A Survey of U.S Adults' Opinions about Conduct of a Nationwide Precision Medicine Initiative® Cohort Study of Genes and Environment.

OBJECTIVES: A survey of a population-based sample of U.S adults was conducted to measure their attitudes about, and inform the design of the Precision Medicine Initiative's planned national cohort study. METHODS: An online survey was conducted by GfK between May and June of 2015. The influence of different consent models on willingness to share data was examined by randomizing participants to one of eight consent scenarios. RESULTS: Of 4,777 people invited to take the survey, 2,706 responded and 2,601 (54% response rate) provided valid responses. Most respondents (79%) supported the proposed study, and 54% said they would definitely or probably participate if asked. Support for and willingness to participate in the study varied little among demographic groups; younger respondents, LGBT respondents, and those with more years of education were significantly more likely to take part if asked. The most important study incentive that the survey asked about was learning about one's own health information. Willingness to share data and samples under broad, study-by-study, menu and dynamic consent models was similar when a statement about transparency was included in the consent scenarios. Respondents were generally interested in taking part in several governance functions of the cohort study. CONCLUSIONS: A large majority of the U.S. adults who responded to the survey supported a large national cohort study. Levels of support for the study and willingness to participate were both consistent across most demographic groups. The opportunity to learn health information about one's self from the study appears to be a strong motivation to participate.

The BRAIN Initiative: developing technology to catalyse neuroscience discovery.

The evolution of the field of neuroscience has been propelled by the advent of novel technological capabilities, and the pace at which these capabilities are being developed has accelerated dramatically in the past decade. Capitalizing on this momentum, the United States launched the Brain Research through Advancing Innovative Neurotechnologies (BRAIN) Initiative to develop and apply new tools and technologies for revolutionizing our understanding of the brain. In this article, we review the scientific vision for this initiative set forth by the National Institutes of Health and discuss its implications for the future of neuroscience research. Particular emphasis is given to its potential impact on the mapping and study of neural circuits, and how this knowledge will transform our understanding of the complexity of the human brain and its diverse array of behaviours, perceptions, thoughts and emotions.

Public opinion about the importance of privacy in biobank research.

Concerns about privacy may deter people from participating in genetic research. Recruitment and retention of biobank participants requires understanding the nature and magnitude of these concerns. Potential participants in a proposed biobank were asked about their willingness to participate, their privacy concerns, informed consent, and data sharing. A representative survey of 4659 U.S. adults was conducted. Ninety percent of respondents would be concerned about privacy, 56% would be concerned about researchers having their information, and 37% would worry that study data could be used against them. However, 60% would participate in the biobank if asked. Nearly half (48%) would prefer to provide consent once for all research approved by an oversight panel, whereas 42% would prefer to provide consent for each project separately. Although 92% would allow academic researchers to use study data, 80% and 75%, respectively, would grant access to government and industry researchers. Concern about privacy was related to lower willingness to participate only when respondents were told that they would receive $50 for participation and would not receive individual research results back. Among respondents who were told that they would receive $200 or individual research results, privacy concerns were not related to willingness. Survey respondents valued both privacy and participation in biomedical research. Despite pervasive privacy concerns, 60% would participate in a biobank. Assuring research participants that their privacy will be protected to the best of researchers' abilities may increase participants' acceptance of consent for broad research uses of biobank data by a wide range of researchers.

The Scientific Foundation for personal genomics: recommendations from a National Institutes of Health-Centers for Disease Control and Prevention multidisciplinary workshop.

The increasing availability of personal genomic tests has led to discussions about the validity and utility of such tests and the balance of benefits and harms. A multidisciplinary workshop was convened by the National Institutes of Health and the Centers for Disease Control and Prevention to review the scientific foundation for using personal genomics in risk assessment and disease prevention and to develop recommendations for targeted research. The clinical validity and utility of personal genomics is a moving target with rapidly developing discoveries but little translation research to close the gap between discoveries and health impact. Workshop participants made recommendations in five domains: (1) developing and applying scientific standards for assessing personal genomic tests; (2) developing and applying a multidisciplinary research agenda, including observational studies and clinical trials to fill knowledge gaps in clinical validity and utility; (3) enhancing credible knowledge synthesis and information dissemination to clinicians and consumers; (4) linking scientific findings to evidence-based recommendations for use of personal genomics; and (5) assessing how the concept of personal utility can affect health benefits, costs, and risks by developing appropriate metrics for evaluation. To fulfill the promise of personal genomics, a rigorous multidisciplinary research agenda is needed.

Preimplantation genetic screening: a survey of in vitro fertilization clinics.

PURPOSE: The purpose of this study was to determine which US in vitro fertilization clinics provide preimplantation genetic screening for aneuploidy in treating infertility, and to explore clinic directors' attitudes toward this technique. METHODS: Online survey included 415 US assisted reproductive technology clinics. The survey had a valid response rate of 45% or 186 clinics. RESULTS: Nearly 68% of US in vitro fertilization clinics responding to the survey provided preimplantation genetic screening in an effort to increase success rates of fertility treatment. More than half of these in vitro fertilization clinics (56%) provided preimplantation genetic screening for advanced maternal age and the same percentage provided preimplantation genetic screening to treat repeated in vitro fertilization failure, whereas 66% provided preimplantation genetic screening to treat women with repeated miscarriage. Opinions of the effectiveness of preimplantation genetic screening for these indications varied widely, even among those providing it. Most directors (85%) of clinics providing preimplantation genetic screening believed that more data are needed to determine whether and to whom it should be offered. CONCLUSIONS: Despite the lack of data supporting the use of preimplantation genetic screening for recurrent pregnancy loss, in vitro fertilization failure, and advanced maternal age, a majority of in vitro fertilization clinics in the United States offer preimplantation genetic screening for these purposes. There is significant support among clinic directors for more research into the effectiveness of preimplantation genetic screening and for professional guidelines in this area.

Genetic testing of embryos: practices and perspectives of US in vitro fertilization clinics.

OBJECTIVE: To better understand the current practices of IVF clinics regarding preimplantation genetic diagnosis (PGD) and explore the attitudes and opinions of clinic directors toward PGD. DESIGN: On-line Survey of 415 assisted reproductive technology (ART) clinics in the United States. The Survey had a valid response rate of 45% (186 clinics). SETTING: Not applicable. PATIENT(S): Respondents were medical directors, laboratory directors, IVF directors, or directors' designees of ART clinics offering IVF. INTERVENTION(S): Not applicable. MAIN OUTCOME MEASURE(S): Practices and beliefs of IVF clinic directors with respect to PGD. RESULT(S): Preimplantation genetic diagnosis is widely provided for a variety of indications, and clinic directors support professional guidelines to guide PGD in the future. CONCLUSION(S): Preimplantation genetic diagnosis is an established technology and medical procedure offered by a majority of US IVF clinics. Many clinics currently provide PGD for controversial indications such as sex selection. Although there is little support for government regulation of PGD, there is significant support among IVF clinics for strong professional guidelines for PGD practice. Ongoing collection of data on PGD practice and outcomes would help patients make informed decisions and aid professionals in developing appropriate guidelines and standards.