Biobanks-When is Re-consent Necessary?

被引:29
作者
Steinsbekk, Kristin Solum [1 ]
Solberg, Berge [1 ]
机构
[1] Norwegian Univ Sci & Technol NTNU, DMF, ISM, Dept Publ Hlth & Gen Practice,Fac Med, N-7491 Trondheim, Norway
关键词
STORED BIOLOGICAL SAMPLES; INFORMED-CONSENT; RESEARCH ETHICS; PUBLIC-HEALTH; BROAD CONSENT; INFORMATION; BENEFITS; SOCIETY; SCIENCE; MODEL;
D O I
10.1093/phe/phr031
中图分类号
B82 [伦理学(道德学)];
学科分类号
摘要
The unknown nature of tomorrow's research makes informed consent in biobank research a challenge. Whether the consent given by biobank participants is 'broad' or 'narrow', the ever present question remains the same: are new activities covered by the original consent? In this article, we focus on the meaning of, and the relation between, broad consent and re-consent in biobank research. We argue that broad consent should be understood as consenting to a framework-a framework which covers aims, core conditions for acceptable use, governance and how these affect participants. Changes that alter the framework in a fundamental way call for re-consent. Three biobank cases of current international interest are used to debate when re-consent is an ethical necessity: whole-genome sequencing, data sharing and commercial utilization. These reflections give us a more nuanced view on what consent is for. We claim that the introduction of broad consents in biobank research has not represented a betrayal of individual participant interests, as some critics have asserted. Broad consents combined with the possible use of re-consent are in certain settings not inferior, but rather ethically superior to narrow consents. In population-based research biobanks, they allow for a reconciliation between individual interest and public matters in society at large.
引用
收藏
页码:236 / 250
页数:15
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