Wright Megan S, Ulrich Michael R, Fins Joseph J
Kennedy Inst Ethics J. 2017;27(1):43-70. doi: 10.1353/ken.2017.0003.
We review relevant federal law about research on human subjects and state laws on guardian authority to determine whether guardians can consent on behalf of their wards to participation in research. The Common Rule is silent on the issue as are most state guardianship laws. Our analysis shows significant variation in guardians' decision-making authority in the states that do regulate wards' participation in research.We consider how the appointment of guardians for patients with disorders of consciousness (DOC) impacts such patients' access to research. We assert that it is important that such persons be permitted to participate in research, so that their conditions and potential medical interventions can be studied, and that those with similar conditions can benefit from the knowledge gained from these studies. We argue that state guardianship laws should be adapted to specifically give guardians the authority to consent to research on behalf of wards who may be able to regain decisional capacity.
我们审查了有关人体研究的相关联邦法律以及关于监护人权力的州法律，以确定监护人是否可以代表其受监护人同意参与研究。《通用规则》对此问题未作规定，大多数州的监护法律也是如此。我们的分析表明，在确实对受监护人参与研究进行规范的州，监护人的决策权存在很大差异。我们考虑为意识障碍（DOC）患者指定监护人如何影响此类患者参与研究的机会。我们断言，允许此类人员参与研究非常重要，这样可以对他们的病情和潜在的医学干预措施进行研究，并且患有类似病症的人可以从这些研究中获得的知识中受益。我们认为，州监护法律应进行调整，专门赋予监护人代表可能恢复决策能力的受监护人同意参与研究的权力。
