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Realizing Informed Consent in Times of Controversy: Lessons from the SUPPORT Study.

Robert J Morse1, Robin Fretwell Wilson1

  • 1Robert J. Morse, J.D., is a graduate of the Class of 2016 at the University of Illinois College of Law. Robin Fretwell Wilson, J.D., is the Roger and Stephany Joslin Professor of Law and Co-Director of the Epstein Program in Health Law and Policy at University of Illinois College of Law.

The Journal of Law, Medicine & Ethics : a Journal of the American Society of Law, Medicine & Ethics
|September 3, 2016
PubMed
Summary
This summary is machine-generated.

Informed consent for medical treatment and research is crucial. The SUPPORT trial highlights complexities in ensuring informed consent, especially for vulnerable infants and physician-researchers.

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Area of Science:

  • Medical Law
  • Bioethics
  • Clinical Research Ethics

Background:

  • The principle of informed consent is fundamental to medical treatment and human research.
  • Legal and regulatory frameworks have evolved to mandate informed consent.
  • The Surfactant, Positive Pressure, and Oxygenation Randomized Trial (SUPPORT) provides a case study for examining these principles.

Purpose of the Study:

  • To examine the complexities and shortcomings of informed consent duties in modern clinical research.
  • To analyze the legal standards for informed consent in research and treatment contexts.
  • To explore the application of informed consent principles when researchers also serve as treating physicians.

Main Methods:

  • Analysis of case law and the common rule regarding informed consent.
  • Case study examination of the SUPPORT trial involving extremely low birth weight infants.
  • Exploration of legal standards: professional vs. patient-centered material risk.

Main Results:

  • The SUPPORT trial revealed modern complexities in securing informed consent.
  • The duty of informed consent is assessed by the foreseeability of risks and benefits.
  • Jurisdictional differences exist in applying informed consent standards to physician-researchers.

Conclusions:

  • Existing legal frameworks for informed consent face challenges in complex research settings.
  • Ensuring truly informed consent requires adapting legal standards to evolving research practices.
  • Upholding the right to bodily autonomy necessitates robust informed consent procedures.