Law and ethics in consensual harm

Veena Johari1

  • 1Advocate, Courtyard Attorneys, 47/1345, MIG Adarsh Nagar, Worli, Mumbai 400 030, India., courtyard attorneys@gmail.com.

Insights

Controlled Human Infection Model studies involve infecting healthy volunteers with pathogens to develop cures. This research examines the complex legal and ethical issues surrounding informed consent for harm in these vital scientific endeavors.

Area of Science:

  • Biomedical research ethics
  • Infectious disease modeling

Background:

  • Growing interest in Controlled Human Infection Model (CHIM) studies in low-and-middle-income countries.
  • CHIM studies involve controlled infection of healthy volunteers with attenuated pathogens.
  • These studies aim to accelerate the development of disease preventions and cures.

Purpose of the Study:

  • To analyze the legal and ethical considerations of obtaining consent for harm in CHIM studies.
  • To examine the justification of potential harm to individuals for the greater good or scientific advancement.

Main Methods:

  • Legal analysis of consent to harm principles.
  • Ethical review of CHIM study protocols.
  • Examination of existing literature on research ethics and human subject protection.

Main Results:

  • Identified legal complexities in justifying "consent to harm" for scientific benefit.
  • Highlighted ethical challenges in balancing individual rights with public health goals.
  • Discussed the "greater good" argument in the context of human experimentation.

Conclusions:

  • CHIM studies present unique ethical dilemmas regarding informed consent.
  • A thorough legal and ethical framework is crucial for conducting CHIM studies responsibly.
  • Further discourse is needed to navigate the nuances of consent for harm in medical research.

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