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

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

Full Transcript:

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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
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