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Understanding voluntariness of consent in first-in-human cell therapy trials

Hug, Kristina LU (2020) In Regenerative Medicine 15(5). p.1647-1660
Abstract

Consensus about contents of voluntariness in informed consent is lacking. Core criteria for voluntary consent are needed to ensure voluntariness. This article outlines the multidimensionality of voluntariness and identifies what could reduce voluntariness, especially in first-in-human clinical trials involving cell therapies. In such trials, truly voluntary consent is especially important because: such trials may involve risk of serious harm, while in case of some diseases, eligible patients often have potentially effective therapeutic alternatives; patients considering participation in high-risk first-in-human trials may feel more desperate and some may be dependent on their caregivers, including those in the family; implanted cells... (More)

Consensus about contents of voluntariness in informed consent is lacking. Core criteria for voluntary consent are needed to ensure voluntariness. This article outlines the multidimensionality of voluntariness and identifies what could reduce voluntariness, especially in first-in-human clinical trials involving cell therapies. In such trials, truly voluntary consent is especially important because: such trials may involve risk of serious harm, while in case of some diseases, eligible patients often have potentially effective therapeutic alternatives; patients considering participation in high-risk first-in-human trials may feel more desperate and some may be dependent on their caregivers, including those in the family; implanted cells cannot be taken out of the patient's body if the patient wants to withdraw.

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author
organization
publishing date
type
Contribution to journal
publication status
published
subject
keywords
cell therapy, first-in-human clinical trials, informed consent, Parkinson's disease, regenerative medicine, research ethics, voluntariness
in
Regenerative Medicine
volume
15
issue
5
pages
14 pages
publisher
Future Medicine Ltd.
external identifiers
  • pmid:32609059
  • scopus:85088611233
ISSN
1746-0751
DOI
10.2217/rme-2019-0126
language
English
LU publication?
yes
id
feea1eb2-ed18-4779-8fc3-f0e664a12fce
date added to LUP
2020-08-05 09:35:53
date last changed
2020-08-12 09:09:32
@article{feea1eb2-ed18-4779-8fc3-f0e664a12fce,
  abstract     = {<p>Consensus about contents of voluntariness in informed consent is lacking. Core criteria for voluntary consent are needed to ensure voluntariness. This article outlines the multidimensionality of voluntariness and identifies what could reduce voluntariness, especially in first-in-human clinical trials involving cell therapies. In such trials, truly voluntary consent is especially important because: such trials may involve risk of serious harm, while in case of some diseases, eligible patients often have potentially effective therapeutic alternatives; patients considering participation in high-risk first-in-human trials may feel more desperate and some may be dependent on their caregivers, including those in the family; implanted cells cannot be taken out of the patient's body if the patient wants to withdraw.</p>},
  author       = {Hug, Kristina},
  issn         = {1746-0751},
  language     = {eng},
  number       = {5},
  pages        = {1647--1660},
  publisher    = {Future Medicine Ltd.},
  series       = {Regenerative Medicine},
  title        = {Understanding voluntariness of consent in first-in-human cell therapy trials},
  url          = {http://dx.doi.org/10.2217/rme-2019-0126},
  doi          = {10.2217/rme-2019-0126},
  volume       = {15},
  year         = {2020},
}