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A Call to Revise the Declaration of Helsinki’s Placebo Guidelines

Published online by Cambridge University Press:  28 July 2023

Dien Ho*
Affiliation:
Center for Health Humanities, Massachusetts College of Pharmacy and Health Sciences, Boston, MA, USA

Extract

Since its introduction in 1964, the World Medical Association’s Declaration of Helsinki—Ethical Principles for Medical Research Involving Human Subjects has enshrined the importance of safeguarding the well-being of human subjects in clinical research. The Declaration has undergone seven revisions, often in response to requests for clarification. I want to argue that the Declaration is in need of another revision in light of recent discoveries in placebo research.

Type
Brief Report
Copyright
© The Author(s), 2023. Published by Cambridge University Press

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References

Notes

1. Kimmelman, J. Better to be in the placebo arm for trials of neurological therapies? Cell Transplantation 2018;27(4):677–81CrossRefGoogle ScholarPubMed.

2. Kallmes, DF, Comstock, BA, Heagerty, PJ, Turner, JA, Wilson, DJ, Diamond, TH, et al. A randomized trial of vertebroplasty for osteoporotic spinal fractures. New England Journal of Medicine 2009;361(6):569–79CrossRefGoogle ScholarPubMed.

3. Firanescu, CE, de Vries, J, Lodder, P, Venmans, A, Schoemaker, MC, Smeet, AJ, et al. Vertebroplasty versus sham procedure for painful acute osteoporotic vertebral compression fractures (VERTOS IV): Randomised sham controlled clinical trial. BMJ 2018;361:k1551 CrossRefGoogle ScholarPubMed.

4. Hochmuth, K, Proschek, D, Schwarz, W, Mack, M, Kurth, AA, Vogl, TJ. Percutaneous vertebroplasty in the therapy of osteoporotic vertebral compression fractures: A critical review. European Radiology 2006;16(5):998 CrossRefGoogle ScholarPubMed.