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Author! Author! Who Should Be Named in a Published Study? An Ethics Case Study

  • Authors: Sheryl Mitnick, RN, MPH; Michael Werner, JD
  • CME Released: 12/31/2009; Reviewed and Renewed: 9/5/2014
  • Valid for credit through: 9/5/2015
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Target Audience and Goal Statement

This activity is intended for health professionals, researchers, and any individuals who contribute to the publication of clinical study results.

The goal of this activity is to educate authors and contributors to clinical studies on their responsibilities and conflicts of interest involved with their publications.

Upon completion of this activity, participants will be able to:

  1. List the criteria for named authorship of a published study
  2. Define the role of a statistician in a published study
  3. Recognize one's responsibility as a contributor or author in instances of conflicts of interest


As an organization accredited by the ACCME, Medscape, LLC, requires everyone who is in a position to control the content of an education activity to disclose all relevant financial relationships with any commercial interest. The ACCME defines "relevant financial relationships" as financial relationships in any amount, occurring within the past 12 months, including financial relationships of a spouse or life partner, that could create a conflict of interest.

Medscape, LLC, encourages Authors to identify investigational products or off-label uses of products regulated by the US Food and Drug Administration, at first mention and where appropriate in the content.


  • Sheryl Mitnick, RN, MPH

    Senior Associate, American College of Physicians, Center for Ethics and Professionalism, Philadelphia, Pennsylvania


    Disclosure: Sheryl Mitnick, RN, MPH, has disclosed no relevant financial relationships.

  • Michael Werner, JD

    Partner, Holland & Knight, Washington, DC


    Disclosure: Michael Werner, JD, has disclosed the following relevant financial relationships:
    Served as an advisor or consultant for: Pfizer Inc.; Aldagen, Inc; Life Technologies Corporation; Celgene Corporation; Cell Therapeutics, Inc.; Novo Nordisk


  • Carol Peckham

    Director, Editorial Development, Medscape, LLC


    Disclosure: Carol Peckham has disclosed no relevant financial relationships.

CME Reviewer(s)

  • Laurie E. Scudder, MS, NP

    Accreditation Coordinator, Continuing Professional Education Department, Medscape, LLC; Clinical Assistant Professor, School of Nursing and Allied Health, George Washington University, Washington, DC; Nurse Practitioner, School-Based Health Centers, Baltimore City Public Schools, Baltimore, Maryland


    Disclosure: Laurie E. Scudder, MS, NP, has disclosed no relevant financial relationships.

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    Medscape, LLC staff have disclosed that they have no relevant financial relationships.

    The cases and commentary were developed by the American College of Physicians.

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Author! Author! Who Should Be Named in a Published Study? An Ethics Case Study

Authors: Sheryl Mitnick, RN, MPH; Michael Werner, JDFaculty and Disclosures

CME Released: 12/31/2009; Reviewed and Renewed: 9/5/2014

Valid for credit through: 9/5/2015


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.

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