Transcript FAQ's
    • How Can I Access Transcripts?
      You must be a Member in good standing.

    • Can I access the Video?
      Yes, you can access the video if you have the Adobe Flash plugin installed. Click on the video camera icon when you mouse over each paragraph. The media will begin playback at that point.

    • Can I get CLE credit for reading the transcript?
      No, CLE credit cannot be earned for reading a transcript. CLE credit is issued only for verified attendance while watching a web program. If seeking credit, please verify the program's eligibility for credit and expiration date in your jurisdiction on the web segment launch page before commencing the program.
    
    • FOLLOW PLI:
    • twitter
    • LinkedIn
    • YouTube
    • RSS

    All Contents Copyright © 1996-2018 Practising Law Institute. Continuing Legal Education since 1933.

    © 2018 PLI PRACTISING LAW INSTITUTE. All rights reserved. The PLI logo is a service mark of PLI.