This proposal requests funding to support an evaluation of existing regulatory frameworks and their appropriateness for the regulation of new probiotic products that are available in the market or will be available in the near future.
This project will address the ethical, legal and social implications of the use of genetic testing as part of US immigration procedures for family reunification. Last year, approximately two-thirds of immigrants who came to the US as legal permanent residents were family sponsored under the family reunification provision. Under this provision a sponsor, who must be a US citizen or permanent resident, petitions to the US Citizenship and Immigration Services (USCIS) to bring his or her family members (spouse, children, parents or siblings) to the U.S.
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.
Researchers and institutions are ethically and legally obligated to safeguard research participants' privacy and the confidentiality of their data. Indeed, the success of the research enterprise depends on the public's confidence that private information will be vigorously protected. Certificates of Confidentiality, authorized by federal law, are an important tool for meeting this expectation.
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 proposed research seeks to contribute to an emerging literature that assesses the philosophical implications of the ecological concepts, metaphors, and analogies that are beginning both to frame our understanding of the human microbiome and to challenge entrenched mechanistic concepts of the human body and the human being -- entrenched concepts that not only include the "blueprint" analogies of the Human Genome Project but stretch back at least to the discovery of the circulation of the blood.
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.
Genomic biobank research, like much scientific and biomedical research, aims to produce generalizable knowledge of collective benefit to humans and possibly other living organisms. Direct benefit to individual participants is not a paramount goal, if a goal at all. But this raises ethical concerns. Biobank research may uncover medically significant information. Some have argued that there is an ethical duty to inform individual participants of such findings. In this project, I will develop a presumptive case against returning any individual results to subjects in biobank research.
The specific aim of this project is to determine what criteria should govern return of individual results of pediatric genomic research, using analysis of US law and international guidelines regarding decision making for and by minors as the foundation. This issue, which has received remarkably little attention, must be resolved if this research, which is vital to understanding the contributions of genetic variation to the health of children, is to proceed.