Pragmatic clinical trials and the consent process

Research Ethics 14 (2):1-14 (2018)
  Copy   BIBTEX


Pragmatic clinical trials are a relatively new methodological approach to the execution of clinical research that can increase research efficiency and provide access to unique data. Some have suggested that the costs and delays associated with obtaining informed consent could make PCTs difficult or even impossible to execute. Alternative consent models have been proposed, some of which lower standards of disclosure, delay consent, or waive it altogether. We analyze the permissibility of changes to informed consent in the context of Canadian research ethics policies, legislation, common law, professional codes of ethics, and professional standards of practice. We find that Canadian law and policy relating to informed consent clearly applies to any clinician who might be involved in a PCT. In addition, existing consent norms seem unable to accommodate alternative consent models for pragmatic research if such models would involve lowering the standard of disclosure. The strong emphasis on the primacy...



    Upload a copy of this work     Papers currently archived: 89,685

External links

Setup an account with your affiliations in order to access resources via your University's proxy server

Through your library

Similar books and articles

Empty Ethics: The Problem with Informed Consent.Oonagh Corrigan - 2003 - Sociology of Health & Illness 25 (3):768-792.
Informed consent in acute myocardial infarction research.Anne Gammelgaard - 2004 - Journal of Medicine and Philosophy 29 (4):417 – 434.
Informed consent: a primer for clinical practice.Deborah Bowman - 2012 - New York: Cambridge University Press. Edited by John Spicer & Rehana Iqbal.


Added to PP

13 (#877,127)

6 months
3 (#434,103)

Historical graph of downloads
How can I increase my downloads?

Citations of this work

No citations found.

Add more citations

References found in this work

Add more references