‘No Time to be Lost!’: Ethical Considerations on Consent for Inclusion in Emergency Pharmacological Research in Severe Traumatic Brain Injury in the European Union

Science and Engineering Ethics 13 (3):371-381 (2007)
  Copy   BIBTEX

Abstract

Severe Traumatic Brain Injury (TBI) remains a major cause of death and disability afflicting mostly young adult males and elderly people, resulting in high economic costs to society. Therapeutic approaches focus on reducing the risk on secondary brain injury. Specific ethical issues pertaining in clinical testing of pharmacological neuroprotective agents in TBI include the emergency nature of the research, the incapacity of the patients to informed consent before inclusion, short therapeutic time windows, and a risk-benefit ratio based on concept that in relation to the severity of the trauma, significant adverse side effects may be acceptable for possible beneficial treatments. Randomized controlled phase III trials investigating the safety and efficacy of agents in TBI with promising benefit, conducted in acute emergency situations with short therapeutic time windows, should allow randomization under deferred consent or waiver of consent. Making progress in knowledge of treatment in acute neurological and other intensive care conditions is only possible if national regulations and legislations allow waiver of consent or deferred consent for clinical trials.

Links

PhilArchive



    Upload a copy of this work     Papers currently archived: 74,480

External links

Setup an account with your affiliations in order to access resources via your University's proxy server

Through your library

Analytics

Added to PP
2009-01-28

Downloads
32 (#362,084)

6 months
1 (#417,896)

Historical graph of downloads
How can I increase my downloads?