Virtual Mentor. August 2001, Volume 3, Number 8.

Cases in Law and Ethics

My Doctor the Researcher

A family physician enters into contract with a clinical research organization to recruit patients. As a clinical investigator, she is paid for each patient she recruits. Ethical questions for discussion are raised.

Kayhan Parsi, JD, PhD

Dr. Fiddler learns about a contract research organization that matches pharmaceutical companies who are conducting clinical research trials with physicians. The company wants to test a new medication for prostate cancer and will pay Dr. Fiddler a lump sum of $3000 for each patient of hers whom she enrolls in the clinical trial. She will follow the patients and document their responses to the trial therapy. Dr. Fiddler thinks several of her patients are suitable candidates for the study. The first one she talks to is Mr. Upinsky. During the informed consent process, Dr. Fiddler properly informs Mr. Upinsky about the risks and benefits of the trial and her role as a clinical investigator. She explains that she will continue to be his physician, that the trial is not a treatment, that he can withdraw from the trial at any time, and that he owes her no duty to participate. She does not tell Mr. Upinsky that she is being paid by the pharmaceutical company to enroll subjects in the trial.

Dr. Fiddler believes that the amount she is receiving will cover her administrative costs and produce a small profit. She has no financial investment in the pharmaceutical company that is conducting the trial. Dr. Fiddler sees no ethical conflict in enrolling her patients in the clinical trial, as long as they understand that it is not a treatment and that they are free to decide whether or not to participate.

Questions

  1. Is Dr. Fiddler’s arrangement with the pharmaceutical company ethical?
    See AMA Opinion 8.032, Conflicts of Interest in the Conduct of Clinical Trials.
  2. Does disclosure or non-disclosure of Dr. Fiddler’s financial arrangement to candidate clinical trial subjects make an ethical difference?
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