Cambon-Thomsen A, Rial-Sebbag E
Inserm U 558-Epidémiologie et Analyses en Santé Publique, Risques, Maladies Chroniques et Handicaps , Faculté de Médecine, 37, allées Jules-Guesde, 31073 Toulouse Cedex.
Rev Epidemiol Sante Publique. 2003 Feb;51(1 Pt 2):101-10.
Numerous activities in the domain of epidemiology require the constitution or the use of biological sample banks. Such biobanks raise ethical issues. A number of recommendations are applicable to this field, in France and elsewhere. Major principles applicable to biobanks include the respect of person's autonomy, the respect of human body, the respect of confidentiality. These principles are translated into practices through the following procedures: relevant information to the persons regarding their sample management prior to informed consent, opinion of an independent ethics committee, actual implementation of conditions for protecting samples and data. However, although those principles may appear quite simple and obvious, in the context of a largely international practice of research and given the large variety of biobanks, it is not always obvious for researchers to find their way. The attitudes vary between countries, there are numerous texts for various types of biobanks, the same texts raise different interpretations in different institutions, there are new ethical opinions expressed, and mainly the novelty of questions raised by the uses of samples that are possible today, especially in genetics, and were not foreseeable at the time of sampling make the field difficult in practice. This article reviews the types of biobanks, the relevant ethical issues. It also underlines the still unclear or ambiguous situations using some examples of practical situations.
流行病学领域的众多活动都需要建立或使用生物样本库。此类生物样本库引发了伦理问题。在法国及其他地方,有一些建议适用于该领域。适用于生物样本库的主要原则包括尊重个人自主、尊重人体、尊重保密性。这些原则通过以下程序转化为实践:在获得知情同意之前向个人提供有关其样本管理的相关信息、独立伦理委员会的意见、保护样本和数据条件的实际落实。然而,尽管这些原则看似相当简单明了,但在研究基本属于国际实践且生物样本库种类繁多的背景下,研究人员要找到方向并非总是易事。各国态度各异,针对各类生物样本库有众多文本,相同文本在不同机构引发不同解读,有新的伦理观点表达出来,而且主要是如今样本使用所引发问题的新颖性,尤其是在遗传学方面,在采样时无法预见,这使得该领域在实践中颇具难度。本文回顾了生物样本库的类型、相关伦理问题。它还通过一些实际情况的例子强调了仍不明确或模糊的情形。