Managing Legal Risks in Structuring and Conducting Clinical Trials

September 26, 20079:45am

Boston Marriott Copley Place, Boston MA

Tips, Traps, and Trends in Informed Consent and Secondary Research

Informed Consent

  • Translating complicated legal requirements, clinical information, and scientific jargon into easily understandable language on:
    • the investigational procedure and related risks
    • alternatives to participation
    • realistic benefits
  • Taking into account local context/vulnerable populations
  • Understanding the regulatory requirements and recent guidance on informed consent for emergency research
  • Assessing the impact of recent litigation on informed consent

Secondary Research

  • Understanding current trends in secondary research
  • Identifying key regulatory requirements:
    • human subjects protections
    • HIPAA/state privacy laws
  • Examining key concerns and controversies:
    • informed consent to use data/specimens
    • property rights in specimens
    • subject/patient privacy
  • Considering the impact of recent litigation
  • Providing practical guidelines for ensuring compliance