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

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.

journal_name

Trials

journal_title

Trials

authors

Iwanowski P,Budaj A,Członkowska A,Wasek W,Kozłowska-Boszko B,Oledzka U,Masełbas W

doi

10.1186/1745-6215-9-45

subject

Has Abstract

pub_date

2008-07-21 00:00:00

pages

45

issn

1745-6215

pii

1745-6215-9-45

journal_volume

9

pub_type

杂志文章

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