The social filter effect of informed consent in clinical research

Few would disagree with the moral principle of respect for individual autonomy in the conduct of clinical research.1-3 After all, self-determination and informed choice are the cultural norms of free societies. Rather, it is the legal and regulatory provisions of the informed consent doctrine that h...

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Bibliographic Details
Published in:Pediatrics (Evanston) 1991-04, Vol.87 (4), p.568-569
Main Authors: THONG, Y. H, HARTH, S. C
Format: Article
Language:English
Subjects:
Beneficence
Bioethics
Biological and medical sciences
Child
Clinical Trials as Topic
Demographic aspects
Disclosure
Ethical aspects
Government regulation
Human experimentation in medicine
Human medical experimentation
Humans
Informed consent
Informed consent (Medical law)
Informed Consent - legislation & jurisprudence
Laws, regulations and rules
Medical research
Medical sciences
Medicine, Experimental
Parental Consent
Patient Selection
Public health. Hygiene
Public health. Hygiene-occupational medicine
Research Subjects
Risk Assessment
Self-experimentation in medicine
Socioeconomic Factors
Therapeutic Human Experimentation
United States
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Summary:Few would disagree with the moral principle of respect for individual autonomy in the conduct of clinical research.1-3 After all, self-determination and informed choice are the cultural norms of free societies. Rather, it is the legal and regulatory provisions of the informed consent doctrine that have caused the most difficulties. Some 25 years after the promulgation of this doctrine,4,5 many problems remain with its practical implementation. The doctrine of informed consent has four essential components. 6-8First, there must be full disclosure of risks and benefits and the therapeutic alternatives. Second, the information must be provided in writing in an easily comprehensible form, but given the intermix of medical terminology and legal jargon, this is easier said than done.9
ISSN:0031-4005
1098-4275
DOI:10.1542/peds.87.4.568