Research on human biological materials and the council of Europe: Some unanswered questions, overlaps and empty boxes

European Journal of Health Law

Volumn 15, Issue 1, 2008, Pages 1-6

  Nys, Herman ^a  

^a Centre for Biomedical Ethics and Law   (Belgium)

Author keywords

[No Author keywords available]

Indexed keywords

BIOMATERIAL;

ACCESS TO INFORMATION; CONFIDENTIALITY; EDITORIAL; ETHICS; EUROPEAN UNION; INFORMED CONSENT; LAW; LAW ENFORCEMENT; MEDICAL RESEARCH; POLICY; PRACTICE GUIDELINE; PUBLICATION; TISSUE PRESERVATION;

EID: 44349189771     PISSN: 09290273     EISSN: 15718093     Source Type: Journal    
DOI: 10.1163/092902708X292460     Document Type: Editorial

References (11)

1. A final explanatory memorandum is not available on the website of the Council of Europe. However, there appears to be only slight differences between the final draft recommendation and the recommendation itself so that it is justified to use the draft explanatory memorandum to clarify the object and the purpose of the recommendation and to better understand the scope of its provisions. It should be noted however that the explanatory memorandum is not an authoritative interpretation of the Recommendation.
2. The only known article that is entirely dealing with the Rec is S.H.E. Harmon, "The Recommendation on research on biological materials of human origin: another brick in the wall", European Journal of Health Law, 2006, 293-301. Lots of other articles refer to it at different places as a source of information but without discussing it.
3. This Additional Protocol has entered into force on 1 September 2007 after the fifth ratification notably by Bosnia and Herzegovina. The other 4 ratifying States are Bulgaria, Greece, Slovakia and Slovenia.
4. Explanatory memorandum to the Recommendation, §16.
5. Explanatory memorandum to the Additional Protocol, §19.
6. Ironically §3 of the explanatory memorandum to the Recommendation points out that the "revised Declaration of Helsinki states that biomedical research involving human subjects includes research on identifiable human material, specific provisions on the principles of the Declaration that should apply in practice to the research use of biological materials are not included". The Recommendation suffers of the same deficiency.
7. Explanatory memorandum to the Recommendation, §44.
8. Not always e.g. hair, nails, urine.
9. Explanatory memorandum to the Recommendation, § 43.
10. Explanatory memorandum to the Recommendation, §80 .
11. Explanatory memorandum to the Recommendation, §81.