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The ethics of withdrawal : The case of follow-up from first-in-human clinical trials

Hug, Kristina LU and Johansson, Mats LU (2017) In Regenerative Medicine 12(1). p.25-36
Abstract
This paper aims to analyze whether patients should be allowed to veto research-related use of medical data collected during routine follow-ups after their withdrawal from first-in-human clinical trials. Forms of withdrawal are identified and it is argued that the right to withdraw might be limited to some of these. The paper concludes that if veto right is denied, then: the research participant should be informed about the potential use of his/her follow-up data in case of his/her withdrawal and consent to it; follow-up should not be initiated for research purposes; compulsory use of follow-up data should imply the use of data anyway collected, requiring no additional effort from the patient; and before deciding about the veto right,... (More)
This paper aims to analyze whether patients should be allowed to veto research-related use of medical data collected during routine follow-ups after their withdrawal from first-in-human clinical trials. Forms of withdrawal are identified and it is argued that the right to withdraw might be limited to some of these. The paper concludes that if veto right is denied, then: the research participant should be informed about the potential use of his/her follow-up data in case of his/her withdrawal and consent to it; follow-up should not be initiated for research purposes; compulsory use of follow-up data should imply the use of data anyway collected, requiring no additional effort from the patient; and before deciding about the veto right, investigation of concerned patients’ value preferences is needed. (Less)
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author
organization
publishing date
type
Contribution to journal
publication status
published
subject
keywords
ethics of withdrawal
in
Regenerative Medicine
volume
12
issue
1
pages
25 - 36
publisher
Future Medicine Ltd.
external identifiers
  • scopus:85007344914
  • wos:000391864700005
ISSN
1746-0751
DOI
10.2217/rme-2016-0116
language
English
LU publication?
yes
id
62afd007-b4ce-46c8-b71d-b088c2b6012a
date added to LUP
2016-10-24 16:38:57
date last changed
2018-03-06 10:59:03
@article{62afd007-b4ce-46c8-b71d-b088c2b6012a,
  abstract     = {This paper aims to analyze whether patients should be allowed to veto research-related use of medical data collected during routine follow-ups after their withdrawal from first-in-human clinical trials. Forms of withdrawal are identified and it is argued that the right to withdraw might be limited to some of these. The paper concludes that if veto right is denied, then: the research participant should be informed about the potential use of his/her follow-up data in case of his/her withdrawal and consent to it; follow-up should not be initiated for research purposes; compulsory use of follow-up data should imply the use of data anyway collected, requiring no additional effort from the patient; and before deciding about the veto right, investigation of concerned patients’ value preferences is needed.},
  author       = {Hug, Kristina and Johansson, Mats},
  issn         = {1746-0751},
  keyword      = {ethics of withdrawal },
  language     = {eng},
  number       = {1},
  pages        = {25--36},
  publisher    = {Future Medicine Ltd.},
  series       = {Regenerative Medicine},
  title        = {The ethics of withdrawal : The case of follow-up from first-in-human clinical trials},
  url          = {http://dx.doi.org/10.2217/rme-2016-0116},
  volume       = {12},
  year         = {2017},
}