Analysis

Involving patients in enrolment decisions for acute myocardial infarction trials

BMJ 2015; 351 doi: https://doi.org/10.1136/bmj.h3791 (Published 29 July 2015) Cite this as: BMJ 2015;351:h3791

This article has a correction. Please see:

  1. Neal W Dickert, assistant professor12,
  2. Franklin G Miller, senior faculty member3
  1. 1Department of Medicine, Emory University School of Medicine, Atlanta, GA 30322, USA
  2. 2Department of Epidemiology, Emory University Rollins School of Public Health, Atlanta
  3. 3Department of Bioethics, National Institutes of Health, Bethesda, MD, USA
  1. Correspondence to: N W Dickert njr{at}emory.edu
  • Accepted 11 June 2015

Seriously ill patients requiring emergency treatment are unlikely to be able to give full informed consent for a clinical trial, but Neal W Dickert and Franklin G Miller argue that this does not mean that they shouldn’t be involved in enrolment decisions at all

Controversy over informed consent for clinical trials in acute ST elevation myocardial infarction (STEMI) has existed for over 30 years.1 2 3 How can a patient with dyspnoea and angina in need of emergency percutaneous coronary intervention possibly make an informed, considered decision about whether to enrol in a clinical trial? Some authors have argued that seeking consent for research in this context is not only impracticable but unethical.4 Nevertheless, it has remained standard practice to ask STEMI patients or surrogates to consent to enrolment in trials. The recent Unfractionated Heparin versus Bivalirudin in Primary Percutaneous Coronary Intervention (HEAT-PPCI) trial, in which patients were randomised without prospective consent, has forced a re-examination of this long simmering question.5 6 7 This discussion is particularly timely given the growing emphasis on pragmatic comparative effectiveness trials that integrate clinical care and research. We contend that the principle of respect for persons supports involving patients in enrolment decisions for trials, even when trials pose few risks and patients cannot give valid consent.

Consent related challenges in emergency care research

Prospective informed consent is a general ethical requirement for most clinical research, but research in acute illness must sometimes be conducted without it. For example, most countries and international guidelines permit waiving consent for clinical trials in conditions like cardiac arrest and traumatic brain injury, when patients are unconscious and surrogates cannot provide consent within an appropriate timeframe.8 9 The creation of regulatory frameworks to accommodate these situations is an important ethical achievement and has facilitated substantial progress in treating severely ill patients. The …

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