Data storage and DNA banking for biomedical research: informed consent, confidentiality, quality issues, ownership, return of benefits. A professional perspective

• Published in: European journal of human genetics : EJHG Vol. 11; no. S2; pp. S88 - S122
• Main Authors: Godard, Béatrice, Schmidtke, Jörg, Cassiman, Jean-Jacques, Aymé, Ségolène
• Format: Journal Article
• Language: English
• Published: England Nature Publishing Group 01.12.2003
• Subjects: Biomedical Research; Childrens health; Collections; Conferences; Confidentiality; Consent; Cooperation; Data collections; Deoxyribonucleic acid; DNA; Ethics; Europe; Genetic testing; Genetics; Hospitals; Humans; Information storage; Information Storage and Retrieval - ethics; Information Storage and Retrieval - standards; Informed Consent; International cooperation; Laboratories; Legal medicine; Medicine; Ownership; Quality Assurance, Health Care; Standardization; Europe; France; Genetics and Reproduction; Biomedical and Behavioral Research
• ISSN: 1018-4813; 1476-5438
• DOI: 10.1038/sj.ejhg.5201114

The purpose of this paper is to formulate a professional and scientific view on the social, ethical, and legal issues that impact on data storage and DNA banking practices for biomedical research in Europe. Many aspects have been considered, such as the requirements for data storage and DNA banking in the public and private sectors in Europe and the issues relating to DNA banking, that is to say the consent requirements for the banking and further uses of DNA samples, their control and ownership, and the return of benefit derived from DNA exploitation to the community. The methods comprise primarily the review of the existing professional guidelines, legal frameworks and other documents related to the data storage and DNA banking practices in public and private sectors in Europe. Then, the issues related to DNA banking were examined during an international workshop organized by the European Society of Human Genetics Public and Professional Policy Committee in Paris, France, 07-08, April, 2000. A total of 50 experts from 12 European countries attended this workshop. It came out that DNA banking for medical and research purposes is indispensable. It facilitates the constitution of large collections, sharing of samples, multiple testing on the same samples, and repeating testing over the years. However, banking organization is complex, requires multiple actors, and concerns are expressed in various countries. International standardization of ethical requirements and policies with regard to DNA banking has been recommended. Such standardization would facilitate a greater protection of individuals as well as future international cooperation in biomedical research.