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Informed consent in randomised controlled trials: development and preliminary evaluation of a measure of participatory and informed consent (PIC)

Abstract:
Background Informed consent (IC) is an ethical and legal prerequisite for trial participation, yet current approaches evaluating participant understanding for IC during recruitment lack consistency. No validated measure has been identified that evaluates participant understanding for IC based on their contributions during consent interactions. This paper outlines the development and formative evaluation of the Participatory and Informed Consent (PIC) measure for application t... Expand abstract
Publication status:
Published
Peer review status:
Peer reviewed

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Publisher copy:
10.1186/s13063-017-2048-7

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Grant:
iNnovationforDifficUlt
ConDuCT-IIHub(COllaboration
omisedcontrolledTrialsInInvasiveprocedures–MR/K025643/1
Complexr
Publisher:
BioMed Central Publisher's website
Journal:
Trials Journal website
Volume:
18
Issue:
1
Article number:
327
Publication date:
2017-07-17
Acceptance date:
2017-06-09
DOI:
ISSN:
1745-6215
Source identifiers:
700954
Pubs id:
pubs:700954
UUID:
uuid:020f8b5a-f01f-4c11-aab1-7feab7e3df0c
Local pid:
pubs:700954
Deposit date:
2017-07-20

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