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

Piotr Iwanowski¹^,2 , Andrzej Budaj³ , Anna Członkowska⁴^,5 , Wojciech Wąsek³ , Beata Kozłowska-Boszko¹^,6 , Urszula Olędzka¹^,2 and Wojciech Masełbas¹^,7

¹Association for Good Clinical Practice in Poland, ul. Postępu 18B (Neptun), 02-676 Warszawa, Poland

²International Centre for Therapeutic Research, Servier Poland, ul. Jana Kazimierza 10, 01-248 Warszawa, Poland

³Centre of Postgraduate Medical Education, Department of Cardiology, Grochowski Hospital, ul. Grenadierów 51/59, 04-073 Warszawa, Poland

⁴Institute of Psychiatry and Neurology, 2nd Department of Neurology, ul. Sobieskiego 9, 02-957 Warszawa, Poland

⁵Department of Experimental and Clinical Pharmacology, Medical University, Warsaw, ul. Krakowskie Przedmieście 26/28, 00-325 Warszawa, Poland

⁶Bayer HealthCare, Medical Department, Al. Jerozolimskie 158, 02-326 Warszawa, Poland

⁷PPD Development, ul. Postępu 18B (Orion), 02-676 Warszawa, Poland

author email corresponding author email

Trials 2008, 9:45doi:10.1186/1745-6215-9-45


Published:	21 July 2008

Abstract

Background

During 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.

Methods

A standardised anonymous 14-item questionnaire was distributed to Polish cardiac and stroke centres.

Results

Two 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.

Conclusion

An update of national and European regulations is required to enable implementation of the emergency trial consent model referred to in GCP guidelines.