化解知情同意模式之争:从公平原则分析

Revolving Biobank Consent Debate Through the Principle of Justice

当代就何种知情同意模式适用于公共层面的生物医学研究的争论中,不同模式的支持者都会援引尊重自主性原则批评彼此并辩护自身。文章表明产生这一悖反的根源在于"尊重自主性"有双重内涵。一是尊重"理性人"的自主性,二是尊重不同个人依据自己的取向进行选择的自主性。尊重"理性人"的自主性要求个人在科研人员每一次使用自己的样本或数据前进行同意授权,随着研究风险的降低以及参与者人群的急剧扩大,"理性人"的标准面临越来越大的困难。"尊重自主性"原则本身缺乏足够的理论资源化解上述困境,"公平"原则可以为此提供助益。

In the current debate around which consent model is ethically acceptable in population level biomedical research, the principle of respecting autonomy has been used to both argue for and against each consent model, including broad consent, dynamic consent and meta consent. The article argues that this is due to the principle of respecting autonomy has two different meanings. One is respecting a reasonable person’s autonomy while the other is respecting different peoples’ preferences. Respecting a reasonable person’s autonomy requires researchers to obtain specific informed consent before any research usages of subject’s sample or data. Such requirement became ever more unsuitable when research risks became minimal and population became large. The principle of respecting autonomy does not have enough theoretical resources to dissolve the above problem. The article draws from the principle of justice to shed light on it.