PROJECT NARRATIVE Consumer protections are of rising importance to the sustainability of personal genomics and mobile health industries and realization of precision health, yet the extent of consumer protections available from the Federal Trade Commission (the primary federal agency in the United States responsible for ensuring online privacy and data security beyond medical settings, for the prevention of unfair and deceptive trade practices of companies that might not be governed by HIPAA, and for promoting innovation) are poorly characterized and have received surprisingly little ELSI re

PROJECT NARRATIVE Consumer protections are of rising importance to the sustainability of personal genomics and mobile health industries and realization of precision health, yet the extent of consumer protections available from the Federal Trade Commission (the primary federal agency in the United States responsible for ensuring online privacy and data security beyond medical settings, for the prevention of unfair and deceptive trade practices of companies that might not be governed by HIPAA, and for promoting innovation) are poorly characterized and have received surprisingly little ELSI re

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.

Researchers and bioethicists have developed guidelines to protect human subjects in clinical experiments involving genetic technologies. However, these rules were developed for investigations of therapeutic interventions and do not address the risks involved in the potential use of genetic technologies for enhancement purposes.

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.

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.