Science and Engineering Ethics

, Volume 23, Issue 4, pp 1199–1205 | Cite as

Institutional Responsibility and the Flawed Genomic Biomarkers at Duke University: A Missed Opportunity for Transparency and Accountability

  • David L. DeMetsEmail author
  • Thomas R. Fleming
  • Gail Geller
  • David F. Ransohoff


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.


Genomic predictors Research fraud Institutional review Office of Research Integrity 


  1. Baggerly, K., & Coombes, K. (2009). Deriving chemosensitivity from cell lines: forensic bioinformatics and reproducibility research in high-throughput biology. Annals of Applied Statistics, 3, 1309–1334.CrossRefGoogle Scholar
  2. Baggerly, K., & Gunsalus, C. K. (2015). Penalty too light. The Cancer Letter, 41(42).
  3. Barbash, F. (2015). Scientist falsified data for cancer research once described as ‘holy grail’. Washington Post, November 9, 2015Google Scholar
  4. Colliton, B. J. (1983). Coping with fraud: The Darsee case. Science, 220, 31–35.CrossRefGoogle Scholar
  5. Duke University Student Newspaper. (2016). From last paragraph in
  6. Geller, G., Boyce, A., Ford, D. E., & Sugarman, J. (2010). Beyond, “Compliance”: The role of institutional culture in promoting research integrity. Academic Medicine, 85, 1296–1302.CrossRefGoogle Scholar
  7. Goldberg, P. (2009) A biostatistics paper alleges patient harm in two Duke clinical studies. The Cancer Letter, 35(36), 1–2.Google Scholar
  8. Goldberg, P. (2010). By defending Potti, Duke officials become targets of charges of institutional failure. The Cancer Letter, 26(28), 1–2.Google Scholar
  9. Goldberg, P. (2011a). IOM Committee will probe Duke scandal together with other “omics” case studies. Cancer Letter, 37(1), 1–2.Google Scholar
  10. Goldberg, P. (2011b). Deans acknowledge with holding key document from outside reviewers. The Cancer Letter, 37(2), 1, 6.Google Scholar
  11. Goldberg, P. (2011c). FDA auditors spend two weeks at Duke: Nevins loses position in reorganization. The Cancer Letter, 37(4), 1–2.Google Scholar
  12. Goldberg, P. (2011d). The Duke Scandal: Lancet Oncology yanks paper: NEJM says “no retraction”. The Cancer Letter, 37(5), 5, 6.Google Scholar
  13. Goldberg, P. (2015a). Med students memo-research concerns. The Cancer Letter, 41(1), 1, 11.Google Scholar
  14. Goldberg, P. (2015b). Duke officials silenced med student who reported trouble in Anil Potti’s lab. The Cancer Letter, 41(1), 1–2.Google Scholar
  15. Goldberg, P. (2015c). Duke scientist: I hope NCI doesn’t get original data. The Cancer Letter, 41(2), 1–2.Google Scholar
  16. Goldberg, P. (2015d). Duke’s legal stance: We did no harm. The Cancer Letter, 41(3), 1, 6.Google Scholar
  17. Goldberg, P. (2015e). Duke settles with Potti’s patients: Misconduct probe now in fifth year. The Cancer Letter, 41(18), 1, 13.Google Scholar
  18. Goldberg, P. (2015f). ORI’s deal with Potti doesn’t address the role Duke deans played in scandal. The Cancer Letter, 41(42), 1–2.Google Scholar
  19. Hinkes-Jones, L. (2015). Patients, researchers demand further prosecution in Duke case, Bloomberg Daily Report for Executives. Special Report: Health Care, December 7, 2015.
  20. Institute of Medicine (IOM). (2012). Evolution of translation genomics: lessons learned and a path forward. National Academies Press.
  21. Knox, R. (1983). The Harvard fraud case: Where does the problem lie. JAMA, 249(1797–1799), 1802–1807.Google Scholar
  22. Master, Z. (2015). A book review, A review of research misconduct policy in biomedicine: Beyond the bad-apple approach. Accountability in Research-Policies and Quality Assurance, 22, 192–197.Google Scholar
  23. Office of Research Integrity in Office of the Secretary. (2015). Department of Health and Human Services, Findings of Research Misconduct, Federal Registry Code 4150-31, November 9, 2015.
  24. Redman, B. (2013). Research misconduct policy in biomedicine: Beyond the bad-apple approach. Cambridge: MIT Press.CrossRefGoogle Scholar
  25. Resnik, D. B. (2003). From Baltimore to Bell Labs: Reflections on two decades of debate about scientific misconduct. Account Research, 10, 123–135.CrossRefGoogle Scholar
  26. The Office of Research Integrity. (2016). Accessed October 30, 2016
  27. The Office of Research Integrity: Policies-Mission. (2016). Accessed October 30, 2016
  28. The Office of Research Integrity: Whistleblowers. (2016). Accessed October 30, 2016
  29. Yarborough, M., Fryer-Edwards, K., Geller, G., & Sharp, R. (2009). Transforming the culture of biomedical research from compliance to trustworthiness: Insights from non-medical sectors. Academic Medicine, 84, 472–477.CrossRefGoogle Scholar

Copyright information

© Springer Science+Business Media Dordrecht 2016

Authors and Affiliations

  1. 1.Department of Biostatistics and Medical InformaticsUniversity of Wisconsin-MadisonMadisonUSA
  2. 2.Department of BiostatisticsUniversity of WashingtonSeattleUSA
  3. 3.Department of MedicineJohns Hopkins School of MedicineBaltimoreUSA
  4. 4.School of MedicineUniversity of North Carolina-Chapel HillChapel HillUSA

Personalised recommendations