Alternative consent models for biobanks: The new spanish law on biomedical research

Bioethics

Volumn 22, Issue 8, 2008, Pages 440-447

  Da Rocha, Antonio Casado ^a   Seoane, José Antonio ^b  

^a UNIVERSITY OF THE BASQUE COUNTRY UPV EHU   (Spain)

^b UNIVERSITY OF A CORUÑA   (Spain)

Author keywords

Biobanks; Biomedical Research Act; Consent; Spain

Indexed keywords

ARTICLE; ETHICS; GENETICS; HEALTH CARE FACILITY; HUMAN; INFORMED CONSENT; LEGAL ASPECT; MEDICAL RESEARCH; NONBIOLOGICAL MODEL; SPAIN;

BIOLOGICAL SPECIMEN BANKS; BIOMEDICAL RESEARCH; GENETIC RESEARCH; HUMANS; INFORMED CONSENT; MODELS, ORGANIZATIONAL; SPAIN;

EID: 51349133577     PISSN: 02699702     EISSN: 14678519     Source Type: Journal    
DOI: 10.1111/j.1467-8519.2008.00673.x     Document Type: Article

References (44)

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26. E.g. some of the sources of harm identified by Maschke, op. cit. note 18.
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33. Helgesson et al., op. cit. note 2. See also Andorno, op. cit. note 26.
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36. Á. de Cózar. 2007. Arranca la Ley Más Paradójica. El País 5 July: 46.
37. It is generally considered that strengthening the relationship between research projects is a good thing in the context of R&D policies, so at least one thing is for sure: this condition of 'project relatedness' is not neutral or value-free.
38. Shickle, op. cit. note 12.
39. Wendler, op. cit. note 28.
40. Comité de Ética del Instituto de Investigación de Enfermedades Raras (IIER). Recomendaciones sobre los aspectos éticos de las colecciones de muestras y bancos de materiales humanos con fines de investigación biomédica. Rev Esp Salud Publica 2007 81 (2 95 111
41. D.L. Dickenson. Cross-cultural Issues in European Bioethics. Bioethics 1999 13 : 249 255.
42. IIER, op. cit. note 38, p. 101, 108. The Research Ethics Committee may approve using existing samples without explicit consent provided the conditions a-d described in the Spanish law are met. See Biomedical Research Act, note 33, Second Transitional Provision.
43. D.L. Dickenson. Cross-cultural Issues in European Bioethics. Bioethics 1999 13 : Ibid: 102 & 105. Opting out does not necessarily involve the destruction of previous data. See also Biomedical Research Act, note 33, Art. 60.3. In case of deceased persons without explicit objections, samples may be used without consent, but the IIER recommends that relatives or other proxies should be informed about the proposed use of the sample, and their consent sought. (Ibid: 107.)
44. The new Spanish law may still allow for those samples to be transferred to other research projects, provided the relevant Research Ethics Committee authorizes their request. See also Biomedical Research Act, note 33, Art. 69.