Placebo Effects and Neuromodulation: Ethical Considerations and Recommendations
Placebo-controlled trials are the gold standard of evaluating treatment efficacy in clinical research. Neuromodulation is emerging as an important treatment pathway for many neuropsychiatric conditions, and placebo control arms of these trials require careful design with unique considerations (e.g.,...
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| Veröffentlicht in: | Canadian journal of neurological sciences 2023-06, Vol.50 (s1), p.s34-s41 |
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| container_title | Canadian journal of neurological sciences |
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| creator | Mollica, Adriano Greben, Rachel Cyr, Marieve Olson, Jay A. Burke, Matthew J. |
| description | Placebo-controlled trials are the gold standard of evaluating treatment efficacy in clinical research. Neuromodulation is emerging as an important treatment pathway for many neuropsychiatric conditions, and placebo control arms of these trials require careful design with unique considerations (e.g., sham devices that mimic active stimulation, blinding effectiveness). Inherent to placebo-controlled trials are ethical concerns, such as deception, and potential harm of not receiving the active treatment. In this article, we outline important ethical considerations of placebo-controlled trials across neuromodulation approaches and provide recommendations on how ethical principles can be adhered to going forward. We specifically address issues of autonomy and respect for persons, beneficence, and justice. Within the context of this ethical framework, we also discuss factors influencing placebo effects in neuromodulation, the importance of adequate blinding, and alternative trial designs that could be considered. |
| doi_str_mv | 10.1017/cjn.2023.24 |
| format | Article |
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| source | MEDLINE; Cambridge Journals |
| subjects | Brain research Consent Deception Electroconvulsive therapy Ethics Humans Intervention Irritable bowel syndrome Patients Personal Autonomy Placebo Effect Randomized Controlled Trials as Topic - ethics Respect Review Article Social Justice Ultrasonic imaging |
| title | Placebo Effects and Neuromodulation: Ethical Considerations and Recommendations |
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