Genomic medicine has, on one hand, the power to predict potentially debilitating disease before its actual onset; on the other hand, it creates challenges for patients in determining how to assess uncertainty and the risk of developing genomic-related adult-onset medical conditions. If adults are married when genetic testing occurs, they may discuss the test results with their spouses and decide on future actions together, such as disclosing the genetic test results to others; their spouses may also be affected by these discussions and decisions.

The prevailing model for ethical review of multicenter clinical trials is a distributed system of reviews conducted by the Institutional Review Board (IRB) of each institution engaged in the conduct of the trial. Conducting multiple reviews of a single protocol can delay the commencement of multicenter research and delay patient access to potentially beneficial treatments.

Genomics-based technologies are increasingly used in clinical care and are highly relevant to public health because of their potential use in assessing risk, diagnosing, and developing treatment plans. Access to genomic tests often depends on cost and coverage of services by the health plan. No studies, to our knowledge, identify whether access and reimbursement issues relating to guideline-recommended pharmacogenomic tests exist, and what the potential implications of barriers to access and/or differential access for patients, providers, and society are.

Prenatal testing is evolving in two important ways: first, advances in genomic medicine mean that samples of fetal DNA obtained with invasive methods (such as amniocentesis) can be analyzed using microarray analysis or whole genome sequencing, revealing far more information about the fetus's genetic make-up than was previously possible; and second, new, non-invasive prenatal tests have been introduced that isolate fragments of fetal DNA circulating in a pregnant woman's blood, making possible safe, highly accurate genetic testing much earlier in pregnancy than was previously possi

Interactive Multimedia Consent for Biobanking Abstract Many biobanks in the U.S. consent thousands of contributors of biospecimens and health information. There is growing interest in the efficiency of electronic consenting (e-consent) given the scale of these efforts. However, e-consent tools also need to promote diverse users' understanding and trust, and demonstrate their effectiveness in comparison to traditional methods such as face-to-face (F2F) consenting.

The eMERGE project brings together researchers with a wide range of expertise in genomics, statistics, ethics, informatics, and clinical medicine from leading medical research institutions across the country to conduct research in genomics, including discovery, clinical implementation and public resources. The primary goal of eMERGE is to develop, disseminate, and apply approaches to research that combine biorepositories with electronic medical record (EMR) systems for genomic discovery and genomic medicine implementation research.

Obtaining adequate informed consent from potential research participants is a significant challenge for biobank-dependent research. To maintain public trust and support, it is important to establish an informed decision-making process for the collection and use of biospecimens collected within clinical settings. For the majority of all infants born in the US, residual dried blood biospecimens are generated after newborn screening is completed. Some programs have chosen to store these specimens for several uses including biomedical research.

Advances in psychiatric genetics are likely to offer major diagnostic and therapeutic benefits, but also legal and social-related risks, to individuals who were diagnosed with, or have a proclivity for, psychiatric disorders. In response, courts and policy-makers will have to ensure that psychiatric genetic data are used to promote, and not to obstruct, equality, justice, and social inclusion.

A big data ecosystem is evolving in our society in which people may have, or feel they have, little control over the flow of their personal health information, and thus their privacy. Further, although there has been significant discussion related to big data and privacy at the highest levels of government, there is little consensus among scholars and stakeholders as to what privacy actually is, not to mention a lack of data from individuals as to personal conceptions of privacy.

Many national and international public and private initiatives are forming to collect and share data on a large scale for research and clinical use. Collectively, these efforts may lead to the creation of a medical information commons, a networked environment in which diverse sources of health, medical, and genomic data on large populations become widely shared resources.