|
Excerpts from Nuremberg Code,1 Declaration of Helsinki,2 International Covenant on Civil and Political Rights,3 United Nations Convention on the Rights of the Child,4 and Tri-Council Policy Statement on Ethical Standards for Research Involving Humans.5 PERMISSIBLE MEDICAL EXPERIMENTS 1. The voluntary consent of the human subject is absolutely essential. 4. The experiment should be so conducted as to avoid all unnecessary physical and mental suffering and injury. 9. During the course of the experiment the human subject should be at liberty to bring the experiment to an end if he has reached the physical or mental state where continuation of the experiment seems to him to be impossible.
DECLARATION OF HELSINKI I. BASIC PRINCIPLES 5. Every biomedical research project involving human subjects should be preceded by careful assessment of predictable risks in comparison with foreseeable benefits to the subject or to others. Concern for the interests of the subject must always prevail over the interests of science and society. 11. In case of legal incompetence, informed consent should be obtained from the legal guardian in accordance with national legislation. Where physical or mental incapacity makes it impossible to obtain informed consent, or when the subject is a minor, permission from the responsible relative replaces that of the subject in accordance with national legislation.
INVOLVING HUMAN SUBJECTS 4. In research on man, the interest of science and society should never take precedence over considerations related to the well-being of the subject.
INTERNATIONAL COVENANT ON CIVIL AND POLITICAL RIGHTS Article 7 No one shall be subjected to torture or to cruel, inhuman or degrading treatment or punishment. In particular, no one shall be subjected without his free consent to medical or scientific experimentation. Article 9 1. Everyone has the right to liberty and security of person. No one shall be subjected to arbitrary arrest or detention. No one shall be deprived of his liberty except on such grounds and in accordance with such procedures as are established by law. Article 10 1. All persons deprived of their liberty shall be treated with humanity and with respect for the inherent dignity of the human person. Article 24 1. Every child shall have, without any discrimination as to race, colour, sex, language, religion, national or social origin, property or birth, the right to such measures of protection as are required by his status as a minor, on the part of his family, society and the State.
UNITED NATIONS CONVENTION ON THE RIGHTS OF THE CHILD Article 6 1. States Parties recognize that every child has the inherent right to life.
Article 19 1. States Parties shall take all appropriate legislative, administrative, social and educational measures to protect the child from all forms of physical or mental violence, injury or abuse, neglect or negligent treatment, maltreatment or exploitation, including sexual abuse, while in the care of parent(s), legal guardian(s) or any other person who has the care of the child Article 24 3. States Parties shall take all effective and appropriate measures with a view to abolishing traditional practices prejudicial to the health of children
TRI-COUNCIL POLICY STATEMENT ON ETHICAL STANDARDS FOR RESEARCH INVOLVING HUMANS CONTEXT OF AN ETHICS FRAMEWORK B. A Moral Imperative: Respect for Human Dignity It is unacceptable to treat persons solely as means (mere objects or things), because doing so fails to respect their intrinsic human dignity and thus impoverishes all of humanity. C. Guiding Ethical Principles Respect for Vulnerable Persons: Respect for human dignity entails high ethical obligations towards vulnerable personsto those whose diminished competence and/or decision-making capacity make them vulnerable. Children, institutionalized persons or others who are vulnerable are entitled, on grounds of human dignity, caring, solidarity and fairness, to special protection against abuse, exploitation or discrimination. Minimizing Harm: A principle directly related to harms-benefits analysis is non-maleficence, or the duty to avoid, prevent or minimize harms to others. Research subjects must not be subjected to unnecessary risks of harm...
1 From Trials of War Criminals before the Nuremberg Military Tribunals under Control Council Law No. 10, Vol. 2, pp. 181-182. Washington, D.C.: U.S. Government Printing Office, 1949. 2 Adopted by the 18th World Medical Assembly Helsinki, Finland, June 1964; amended by the 29th World Medical Assembly Tokyo, Japan, October, 1975; 35th World Medical Assembly Venice, Italy, October 1983; and the 41st World Medical Assembly Hong Kong, September 1989. 3 Adopted and opened for signature, ratification and accession by General Assembly resolution 2200A (XXI) of 16 December 1966; entry into force 23 March 1976, in accordance with Article 49. 4 Adopted and opened for signature, ratification and accession by General Assembly resolution 44/25 of 20 November 1989; entry into force 2 September 1990, in accordance with Article 49. 5 Medical Research Council of Canada; Natural Sciences and Engineering Research Council of Canada; Social Sciences and Humanities Research Council of Canada. August 1998. *** |