Ethical issues in pragmatic randomized controlled trials: a review of the recent literature identifies gaps in ethical argumentation [Book Review]

BMC Medical Ethics 19 (1):14 (2018)
  Copy   BIBTEX

Abstract

Pragmatic randomized controlled trials are designed to evaluate the effectiveness of interventions in real-world clinical conditions. However, these studies raise ethical issues for researchers and regulators. Our objective is to identify a list of key ethical issues in pragmatic RCTs and highlight gaps in the ethics literature. We conducted a scoping review of articles addressing ethical aspects of pragmatic RCTs. After applying the search strategy and eligibility criteria, 36 articles were included and reviewed using content analysis. Our review identified four major themes: 1) the research-practice distinction; 2) the need for consent; 3) elements that must be disclosed in the consent process; and 4) appropriate oversight by research ethics committees. 1) Most authors reject the need for a research-practice distinction in pragmatic RCTs. They argue that the distinction rests on the presumptions that research participation offers patients less benefit and greater risk than clinical practice, but neither is true in the case of pragmatic RCTs. 2) Most authors further conclude that pragmatic RCTs may proceed without informed consent or with simplified consent procedures when risks are low and consent is infeasible. 3) Authors who endorse the need for consent assert that information need only be disclosed when research participation poses incremental risks compared to clinical practice. Authors disagree as to whether randomization must be disclosed. 4) Finally, all authors view regulatory oversight as burdensome and a practical impediment to the conduct of pragmatic RCTs, and argue that oversight procedures ought to be streamlined when risks to participants are low. The current ethical discussion is framed by the assumption that the function of research oversight is to protect participants from risk. As pragmatic RCTs commonly involve usual care interventions, the risks may be minimal. This leads many to reject the research-practice distinction and question the need for informed consent. But the function of oversight should be understood broadly as protecting the liberty and welfare interest of participants and promoting public trust in research. This understanding, we suggest, will focus discussion on questions about appropriate ethical review for pragmatic RCTs.

Links

PhilArchive



    Upload a copy of this work     Papers currently archived: 89,378

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

An Argument for Fewer Clinical Trials.Kirstin Borgerson - 2016 - Hastings Center Report 46 (6):25-35.
Will the real Charles Fried please stand up?Paul B. Miller & Charles Weijer - 2003 - Kennedy Institute of Ethics Journal 13 (4):353-357.
Pharmacogenetics: the bioethical problem of DNA investment banking.Oonagh P. Corrigan & Bryn Williams-Jones - 2006 - Studies in History and Philosophy of Science Part C: Studies in History and Philosophy of Biological and Biomedical Sciences 37 (3):550-565.
Clinical equipoise and the incoherence of research ethics.Franklin G. Miller & Howard Brody - 2007 - Journal of Medicine and Philosophy 32 (2):151 – 165.
Ethics in Neonatal Pain Research.Anna Axelin & Sanna Salanterä - 2008 - Nursing Ethics 15 (4):492-499.

Analytics

Added to PP
2018-02-27

Downloads
28 (#482,738)

6 months
4 (#306,312)

Historical graph of downloads
How can I increase my downloads?

Author Profiles

Cory E. Goldstein
University of Western Ontario
Charles Weijer
University of Western Ontario