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While diabetes mellitus types 1 and 2 used to be distinguished largely by age at onset, in the past decade there has been an increase in the number of children presenting with diabetes that can be controlled with oral medications. This has lead to these children being diagnosed with type 2 diabetes mellitus despite their young age. This chapter offers an… (More)
As more research studies incorporate next-generation sequencing (including whole-genome or whole-exome sequencing), investigators and institutional review boards face difficult questions regarding which genomic results to return to research participants and how. An American College of Medical Genetics and Genomics 2013 policy paper suggesting that… (More)
The return of individual results to research participants has been vigorously debated. Consensus statements indicate that researchers and bioethicists consider the return of research results most appropriate when the findings are clinically relevant. Even when clinical utility is the motivator, however, the return of individual research results is not… (More)
The US Food and Drug Administration (FDA) Amendments Act of 2007, when fully implemented, will offer new sources of evidence and new regulatory mechanisms during the postmarket phase of drug life. If artfully and carefully applied, these new capabilities could help resolve problems that have long impeded the clinical translation of pharmacogenomics.
This article explores whether laws that restrict the communication of genetic test results may, under certain circumstances, violate the First Amendment to the U.S. Constitution. The focus is whether investigators have a right to return results from non-CLIA-certified laboratories in situations where a research participant requests the results and the… (More)