Research Guideline Recommendations for Broad Consent Forms in Biobank Research and How They Are Currently Addressed in Practice

Author:

Strech Daniel,Kahrass Hannes,Hirschberg Irene

Publisher

Informa UK Limited

Subject

Health Policy,Issues, ethics and legal aspects

Reference9 articles.

1. Council for International Organizations of Medical Sciences. 2002. International ethical guidelines for biomedical research involving human subjects. Geneva, Switzerland: CIOMS. Available at: http://www.cioms.ch/publications/guidelines/guidelines_nov_2002_blurb.htm (accessed June 26, 2013).

2. Council of Europe. 1997. Convention for the protection of human rights and dignity of the human being with regard to the application of biology and medicine: Convention on human rights and biomedicine. Strasbourg Council of Europe. Available at: http://conventions.coe.int/Treaty/EN/Treaties/Html/164.htm (accessed June 26, 2013).

3. European Medicines Agency. 2002. CPMP/ICH/135/95 Guideline for good clinical practice, ICH Topic E 6 (R1). London, UK: EMA. Available at: http://www.emea.europa.eu/docs/en_GB/document_library/Scientific_guideline/2009/09/WC500002874.pdf (accessed June 26, 2013).

4. European Parliament and the Council of the European Union. 2001 Directive 2001/20/EC 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. Luxembourg. Available at: http://eur-lex.europa.eu/LexUriServ/LexUriServ.do?uri=OJ:L:2001:121:0034:0044:EN:PDF (accessed June 26, 2013).

5. Broad Consent for Research With Biological Samples: Workshop Conclusions

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