Informed consent for clinical trials in acute coronary syndromes and stroke following the European Clinical Trials Directive: investigators' experiences and attitudes.

Piotr Iwanowski,Wojciech Masełbas,Wojciech Wąsek,Beata Kozłowska-Boszko,Urszula Olędzka,Andrzej Budaj,Anna Członkowska

doi:10.1186/1745-6215-9-45

Abstract

BackgroundDuring clinical trials in emergency medicine, providing appropriate oral and written information to a patient is usually a challenge. There is little published information regarding patients' opinions and competence to provide informed consent, nor on physicians' attitudes towards the process. We have investigated the problem of obtaining consent from patients in emergency-setting clinical trials (such as acute coronary syndromes (ACS) and stroke) from a physicians' perspective.MethodsA standardised anonymous 14-item questionnaire was distributed to Polish cardiac and stroke centres.ResultsTwo hundred and fourteen informative investigator responses were received. Of these investigators, 73.8% had experience with ACS and 25.2% had experience with acute stroke trials (and 1% with both fields). The complete model of informed consent (embracing all aspects required by Good Clinical Practice (GCP) and law) was used in 53.3% of cases in emergency settings, whereas the legal option of proxy consent was not used at all. While less than 15% of respondents considered written information to have been fully read by patients, 80.4% thought that the amount of information being given to emergency patients is too lengthy. Although there is no legal obligation, more than half of the investigators sought parallel consent (assent) from patients' relatives. Most investigators confirmed that they would adopt the model proposed by the GCP guidelines: abbreviated verbal and written consent in emergency conditions with obligatory "all-embracing" deferred consent to continue the trial once the patient is able to provide it. However, this model would not follow current Polish and European legislation.ConclusionAn update of national and European regulations is required to enable implementation of the emergency trial consent model referred to in GCP guidelines.

Highlights

During clinical trials in emergency medicine, providing appropriate oral and written information to a patient is usually a challenge
It has been recently demonstrated that allowing deferred consent for enrolment in a traumatic brain injury (TBI) trial reduces time to study drug administration by 50% compared to written proxy consent [5]
* two respondents declaring experience with both acute coronary syndrome and stroke trials were not taken into account for subgroup analysis ** multiple choice possible; all other items were single choice *** embracing all aspects required by Good Clinical Practice (GCP) and law for a regular trial sponsor of a stroke trial (Servier)

Summary

Introduction

During clinical trials in emergency medicine, providing appropriate oral and written information to a patient is usually a challenge. Despite tremendous advances in pharmacotherapy over recent decades, the expectations of both medical professionals and patients towards more effective and safer therapies are even greater This is true for treatment of vascular diseases such as acute coronary syndromes (ACS) and acute stroke, considering the numerous complications that can occur. Clinical research nowadays is governed by widely accepted strict ethical and quality standards, based on the Declaration of Helsinki [1] and Good Clinical Practice (GCP) guidelines (Good Clinical Practice standards by the International Conference on Harmonisation, ICH, 1996, introduced into general law in most European countries over recent years by the means of two European Community directives, 2001/20/EC and 2005/28/EC) Essential to these standards are the respect of autonomy of research participants and the importance of their well-being over the interests of science and society. It has been recently demonstrated that allowing deferred consent for enrolment in a traumatic brain injury (TBI) trial reduces time to study drug administration by 50% compared to written proxy consent [5]

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Conclusion