Medical Application: Ethical Guideline & Soft Law

  • (2015) Gray Matters: Topics at the Intersection of Neuroscience, Ethics, and Society.
    It is the second volume of the Bioethics Commission’s two-part response to President Obama’s request related to the Brain Research through Advancing Innovative Neurotechnologies (BRAIN) Initiative. In this report, the Bioethics Commission broadly focused its analysis on three particularly controversial topics that illustrate the ethical tensions and societal implications of advancing neuroscience and technology: cognitive enhancement, consent capacity, and neuroscience and the legal system.
  • (2014): RoboLaw Project Final Report: Ethics and Law for implementation of Robotic Devices
    The European RoboLaw project addresses legal challenges of novel robotic technology and attempts to provide answers with regard to: the legal tools that better suit the goal of regulating technology; the type of ethical analysis that should be conducted on technological innovation, and the methodology to apply legal instruments in order to align research and technology implementation with EU policy on Responsible Research and Innovation (RRI). Three of four case studies presented in the project entail medical applications including neural prostheses, surgical intervention, and medical management devices (e.g., care bots). The project also conducts a lengthy analysis of human augmentation.
  • (2006) UNESCO Universal Declaration on Bioethics and Human Rights
    This Declaration addresses ethical issues related to medicine, life sciences and associated  technologies  as  applied  to  human  beings,  taking  into  account  their social, legal and environmental dimensions
  • (2000) Emanuel EJ, Wendler D, Grady C. What makes clinical research ethical? JAMA. 2000 May 24-31;283(20):2701-11. doi: 10.1001/jama.283.20.2701. PMID: 10819955
    Specifies seven fundamental ethical requirements of clinical research, including: (1) anticipated improvements in health or knowledge derived from the research; (2) scientific validity, via methodological rigor; (3) fair subject selection based on scientific objectives (vs. vulnerability or privilege); (4) favorable risk-benefit ratio within the given clinical context (5) independent review and approval; (6) informed consent; and (7) respect for enrolled subjects-subjects should have their privacy protected, the opportunity to withdraw, and their well-being monitored. 


Technical guidelines