The significant ethical implications of human-subject research were highlighted by the hideous “experiments” performed on human beings in the Nazi period, at times under the guise of medical research, in violation of the subjects’ rights and often seriously harming their health. Consequently, the international medical community has determined ethical principles and rules for the performance of human-subject research, and these have been anchored in codes and international treaties. The 1947 Nuremberg Code, developed during the Nuremburg Trials as a basis for prosecuting doctors and scientists who had performed medical experiments on concentration-camp inmates, became a prototype for many of the later ethical codes. The Helsinki Declaration – the Human Experimentation Code of Ethics of the World Medical Association (WMA) – drafted in 1964 and revised several times since then (most recently in 2013) – is the most important guide in this regard. Its principles include:

• The primary purpose of human-subject medical research is to understand the causes, development and impact of diseases and improve preventative, diagnostic, and therapeutic interventions (article 7).
• The obligation of doctors involved in medical research to protect the lives, health, dignity, wholeness, and rights to integrity and privacy of the research subjects and the confidentiality of their personal information (article 9).
• Granting groups that are underrepresented in medical research access to participation (article 13).
• Medical research in human subjects will only be carried out if the importance of its goal outweighs the risks posed to the participants and the burden placed upon them (article 16).
• Participation in research must be based on free will, and therefore informed consent must be given by the participant or his or her representative (articles 25–32).

The United Nations and the World Health Organization (WHO) have enlisted many countries to sign joint treaties on this issue, reflecting a broad international agreement regarding the basic principles of human-subject research. Among other things, UNESCO’s Universal Declaration on Bioethics and Human Rights (2005) anchors and highlights the ethical principles of medical research involving humans.

Clinical experiments on humans have not yet been anchored and regulated by primary legislation in Israel, although the Clinical Trials in Humans Bill (5776/2016) was placed on the Knesset’s agenda in July 2016 for preliminary discussion in the plenum. The Public Health Regulations (Clinical Trials in Humans) promulgated in 5741/1980 adopted the rules of the Helsinki Declaration in their first addendum. The Patient’s Rights Law (5756/1996), the Genetic Information Law (5761/2000), and various temporary provisions also refer to medical research on humans.

https://history.nih.gov/research/downloads/nuremberg.pdf

https://www.wma.net/publications/wma-doh-1964-2014/

http://www.who.int/en/

http://www.unesco.org/new/en/social-and-human-sciences/themes/bioethics/bioethics-and-human-rights/

https://www.health.gov.il/LegislationLibrary/Briut18.pdf