Teaching Responsible Conduct of Research (RCR): A Resource Guide for Professional Science Master’s Degree Programs

Case Studies from Computational Sciences

Case: Concerns with Data Integrity

Discipline: Computational Sciences
Title: Concerns with Data Integrity
Authors: John Newsam, Ph.D., Rob Edward, Ph.D., Carney Cheng, M.S.

Amserve, Inc. has a drug that mitigates the effects of Multiple Sclerosis (“MS”).All of the company’s revenues derive from this drug and the drug will be the only contributor to revenues for quite some time.

Dr. David Biltmore, A biostatistician at Amserve has recently completed a meta-analysis of clinical data. His findings suggest that the drug causes birth defects in women. However, the meta-analysis was based on data from quite small patient populations and the results, while significant in the meta-analysis, could not confidently be extrapolated to the much larger population of actual drug users. David presents his results to upper management in a meeting in which his results are discussed in great detail. At the end of the meeting, the Amserve executive team decides that David’s findings should be shelved. The users of the drug have realize substantial quality of life benefits from taking the drug, and any potential negative publicity relative to the drug would compromise Amserve’s sole revenue stream. This executive decision, though, is counter to David’s better judgment. What should he do?

Teaching Questions:

  • Parties – Who is involved?
  • Actions – What are the possible options?
  • Consequences – What are the potential consequences?
  • Obligations – What are the obligations?

Teaching Questions with Analysis

  • Parties
  • Amserve, Inc., the Amserve executive team and shareholders
  • Dr. David Biltmore
  • The users of the drugs and MS patients in general
  • Actions
  • David again talks to the CSO and re-stresses his point.
  • David becomes a whistleblower.
  • David talks to one or more of his colleagues, perhaps including someone who might have more influence with the senior level executives.
  • Consequences
  • David will probably lose his job regardless of the outcome.
  • Amserve may lose it’s sole source of revenues.
  • A population of babies may needlessly live challenged lives
  • Obligations
  • Amserve has an obligation to society to improve peoples’ lives.
  • David has an obligation to the science community.

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