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Some socially identifiable groups have historically perceived genetic research with considerable mistrust. For this reason, and to better understand the salience of community-based ethical, legal and social issues (ELSI) with emerging genetic knowledge, a need exists to systematically engage communities simultaneously with conducting human genetic research. Community engagement processes also intended to provide protection assurances from potential harms by identifying and minimizing group perceived risks that may be acute or ongoing barriers to genetic research participation.

The Haplotype Map (HapMap) Project is an international collaborative project to produce a haplotype map of the human genome. The HapMap is expected to be a key resource for more efficient genome-wide scans associating genetic variation with phenotypic variation, particularly in disease risk and drug response. The overall project will include a number of components, including community engagement, collection of blood samples from various populations, genotyping of these samples, and analysis of the resulting data.

The impetus for this proposal began with the decisions to include a Southern European population sample in the new Haplotype Map Project (HapMap Project) and to undertake this research among identified populations through a process referred to unofficially as 'community engagement.' Together, these two tracks led more specifically to the P.I., an American medical anthropologist who had lived and conducted research for many years in Florence, Italy.

The proposed project explores how researchers in the new and growing arena of gene- environment interaction (GxE) research operationalize the concept of "a human population." The proposed project will add critical information about how traditional epidemiologists and genetic epidemiologists, using different kinds of data, work together to operationalize groups in their biomedical studies of disease.

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.

This research project will collect and analyze qualitative and quantitative data about US biobanks, exploring how organizational strategies, features, and attributes affect both framing and response to ELSI and policy choices. We argue that a biobank's organizational features impact 1) policy choices directly, and 2) members' framing and response to ELSI which in turn impact policy choices.

The ability to utilize biospecimens collected at the time of birth for research that integrates genetic variation, social and environmental exposures, and health outcomes may be an invaluable resource in promoting epigenetic approaches to disease prevention and health promotion. There are a growing number of perinatal biobanks in the US and globally, including many focused on preventing prematurity, specific childhood conditions, or birth defects.

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