Personalized medicine (PM) has the potential to transform medicine and the health care system over the next decade. An overlooked variable that will play an important role in the implementation of PM is the potential for legal liability. Physicians, a key gatekeeper in the uptake of PM, are at the greatest risk of liability. Currently, there is great uncertainty, disagreement and rapid change with regard to the use of PM tests in clinical care.
New technologies are enabling the arrival of the much awaited affordable genome the ability to sequence an individuals or a tumors entire genome quickly and inexpensively [whole genome sequencing (WGS)]. WGS is now being offered in clinical care and is expected to become more widely used in the near future, particularly in cancer. However, this technological advance threatens to outpace our ability to use it effectively in clinical practice and to address the associated health policy issues.
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.
This application proposes the establishment of a Center for Research on the Ethical, Legal and Social Implications of Psychiatric, Neurologic and Behavioral (PNB) Genetics at Columbia University Medical Center (CUMC). Since April 2010, we have been funded under a P20 Developing Center grant to create the infrastructure and begin development of such a Center.
As clinical neuroscience rapidly progresses, mental disorders are increasingly explained in terms of biological mechanisms (e.g., depression is caused by chemical imbalances). The proposed project will examine (i) whether laypeople and practicing clinicians are open to such biological explanations, (ii) how biological explanations impact opinions about mental disorders among clinicians and those who display symptoms, and (iii) how negative effects of biological accounts can be reduced.
Recent progress in genomic science has been accompanied by great expectations that we are on the verge of a medical revolution where genetic knowledge of the complex interaction between multiple genes and the environmental/behavioral factors impacting their expression, will redefine illness and health, guiding risk prediction, disease diagnosis and treatment strategies. As yet, with a few notable exceptions, the promise of genetically driven diagnoses and treatment remains largely theoretical.
This application proposes the continuation of a Center for Research on the Ethical, Legal & Social Implications of Psychiatric, Neurologic & Behavioral (PNB) Genetics at Columbia University Medical Center (CUMC), in collaboration with The Hastings Center. We have been funded since April 2010, initially under a developing center award and since 2013 as a full Center of Excellence in ELSI Research (CEER).
Sub Saharan Africa with only 11% of the world's population has more than 24% of the global disease burden, over 70% of the world's HIV infected persons, and only 3% of the global work force, and spends less than 1% of the world financial resources on health. In the case of Uganda, a country of 35 million people who suffer with a heavy disease burden, there are only 7 Ugandan specialists trained at masters level in bioethics.
Rapid advances in human genetics have prompted concerns about the public's readiness to process and utilize the knowledge gained to make informed decisions about their health. To facilitate "genetic literacy," several government agencies including the Office of the Surgeon General and the Centers for Disease Control and Prevention (CDC) have advocated for the increased use of family health history assessment. The family health history, currently underutilized in primary care, offers an ideal proxy to assess genomic risk and is the simplest applied genomic tool available.