Vickers believes that a couple of statements contained in our article [
[1]
] are ‘grossly erroneous’ [
[2]
]. One is that the control group participants of Just-in-time consent “would not know
that their assignment was made by a random process”. The second is that Just-in-time
consent does not “fulfil the three following ethical features: participants must agree
to contribute to the trial, this must be known at the time they are recruited, and
they must know that they have participated in it.” [
- Vickers A.
Inaccurate description of staged consent.
Eur J Intern Med. 2022; https://doi.org/10.1016/j.ejim.2022.11.019
[2]
]. We disagree with Vickers. We believe that from the article he co-authored [
- Vickers A.
Inaccurate description of staged consent.
Eur J Intern Med. 2022; https://doi.org/10.1016/j.ejim.2022.11.019
[3]
], which we used as a reference for our article [
[1]
], our two statements are correct.Keywords
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References
- Participants’ informed consent in adaptive, platform drug trials in hospitalized COVID-19 patients: not all approaches are ethically acceptable.Eur J Intern Med. 2022; 103: 1-3
- Inaccurate description of staged consent.Eur J Intern Med. 2022; https://doi.org/10.1016/j.ejim.2022.11.019
- Just-in-time consent–the ethical case for an alternative to traditional informed consent in randomized trials comparing an experimental intervention with usual care.Clin Trials. 2018; 15: 3-8
- Innovative approaches to informed consent for randomized clinical trials–Identifying the ethical challenges.Clin Trials. 2018; 15: 17-20
- Informed consent for research obtained during the intensive care unit stay.Crit Care. 2006; 10: R170
- Recall of clinical trial participation and attrition rates in survivors of acute respiratory distress syndrome.J Crit Care. 2021; 64: 160-164
- Patient and proxy recall after providing written or oral informed consent to participate in an interventional trial.JAMA Netw Open. 2022; 5e2214052
Article info
Publication history
Published online: November 29, 2022
Accepted:
November 24,
2022
Received:
November 21,
2022
Publication stage
In Press Corrected ProofIdentification
Copyright
© 2022 European Federation of Internal Medicine. Published by Elsevier B.V. All rights reserved.