Biomaterial Database

Ethical considerations in modern human experimentation. 1991

A Steinberg

Program of Medical Ethics, Hebrew University-Hadassah Medical School, Jerusalem, Israel.

The use of properly controlled clinical trials in medical experimentation has been of vital importance to the progress of medical science. At the same time, the new form of experimentation has also generated some of our most difficult and perplexing moral dilemmas. The solutions to the many complicated ethical problems involved in human experimentation are not straightforward, and despite numerous books, articles, codes, guidelines, and declarations, many specific issues of right and wrong in human experimentation have not yet been definitively resolved. Society today has an obligation greater than ever to control, regulate, and enforce properly balanced codes of human experimentation in order to minimize the unacceptable ethical problems and maximize the desired results of modern human experimentation. These, however, are not sufficient. The patient's greatest safeguard in experimentation is a skillful, intelligent, and conscientious physician and investigator. Thus, the investigator bears great responsibility in balancing between the common good and the individual's rights. In this article the relevant secular and Jewish ethical principles and rules concerning human experimentation are specified and methodologically organized. Particular emphasis is placed on the elucidation and evaluation of the ethical controversies surrounding randomized clinical trials.

UI	MeSH Term	Description	Entries
D007585	Jews	An ethnic group with historical ties to the land of ISRAEL and the religion of JUDAISM.	Jew
D004992	Ethics, Medical	The principles of professional conduct concerning the rights and duties of the physician, relations with patients and fellow practitioners, as well as actions of the physician in patient care and interpersonal relations with patient families.	Medical Ethics
D006801	Humans	Members of the species Homo sapiens.	Homo sapiens,Man (Taxonomy),Human,Man, Modern,Modern Man
D006805	Human Experimentation	The use of humans as investigational subjects.	Human Research Subject Protection,Experimentation, Human
D012926	Social Control, Formal	Control which is exerted by the more stable organizations of society, such as established institutions and the law. They are ordinarily embodied in definite codes, usually written.	Regulation,Social Control,Control, Social,Controls, Social,Formal Social Control,Formal Social Controls,Regulations,Social Controls
D012935	Social Justice	An interactive process whereby members of a community are concerned for the equality and rights of all.	Food Justice,Common Good,Justice,Obligations of Society,Good, Common,Justice, Food,Justice, Social
D016032	Randomized Controlled Trials as Topic	Works about clinical trials that involve at least one test treatment and one control treatment, concurrent enrollment and follow-up of the test- and control-treated groups, and in which the treatments to be administered are selected by a random process, such as the use of a random-numbers table.	Clinical Trials, Randomized,Controlled Clinical Trials, Randomized,Trials, Randomized Clinical
D018570	Risk Assessment	The qualitative or quantitative estimation of the likelihood of adverse effects that may result from exposure to specified health hazards or from the absence of beneficial influences. (Last, Dictionary of Epidemiology, 1988)	Assessment, Risk,Benefit-Risk Assessment,Risk Analysis,Risk-Benefit Assessment,Health Risk Assessment,Risks and Benefits,Analysis, Risk,Assessment, Benefit-Risk,Assessment, Health Risk,Assessment, Risk-Benefit,Benefit Risk Assessment,Benefit-Risk Assessments,Benefits and Risks,Health Risk Assessments,Risk Analyses,Risk Assessment, Health,Risk Assessments,Risk Benefit Assessment,Risk-Benefit Assessments
D026684	Personal Autonomy	Self-directing freedom and especially moral independence. An ethical principle holds that the autonomy of persons ought to be respected. (Bioethics Thesaurus)	Autonomy, Personal,Free Will,Self Determination
D026686	Beneficence	The state or quality of being kind, charitable, or beneficial. (from American Heritage Dictionary of the English Language, 4th ed). The ethical principle of BENEFICENCE requires producing net benefit over harm. (Bioethics Thesaurus)	Benevolence,Nonmaleficence