知情同意在生物样本数据库中面临的问题与同意模式之争——对选择同意类型权利的考察

The Biobank Consent Debate: Assessing the Right to Choose Consent Types

生物样本数据库研究难以满足传统知情同意在开展前就告知研究具体目的要求。为了解决该问题,出现了多种不同的同意模式,并发生了"何种同意模式更好?"这一"生物样本数据库同意模式之争"。当下的争论主要发生在宽泛同意-同意治理模式与元同意(meta consent)模式之间。元同意向参与者提供依据自身偏好选择不同同意类型的权利。批评者认为该权利不存在,且赋予参与者依据个人偏好选择的权利会导致滑坡。本文论证参与者有选择同意类型的权利,设置这一权利可以保护参与者的正当偏好,不会导致滑坡。该权利可以从隐私权,以及公民参与科学研究的权利中演绎出。元同意能够以道德物化的形式实现对该权利的保护,但该权利也可以通过诉诸可靠治理实现。因而参与者有选择同意类型的权利,并不意味着元同意模式比宽泛同意-同意治理模式好。可靠的治理要求作为道德行动者的科研人员不完全依靠元同意模式。

Biobank aims to preserve subjects’ sample and data for long-term,uncertain research,this is incompatible with the standard of traditional informed consent.To solve this problem,many different consent models have been provided.There is a debate on which consent model is best for biobank research.Current debate happens between broad consent model and meta consent model.Meta consent model procides options to choose different consent types according to participants’ own preferences.Those who argue against meta consent have critiqued that meta consent provides participants a right that does not exist.Further,the right to choose different consent types based on preferences may leads to slippery slope.The article will argue that participants do have a right to choose different consent types for different data types and there is no slippery slope here.Such right has its roots in the right to privacy and right to science.We further argue that meta consent protected this right by the materialization of morality.But this does not show that meta consent model is better than broad consent model.Reliable governance requires that researchers as moral agents not wholly rely on meta consent model.