title: Genomic research with human samples. Points of view from scientists and research subjects about disclosure of results and risks of genomic research. Ethical and empirical approach.
abstract: Biomedical researchers often now ask subjects to donate samples to be deposited in biobanks. This is not only of interest to researchers, patients and society as a whole can benefit from the improvements in diagnosis, treatment, and prevention that the advent of genomic medicine portends. However, there is a growing debate regarding the social and ethical implications of creating biobanks and using stored human tissue samples for genomic research. Our aim was to identify factors related to both scientists and patients' preferences regarding the sort of information to convey to subjects about the results of the study and the risks related to genomic research. The method used was a survey addressed to 204 scientists and 279 donors from the U.S. and Spain. In this sample, researchers had already published genomic epidemiology studies; and research subjects had actually volunteered to donate a human sample for genomic research. Concerning the results, patients supported more frequently than scientists their right to know individual results from future genomic research. These differences were statistically significant after adjusting by the opportunity to receive genetic research results from the research they had previously participated and their perception of risks regarding genetic information compared to other clinical data. A slight majority of researchers 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. Also among patients, almost half of them would always prefer to be informed about individual results from future genomic research. The three main factors associated to a higher support of a non-limited access to individual results were: being from the US, having previously been offered individual information and considering genomic data more sensitive than other personal medical data. Moreover, the disease of patients, the educational level and the patient's country of origin were factors associated with the perception of risks related to genomic information. As a conclusion, it is mandatory to clarify the criteria required to establish when individual results from genomic research should be offered to participants.
authors.affiliation: ignaciovalle@hotmail.com
authors.forename: José Ignacio
authors.initials: JI
authors.lastname: Valle Mansilla
mesh_terms: D001290:Attitude; D005260:Female; D036281:Genetic Research / Q000941:ethics*; D015894:Genome, Human; D006801:Humans; D008297:Male; D008875:Middle Aged; D013030:Spain; D011795:Surveys and Questionnaires; D014481:United States