Reporting the details of consent procedures in clinical trials

[...]the applicable guidelines and laws often depend on the types of intervention assessed in the trial and can heavily affect the content of the PIS. In most cases, we should be content with the review of PIS conducted by RECs in each country. Because RECs approved the three RCTs mentioned previous...

Full description

Saved in:
Bibliographic Details
Published in:Journal of clinical epidemiology 2020-01, Vol.117, p.150-151
Main Authors: Dal−Ré, Rafael, Solberg, Berge, Fuhr, Uwe, Eriksson, Stefan
Format: Article
Language:English
Subjects:
Bioethics
Bioetik
Clinical trials
Ethics
Information processing
Informed consent
informerat samtycke
kliniska prövningar
Statistical analysis
Citations: Items that this one cites
Items that cite this one
Online Access:Get full text
Tags: Add Tag
No Tags, Be the first to tag this record!
Description
Summary:[...]the applicable guidelines and laws often depend on the types of intervention assessed in the trial and can heavily affect the content of the PIS. In most cases, we should be content with the review of PIS conducted by RECs in each country. Because RECs approved the three RCTs mentioned previously [2–4], there is no reason why readers should assume that the PISs used did not fulfill the national regulations and that the “very brief” information reported in the articles was the only information actually provided to participants. [...]the informed consent process information is only a small part of the trial documentation, and if full transparency for the public should be achieved to allow unrestricted assessment, other documents such as the protocol, the (core) clinical trial report, the statistical analysis plan, and any raw data might be more relevant.
ISSN:0895-4356
1878-5921
1878-5921
DOI:10.1016/j.jclinepi.2019.09.014