Informed Consent in Emergency Clinical Trials
Author Information
Author(s): Iwanowski Piotr, Budaj Andrzej, Członkowska Anna, Wąsek Wojciech, Kozłowska-Boszko Beata, Olędzka Urszula, Masełbas Wojciech
Primary Institution: Association for Good Clinical Practice in Poland
Hypothesis
What are the experiences and attitudes of investigators regarding informed consent in emergency clinical trials for acute coronary syndromes and stroke?
Conclusion
An update of national and European regulations is required to enable implementation of the emergency trial consent model referred to in GCP guidelines.
Supporting Evidence
- 73.8% of investigators had experience with ACS trials.
- 80.4% thought the information given to patients was too lengthy.
- 53.3% used the complete model of informed consent in emergency settings.
Takeaway
Doctors often find it hard to get patients' consent for emergency trials because patients are usually not in a good state to understand the information.
Methodology
A standardized anonymous 14-item questionnaire was distributed to Polish cardiac and stroke centres.
Potential Biases
Potential bias due to self-reported data from investigators.
Limitations
The study may not represent all physicians involved in emergency trials as it was limited to Polish centres.
Participant Demographics
Investigators from Polish cardiac and stroke centres.
Digital Object Identifier (DOI)
Want to read the original?
Access the complete publication on the publisher's website