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Titolo:
The ethical use of placebo controls in clinical research: The declaration of Helsinki
Autore:
La Vaque, TJ; Rossiter, T;
Indirizzi:
Stress Clin, Green Bay, WI 54301 USA Stress Clin Green Bay WI USA 54301Stress Clin, Green Bay, WI 54301 USA Rogers Mem Hosp, Clin Psychophysiol Ctr, Milwaukee, WI 53704 USA Rogers Mem Hosp Milwaukee WI USA 53704 ysiol Ctr, Milwaukee, WI 53704 USA Biofeedback Ctr, Green Bay, WI 54301 USA Biofeedback Ctr Green Bay WI USA54301 dback Ctr, Green Bay, WI 54301 USA
Titolo Testata:
APPLIED PSYCHOPHYSIOLOGY AND BIOFEEDBACK
fascicolo: 1, volume: 26, anno: 2001,
pagine: 23 - 37
SICI:
1090-0586(200103)26:1<23:TEUOPC>2.0.ZU;2-C
Fonte:
ISI
Lingua:
ENG
Soggetto:
DEFICIT HYPERACTIVITY DISORDER; DOUBLE-BLIND; DEVELOPING-COUNTRIES; CONTROLLED TRIALS; PSYCHIATRIC RESEARCH; PARKINSONS-DISEASE; COGNITIVE THERAPY; MEDICAL-RESEARCH; HUMAN-RIGHTS; METHYLPHENIDATE;
Keywords:
ethics of clinical research; EEG biofeedback; sham treatment controls; placebo treatment controls; active treatment controls; ADHD; TBI; depression; Declaration of Helsink;
Tipo documento:
Article
Natura:
Periodico
Settore Disciplinare:
Social & Behavioral Sciences
Citazioni:
76
Recensione:
Indirizzi per estratti:
Indirizzo: La Vaque, TJ Stress Clin, 125 S Jefferson,Ste 306, Green Bay, WI 54301 USAStress Clin 125 S Jefferson,Ste 306 Green Bay WI USA 54301 SA
Citazione:
T.J. La Vaque e T. Rossiter, "The ethical use of placebo controls in clinical research: The declaration of Helsinki", APPL PSY BI, 26(1), 2001, pp. 23-37

Abstract

Medical ethicists have questioned the use of no-treatment (placebo and sham procedure) controlled studies of new therapies when safe and effective standard therapies are available for use as an active or "equivalence" control. Current ethical principles of conduct for biomedical research specifically prohibit designs that withhold or deny "the best proven diagnostic and therapeutic" treatment to any participant in a clinical study, including those individuals who consent to randomization into a control group. Studies of psychophysiological therapies are often criticized on the grounds they lack a placebo or sham treatment control group. This paper briefly reviews the history of the problem and discusses the ethical standards that govern human research as derived from the Nuremberg Code and the Declaration of Helsinki. An examination of the problem with regard to research involving EEG biofeedback therapy for Attention-Deficit/Hyperactivity Disorder Traumatic Brain Injury, and depression serves to highlight the issues. It is concludedthat the active treatment control (treatment equivalence) design is most appropriate for those clinical studies examining disorders for which there is a known, effective treatment. Sham- or placebo-controlled studies are ethically acceptable for those disorders for which no effective treatment is available.

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Documento generato il 27/01/20 alle ore 01:37:40