期刊
EUROPEAN JOURNAL OF HEALTH LAW
卷 18, 期 5, 页码 491-519出版社
BRILL ACADEMIC PUBLISHERS
DOI: 10.1163/157180911X598744
关键词
consent; ethical oversight; genomics; regulation; research governance
类别
资金
- EU FP6 Procardis consortium [LSHM-CT-2007-037273]
- EPSRC EnCoRe Project [EP/G002541/1]
- EU FP7 BioSHaRE-EU Project [261433]
- Wellcome Trust Research Fellow [WT081407/Z/06/Z]
- NIHR Biomedical Research Centre, Oxford, UK
- ESRC Administrative Data Liaison Service Project [RES-232-25-004]
Consent forms are the principal method for obtaining informed consent from biomedical research participants. The significance of these forms is increasing as more secondary research is undertaken on existing research samples and information, and samples are deposited in biobanks accessible to many researchers. We reviewed a selection of consent forms used in European Genome-Wide Association Studies (GWAS) and identified four common elements that were found in every consent form. Our analysis showed that only two of the four most commonly found elements in our sample of informed consent forms were required in UK law. This raises questions about what should be put in informed consent forms for research participants. These findings could be beneficial for the formulation of participant information and consent documentation in the future studies.
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