Medical Application: Ethical Guideline & Soft Law

(ongoing) The Neurotech “Ethics and Future Discussions” Working Group
A neuroethics workgroup within the neuromorphic engineering community working with ethics experts and researchers to formulate strategies that ensure Neuromorphic Computing technology makes a positive and sustainable contribution to society. If you are interested in joining this WG please contact neurotech.administrators@ini.uzh.ch.
(2020) Guidance document, Use of International Standard ISO 10993- 1, “Biological evaluation of medical devices – Part 1: Evaluation and testing within a risk management process”.
(2019-2021) IEEE Ethically Aligned Design (First Edition)
A Vision for Prioritizing Human Well-being with Autonomous and Intelligent Systems. They also included a glossary for terms reported for: ordinary language, computational disciplines, engineering, economics & social sciences, ethics & philosophy, international law & policy.
Related to IEEE P7000 series of approved standardization projects. This is the first series of standards in the history of the IEEE Standards Association that explicitly focuses on societal and ethical issues associated with a certain field of technology.
There are two published standards at the moment:
1) IEEE 7010-2020, IEEE Recommended Practice for Assessing the Impact of Autonomous and Intelligent Systems on Human Well-Being
2) IEEE 7000-2021, IEEE Standard Model Process for Addressing Ethical Concerns during System Design
(2019) Recommendation of the Council on Responsible Innovation in Neurotechnology (OECD)
By the Organisation for Economic Co-operation and Development (OECD). The first international standard in this domain, the Recommendation aims to guide governments and innovators to anticipate and address the ethical, legal and social challenges raised by novel neurotechnologies while promoting innovation in the field.
(2019) Royal Society: Neural Interfaces Report
This perspective highlights two challenges introduced by neurotechnologies. The first is to fulfil the potential of neural interfaces in medicine by advancing innovation, lowering cost and ensuring that safe, effective treatments can be approved efficiently and disseminated to millions who could benefit. The second is to manage the risks associated with wider societal use of neural interfaces in everyday life.
(2019) OCEANIS “Think Piece” – Role of Standards in Facilitating Innovation while Addressing Ethics and Value in Autonomous and Intelligent Systems (A/IS)
(2017) Ethics, Ethicists, and Professional Organizations in the Neurological Sciences
By Tabitha Moses & Judy Illes. Analysis of the representation of ethicists across neuro-related professional organizations. Authors suggest that all professional organizations that focus on the neurological sciences should have a resident ethics committee or an identified pathway to an authoritative consulting body with neuroethics expertise.
(2016) “Open Letter Concerning Do-it-yourself Users of Transcranial Direct Current Stimulation” (Annals of Neurology)
43 neurotechnology experts have signed an open letter to all do-it-yourself users of transcranial direct current stimulation (tDCS) in an attempt to raise awareness of the many unknown factors affecting use of such brain stimulation both in the short and long term. The letter highlights that the parameters of such brain stimulation are still being investigated and that while some cognitive abilities may be enhanced by stimulation, it could be at the cost of others and that changes may last a lot longer than the user thinks.
(2016) American Medical Association (AMA) – Code of Medical Ethics
Opinions of the AMA Council on Ethical and Judicial Affairs lay out the ethical responsibilities of physicians as members of the profession of medicine. In these opinions, the term “ethical” refers to matters involving moral principles, values, and practices, as well as matters of social policy involving issues of morality in the practice of medicine.

(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.

(2013): FDA Guidance: Investigational Device Exemptions (IDEs) for Early Feasibility Medical Device Clinical Studies, Including Certain First in Human (FIH) Studies
This guidance document outlines the regulatory pathway and key considerations in the risk-benefit assessment for emerging translational technologies.
(2013) Nuffield Council on Bioethics: Novel Neurotechnologies
In this report ethical, legal and social issues that arise from the use of novel neurotechnologies are addressed. Primarily in the context of the therapeutic applications of these technologies, because it is here that there is the greatest potential for social benefit and where research and practical uses are most advanced.
(2010) World Health Organization bioethics national committees database
Opinions of the National Ethics Committees (ONEC) – extensive general database.
E.g., Opinions of the Italian Committee for Bioethics on bioethical issues for neurotechnologies and human experiments.

(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