"Personalized genomic medicine" (PGM) is being promoted as a "new paradigm for health care" and a major goal for translational genomic research (TGR). In addition to overcoming TGR's remaining scientific hurdles, achieving that goal will involve addressing a number of ethical, legal, and social challenges. Some of those challenges reflect the ways that different social policies and health care economies will complicate TGR's ability to realize PGM as a viable health care paradigm. But other challenges might emerge from the goal itself, depending upon how PGM is interpreted by those who shape it as a social practice. This project explores this suggestion by documenting how PGM and its most attractive virtues are interpreted by those involved in defining them for TGR and society, and the challenges and choices they are encountering in the process. PGM is a goal that unites a wide array of biomedical initiatives, from medical sequencing, gene expression, and pharmacogenomics research to public health, clinical, and commercial services. Its promissory virtues are precision diagnosis and risk prediction, individualized therapy, prevention, health promotion, and patient empowerment. Different proponents of PGM interpret and rank these promises differently, with different implications for the realization of PGM as a health care paradigm. We focus on four sets of interpreters that will have particularly important roles in shaping the way PGM emerges as a social practice: (1) the scientists, research sponsors, companies, and policy organizations that promote PGM as a biomedical paradigm;(2) the journals, public review bodies and educational institutions that mediate the implementation of this paradigm;(3) the health care institutions and professionals that pioneer the paradigm by providing PGM services in practice;(4) the patient-based organizations that increasingly help shape its public reception. Our empirical studies of the views of these social co-producers of PGM will then be used to generate an analytic map of their different visions, designed to draw out their ethical, legal, and social implications for TGR and health policy. The "translational pipeline" of genomic research will have many branches towards its distal end. This project is designed to anticipate the directional choices that these branches will require, so that the PGM that TGR finally delivers into the complicated plumbing of our society is as clean and safe as possible.

Public Health Relevance

A major goal of genomic research is to develop health care tools that can achieve more precise diagnoses and risk predictions, individualized therapy, prevention, health promotion, and greater patient empowerment. The proponents of these advances call their goal "personalized genomic medicine." But many different parties are involved in shaping this vision for health care, and their different interpretations of its virtues carry different ethical, social, and legal implications. The purpose of this project is to study how some of the most influential parties who are promoting, implementing, providing, and using "personalized genomic medicine" understand its promises and potential pitfalls. This understanding will allow us to define the policy choices that lie ahead for researchers, health care providers, and the public as translational genomic research moves closer to its goal.

Agency
National Institute of Health (NIH)
Institute
National Human Genome Research Institute (NHGRI)
Type
Research Project (R01)
Project #
5R01HG005277-10
Application #
8537502
Study Section
Special Emphasis Panel (ZRG1-GGG-N (02))
Program Officer
Boyer, Joy
Project Start
2001-09-30
Project End
2014-08-31
Budget Start
2013-09-01
Budget End
2014-08-31
Support Year
10
Fiscal Year
2013
Total Cost
$383,334
Indirect Cost
$33,600
Name
University of North Carolina Chapel Hill
Department
Other Health Professions
Type
Schools of Medicine
DUNS #
608195277
City
Chapel Hill
State
NC
Country
United States
Zip Code
27599
McGowan, Michelle L; Settersten Jr, Richard A; Juengst, Eric T et al. (2014) Integrating genomics into clinical oncology: ethical and social challenges from proponents of personalized medicine. Urol Oncol 32:187-92
McGowan, Michelle L; Fishman, Jennifer R; Settersten Jr, Richard A et al. (2014) Gatekeepers or intermediaries? The role of clinicians in commercial genomic testing. PLoS One 9:e108484