Boddington Paula, Curren Liam, Kaye Jane, Kanellopoulou Nadja, Melham Karen, Gowans Heather, Hawkins Naomi
HeLEX Centre for Health, Law and Emerging Technologies, Department of Public Health, University of Oxford, Oxford OX3 7LF, UK.
Eur J Health Law. 2011 Dec;18(5):491-519. doi: 10.1163/157180911x598744.
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.
同意书是从生物医学研究参与者那里获得知情同意的主要方式。随着对现有研究样本和信息进行越来越多的二次研究,并且样本被存放在许多研究人员都可访问的生物样本库中,这些同意书的重要性日益增加。我们审查了欧洲全基因组关联研究(GWAS)中使用的一系列同意书,并确定了每份同意书中都存在的四个共同要素。我们的分析表明,在我们的知情同意书样本中最常出现的四个要素中,只有两个是英国法律所要求的。这就引发了关于研究参与者的知情同意书中应包含哪些内容的问题。这些发现可能有助于未来研究中制定参与者信息和同意文件。