title: Institutional Responsibility and the Flawed Genomic Biomarkers at Duke University: A Missed Opportunity for Transparency and Accountability.
abstract: When there have been substantial failures by institutional leadership in their oversight responsibility to protect research integrity, the public should demand that these be recognized and addressed by the institution itself, or the funding bodies. This commentary discusses a case of research failures in developing genomic predictors for cancer risk assessment and treatment at a leading university. In its review of this case, the Office of Research Integrity, an agency within the US Department of Health and Human Services, focused their report entirely on one individual faculty member and made no comment on the institution's responsibility and its failure to provide adequate oversight and investigation. These actions missed an important opportunity to emphasize the institution's critical responsibilities in oversight of research integrity and the importance of institutional transparency and accountability.
authors.affiliation: Department of Biostatistics and Medical Informatics, University of Wisconsin-Madison, 201 WARF, 610 Walnut Street, Madison, WI, 53726, USA. demets@biostat.wisc.edu.
authors.forename: David L
authors.identifier: 0000-0003-3348-8754
authors.initials: DL
authors.lastname: DeMets
authors.affiliation: Department of Biostatistics, University of Washington, Box 357232, 1959 NE Pacific Street, Seattle, WA, 98195, USA.
authors.forename: Thomas R
authors.initials: TR
authors.lastname: Fleming
authors.affiliation: Department of Medicine, Johns Hopkins School of Medicine, 1809 Ashland Ave, Baltimore, MD, 21205, USA.
authors.forename: Gail
authors.initials: G
authors.lastname: Geller
authors.affiliation: School of Medicine, University of North Carolina-Chapel Hill, 101 Manning Dr, Chapel Hill, NC, 27514, USA.
authors.forename: David F
authors.initials: DF
authors.lastname: Ransohoff
mesh_terms: D015415:Biomarkers; D000068598:Data Accuracy; D023281:Genomics; D012941:Social Responsibility; D014481:United States; D018172:United States Office of Research Integrity; D014495:Universities / Q000941:ethics* / Q000592:standards
chemical_list: D015415:Biomarkers
keywords: Genomic predictors; Institutional review; Office of Research Integrity; Research fraud