生物样本库泛知情同意在中国的实践与思考

Practice and Reflection on Broad Informed Consent for Biobanks in China

结合《涉及人的生命科学和医学研究伦理审查办法》等相关法律,对生物样本及相关信息二次使用的泛知情同意的引入、要素以及在中国的合法性进行了探讨。首先,泛知情同意是生物样本及相关信息二次使用知情同意在特定情形下的一种替代方式,并不是免除知情同意;其次,泛知情同意本身往往只是出于保藏的具体目的,不能等同于个人对未来研究的具体目的的同意;最后,通过管理制度,由机构伦理委员会对特定目的和必要性进行把关,不能等同于取得了个人对该具体目的的同意。因此,泛知情同意在我国现行法律框架下可能缺乏充分的法律依据。

This paper discusses the introduction,elements and legality of broad informed consent for the secondary use of biospecimen and related information according to"Ethical Review Measures for Life Science and Medical Research Involving Humans".First of all,broad informed consent is an alternative to specific informed consent for the secondary use of biospecimen and related information in a specific situation,and does not exempt the need for informed consent;Secondly,broad informed consent itself is usually for the specific purpose of preservation,and cannot be equated with an individual's consent to the specific purpose in future research;Thirdly,through the management system,institutional ethics committee should review specific purpose and necessity,and obtaining broad informed consent does not equate to obtaining the consent of an individual to specific purpose.Therefore,broad informed consent may lack sufficient legal basis under the current legal framework in China.