The proposed project explores a new direction in our larger research on the use of human genetic variation studies in the search for biomedically related genetic markers. Broadly, the aim of the new add-on project and the original project is to understand how human genetic variation researchers operationalize the concept of "a human population." Together, these studies will provide empirical information that will help geneticists and bioethicists to understand whether there may be potential downstream social and biomedical consequences of different conceptualizations.
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 relevance of genomics research for addressing health disparities between population groups is currently being debated. As a practical matter, if genomics hopes to have any role in reducing health disparities, its assumptions and goals will have to make sense to the communities involved. We know very little about what underserved and minority communities that are experiencing health inequities know and think about genomic research and health disparities, and how they might inform research plans if they were invited to discuss it. This project seeks to fill that gap.
This qualitative study is designed to examine the ethical conduct of clinical research, including the conduct of clinical trials, in rural healthcare settings. This study is of great significance since more than half of the clinical research, including pharmacogenomic studies, conducted in the U.S. takes place in physicians' offices, clinics, and hospitals.(1-8) It is no longer unusual to encounter rural physicians, nurses, research coordinators, and hospital administrators who are engaged, in various capacities, in the clinical research enterprise.
Biomedical research involving humans generates results that fall on a continuum of potential interest to participants. Some results, such as blood pressure, have obvious clinical utility, and elevated blood pressure is actionable by taking blood pressure medication. At the other end of the continuum, results from research on the genetics of complex diseases holds great promise for future clinical management; however the results are not immediately actionable and may only be of scientific interest.
The Advancing Research Ethics training in Southern Africa (ARESA) program will promote responsible research in southern Africa by offering a postgraduate Diploma/Masters level educational program to health care and other professionals in research ethics and by developing a national network for Research Ethics Committee (REC) members.
The purpose of this study is to provide empirical data on effects of intellectual property (IP) and commercialization on clinical translation of noninvasive prenatal genetic testing (NIPT) and identify potential barriers to clinical adoption and patient access. Advances in technologies for genetic analysis of cell-free fetal DNA could make NIPT routine. Early clinical trials indicate that sequencing-based NIPT tests for chromosomal aneuploidies are more accurate than currently used noninvasive screening tests.
The goal of this initiative is to develop research ethics leaders in Southeast Asia to meet the emerging research and health system evaluation demands of societies undergoing rapid transition. Ethical behavior in healthcare-related research is a worldwide issue and concern. Currently, there remains no regional capacity to train emerging leaders to identify problems, analyze possible solutions, and apply ethical principles to meet their countries' challenges in research and evaluation.
H3Africa provides an unprecedented opportunity to study genetic and genomic technologies into research, diagnosis, intervention, and treatment for sickle cell disease (SCD) in Africa. As such, involving a few African Centers already involved in the forefront of Sickle Cell Disease Research in Africa with moderate expertise on psychosocial research (Cameroon), newborn screening (Ghana) or genomics studies (Tanzania) could serves as a reservoir for rigorous examination of a wide range of accompanying ethical, psychosocial, cultural, and policy issues.
In recent years, researchers from around the world have begun developing repositories of tissues and socio-demographic data for genetics and other biomedical research. These biobanks, often linked with patient health care records, have been an invaluable resource in helping to understand cancer, diabetes, and various genetic-related disorders. The specimens and data are especially valuable when combined and analyzed with specimens and data from other countries, because rare variations can be detected and examined.