David Bourget (Western Ontario)
David Chalmers (ANU, NYU)
Rafael De Clercq
Ezio Di Nucci
Jack Alan Reynolds
Learn more about PhilPapers
Science and Engineering Ethics 13 (3):371-381 (2007)
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.
|Keywords||Clinical ethics Proxy consent Waiver of consent Deferred consent Traumatic brain injury Pharmacological trial|
|Categories||categorize this paper)|
Setup an account with your affiliations in order to access resources via your University's proxy server
Configure custom proxy (use this if your affiliation does not provide a proxy)
|Through your library|
References found in this work BETA
C. E. Blixen (2005). Stroke Patients' Preferences and Values About Emergency Research. Journal of Medical Ethics 31 (10):608-611.
Citations of this work BETA
No citations found.
Similar books and articles
Andrew D. McRae & Charles Weijer, Lessons From Everyday Lives: A Moral Justification for Acute Care Research.
Piotr Zaborowski & Adam Górski (2004). Informed Consent and the Use of Placebo in Poland: Ethical and Legal Aspects. Science and Engineering Ethics 10 (1):167-178.
Andrew D. McRae, Stacy Ackroyd-Stolarz & Charles Weijer, Risk in Emergency Research Using a Waiver of/Exception From Consent: Implications of a Structured Approach for Institutional Review Board Review.
Michelle H. Biros (2007). Research Without Consent: Exception From and Waiver of Informed Consent in Resuscitation Research. Science and Engineering Ethics 13 (3):361-369.
David Wendler (2009). Must Research Participants Understand Randomization? American Journal of Bioethics 9 (2):3 – 8.
Joanna Różyńska & Marek Czarkowski (2007). Emergency Research Without Consent Under Polish Law. Science and Engineering Ethics 13 (3):337-350.
Ritva Halila (2007). Assessing the Ethics of Medical Research in Emergency Settings: How Do International Regulations Work in Practice? Science and Engineering Ethics 13 (3):305-313.
Piotr S. Iwanowski (2007). Informed Consent Procedure for Clinical Trials in Emergency Settings: The Polish Perspective. Science and Engineering Ethics 13 (3):333-336.
Added to index2009-01-28
Total downloads12 ( #287,071 of 1,796,321 )
Recent downloads (6 months)1 ( #467,624 of 1,796,321 )
How can I increase my downloads?