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.

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.

Obesity rates in the United States have escalated in recent decades and present a growing challenge in public health prevention efforts. Advances in genomics have begun to shed light on the genetic contributions to obesity. At present, it is unknown whether information about one's personal genetic predisposition to obesity will add value to traditional risk communication efforts and increase the likelihood that individuals will engage in health behaviors to reduce obesity risk.

Forensic DNA profiling is increasingly becoming a standard tool in the search for missing people in the aftermath of mass violence and mass disaster. Yet, there has been very little systematic effort to identify and analyze the major ethical and policy challenges associated with this new use of genetic technology. Thus, stakeholders involved in post-conflict and post-disaster investigations have had to develop their own ad hoc rules and ethical principles for the identification process.

Health information technology (HIT) is believed to be central to improving the quality and cost effectiveness of health care in the United States. As a result of recent major federal investment, the diffusion of HIT is expected to surge in the next five years. As HIT becomes widespread, it will be a potent source of detailed, population-level health information and provide new insights on how health care is delivered in the U.S. These databases will have significant value for research including genomics, comparative effectiveness studies, health services research, and clinical trials.

The policies of academic health centers (AHCs) for human subjects protection in the collection, storage, use, and sharing of biospecimens and associated data (i.e., biobanking) will have significant effects on the country's capacity to advance genetic science through collaborative multi-institutional research. Variation in policies for core issues such as informed consent to obtain biospecimens and sharing biospecimens and/or data across institutions can impede or prevent collaborative research. Our preliminary data suggest that this is already occurring.

The overall purpose of this grant is to explore the nature, extent and consequences of data-sharing and data- withholding in academic genetics and the other life sciences.

Two major forces in clinical medicine on the horizon are expected to change the paradigm of clinical care. One is personalized genomic medicine (PGM), which seeks to harness knowledge about the genetic endowment of the individual to individually tailor specific medical therapies. The second driving force in healthcare today is to conduct comparative effectiveness research (CER) to directly compare the effectiveness, and sometimes the cost, of alternative therapies or diagnostic modalities for the same disease or condition.

This empirical and normative bioethics research project will guide policy and practice about the disclosure of genomic incidental findings (GIFD), a much-debated topic. With ethical guidance from a multidisciplinary ELSI Working Group, we will conduct an experiment designed to develop strategies for offering incidental findings to family members of probands in a biobank for pancreatic cancer.

In 2009, 192,370 new cases of female breast cancer (BC) were diagnosed in the U.S. Of these cases, 5%- 10% were attributed to BRCA mutations. This translates to approximately 9,000 to 18,000 high-risk women who may be impacted by hereditary BC. In a given year, the number of high-risk BC patients is similar to or greater than the total number of cases of other cancers in women (e.g., oral cancer, n=10,480; stomach cancer, n=8,310; cervical cancer n=11,720; myeloma n=8,900).