title: Gatekeepers or intermediaries? The role of clinicians in commercial genomic testing.
abstract: BACKGROUND
  Many commentators on "direct-to-consumer" genetic risk information have raised concerns that giving results to individuals with insufficient knowledge and training in genomics may harm consumers, the health care system, and society. In response, several commercial laboratories offering genomic risk profiling have shifted to more traditional "direct-to-provider" (DTP) marketing strategies, repositioning clinicians as the intended recipients of advertising of laboratory services and as gatekeepers to personal genomic information. Increasing popularity of next generation sequencing puts a premium on ensuring that those who are charged with interpreting, translating, communicating and managing commercial genomic risk information are appropriately equipped for the job. To shed light on their gatekeeping role, we conducted a study to assess how and why early clinical users of genomic risk assessment incorporate these tools in their clinical practices and how they interpret genomic information for their patients.
  
  
  RESULTS
  We conducted qualitative in-depth interviews with 18 clinicians providing genomic risk assessment services to their patients in partnership with DNA Direct and Navigenics. Our findings suggest that clinicians learned most of what they knew about genomics directly from the commercial laboratories. Clinicians rely on the expertise of the commercial laboratories without the ability to critically evaluate the knowledge or assess risks.
  
  
  CONCLUSIONS
  DTP service delivery model cannot guarantee that providers will have adequate expertise or sound clinical judgment. Even if clinicians want greater genomic knowledge, the current market structure is unlikely to build the independent substantive expertise of clinicians, but rather promote its continued outsourcing. Because commercial laboratories have the most "skin in the game" financially, genetics professionals and policymakers should scrutinize the scientific validity and clinical soundness of the process by which these laboratories interpret their findings to assess whether self-interested commercial sources are the most appropriate entities for gate-keeping genomic interpretation.
authors.affiliation: Department of Bioethics, Case Western Reserve University School of Medicine, Cleveland, Ohio, United States of America.
authors.forename: Michelle L
authors.initials: ML
authors.lastname: McGowan
authors.affiliation: Biomedical Ethics Unit, McGill University Faculty of Medicine, Montreal, Quebec, Canada.
authors.forename: Jennifer R
authors.initials: JR
authors.lastname: Fishman
authors.affiliation: College of Public Health and Human Sciences, Oregon State University, Corvallis, Oregon, United States of America.
authors.forename: Richard A
authors.initials: RA
authors.lastname: Settersten
authors.affiliation: Department of Bioethics, Case Western Reserve University School of Medicine, Cleveland, Ohio, United States of America.
authors.forename: Marcie A
authors.initials: MA
authors.lastname: Lambrix
authors.affiliation: Center for Bioethics, Department of Social Medicine, University of North Carolina - Chapel Hill, Chapel Hill, North Carolina, United States of America.
authors.forename: Eric T
authors.initials: ET
authors.lastname: Juengst
mesh_terms: D030541:Databases, Genetic; D003695:Delivery of Health Care; D005817:Genetic Counseling; D005820:Genetic Testing; D023281:Genomics; D059014:High-Throughput Nucleotide Sequencing; D006801:Humans