Purpose: Sharing study data within the research community generates tension between two important goods: promoting scientific goals and protecting the privacy interests of study participants. This study was designed to explore the perceptions, beliefs, and attitudes of research participants and possible future participants regarding genome-wide association studies and repository-based research. Methods: Focus group sessions with (1) current research participants, (2) surrogate decision-makers, and (3) three age-defined cohorts (18 -34 years, 35-50, Ͼ50). Results: Participants expressed a variety of opinions about the acceptability of wide sharing of genetic and phenotypic information for research purposes through large, publicly accessible data repositories. Most believed that making de-identified study data available to the research community is a social good that should be pursued. Privacy and confidentiality concerns were common, although they would not necessarily preclude participation. and increased the feasibility of genome-wide association studies (GWAS), and still more comprehensive genomic investigation, in the form of whole-exome research and full genome re-sequencing, is on the horizon. Because the contribution of individual gene variants to common diseases tends to be small, and because more definitive mutations tend to be quite rare, these forms of research require large sample sizes-in some cases, tens of thousands of participants. 1,2 Sharing study data within the research community is an attractive solution to the problem of amassing sufficient datasets; it also promises to increase research efficiencies, maximizing the utility of existing datasets while minimizing participant burden. These benefits have informed policies of the National Institutes of Health (NIH) aimed at promoting data sharing. 3,4 However, making such data available to the research community generates tension between two important goods: advancing scientific goals and protecting the privacy interests of study participants. [5][6][7][8][9] Because every person's DNA is unique, the traditional means of safeguarding research participants' privacy-de-identification of study data and biospecimensdoes not guarantee protection. 10 -14 In addition, trade-offs exist between de-identification and other possible participant concerns, such as the ability to receive individual research findings or the ability to withdraw from research participation. 9,15,16 Numerous previous studies have characterized potential participants' views about willingness to participate in biobanks and related forms of population-based genomic research and how informed consent ought to be handled. [17][18][19][20][21][22][23][24][25][26][27][28][29][30][31][32][33] There are also some published reports regarding participants' views about research access to medical record data. 34 -39 However, relatively little is known about participants' and the general public's attitudes and perceptions regarding newer data-sharing mechanisms, such as the Federal database of...

Background To promote effective genome-scale research, genomic and clinical data for large population samples must be collected, stored, and shared. Methods We conducted focus groups with 45 members of a Seattle-based integrated healthcare delivery system to learn about their views and expectations for informed consent in genome-scale studies. Results Participants viewed information about study purpose, aims, and how and by whom study data could be used to be at least as important as information about risks and possible harms. They generally supported a tiered consent approach for specific issues, including research purpose, data sharing, and access to individual research results. Participants expressed a continuum of opinions with respect to the acceptability of broad consent, ranging from completely acceptable to completely unacceptable. Older participants were more likely to view the consent process in relational – rather than contractual – terms, compared with younger participants. The majority of participants endorsed seeking study subjects’ permission regarding material changes in study purpose and data sharing. Conclusions Although this study sample was limited in terms of racial and socioeconomic diversity, our results suggest a strong positive interest in genomic research on the part of at least some prospective participants and indicate a need for increased public engagement, as well as strategies for ongoing communication with study participants.

Treatment with IdB 1016 is associated with reduced body iron stores, especially among patients with advanced fibrosis stage.