Consent to medical research of vulnerable subjects from the French point of view: The example of consent in research in the case of Alzheimer disease

Medicine and Law

Volumn 30, Issue 4, 2011, Pages 613-627

  Duguet, Anne Marie ^a   Boyer Beviere, Bénédicte ^b  

^a INSERM   (France)

^b UNIVERSITÉ DE FRANCHE COMTÉ   (France)

Author keywords

Alzheimer; Autonomy; Ethics In Research; Incompetent Patient; Informed Consent

Indexed keywords

ADULT; ALZHEIMER DISEASE; ARTICLE; ETHICS; FRANCE; HUMAN; HUMAN EXPERIMENT; HUMAN RIGHTS; INFORMED CONSENT; LEGAL ASPECT; MEDICAL ETHICS; PERSONAL AUTONOMY; VULNERABLE POPULATION;

ADULT; ALZHEIMER DISEASE; FRANCE; HELSINKI DECLARATION; HUMAN EXPERIMENTATION; HUMAN RIGHTS; HUMANS; INFORMED CONSENT; PERSONAL AUTONOMY; VULNERABLE POPULATIONS;

EID: 84856540310     PISSN: 07231393     EISSN: None     Source Type: Journal    
DOI: None     Document Type: Article

References (30)

1. WHO-CIOMS Ethical Guideline n13: http://www.cioms.ch/frame_guidelines_nov_2002.Htm
2. http://www.wma.net/en/30publications/10policies/b3/
3. CIOMS International Ethical Guidelines for Biomedical Research Involving Human Subject http://www.cioms.ch/publications/layout_guide2002.pdf
4. Oviedo Convention, 4 April 1997 http://www.coe.int/t/dg3/healthbioethic/Activities/01_Oviedo%20Convention/
5. Article 6 - Protection of individuals not able to consent to medical intervention. Subject to Articles 17 and 20 below, an intervention may only be carried out on an individual who does not have the capacity to consent, for his or her direct benefit. Where, according to law, a minor does not have the capacity to consent to an intervention, the intervention may only be carried out with the authorization of his or her representative or an authority or an individual or body provided for by law. The opinion of the minor shall be taken into consideration as an increasingly determining factor in proportion to his or her age and degree of maturity. Where, according to law, an adult does not have the capacity to consent to an intervention because of a mental disability, a disease or for similar reasons, the intervention may only be carried out with the authorization of his or her representative or an authority or a individual or body provided for by law.
6. The individual concerned shall as far as possible take part in the authorization procedure. The representative, the authority, the individual or the body mentioned in paragraphs 2 and 3 above shall be given, under the same conditions, the information referred to in Article 5. The authorization referred to in paragraphs 2 and 3 above may be withdrawn at any time in the best interests of the individual concerned. Article 7 - Protection of individuals who have a mental disorder. Subject to protective conditions prescribed by law, including supervisory, control and appeal procedures, an individual who has a mental disorder of a serious nature may be subjected, without his or her consent, to an intervention aimed at treating his or her mental disorder only where, without such treatment, serious harm is likely to result to his or her health.
7. On the approximation of the laws, regulations and administrative provisions of the Member States relating to the implementation of good clinical practice in the conduct of clinical trials on medicinal products for human use http://ec.europa.eu/health/human-use/clinicaltrials/index_en.htm.
8. From the name of the two senators who presented the law to the assemblies.
9. The civil code protects the administration of patrimony and goods. The Judge designates a legal representative for the adult who needs to be protected because he or she is not more capable to defend his or her interests (art 488).
10. Law of 5 March 2007 and article 425 of the Civil Code.
11. Article 440 of the Civil Code.
12. 2004-806 law concerning public health policy.
13. Law 2002-303 of March 2002, on patients rights and quality of health system JO 5 March 2002 and Arrêté of March 5, 2004 OJ of 17 March 2004 for approval of recommendations of good practice on access to health information.
14. http://www.plan-alzheimer.gouv.fr/-un-engagement-politique-fort-.html
15. http://www.plan-alzheimer.gouv.fr
16. This plan is financed in the amount of 1.6 billion Euros by the State, the Health Insurance scheme and the French national funding agency for the elderly and handicapped. http://www.plan-alzheimer.gouv.fr/IMG/pdf/planalzheimer-2008-2012.pdf
17. A-M. Duguet., 1997., http://www.sante.gouv.fr/IMG/ppt/duguet.ppt
18. http://www.plan-alzheimer.gouv.fr/measure-no41.html
19. In order to ensure that patients are informed about research protocols and have equal access to them, we propose that information about all the research currently under way in France be published on the National Observatory for Alzheimer's Disease Research (Observatoire national de la recherche sur la maladie d'Alzheimer, ONRA) website, in association with the France Alzheimer site.
20. Avis n° 58 12 june, 1998 www.ccne-ethique.org in French and in English.
21. C Dumont, D Rolland, B Vellas, « Maladie d'Alzheimer, consentement et éthique » in « Droit et éthique de la recherche biomédicale: originalité de la législation Française, limites, et questions éthiques » Les Etudes Hospitalières www.etudes-hospitalieres.fr p 31.
22. Kim SY, Cox C, Caine ED Impaired decision-making ability in Alzheimer's disease and willingness to participate in research. Am J Psychiatry 2002 May; 159 (5) 797-802.
23. Wendler D, Martinez RA, Fairelough D, Sumderland T, Emmanuel E. Views of potential subjects toward proposed regulations for clinical research with adults unable to consent. Am J Psychiatry 2002,159(4) 585-591.
24. Such as the Declaration of Helsinki, and the CIOM recommendations.
25. The Ministry of Health has the right to interrupt or to stop the research program which does not respect the Law, and punitive sanctions can be inflicted to the sponsor or the investigator (art L 1126-1 of the Public health Code).
26. Duguet AM, Laudy D, Hervé CH. Research consent in Alzheimer disease cases: some sharde thoughts between ethics board in France and Canada. Joint meeting, ASBH Conference of Canadian Bioethics Society Montreal October 22-26, 2003.
27. article L 1111-11.
28. art 477 of the civil code.
29. Dementia in Europe. Yearbook 2009 and www.alzheimer-europe.org, www.dementia-ineurope.Eu
30. Wolf M, Gaillard M Herve C. Plaidoyer pour une dimension pluridisciplinaire de la médecine. Presse med. 2000,29,14:793-796.