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

BMC Medical Ethics
Cory E GoldsteinMonica Taljaard

Abstract

Pragmatic randomized controlled trials (RCTs) 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) Aut...Continue Reading

References

Aug 1, 1967·Journal of Chronic Diseases·D Schwartz, J Lellouch
Sep 2, 2000·Science·C Weijer, E J Emanuel
Jan 1, 1994·European Journal of Health Law·Johan Legemaate
Sep 25, 2003·JAMA : the Journal of the American Medical Association·Sean R TunisCarolyn M Clancy
Apr 8, 2009·Journal of Clinical Epidemiology·Kevin E ThorpeKalipso Chalkidou
Feb 9, 2012·BMJ : British Medical Journal·Tjeerd-Pieter van StaaLiam Smeeth
Apr 19, 2012·JAMA : the Journal of the American Medical Association·Nancy KassSean Tunis
Jun 14, 2012·BMJ : British Medical Journal·Edwin A M Gale
Jul 4, 2012·Clinical Trials : Journal of the Society for Clinical Trials·Kalipso ChalkidouMerrick Zwarenstein
Feb 27, 2013·The Hastings Center Report·Emily A LargentSteven Joffe
Feb 27, 2013·The Hastings Center Report·Jerry Menikoff
Feb 27, 2013·The Hastings Center Report·Joe V Selby, Harlan M Krumholz
Feb 27, 2013·The Hastings Center Report·Richard PlattHarry P Selker
Feb 27, 2013·The Hastings Center Report·Joel Kupersmith
Jul 23, 2013·Journal of Clinical Pharmacology·Frederick A CurroFrederick Naftolin
Aug 24, 2013·The New England Journal of Medicine·Chris FeudtnerJohn D Lantos
Oct 22, 2013·JAMA : the Journal of the American Medical Association·UNKNOWN World Medical Association
Nov 22, 2013·The American Journal of Bioethics : AJOB·David Wendler
Nov 22, 2013·The American Journal of Bioethics : AJOB·Ryan SpellecyMichael Farrell
Feb 21, 2014·The New England Journal of Medicine·Ruth R FadenNancy E Kass
Feb 21, 2014·The New England Journal of Medicine·Scott Y H Kim, Franklin G Miller
Mar 15, 2014·JAMA : the Journal of the American Medical Association·Richard PlattDeven McGraw
Apr 10, 2014·JAMA : the Journal of the American Medical Association·Zubin J EapenRobert J Temple
May 9, 2014·JAMA : the Journal of the American Medical Association·Jeremy Sugarman, Robert M Califf
May 16, 2014·The New England Journal of Medicine·Ruth R FadenNancy E Kass
May 16, 2014·The New England Journal of Medicine·Ahmed Elsayyad
May 16, 2014·The New England Journal of Medicine·Robin T W Williams
Jan 15, 2015·Journal of General Internal Medicine·David Wendler
Jan 16, 2015·JAMA : the Journal of the American Medical Association·Scott Y H Kim, Franklin G Miller
Feb 11, 2015·BMJ : British Medical Journal·K HemmingR J Lilford
Mar 22, 2015·Drug Discovery Today·Shona KalkmanJohannes J M van Delden
May 10, 2015·BMJ : British Medical Journal·Kirsty LoudonMerrick Zwarenstein
Jul 3, 2015·International Journal of Evidence-based Healthcare·Micah D J PetersCassia Baldini Soares
Sep 17, 2015·Clinical Trials : Journal of the Society for Clinical Trials·Robert M Califf, Jeremy Sugarman
Sep 17, 2015·Clinical Trials : Journal of the Society for Clinical Trials·Ross E McKinneyKevin Weinfurt
Sep 17, 2015·Clinical Trials : Journal of the Society for Clinical Trials·P Pearl O'RourkeJohn D Lantos
Sep 17, 2015·Clinical Trials : Journal of the Society for Clinical Trials·Joseph AliC Egla Rabinovich
Sep 17, 2015·Clinical Trials : Journal of the Society for Clinical Trials·Mary Jane WelchBenjamin Wilfond
Sep 17, 2015·Clinical Trials : Journal of the Society for Clinical Trials·Jonathan A FinkelsteinJeremy Sugarman
Sep 17, 2015·Clinical Trials : Journal of the Society for Clinical Trials·John D LantosGeraldine Bliss
Jul 2, 2016·Clinical Trials : Journal of the Society for Clinical Trials·Stephanie C Chen, Scott Yh Kim
Aug 26, 2016·Clinical Research in Cardiology : Official Journal of the German Cardiac Society·Martin R CowieAndrew Zalewski
Jan 7, 2017·Bioethics·Shona KalkmanJohannes van Delden
Jan 4, 2018·BMJ : British Medical Journal·John P NewJ Martin Gibson

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Citations

Aug 9, 2018·Proceedings of the National Academy of Sciences of the United States of America·Nir EyalDan Wikler
Dec 4, 2019·Anesthesiology·Tanya J SymonsDaniel I Sessler
Sep 17, 2020·Cancer Biotherapy & Radiopharmaceuticals·J Harvey Turner
Sep 27, 2019·The American Journal of Bioethics : AJOB·Kristin Canavera, Kendra Parris
Dec 25, 2019·Trials·Stuart G NichollsUNKNOWN Ethics of Pragmatic Trials project
Jun 12, 2019·Clinical Trials : Journal of the Society for Clinical Trials·Theodosios BisdasVincent Riambau
Jan 20, 2021·Ethics & Human Research·Stephanie R MorainRuth R Faden
Nov 4, 2020·Archives of Disease in Childhood. Fetal and Neonatal Edition·Jenny McLeishUNKNOWN Members of the WHEAT trial development group
Nov 2, 2020·Journal of Pain and Symptom Management·Joan G CarpenterMary Ersek
Apr 23, 2021·Clinical Trials : Journal of the Society for Clinical Trials·Anastasiya ChirkovaPavel Vasilyev
May 16, 2021·Journal of Medical Ethics·Thomas Grote
May 30, 2021·European Journal of Pain : EJP·Johan Hans Peter Alexander van LennepKarolina Maria Szadek

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