We propose to explore the potential of technology trusts - enabling collective action by the public sector involving diverse stakeholders - to pool intellectual property and to cultivate collective norms that can harness to R&D promising genomic technologies that can yield benefits for the poor and excluded. For markets that are small or resource-poor, the hurdles to benefiting from genomic technologies can easily become barricades to access.

Most, if not all, human diseases have one or more genetic factors that contribute to cause, likelihood of occurrence, severity, and response to existing or experimental treatments. There is a general perception that the ability to define a person's genetic makeup will lead to better health, improved treatments and a better understanding of risks to other family members. However, many genetic technologies increase uncertainty and confusion in the minds of patients, relatives, doctors, health insurers and others.

Newborn screening (NBS) is conducted on virtually every child born in the U.S. primarily through state-based public health programs. Following testing, there is blood leftover on each child that is retained by many state health departments. Residual samples have been used for a variety of purposes including quality assurance for the NBS programs, forensic testing, and for research. Our project will focus on the potential use of residual samples for biomedical research. Many states are experiencing requests from investigators in academia and industry for access to residual NBS samples.

Genetic testing for BRCA1 and BRCA2 (BRCA1/2) mutations is part of routine clinical care for women with a family history of breast or ovarian cancer. However, a mutation in these genes is not identified in most women who pursue testing. Such "uninformative" results do not rule out the possibility of an inherited susceptibility to these cancers. The absolute risks for breast and ovarian cancer are heterogeneous and must be estimated based upon an analysis of the family pedigree.

Evolving intellectual property (IP) policies of governments and organizations are impacting biotechnology sectors and access to genetic materials for development of pharmaceuticals. The National Institutes of Health, through the Human Genome Project among others, specifically recognizes the need for policy options in the area of intellectual property to facilitate the widespread use of genetic and genomic information in both research and clinical settings.

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 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.

Forensic DNA profiling is increasingly becoming a standard tool in the search for missing people in the aftermath of mass violence and mass disaster. Yet, there has been very little systematic effort to identify and analyze the major ethical and policy challenges associated with this new use of genetic technology. Thus, stakeholders involved in post-conflict and post-disaster investigations have had to develop their own ad hoc rules and ethical principles for the identification process.

Genomic data, including findings incidental to the purpose for which a study is undertaken, can contain information of use and importance to research subjects related to their health, lifestyle, and reproductive choices. A growing consensus of expert groups is that at least some information from genomic studies should be available to participants. It seems clear that return of results from genomic studies should and will require the informed consent of research subjects.

Chromosomal Microarray Analysis (CMA) is a genome-wide technology that allows for identification of genomic alterations, such as deletions and duplications, at an unprecedented resolution. However, many genetic variations are identified that have unknown or uncertain clinical significance. New clinical guidelines recommend CMA testing for children with Autism Spectrum Disorder (ASD). ASD is one of the most common serious developmental disorders, found in almost 1% of children in the United States.