Ethical considerations in neuroclinical trials

Ethical considerations in neuroclinical trials

Ethical decision making in clinical trials has become increasingly emphasized at many levels of the review process. Ethical concepts applicable to Neuroclinical Trials (NCT) are reviewed. The discussion is directed towards ethical concerns that investigators must consider and justify prior to Instit...

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Veröffentlicht in:Neurosurgical review 1997, Vol.20 (3), p.161-170
Hauptverfasser: MACCIOCCHI, S. N, ALVES, W. A
Format: Artikel
Sprache:eng
Schlagworte:
Bioethics
Biological and medical sciences
Clinical Trials as Topic - standards
Ethics, Medical
General aspects
Humans
Informed Consent
Medical sciences
Mental Competency
Methods
Neurology - standards
Neuropharmacology
Pharmacology. Drug treatments
Placebos
Professional Staff Committees
Random Allocation
Risk
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Zusammenfassung:Ethical decision making in clinical trials has become increasingly emphasized at many levels of the review process. Ethical concepts applicable to Neuroclinical Trials (NCT) are reviewed. The discussion is directed towards ethical concerns that investigators must consider and justify prior to Institutional Review Board (IRB) submission. Risk-benefit analysis, methodology (randomization: placebo; design) and consent (informed; deferred; waived) are reviewed and Office for Protection from Research Risk (OPRR) guidelines are described. Our conclusions: Investigators proposing NCT face increasing ethical scrutiny by IRBs. Attention to ethical issues early in trial planning process is recommended.
ISSN:0344-5607
1437-2320
DOI:10.1007/BF01105559