Godard Béatrice, Schmidtke Jörg, Cassiman Jean-Jacques, Aymé Ségolène
INSERM SC11, Hopital Broussais, Paris, France.
Eur J Hum Genet. 2003 Dec;11 Suppl 2:S88-122. 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.
本文旨在就影响欧洲生物医学研究数据存储和DNA库实践的社会、伦理和法律问题形成专业且科学的观点。已考虑诸多方面，如欧洲公共和私营部门数据存储和DNA库的要求，以及与DNA库相关的问题，即DNA样本库建立及后续使用的同意要求、其管控与所有权，以及将DNA开发所获利益回馈给社会。方法主要包括审查欧洲公共和私营部门与数据存储和DNA库实践相关的现有专业指南、法律框架及其他文件。然后，在2000年4月7 - 8日于法国巴黎由欧洲人类遗传学学会公共与专业政策委员会组织的一次国际研讨会上，对与DNA库相关的问题进行了探讨。来自12个欧洲国家的50名专家参加了此次研讨会。结果表明，用于医学和研究目的的DNA库必不可少。它有助于构建大型样本库、样本共享、对同一样本进行多次检测以及多年来重复检测。然而，建库组织复杂，需要多个行为主体，且各国都表达了关切。有人建议对DNA库的伦理要求和政策进行国际标准化。这种标准化将有助于更好地保护个人以及未来生物医学研究中的国际合作。
