The Case

Doctors Perry and Robin are internist colleagues who would like to participate in the research endeavor, further their careers and serve as principal investigators for a diabetes study. Neither physician has ever conducted clinical research or been published in a professional journal. Their extensive clinical experience providing care for diabetic patients has motivated them to explore the possibility of developing an investigator-initiated trial in collaboration with Prescribe Rx, a pharmaceutical company that manufactures drug SGR. The physicians believe that drug SGR has the potential to reduce diabetes-related complications.

Dr. Robin arranges a meeting for himself and Dr. Perry with several Prescribe Rx executives whom he had met through his wife, the vice president for human resources at the company. The executives agree to provide the physicians with grant funding to conduct a pilot study. In addition, they agree that the company will provide the drug without cost to the participants. A research statistician employed by Prescribe Rx, Joan Smith, Ph.D., is assigned to provide support and guidance for the physicians in the conduct and analysis of the study.

Drs. Perry and Robin develop a protocol with the statistician's assistance. Dr. Perry recruits patients and other physicians to participate in the study while Dr. Robin hires additional staff to assist with clinical tasks and data management. They plan to collaborate on the analysis of the data and writing the manuscript.

Dr. Perry invites Dr. Harmon, a friend since medical school, to participate in the study. Dr. Harmon, an internist with a large diabetic population in her practice, is confident that Dr. Perry's involvement will result in a worthwhile effort and she agrees to recruit patients.

Drs. Perry and Robin each enroll patients onto the study and along with Dr. Harmon and the other physicians forward the data to the company statistician for analysis. They are encouraged by the preliminary results and are anxious to publish, both for the opportunity to contribute to their area of medicine and to gain respect from their colleagues.

The following year at their medical school reunion, Dr. Harmon asks Dr. Perry about the research study. Dr. Perry replies that Dr. Robin has recently informed him that although they wrote the paper together, the company statistician heavily edited Dr. Perry's work and therefore he does not meet the qualifications to be named as an author. Instead he will be listed as a contributor, along with many others, including Dr. Harmon. Dr. Robin will be listed as the sole author, even though Dr. Perry is fairly certain that the company statistician actually wrote the final version of the manuscript. Dr. Perry also expresses his discomfort with the fact that Dr. Robin has failed to disclose that his wife is employed by the pharmaceutical company that provided the drug, funding and statistical support. According to Dr. Perry, Dr. Robin has justified the omission with the explanation "My wife was not involved with the study."

On her way home from the reunion, Dr. Harmon thinks about her conversation with Dr. Perry. She wonders whether Dr. Robin is correct in excluding Dr. Perry from a position of authorship, whether Dr. Robin himself qualifies as an author of the article, and why the company statistician is not listed as a co-author. She also worries about having her name listed as a contributor on a publication in which an author's relationship with the pharmaceutical company is not fully disclosed. Dr. Harmon contemplates her obligation to report the potential misconduct and her options for raising her concerns about the publication of the research.