In its first five years, the CWRU Center for Genetic Research Ethics and Law (CGREAL) explored a range of ethical, legal, and policy issues in the design and conduct of genomic gene-discovery research. We now propose to follow the trajectory of genomics into its "translational" phase, where its expanded research needs and higher clinical aspirations are creating new ethical, legal, and policy challenges. Translational research is often simplified as a linear conversion of scientific discoveries into clinical applications, "from bench to bedside." In reality, it is complicated by interactions among a wide range of stakeholders. As translational genomic research moves increasingly into the "public square" of clinical, commercial, community, and public health settings in its search for data sources and practical applications, it must negotiate the competing interests and values of those settings in order to achieve its scientific goals. CGREAL's 5-year goal is to provide evidence and arguments that can help all parties in that negotiation work toward a just and responsible outcome. In its new incarnation, CGREAL will consist of three programs designed to help develop the policies and practices that should guide that process. Our Transdisciplinary Research Program will study translational genomic research by mapping and comparing stakeholder views on four value-sensitive features: driving hypotheses;instrumental strategies;social constraints;aspirational goals. Wherever divergent interests force decisions about these features, translational genomic research will encounter ethical, legal, and social challenges, triggering our normative and conceptual analyses of the arguments involved. Our Translation to Policy Program will develop our analyses into policy proposals for addressing the challenges our own research uncovers. In addition, we will monitor the field at large to steer our research agenda towards other emergent policy problems. This program will identify and communicate policy options at institutional, professional, regulatory, or legislative levels, in collaboration with other biomedical research policy development programs. Our Training Program will continue to expand its scope to bring a wider range of voices to ELSI research and policy development.

Public Health Relevance

The translation of genomic research into health benefits for the public is a goal that is shared by many scientists, patients, public health agencies, and private enterprises. All these interested parties will need to work together to analyze large collections of DNA and clinical information. Our Center's goal is to help that process by providing the information that will be required to meet the ethical, legal, and social challenges.

Agency
National Institute of Health (NIH)
Institute
National Human Genome Research Institute (NHGRI)
Type
Specialized Center (P50)
Project #
5P50HG003390-09
Application #
8528663
Study Section
Special Emphasis Panel (ZHG1-HGR-P (J1))
Program Officer
Boyer, Joy
Project Start
2004-09-01
Project End
2014-07-31
Budget Start
2013-08-01
Budget End
2014-07-31
Support Year
9
Fiscal Year
2013
Total Cost
$540,103
Indirect Cost
$196,089
Name
Case Western Reserve University
Department
Public Health & Prev Medicine
Type
Schools of Medicine
DUNS #
077758407
City
Cleveland
State
OH
Country
United States
Zip Code
44106
Burke, Wylie; Appelbaum, Paul; Dame, Lauren et al. (2015) The translational potential of research on the ethical, legal, and social implications of genomics. Genet Med 17:20-Dec
Goldenberg, Aaron J; Dodson, Daniel S; Davis, Matthew M et al. (2014) Parents' interest in whole-genome sequencing of newborns. Genet Med 16:78-84
Marshall, Patricia A; Adebamowo, Clement A; Adeyemo, Adebowale A et al. (2014) Voluntary participation and comprehension of informed consent in a genetic epidemiological study of breast cancer in Nigeria. BMC Med Ethics 15:38
Henderson, Gail E; Wolf, Susan M; Kuczynski, Kristine J et al. (2014) The challenge of informed consent and return of results in translational genomics: empirical analysis and recommendations. J Law Med Ethics 42:344-55
Koay, Pei P; Sharp, Richard R (2014) Managing Expectational Language: Translational genetic professionals consider the clinical potential of next-generation sequencing technologies. New Genet Soc 33:126-148
de Vries, Jantina; Abayomi, Akin; Brandful, James et al. (2014) A perpetual source of DNA or something really different: ethical issues in the creation of cell lines for African genomics research. BMC Med Ethics 15:60
Heidt-Forsythe, Erin; McGowan, Michelle L (2013) Whose right to know? The subjectivity of mothers in mandatory paternity testing. Am J Bioeth 13:42-4
Broder, Sherri M; Ponsaran, Roselle S; Goldenberg, Aaron J (2013) US public cord blood banking practices: recruitment, donation, and the timing of consent. Transfusion 53:679-87
McGowan, Michelle L; Sharp, Richard R (2013) Justice in the context of family balancing. Sci Technol Human Values 38:
Koay, Pei P; Sharp, Richard R (2013) The role of patient advocacy organizations in shaping genomic science. Annu Rev Genomics Hum Genet 14:579-95

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