Simplified consent in cluster randomised trials: the new EU Clinical Trials Regulation does not provide sufficient guidance

Cory E Goldstein; Rieke van der Graaf

doi:10.1136/bmj-2023-075773

Simplified consent in cluster randomised trials: the new EU Clinical Trials Regulation does not provide sufficient guidance

Cory E Goldstein
, Rieke van der Graaf

Research output: Contribution to journal › Article › Academic › peer-review

Abstract

Cory Goldstein and Rieke van der Graaf argue that the new EU Clinical Trials Regulation on informed consent in cluster randomised trials is ambiguous and could lead to an overuse of opt-out consent approaches that provide inadequate protections for research participants.

Original language	English
Article number	e075773
Number of pages	4
Journal	BMJ (Clinical research ed.)
Volume	382
DOIs	https://doi.org/10.1136/bmj-2023-075773
Publication status	Published - 13 Sept 2023

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title = "Simplified consent in cluster randomised trials: the new EU Clinical Trials Regulation does not provide sufficient guidance",

abstract = "Cory Goldstein and Rieke van der Graaf argue that the new EU Clinical Trials Regulation on informed consent in cluster randomised trials is ambiguous and could lead to an overuse of opt-out consent approaches that provide inadequate protections for research participants.",

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AB - Cory Goldstein and Rieke van der Graaf argue that the new EU Clinical Trials Regulation on informed consent in cluster randomised trials is ambiguous and could lead to an overuse of opt-out consent approaches that provide inadequate protections for research participants.

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Simplified consent in cluster randomised trials: the new EU Clinical Trials Regulation does not provide sufficient guidance

Abstract

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