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:
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).
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).
groups that are underrepresented in medical research access to participation
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).
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.