Informed consent is a foundational principle in healthcare, research, and legal practice, balancing patient autonomy with ethical and legal obligations. This advanced course provides an in-depth legal analysis of informed consent requirements, exploring federal and state laws, case law, ethical guidelines, and sector-specific regulations. The course examines legal standards, exceptions, documentation requirements, liability risks, and the evolving landscape of digital health consent, biomedical research, and emerging technologies. Students will gain expertise in structuring legally sound consent processes that comply with HIPAA, FDA regulations, Common Rule standards, and global legal frameworks.
Course Objectives
By the end of this course, students will:
-
Understand the Legal Foundations of Informed Consent – Examine its historical evolution, ethical principles, and key legal precedents.
-
Identify Core Elements of Informed Consent – Analyze disclosure requirements, patient comprehension standards, and voluntariness.
-
Assess Legal Standards Across Different Jurisdictions – Compare federal, state, and international regulations on consent.
-
Evaluate Consent in Special Populations – Understand legal complexities involving minors, incapacitated individuals, and emergency medical situations.
-
Navigate Digital and Implied Consent Issues – Explore telemedicine, AI-assisted consent, and emerging trends in health technology.
-
Mitigate Legal and Ethical Risks – Learn how to structure legally sound consent forms, handle revocations, and address liability concerns.
-
Apply Consent Laws in Research and Clinical Trials – Understand FDA, IRB, and international research ethics compliance.
-
Examine Litigation Trends and Case Law – Study major legal disputes and their impact on the evolution of informed consent doctrine.
