Many genotype and genome-wide association studies (GWAS) are conducted using a phenotype-driven approach: cases and controls are identified based on the presence or absence of a particular condition and analyses are undertaken to identify gene variants associated with that condition. The inverse--a genotype-driven approach--is receiving increasing attention as another powerful tool for understanding the impact of genetic variation.
The purpose of this study is to contribute empirical data and critical analysis relevant to patenting and licensing of DNA sequence patents, focusing on genomic diagnostics. Recent survey data suggest that patents have generally not impeded research, but note that problems may arise in the area of diagnostics. Technologies for sequencing, genotyping, and gene expression profiling have created new classes of genomic diagnostics that can simultaneously test thousands of genes for mutations and variations, or for expression level differences.
This proposal requests funding to support an evaluation of existing regulatory frameworks and their appropriateness for the regulation of new probiotic products that are available in the market or will be available in the near future.
This project will address the ethical, legal and social implications of the use of genetic testing as part of US immigration procedures for family reunification. Last year, approximately two-thirds of immigrants who came to the US as legal permanent residents were family sponsored under the family reunification provision. Under this provision a sponsor, who must be a US citizen or permanent resident, petitions to the US Citizenship and Immigration Services (USCIS) to bring his or her family members (spouse, children, parents or siblings) to the U.S.
The NIH data access policy for genetic research provides enormous opportunities for genetic investigators but also raises a number of challenges for educating and recruiting participants into large-scale genetic research studies. The NIH released a final data access and sharing policy for genome-wide association studies (GWAS) in August, 2007. The policy requires specific phenotypic and genetic data from GWAS be deposited into a government controlled, limited access database.
The ethical, legal, and social issues (ELSI) underlying the development and implementation of state-sponsored birth cohort studies and their accompanying biobanks are complex and potentially volatile. Michigan and other states, such as Connecticut and California, are in the midst of investigating and deliberating on how to set up biobanks and there is a pressing need for practical ELSI research and guidelines for these historic initiatives.
The recruitment of American Indians and Alaska Natives (AI/AN) to participate in research is complicated by a long and troubled history between researchers and Native populations of the United States regarding the collection of Native American remains, cultural artifacts, and access to and use of natural resources, as well as health research. This history has led to widespread distrust and reluctance to participate in research.
The ability to manipulate atoms and molecules at the nanoscale has catalyzed the emerging field of nanomedicine. While many biological phenomena occur at the nanoscale, "nanomedicine" denotes material fabricated at the scale of 1-100 nanometers (nm) to take advantage of novel properties (biological, optical, thermal, chemical, and mechanical) that manifest at the nanoscale. A focal area of development is nanodiagnostics and nanotherapeutics.
Primary care physicians have almost no training in genetics, nor in the ethical, legal and social implications (ELSI) of genetic testing, diagnosis and therapy. Further, mere provision of curricular content fails to impact physician behavior. However, programs with elements that are based on established educational and adult learning principles have been shown to effective in affecting behavioral change.
One of the intended goals of the ELSI CEER program is to provide guidance on policy issues that arise from novel genetic and genomic science and applications. This focus, however, misses epigenetic processes. Epigenetics involves the point at which nature and nurture intersect via discrete environmentally imposed modifications to the genome. These modifications include DNA methylation, and their distribution across the genome creates cell-specific epigenomes that control cell-specific expression patterns.