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Conducting Clinical Trials Outside the U.S.: U.S. and Foreign Rules, Regulations, and Guidance

Navigating FDA Requirements, HIPAA, FCPA, Export Controls, Economic Sanctions, Data Protection Laws, and Other Types of Foreign Laws Researchers May Encounter

Recording of a 90-minute CLE video webinar with Q&A

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Conducted on Tuesday, October 17, 2023

Recorded event now available

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This CLE webinar will guide life sciences companies and research institutions that are conducting or considering conducting clinical trials outside the U.S. The panel will discuss the benefits and barriers and address the U.S. and foreign rules and regulations that must be kept in mind. The panel will offer guidance for those considering clinical trials outside the U.S.

Description

Conducting clinical trials outside the U.S. offers benefits for industry and academia. For example, conducting trials outside the U.S. can lower a study’s operational costs and speed its completion, and foreign trials can help researchers study diseases not prevalent in the U.S.

But there are also significant challenges. There are U.S. and foreign laws that sponsors and researcher institutions may not realize apply. For example, the Foreign Corrupt Practices Act creates significant risks. In many countries, healthcare is government run and hospitals are government owned. Consequently, conducting clinical trials can result in extensive interaction with foreign officials. Export controls and economic sanctions may also limit what research can be done in particular countries. Proliferating foreign data protection laws may pose traps for companies and institutions. In addition, studies conducted in resource-limited settings can face ethical and logistical burdens not experienced by studies conducted in high-income countries.

Listen as our authoritative panel examines the benefits and barriers of conducting clinical trials outside the U.S. The panel will address the rules and regulations that those considering clinical trials abroad must keep in mind, including FDA and federal funding requirements, HIPAA, the Common Rule, the FCPA, export controls, economic sanctions, data protection laws, and types of foreign laws researchers may encounter. The panel will also discuss best practices to mitigate risk and help ensure project success.

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Outline

  1. Conducting clinical trials outside the U.S.
    1. Trends in globalization of clinical trials
    2. Benefits and drawbacks of conducting research abroad, for both industry and academia
    3. What can go wrong
  2. Applicable laws
    1. U.S. research laws
      1. FDA
      2. Common Rule
      3. HIPAA
      4. Federal grant requirements
    2. Foreign laws
      1. Research and related laws
      2. Data protection laws
    3. U.S. laws of general applicability
      1. FCPA
      2. Export control
      3. Sanctions
  3. Practical and operational considerations/best practices

Benefits

The panel will review these and other key issues:

  • What laws apply to privately and federally funded research sponsored by U.S. organizations and conducted overseas?
  • How can U.S. organizations ensure that data from foreign clinical trials is collected in such a way that it can be used as intended?
  • What are best practices to mitigate risk and help ensure project success in foreign clinical trials?

Faculty

Hermes, Clint
Clint D. Hermes
Counsel
Bass Berry & Sims

Clint Hermes draws on his experience as Chief Legal Officer of two research institutions to advise clients on all...  |  Read More

McBride-Thaddeus
Thaddeus R. McBride
Member
Bass Berry & Sims

Mr. McBride represents companies and individuals in international trade regulatory, compliance, investigative, and...  |  Read More

Wyman, Roy
Roy Wyman
Member
Bass Berry & Sims

For nearly 30 years, Mr. Wyman has represented a variety of commercial entities on complex data privacy and security...  |  Read More

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