Biomedical research involving patients with disorders of consciousness: ethical and legal dimensions



The directive 2001/20/UE and the research involving patients with docs. Research  involving patients with disorders of consciousness (DOCs) deserves special ethical and  legal attention because of its Janus-faced nature. On the one hand, it raises concerns  about the risk to expose the involved subjects to disproportionate risks not respecting  their individual dignity, particularly their right to be cared for; on the other hand, research  is  an  essential  tool  in  order  to  improve  the  clinical  condition  of  patients  with  DOCs. The present paper concerns the ethical and legal dimensions of biomedical research  involving  patients  with  disorders  of  consciousness.  In  particular,  it  focuses  on  informed consent to experimental treatments, which is a challenging issue both from an  ethical and legal point of view. The first part reads the Directive 2001/20/EU in the light  of the experimentation of patients with DOCs, and suggests a revision in order to better  assess the issue of informed consent.
The particular case of informed consent for observational studies of non-communicative patients. The second part presents an informed consent form for studies through  video-recording of patients unable to communicate their own consent. This form has  been elaborated by the bioethics unit of the project “Review of the nosography of vegetative states: application of methods of behavioral analysis to individuals in coma or  vegetative state” developed at the Italian National Institute of Health.
Relevance of the suggested form. The paper describes the conceptual framework of  the form for informed consent to studies through video-recoding, which is a relevant  example of what issues should be included in an informed consent for any type of studies  through video-recording of patients unable to express their own consent. The article has  been sent on November the 7th 2013, before the adoption of the Regulation (EU) no.  536/2014 (and consequent abrogation of the Directive 2001/20/EU) and the release of  the new edition of the Italian Code of Medical Ethics.

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Michele Farisco

Kathinka Evers

Carlo Petrini

How to Cite
Farisco, M., Evers, K., & Petrini, C. (2014). Biomedical research involving patients with disorders of consciousness: ethical and legal dimensions. Annali dell’Istituto Superiore Di Sanità, 50(3), 221–228. Retrieved from
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