Biomaterial Database

Is informed consent always necessary for randomized, controlled trials? . 1999

R D Truog, and W Robinson, and A Randolph, and A Morris

Children's Hospital, Boston, MA 02115, USA.

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
D010344	Patient Advocacy	Promotion and protection of the rights of patients, frequently through a legal process.	Patient Ombudsmen,Patient Representatives,Clinical Ombudsman,Patient Ombudsman,Advocacy, Patient,Ombudsman, Clinical,Ombudsman, Patient,Ombudsmen, Patient,Patient Representative,Representative, Patient,Representatives, Patient
D011367	Professional Staff Committees	Committees of professional personnel who have responsibility for determining policies, procedures, and controls related to professional matters in health facilities.	Committee, Professional Staff,Committees, Professional Staff,Professional Staff Committee,Staff Committee, Professional,Staff Committees, Professional
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
D012306	Risk	The probability that an event will occur. It encompasses a variety of measures of the probability of a generally unfavorable outcome.	Relative Risk,Relative Risks,Risk, Relative,Risks,Risks, Relative
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
D026724	Ethical Review	A formal process of examination of patient care or research proposals for conformity with ethical standards. The review is usually conducted by an organized clinical or research ethics committee (CLINICAL ETHICS COMMITTEES or RESEARCH ETHICS COMMITTEES), sometimes by a subset of such a committee, an ad hoc group, or an individual ethicist (ETHICISTS).	Review, Ethical