The Mentored Scientist Development Award in Research Ethics will fulfill three main goals: 1) to obtain a broad and in-depth foundation in research ethics and to develop research skills in ethical reasoning and analysis in order to become a resource for those pursuing biomedical research; 2) to build a research program on the ethical implications of human genetic variation research for social distributive justice; and 3) to become an independent investigator in the field of research ethics upon the completion of this career development award.

Accompanying the increase in research activities worldwide, particularly in developing countries where the citizens are poor, vulnerable and un-empowered, is increasing concern about the ethical nature of these studies, the rights of participants, the need to protect vulnerable populations, issues relating to benefitssharing, equity and justice. It has therefore become necessary to equip researchers, particularly in developing countries with state-of-the-art knowledge of research ethics.

One of the promises of genomic research is that information about a genetic disease or risk will increasingly provide the basis for screening and prevention to reduce morbidity and mortality. As a result, much of the meaningful medical action stemming from genetic information will take place under the auspices of primary care providers, underscoring the similarities rather than differences between genetic and other medical information.

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.

Most discussion of the ethical challenges raised by the growth of research biobanks relies on the assumption that the only ethically relevant interests are those that concern risks to subjects' welfare or well-being. Once materials have been collected, and any further risks have been reduced to near-zero by de-identification, it follows that no further protection of the interests of research subjects is required.

A significant number of NIH-funded projects are under the jurisdiction of an explicit data release policy. Such projects include: any project with direct costs of more than $500,00 per year, any genome-wide association study, and most community resource projects.

The convergence of rapid development of increasingly efficient high throughput genetic sequencing technologies and ubiquitous internet use by the public has laid the foundation for the emergence of direct-to-consumer (DTC) personal genomic companies. This growing market niche is premised on predictions of several paradigm shifts in how the public views personal genetic information. The first is a claim that knowledge of a person's genetic code is empowering and will enable individuals to make better decisions about lifestyle, health and medical care.

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.

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.

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.