National Core for Neuroethics, Division of Neurology, the University of British Columbia, 2211 Wesbrook Mall, Koerner S124, Vancouver, BC V6T 2B5, Canada.
Int J Law Psychiatry. 2012 Mar-Apr;35(2):146-52. doi: 10.1016/j.ijlp.2011.12.003. Epub 2012 Feb 2.
In this paper we examine imaging research involving first-episode schizophrenic treatment-naive individuals (FESTNIs) through a legal human rights lens; in particular, the lens of the Additional Protocol to the Convention on Human Rights and Biomedicine Concerning Biomedical Research. We identify a number of ethical and legal hot spots highlighted by the Protocol, and offer a series of recommendations designed to ensure the human rights compatibility of this research. Subsequently, we argue that the lack of reporting on design elements related to ethical concerns frustrates commitments at the heart of the human rights approach, namely, transparency and openness to international scrutiny. To redress this problem, we introduce two norms for the first time: ethical transparency, and ethical reproducibility. When concluding, we offer a set of reporting guidelines designed to operationalize these norms in the context of imaging research involving FESTNIs. Though we will not make this case here, we believe that parallel reporting guidelines should be incorporated into other areas of research involving human subjects.
本文从法律人权的角度,特别是从《人权与生物医学公约关于生物医学研究的附加议定书》的角度,审视了针对首次发作的未经治疗的精神分裂症患者(FESTNIs)的影像学研究。我们确定了该议定书所强调的一些道德和法律热点,并提出了一系列建议,旨在确保这项研究符合人权标准。随后,我们认为,缺乏对与伦理问题相关的设计元素的报告,这使得人权方法的核心承诺,即透明度和接受国际监督,受到了阻碍。为了解决这个问题,我们首次引入了两个规范:伦理透明度和伦理可重复性。在结论部分,我们提供了一套报告指南,旨在将这些规范应用于涉及 FESTNIs 的影像学研究中。虽然我们在这里不会讨论这个问题,但我们认为,类似的报告指南也应该纳入涉及人类受试者的其他研究领域。