Research ethics codes and guidelines for human enhancement

The SIENNA project conducted a survey of selected relevant codes and guidelines for technologies that can be used for human enhancement purposes. The survey was submitted to the European Commission in 2018, and lists a large body of codes and guidelines. Here, you will find a link to our full report, and a selection of guidelines we consider important to be aware of. 

Note that there are no international guidelines for the broad overall topic. Each of the guidelines below offers a specific angle on a particular context, often national or focused on application areas. This is also detailed in other reports from the project. Further note that this is not a comprehensive list, but a selection that offers an impression of the field.The list below builds on Tambornino L, Lanzerath D et al. D3.3 Survey of REC approaches and codes for Human Enhancement, 2018, Public deliverable report from the SIENNA project. You can download report from Zenodo here.

The non-medical use of prescription drugs. Policy direction issues

published by the United Nations Office on Drugs and Crime (UNODC) in 2011 (International)

The paper has the aim to briefly summarize research describing the scope of the problem worldwide; to offer examples of effective evidence-based interventions for prevention and treatment; to suggest directions for policy, and to highlight the need for further research.

The UNODC makes some recommendations on how to tackle the issue of the non-medical use of prescription drugs on pp. 47f.

Link: The non-medical use of prescription drugs. Policy direction issues

World Anti-Doping Code

published by the World Anti-Doping Agency in 2015 (amendments in 2018) (International)

The purposes of the World Anti-Doping Code and the World Anti-Doping Program which supports it are to protect the Athletes’ fundamental right to participate in doping-free sport and thus promote health, fairness and equality for Athletes worldwide, and to ensure harmonized, coordinated and effective anti-doping programs at the international and national level with regard to detection, deterrence and prevention of doping. “To fight doping by promoting the spirit of sport, the Code requires each Anti-Doping Organisation to develop and implement education and prevention programs for Athletes, including youth, and Athlete Support Personnel.“ (p. 14)

Link: World Anti-Doping Code

Responding to requests from adult patients for neuroenhancements. Guidance of the Ethics, Law and Humanities Committee

published by the American Academy of Neurology’s Guidance of the Ethics, Law and Humanities Committee in 2019 (USA)

The following challenges are stated in the document: Authority for off-label prescribing, beneficence & nonmaleficence, respect for autonomy, conflicts of interest.

The solution offered is that physicians prescribing medications “have no obligation to do so and may ethically refuse to do so. Neurologists must exercise their clinical and ethical judgment to decide whether to prescribe medications for neuroenhancement. It is ethically permissible for neurologists to prescribe such therapies, provided that they adhere to well-known bioethical principles of respect for autonomy, beneficence, and nonmaleficence” (p. 6).

The document offers insight into current policy on neuroenhancement for adults.

Link: Responding to requests from adult patients for neuroenhancements. Guidance of the Ethics, Law and Humanities Committee

Pediatric neuroenhancement: Ethical, legal, social, and neurodevelopmental implications

published by the American Academy of Neurology in 2013 (USA)

The document defines two challenges: “the special fiduciary roles and obligations of the physician within doctor-child-parent relationships” and “physicians asked to prescribe pharmacologic neuroenhancement drugs for presumably healthy children and adolescents” (p. 2). The issues are discussed at length, considering trends of use, development of pharmacological drugs, and more. The authors find “Physicians have the authority and the obligation to refuse requests for inappropriate treatment” (p. 6) and “at the present time that neuroenhancement in legally and developmentally nonautonomous children and adolescents is not justifiable. In nearly autonomous adolescents, the fiduciary obligation of the physician may be weaker, but the prescription of neuroenhancement is inadvisable because of numerous social and neurodevelopmental issues (p. 8).

Link: Pediatric neuroenhancement: Ethical, legal, social, and neurodevelopmental implications

Use of biomedical techniques for the ‘neuro-enhancement’ of the non-sick person: ethical stakes

published by the National Ethics Consultative Committee for Life Sciences and Health in France (CCNE), 2013 (France)

The document provides an in-depth exploration of neuro-enhancement and presents the view of the CCNE on the ethical challenges of HET. The document concludes with recommendations (pp. 28ff.). The CCNE points out, among other things, that “the long-term risk-benefit ratio of neuroenhancement techniques is often unknown. In these situations, that means if a lack of knowledge and a potential risk co-exist, the CCNE advises in the strongest terms against the use by children, adolescents and vulnerable individuals. (p. 28).

Link: Use of biomedical techniques for the ‘neuro-enhancement’ of the non-sick person: ethical stakes

Code of Practice for the Pharmaceutical Industry

published by the Association of the British Pharmaceutical Industry in 2016 (UK)

The Code covers, inter alia, aspects that present ethical issues such as, appropriate use of medicines, discredit to, and reduction of confidence in, the industry, marketing authorisations, prescribing information, disparaging references, high standards, format, suitability and causing offence, sponsorship, provision of reprints and the use of quotations, distribution of material, disguised promotion, clinical trials and non - interventional studies of marketed medicines, inducements and inappropriate payments, relationships and contracts with certain organisations , transfers of value to health professionals and healthcare organisations etc.

Link: Code of Practice for the Pharmaceutical Industry

Wish-fulfilling medicine

Published by the centrum voor Ethiek en Gezondheid in 2015 (Netherlands)

This document takes a different approach to HET by looking at it as wish-fulfilling medicine. It states the professional legal and financial frameworks and makes the recommendation that the government should hold back and only interfere if the medicine has exceeded the ethical boundaries or causes harm to the population. The government also has the responsibility to inform the public and provide transparency.

Link: Wish-fulfilling medicine

The Pharmacologically Improved Human. Performance-Enhancing Substances as a Social Challenge

published by the Office of Technology Assessment by the German Bundestag in 2013 (Germany)

The report analyzes the areas of development and use with the greatest social and political relevance now and in the foreseeable future, i.e. current developments and plausible trends regarding the use of psychopharmaceuticals and other drugs to enhance performance in working and everyday life. It examines the options for action in the fields of research, regulation, healthcare consumer protection and prevention.

Link: The Pharmacologically Improved Human. Performance-Enhancing Substances as a Social Challenge

Regulations on Management of Narcotic Drugs and Psychotropic Substances

published by the State Council of the People's Republic of China in 2005 (China)

This document regulates drug abuse in various aspects and can serve as a regulation for HET. Article 13, Chapter 2 indicates that the clinical trials of narcotic drugs and class I psychotropic drugs should not be conducted by on healthy subjects.

The regulations in this document, formulated in accordance with the drug administration law and other relevant laws, strengthen the administration of narcotic drugs and psychotropic substances, ensure the legal, safe and rational use of narcotic drugs and psychotropic substances, and prevent their flow into illegal channels.

Link: Regulations on Management of Narcotic Drugs and Psychotropic Substances