Researchers' preferences and attitudes on ethical aspects of genomics research: a comparative study between the USA and Spain.

INTRODUCTION: The use of human samples in genomic research has increased ethical debate about informed consent (IC) requirements and the information that subjects should receive regarding the results of the research. However, there are no quantitative data regarding researchers' attitudes about these issues. METHODS: We present the results of a survey of 104 US and 100 Spanish researchers who had published genomic epidemiology studies in 61 journals during 2006. RESULTS: Researchers preferred a broader IC than the IC they had actually obtained in their published papers. US authors were more likely than their Spanish colleagues to support obtaining a broad IC, covering either any future research project or any projects related to a group of diseases (67.6% vs 43%; adjusted OR = 4.84, 95% CI, 2.32 to 10.12). A slight majority of researchers (55.8%) supported informing participants about individual genomic results only if the reliability and clinical validity of the information had been established. Men were more likely than women to believe that patients should be informed of research results even if these conditions were not met (adjusted OR = 2.89, 95% CI = 1.46 to 5.72). CONCLUSIONS: This study provides evidence of a wide range of views among scientists regarding some controversial ethical issues related to genomic research, suggesting the need for more study, debate and education. In the interim, journals might consider including the investigators' policies regarding these ethical issues in the papers they publish in the field of genomic epidemiology.

[Deficiencies in consent forms for genomic research]. / Deficiencias en las Hojas de Información de Estudios Genómicos.

INTRODUCTION: 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. MATERIAL AND METHODS: 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. RESULTS: 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. CONCLUSIONS: 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.