Sáenz de Tejada López M, Valle Mansilla J I, Ruiz-Canela M
Hospital Clínico San Carlos, Madrid.
Cuad Bioet. 2010 Jan-Apr;21(71):95-108.
whenever biological samples are requested for genomic research consent from donors is always needed. in this process, appropriate information offered to participants is essential. the aim of this study is to assess the information included in consent forms from genomic studies.
a 51-item checklist was used to perform a content analysis of consent forms offered to sample donors. We included all consent forms used in genomic research projects approved by an Ethics Review Committee between 2004 and 2007.
consent forms from 68 genomic studies were reviewed. 58 (85%) of those were international studies and promoted by the pharmaceutical industry. We found some important deficiencies in the consent forms on the information related to the sample's use: less than 50% mentioned aspects related to the ownership of the sample, the free donation of the sample or the place of sample storage. There have also been frequent omissions related to the genetic data such as the right to know the results of the research, the disclosure of information to family members or the length of time during which these genetic data will be stored.
important omissions have been found in the assessed consent forms on aspects related to the use of samples and genetic data. Therefore, a substantial improvement should be undertaken in the consent forms in order to comply both with the requirements established in the Spanish biomedical law and the ethical demands.
每当需要为基因组研究采集生物样本时，都必须获得捐赠者的同意。在此过程中，向参与者提供适当的信息至关重要。本研究的目的是评估基因组研究知情同意书中包含的信息。
使用一份包含51个条目的清单对提供给样本捐赠者的知情同意书进行内容分析。我们纳入了2004年至2007年间经伦理审查委员会批准的基因组研究项目中使用的所有知情同意书。
对68项基因组研究的知情同意书进行了审查。其中58项（85%）是国际研究，由制药行业推动。我们发现知情同意书中关于样本使用相关信息存在一些重要缺陷：不到50%提及与样本所有权、样本免费捐赠或样本存储地点相关的方面。在遗传数据方面也经常存在遗漏，如了解研究结果的权利、向家庭成员披露信息或这些遗传数据将存储的时长。
在所评估的知情同意书中，发现了与样本和遗传数据使用相关方面的重要遗漏。因此，应大幅改进知情同意书，以符合西班牙生物医学法律规定的要求和伦理要求。
