Justified deception? The single blind placebo in drug research

Evans, Martyn

doi:10.1136/jme.26.3.188

Cited by 21 publications

(13 citation statements)

References 6 publications

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“…A series of between-within ANOVAs were conducted on each of the following POMS scales using time (post-consent vs. post-debrief) as the within-subjects factor and group (authorized deception and non-authorized deception) as the between-subjects factor: (1) tension-anxiety, (2) depressiondejection (3) anger-hostility, (4) vigor-activiry, (5) fatigue-inertia, (6) confusion-bewilderment, and (7) total mood disturbance. Neither the group main effect nor the group x time interaction effect was significant for any of the mood scales.…”

Section: Methodsmentioning

confidence: 99%

“…However, the methodology by which placebo effects are investigated has raised some ethical concerns [5,10,14,151. Because placebo analgesia is strongly influenced by the recipient's expectations [16][17][18], clinical and experimental studies typically rely on the use ofdeception regarding the purpose ofthe research and/or the nature of the treatment being administered, thereby leading the participants to believe that they are receiving a physically active treatment when in fact they are receiving a placebo [14].…”

Section: Introductionmentioning

confidence: 99%

“…The right now rating period was used for the present study. The POMS yields a total mood disturbance (TMD) score and 6-factor analytic-derived scales including; (1) tension-anxiety, (2) depression-dejection, (3) anger-hostility, (4) vigor-activiff, (5) and run studies such as the present one, (3) the extent to which they felt that their individual rights were respecred while taking part in the study, and (4) their willingness to participate in similar research in the future.…”

Section: Introductionmentioning

confidence: 99%

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Inclusion of authorized deception in the informed consent process does not affect the magnitude of the placebo effect for experimentally induced pain

Martínez-Cutillas¹,

Katz²

2010

Pain

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The ethics of placebo research have been of paramount concern since the discovery of the phenomenon. To address these ethical concerns, Miller and colleagues (PLoS Med 2005 Sep;2(9):e262, 0853-0859) propose an altemate approach to placebo research, called "authorized deception", in which participants are alerted of the use of deception in the research prior to study enrollment and thus knowingly permit its use if they decide to participate. The present study sought to investigate the authorized deception methodology in experimentally induced placebo analgesia. The participants were randomly assigned to an authorized deception or non-authorized deception group. A commonly used protocol was employed wherein heat pain stimulation was surreptitiously lowered following the application of a placebo cream during a series of conditioning trials and the magnitude of the placebo effect was subsequently assessed in test trials for which the stimulus intensity was the same for both the placebo and control creams. Authorized deception did not have any negative impact on the magnitude ofthe placebo effect, recruitment and retention of participants, nor did it result in any significant psychological harm. The majority of participants who received this form of consent preferred it to the traditional approach in which the participants are not alerted to the presence of deception. These findings suggest that the use of authorized deception is a viable and ethically preferable alternative consent process for laboratory-based studies on placebo analgesia. Further studies are needed to examine the effect of authorized deception in clinical trials and other placebo research within a clinical setting.

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Section: Methodsmentioning

confidence: 99%

Section: Introductionmentioning

confidence: 99%

Section: Introductionmentioning

confidence: 99%

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Inclusion of authorized deception in the informed consent process does not affect the magnitude of the placebo effect for experimentally induced pain

Martínez-Cutillas¹,

Katz²

2010

Pain

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“…Such intended lack of information has also, however, been used in single blind placebos employed in run in and washout periods of medication studies. 23 Researchers are often convinced that they will cull significant data and reach biomedical truths more readily if they practise some sort of deceit or somehow distort the informed consent process. Bok has called attention to this ''shading of the truth'', rejecting such practices with two powerful arguments: firstly that the institution of trust is morally undermined and loses effectiveness in such a sensitive area as the biomedical practices; and, secondly, agents damage their moral self esteem and risk presenting an increasingly soiled image of their own moral stance as they continue to practise deception.…”

Section: Therapeutic Researchmentioning

confidence: 99%

The battering of informed consent

Kottow¹

2004

J Med Ethics

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Autonomy has been hailed as the foremost principle of bioethics, and yet patients' decisions and research subjects' voluntary participation are being subjected to frequent restrictions. It has been argued that patient care is best served by a limited form of paternalism because the doctor is better qualified to take critical decisions than the patient, who is distracted by illness. The revival of paternalism is unwarranted on two grounds: firstly, because prejudging that the sick are not fully autonomous is a biased and unsubstantial view; secondly, because the technical knowledge of healthcare professionals does not include the ethical qualifications and prerogative to decide for others. Clinical research settings are even more prone to erode subjects' autonomy than clinical settings because of the tendency and temptation to resort to such practices as shading the truth when consent to participation is sought, or waiving consent altogether when research is done in emergency settings. Instead of supporting such dubious practices with unconvincing arguments, it would seem to be the task of bioethics to insist on reinforcing autonomy.

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“…These run-in periods have involved the use of a placebo or an active treatment, including using one of the drugs under study. Although the run-in period has been the object of some ethical discussions [9], it is used extensively, particularly to identify generally compliant patients, although they can introduce some bias in the results [10][11][12][13].…”

mentioning

confidence: 99%