La sperimentazione in soggetti in coma: problematiche etiche e giuridiche
Published: April 30, 2005
Abstract Views: 382
PDF (Italiano): 3
Publisher's note
All claims expressed in this article are solely those of the authors and do not necessarily represent those of their affiliated organizations, or those of the publisher, the editors and the reviewers. Any product that may be evaluated in this article or claim that may be made by its manufacturer is not guaranteed or endorsed by the publisher.
All claims expressed in this article are solely those of the authors and do not necessarily represent those of their affiliated organizations, or those of the publisher, the editors and the reviewers. Any product that may be evaluated in this article or claim that may be made by its manufacturer is not guaranteed or endorsed by the publisher.
Authors
Ricercatrice, .
Dottoranda di ricerca, Centro di Studio e di Ricerca di Bioetica, Cattedra
di Medicina Legale, Università degli Studi di Brescia, Italy.
----------
The inclusion of a person in a clinical trial, as a rule, needs his/her free and informed consent. Complex ethical and legal questions emerge when the person to include in a clinical trial in uncapable of giving legal consent, i. e. when he/she is uncounscious. According to national and international rules and documents (art. 54 c.p.; Convention for the Protection of Human Rights and Dignity of the Human Being with Regard to the Application of Biology and Medicine; GCP - D.M. 15 luglio 1997; Declaration of Helsinki (WMA) International Ethical Guidelines for Biomedical Research involving Human Subjects (CIOMS) including such a person in a clinical trial can be justified in emergency or with the consent of patient's legal representative. We have to verify, in order to pick out a scope for medical research in these hypotheses, apart from emergency and legal representation, the possibility of other "admissibility standards": advance directives and /or substituted decision-maker, and the reversibility of a coma, i. e. the possibility for the patient to heal or be better as a condition for the conduct of clinical trial as an operation intended to recover patient's consciousness. All considerations about inclusion of unconscious persons in clinical trials have to be founded in the consideration that the interest of the patient always prevail over those of science and society, much more if the patient is unable to exercise his/her consent to dispose of his/her body, and then in need of special protection.
How to Cite
PAGEPress has chosen to apply the Creative Commons Attribution NonCommercial 4.0 International License (CC BY-NC 4.0) to all manuscripts to be published.
An Open Access Publication is one that meets the following two conditions:
- the author(s) and copyright holder(s) grant(s) to all users a free, irrevocable, worldwide, perpetual right of access to, and a license to copy, use, distribute, transmit and display the work publicly and to make and distribute derivative works, in any digital medium for any responsible purpose, subject to proper attribution of authorship, as well as the right to make small numbers of printed copies for their personal use.
- a complete version of the work and all supplemental materials, including a copy of the permission as stated above, in a suitable standard electronic format is deposited immediately upon initial publication in at least one online repository that is supported by an academic institution, scholarly society, government agency, or other well-established organization that seeks to enable open access, unrestricted distribution, interoperability, and long-term archiving.
Authors who publish with this journal agree to the following terms:
- Authors retain copyright and grant the journal right of first publication with the work simultaneously licensed under a Creative Commons Attribution License that allows others to share the work with an acknowledgement of the work's authorship and initial publication in this journal.
- Authors are able to enter into separate, additional contractual arrangements for the non-exclusive distribution of the journal's published version of the work (e.g., post it to an institutional repository or publish it in a book), with an acknowledgement of its initial publication in this journal.
- Authors are permitted and encouraged to post their work online (e.g., in institutional repositories or on their website) prior to and during the submission process, as it can lead to productive exchanges, as well as earlier and greater citation of published work.