Tomlinson Tom, De Vries Raymond G
Professor at the Center for Ethics and Humanities in the Life Sciences at Michigan State University.
Professor at the Center for Bioethics and Social Sciences in Medicine at the University of Michigan.
Ethics Hum Res. 2019 Mar;41(2):22-28. doi: 10.1002/eahr.500009.
Contrary to the revised Common Rule, and contrary to the views of many bioethicists and researchers, we argue that broad consent should be sought for anticipated later research uses of deidentified biospecimens and health information collected during medical care. Individuals differ in the kinds of risk they find concerning and in their willingness to permit use of their biospecimens for future research. For this reason, asking their permission for unspecified research uses is a fundamental expression of respect for them as persons and should be done absent some compelling moral consideration to the contrary. We examine three moral considerations and argue that each of them fails: that there is a duty of easy rescue binding on all, that seeking consent creates a selection bias that undermines the validity of biospecimen research, and that seeking and documenting consent will be prohibitively expensive.
与修订后的《通用规则》相反，也与许多生物伦理学家和研究人员的观点相反，我们认为，对于在医疗过程中收集的去标识化生物样本和健康信息，若预期日后会用于研究，应寻求广泛同意。不同个体对他们所关注的风险类型以及允许将其生物样本用于未来研究的意愿存在差异。因此，就未明确的研究用途征求他们的许可，是对他们作为人的尊重的基本体现，并且在没有某些令人信服的相反道德考量的情况下就应该这样做。我们审视了三种道德考量，并认为它们都站不住脚：一是存在对所有人都有约束力的轻松救援义务；二是征求同意会产生选择偏差，从而破坏生物样本研究的有效性；三是征求和记录同意的成本将高得令人望而却步。
