The right to withdraw is a concept in clinical research ethics that a study participant in a clinical trial has a right to end participation in that trial at will. According to ICH GCP guidelines, a person can withdraw from the research at any point in time and the participant is not required to reveal the reason for discontinuation.
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Transcription
Children in research
When children participate in clinical research their parents or guardians must give assent for them to participate, but ethics dictate that even in this case it is best to get the consent of the research subject. Studies have shown that children participating in research have little understanding of the right to withdraw when they are presented with the option.[1][2]
Biobanks
Withdrawal from participating in biobank research is problematic for many reasons, including the fact that participant's data is often de-identified to grant research participant privacy.[3]
References
- ^ Ondrusek, Nancy; Abramovitch, Rona; Pencharz, Paul; Koren, Gideon (1998). "Empirical examination of the ability of children to consent to clinical research". Journal of Medical Ethics. 24 (3): 158–65. doi:10.1136/jme.24.3.158. PMC 1377517. PMID 9650109.
- ^ Edwards, Sarah J.L. (2005). "Research Participation and the Right to Withdraw". Bioethics. 19 (2): 112–30. doi:10.1111/j.1467-8519.2005.00429.x. PMID 15943021.
- ^ Eriksson, Stefan; Helgesson, Gert (2005). "Potential harms, anonymization, and the right to withdraw consent to biobank research". European Journal of Human Genetics. 13 (9): 1071–6. doi:10.1038/sj.ejhg.5201458. PMID 15986039.
This page was last edited on 23 April 2023, at 17:18