Broad Consent for Research With Biological Samples: Workshop Conclusions

Different types of consent are used to obtain human biospecimens for future research. This variation has resulted in confusion regarding what research is permitted, inadvertent constraints on future research, and research proceeding without consent. The National Institutes of Health (NIH) Clinical Center's Department of Bioethics held a workshop to consider the ethical acceptability of addressing these concerns by using broad consent for future research on stored biospecimens. Multiple bioethics scholars, who have written on these issues, discussed the reasons for consent, the range of consent strategies, and gaps in our understanding, and concluded with a proposal for broad initial consent coupled with oversight and, when feasible, ongoing provision of information to donors. This article describes areas of agreement and areas that need more research and dialogue. Given recent proposed changes to the Common Rule, and new guidance regarding storing and sharing data and samples, this is an important and timely topic.     

生物样本泛知情同意的撤回权及相关问题探讨

泛知情同意的撤回权是指通过泛知情同意模式参加生物样本库的捐献者具有随时撤销其泛知情同意的权利,其在国内外都有相应的法律与道德基础。明确这一权利符合捐献者、生物样本库等多方的长远利益,既能更好地保护捐献者,也对生物样本库建设有重要意义。一般情况下,捐献者可随时向生物样本库撤回泛知情同意,然而在涉及国家利益、干细胞治疗、样本去识别等特殊情况时,撤回权将受到一定限制。此外,我们提出信息交互平台的建设是泛知情同意撤回管理的优化策略,为有关机构进一步健全泛知情同意撤回制度和加强实践指导提供理论依据。

     

知情同意—患者的权利与困境

知情同意是目前被广为认可的一项病人权利。从历史渊源看,它可以分为出于医生权威的知情同意与出于尊重患者人格、尊严、个性化权利的知情同意。尽管东西方对权利主体的强调不一致,但都是出于医疗行善的目的。这并不一定能保证病人的真正利益。现实中,有必要对这一权利做一定的限制。     

Informed Consent

Summary

This article focuses on informed consent and the components to be reviewed with clients in the first session or as early as possible thereafter. Recent changes that give patients greater autonomy in the treatment process are also presented. The process of obtaining informed consent or informed refusal places a new responsibility on the practitioner. Informed consent as it pertains to clinical practice, supervision and training, and psychological research is also discussed.     

Harming Consent

I argue that Nafsika Athanassoulis fails to establish the main contention of her paper (“The Role of Consent in Sado-MasochisticPractices”, Res Publica 8, 2 (2002)), namely that, given liberalism, consent should be a defence to a charge of assault occasioning actual bodily harm even when the harm is a consequence of a sado-masochistic encounter. This revised version was published online in August 2006 with corrections to the Cover Date.