Informed Consent in Genome-Scale Research: What Do Prospective Participants Think?

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.

Genomic research and wide data sharing: views of prospective participants.

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, >50). 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. Many participants voiced reservations about sharing data with for-profit organizations. CONCLUSIONS: Trust is central in participants' views regarding data sharing. Further research is needed to develop governance models that enact the values of stewardship.

Silybin treatment is associated with reduction in serum ferritin in patients with chronic hepatitis C.

GOALS: The goal of this study was to examine the effect of a standardized silybin and soy phosphatidylcholine complex (IdB 1016) on serum markers of iron status. BACKGROUND: Milk thistle and its components are widely used as an alternative therapy for liver disease because of purported antioxidant, anti-inflammatory, and iron chelating properties. STUDY: Thirty-seven patients with chronic hepatitis C and Batts-Ludwig fibrosis stage II, III, or IV were randomized to 1 of 3 doses of IdB 1016 for 12 weeks. Serum ferritin, serum iron, total iron binding capacity, and transferrin-iron saturation were measured at baseline, during treatment, and 4 weeks thereafter. Wilcoxon signed rank tests were used to compare baseline and posttreatment values. RESULTS: There was a significant decrease in serum ferritin from baseline to end of treatment (mean, 244 vs. 215 mug/L; median, 178 vs. 148 mug/L; P=0.0005); 78% of subjects had a decrease in serum ferritin level. There was no significant change in serum iron or transferrin-iron saturation. Multivariate logistic regression analysis in a model that included dose, age, sex, HFE genotype, history of alcohol use, and elevated baseline ferritin levels demonstrated that stage III or IV fibrosis was independently associated with decreased posttreatment serum ferritin level. CONCLUSIONS: Treatment with IdB 1016 is associated with reduced body iron stores, especially among patients with advanced fibrosis stage.