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2018 | OriginalPaper | Buchkapitel

9. The Valorization of Tumor Collections: Reconciling the Interests of the Different Actors

verfasst von : Emmanuelle Rial-Sebbag

Erschienen in: Public Regulation of Tumor Banks

Verlag: Springer International Publishing

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Abstract

Tumor banks are at the heart of many expectations, hopes, and objectives, and must consider the often-contradictory interests of the different actors wishing to ensure best use is made of collections of human biological material. These actors include:
  • People who want to know their medical status (patients and their families) but who want to be sure medical practitioners and researchers respect their informed consent when accessing their sample and information stored in tumor banks;
  • People who produce and use medical information (medical practitioners, researchers, professional societies), who question how this information is produced and provided;
  • People who finance research and development, who want optimal use to be made of these resources, or even to make a profit from them;
  • People who supply biological samples and associated data (managers of collections or biological resource centers), who want to maximize the use and development of their resources;
  • People who control biological resources (public control structures, public health decision-makers), for whom assessing the risks associated with using samples is paramount;
  • Civil society, which influences the acceptability of the development of biobanks.

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Fußnoten
1
Loi n° 2002-303 du 4 mars 2002 relative aux droits des malades et à la qualité du système de santé modifiée, Loi n° 2012-300 du 5 mars 2012 relative aux recherches impliquant la personne humaine modifiée par l’ordonnance n° 2016-800 du 16 juin 2016.
 
2
According to the so-called “Pharmacogenetics”.
 
3
Article L1111-2 Public Health Code: “Everyone has the right to be informed about his health. This information relates to the various investigations, treatments or preventive actions that are proposed, their usefulness, their possible urgency, their consequences, the frequent or serious risks that are normally foreseeable, as well as the other possible solutions and the foreseeable consequences in case of refusal (…)”.
 
4
Article L1131-1-2 Public Health Code.
 
5
Article 16-10 Civil Code: “Examination of the genetic characteristics of a person can only be undertaken for medical or scientific research purposes.
The express consent of the person must be obtained in writing prior to the completion of the examination, after being duly informed of its nature and purpose. The consent mentions the purpose of the examination. It is revocable without form and at any time.”
 
6
Article L1211-2 al.2: “The use of elements and products of the human body for a medical or scientific purpose other than that for which they were collected or collected is possible, unless opposed by the person on whom the collection took place, duly informed beforehand of this other purpose.”
 
7
Loi n° 2012-300 du 5 mars 2012 op. cit., entered into force in 2016.
 
8
Opt-out system implemented by Article L1131-1-1 Public Health Code: “Notwithstanding Article 16-10 of the Civil Code and the first paragraph of Article L. 1131-1 of this Code, the examination of the genetic characteristics of a person for the purposes of scientific research may be carried out from elements of the body of that person taken for other purposes when that person, duly informed of the research project, has not expressed his opposition.”
 
9
AFNOR, NF S96-900 Septembre 2011, Qualité des centres de ressources biologiques (CRB)—Système de management d’un CRB et qualité des ressources biologiques.
 
10
Articles L1243-3 and L1243-4 Public Health Code.
 
11
AFNOR op. cit.
 
12
We acknowledge here that a link between the donor and his identification is still existing.
 
13
Lois du 29 juillet 1994, op. cit.
 
14
These principles are: primacy and dignity of the human person, respect, inalienability and non-commercialization of the human body, Article 16-1 of the Civil Code.
 
16
Directive 96/9/EC of The European Parliament and of The Council of 11 March 1996 on the legal protection of databases.
 
17
Regulation (EU) 2016/679 of the European Parliament and of the Council of 27 April 2016 on the protection of natural persons with regard to the processing of personal data and on the free movement of such data, and repealing Directive 95/46/EC (General Data Protection Regulation).
 
18
World Medicla Association, Declaration of Taipei / Research on Health Databases, Big Data and Biobanks, https://​www.​wma.​net/​policies-post/​wma-declaration-of-taipei-on-ethical-considerations-regarding-health-databases-and-biobanks/​.
 
19
Article 16-5 Civil Code.
 
20
Article 16-6 Civil Code.
 
21
Additional rights are granted to individuals: access, rectification, to be forgotten, portability.
 
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Metadaten
Titel
The Valorization of Tumor Collections: Reconciling the Interests of the Different Actors
verfasst von
Emmanuelle Rial-Sebbag
Copyright-Jahr
2018
DOI
https://doi.org/10.1007/978-3-319-90563-1_9

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