Biomaterial Database

[Ethics and research: ethical considerations in clinical research]. 1995

H D'Haenen

Service de Psychiatrie, Chargé de cours à l'Université, A.Z.-V.U.B.

Two subjects are discussed: the use of placebo controls in clinical trials and informed consent. Particularly in trials of drugs for disorders for which there exist effective treatments, the use of placebo is still controversial, although anyhow in violation of the Declaration of Helsinki. Informed consent aims at giving a subject all the necessary information to allow him to decide, with full knowledge, whether to accept a particular treatment or experimental protocol. Its importance would seem, albeit essential, to be rather illusory.

UI	MeSH Term	Description	Entries
D007258	Informed Consent	Voluntary authorization, by a patient or research subject, with full comprehension of the risks involved, for diagnostic or investigative procedures, and for medical and surgical treatment.	Consent, Informed
D012106	Research	Critical and exhaustive investigation or experimentation, having for its aim the discovery of new facts and their correct interpretation, the revision of accepted conclusions, theories, or laws in the light of newly discovered facts, or the practical application of such new or revised conclusions, theories, or laws. (Webster, 3d ed)	Research Priorities,Laboratory Research,Research Activities,Research and Development,Activities, Research,Activity, Research,Development and Research,Priorities, Research,Priority, Research,Research Activity,Research Priority,Research, Laboratory
D002986	Clinical Trials as Topic	Works about pre-planned studies of the safety, efficacy, or optimum dosage schedule (if appropriate) of one or more diagnostic, therapeutic, or prophylactic drugs, devices, or techniques selected according to predetermined criteria of eligibility and observed for predefined evidence of favorable and unfavorable effects. This concept includes clinical trials conducted both in the U.S. and in other countries.	Clinical Trial as Topic
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
D006381	Helsinki Declaration	An international agreement of the World Medical Association which offers guidelines for conducting experiments using human subjects. It was adopted in 1962 and revised by the 18th World Medical Assembly at Helsinki, Finland in 1964. Subsequent revisions were made in 1975, 1983, 1989, and 1996. (From Encyclopedia of Bioethics, rev ed, 1995)	Declaration of Helsinki,Declaration, Helsinki,Helsinki Declarations
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