Participants' written informed consent in low-risk pragmatic clinical trials with medicines.

Abstract:

:Introduction: An important gap within modern medicine is the lack of enough comparative effectiveness research of marketed medicines. Low-risk pragmatic randomized controlled trials (pRCTs) are those conducted resembling usual clinical practice that poses no or minimal incremental risk compared with normal clinical practice.Areas covered: This review addresses one important hurdle in the conduct of low-risk pRCTs: the need to seek participants' written informed consent.Expert opinion: The CIOMS ethical guidelines consider that any research that (a) would not be feasible or practicable to carry out without the waiver or modification, (b) has important social value, and (c) poses no more than minimal risks to participants, and that is approved by the relevant research ethics committee, could be conducted without participants' consent. It is clear that these provisions are applicable to some low-risk RCTs. Recently a research on the EU-CTR registry showed that only 2% of all ongoing phase 4 RCTs could have fulfilled the CIOMS provisions following the investigators' assessment. The EU clinical trial regulation - and that of other jurisdictions - should be debated on the suitableness of the conduct with an alteration or waiver of participants' consent of those low-risk pRCTs that fulfill the three CIOMS provisions.

authors

Dal-Ré R

doi

10.1080/17512433.2020.1732816

subject

Has Abstract

pub_date

2020-03-01 00:00:00

pages

205-210

issue

3

eissn

1751-2433

issn

1751-2441

journal_volume

13

pub_type

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