Skip to main content
Log in

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

  • Commentary
  • Published:
Science and Engineering Ethics Aims and scope Submit manuscript

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.

This is a preview of subscription content, log in via an institution to check access.

Access this article

Price excludes VAT (USA)
Tax calculation will be finalised during checkout.

Instant access to the full article PDF.

Institutional subscriptions

Similar content being viewed by others

References

  • 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.

    Article  Google Scholar 

  • Baggerly, K., & Gunsalus, C. K. (2015). Penalty too light. The Cancer Letter, 41(42). http://www.cancerletter.com/articles/20151113_2.

  • Barbash, F. (2015). Scientist falsified data for cancer research once described as ‘holy grail’. Washington Post, November 9, 2015

  • Colliton, B. J. (1983). Coping with fraud: The Darsee case. Science, 220, 31–35.

    Article  Google Scholar 

  • Duke University Student Newspaper. (2016). From last paragraph in http://www.dukechronicle.com/article/2015/06/unsettled-wake-potti-settlement

  • 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.

    Article  Google Scholar 

  • Goldberg, P. (2009) A biostatistics paper alleges patient harm in two Duke clinical studies. The Cancer Letter, 35(36), 1–2.

    Google Scholar 

  • Goldberg, P. (2010). By defending Potti, Duke officials become targets of charges of institutional failure. The Cancer Letter, 26(28), 1–2.

    Google Scholar 

  • Goldberg, P. (2011a). IOM Committee will probe Duke scandal together with other “omics” case studies. Cancer Letter, 37(1), 1–2.

    Google Scholar 

  • Goldberg, P. (2011b). Deans acknowledge with holding key document from outside reviewers. The Cancer Letter, 37(2), 1, 6.

  • Goldberg, P. (2011c). FDA auditors spend two weeks at Duke: Nevins loses position in reorganization. The Cancer Letter, 37(4), 1–2.

    Google Scholar 

  • Goldberg, P. (2011d). The Duke Scandal: Lancet Oncology yanks paper: NEJM says “no retraction”. The Cancer Letter, 37(5), 5, 6.

  • Goldberg, P. (2015a). Med students memo-research concerns. The Cancer Letter, 41(1), 1, 11.

  • 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 

  • Goldberg, P. (2015c). Duke scientist: I hope NCI doesn’t get original data. The Cancer Letter, 41(2), 1–2.

    Google Scholar 

  • Goldberg, P. (2015d). Duke’s legal stance: We did no harm. The Cancer Letter, 41(3), 1, 6.

  • Goldberg, P. (2015e). Duke settles with Potti’s patients: Misconduct probe now in fifth year. The Cancer Letter, 41(18), 1, 13.

  • 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 

  • Hinkes-Jones, L. (2015). Patients, researchers demand further prosecution in Duke case, Bloomberg Daily Report for Executives. Special Report: Health Care, December 7, 2015. http://www.bna.com/patients-researchers-demand-n57982065145/

  • Institute of Medicine (IOM). (2012). Evolution of translation genomics: lessons learned and a path forward. National Academies Press. http://iom.nationalacademies.org/Reports/2012/Evolution-of-Translational-Omics.aspx

  • Knox, R. (1983). The Harvard fraud case: Where does the problem lie. JAMA, 249(1797–1799), 1802–1807.

    Google Scholar 

  • 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 

  • 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. http://federalregister.gov/a/2015-28437

  • Redman, B. (2013). Research misconduct policy in biomedicine: Beyond the bad-apple approach. Cambridge: MIT Press.

    Book  Google Scholar 

  • Resnik, D. B. (2003). From Baltimore to Bell Labs: Reflections on two decades of debate about scientific misconduct. Account Research, 10, 123–135.

    Article  Google Scholar 

  • The Office of Research Integrity. (2016). http://ori.hhs.gov/about-ori. Accessed October 30, 2016

  • The Office of Research Integrity: Policies-Mission. (2016). http://ori.hhs.gov/ori-mission. Accessed October 30, 2016

  • The Office of Research Integrity: Whistleblowers. (2016). http://ori.hhs.gov/guidelines-whistleblowers. Accessed October 30, 2016

  • 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.

    Article  Google Scholar 

Download references

Author information

Authors and Affiliations

Authors

Corresponding author

Correspondence to David L. DeMets.

Rights and permissions

Reprints and permissions

About this article

Check for updates. Verify currency and authenticity via CrossMark

Cite this article

DeMets, D.L., Fleming, T.R., Geller, G. et al. Institutional Responsibility and the Flawed Genomic Biomarkers at Duke University: A Missed Opportunity for Transparency and Accountability. Sci Eng Ethics 23, 1199–1205 (2017). https://doi.org/10.1007/s11948-016-9844-4

Download citation

  • Received:

  • Accepted:

  • Published:

  • Issue Date:

  • DOI: https://doi.org/10.1007/s11948-016-9844-4

Keywords

Navigation