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J Clin Epidemiol. 2017 Sep;89:181-187. doi: 10.1016/j.jclinepi.2017.03.019. Epub 2017 May 11.

Series: Pragmatic trials and real world evidence: Paper 4. Informed consent.

Author information

1
Department of Medical Humanities, Julius Center for Health Sciences and Primary Care, University Medical Center Utrecht, 3508 GA, Utrecht, The Netherlands. Electronic address: s.kalkman@umcutrecht.nl.
2
Department of Medical Humanities, Julius Center for Health Sciences and Primary Care, University Medical Center Utrecht, 3508 GA, Utrecht, The Netherlands.
3
Department of Epidemiology, Julius Center for Health Sciences and Primary Care, University Medical Center Utrecht, 3508 GA, Utrecht, The Netherlands.
4
Center of Excellence Epidemiology (GPORWE), Eli Lilly and Company Limited, Erl Wood Manor, Sunninghill Road, Windlesham, Surrey GU20 6PH, UK.
5
Global Research & Development, Merck, KGaA, Frankfurter Strasse 250, F135/101, Darmstadt 64293, Germany.
6
Department of Epidemiology, Julius Center for Health Sciences and Primary Care, University Medical Center Utrecht, 3508 GA, Utrecht, The Netherlands; Julius Clinical, Broederplein 41, Zeist 3703 CD, The Netherlands.

Abstract

The GetReal consortium of the Innovative Medicines Initiative aims to develop strategies to incorporate real-world evidence earlier into the drug life cycle to better inform health care decision makers on the comparative risks and benefits of new drugs. Pragmatic trials are currently explored as a means to generate such evidence in routine care settings. The traditional informed consent model for randomized clinical trials has been argued to pose substantial hurdles to the practicability of pragmatic trials: it would lead to recruitment difficulties, reduced generalizability of the results, and selection bias. The present article analyzes these challenges and discusses four proposed alternative informed consent models: integrated consent, targeted consent, broadcast consent, and a waiver of consent. These alternative consent models each aim at overcoming operational and methodological challenges, while still providing patients all the relevant information they need to make informed decisions. Each consent model, however, relies on different attitudes toward the principle of respect for persons and the related duty to inform patients as well as represents different views on whether the common good demands moral duties from patients. Such normative consequences of modifying consent requirements should be at least acknowledged and ought to be assessed in light of the validity of empirical claims.

KEYWORDS:

Comparative effectiveness; Drug research; Informed consent; Pragmatic trials; Real-world evidence; Research ethics

PMID:
28502809
DOI:
10.1016/j.jclinepi.2017.03.019
[Indexed for MEDLINE]
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