Ethics Case Studies in Biodesign

Case 13 - Patient Recruitment

You are a second-year fellow-in-training in Cardiovascular Medicine and your continuity clinic is done under the supervision of a faculty member who is famous for his lectures at national meetings and continuing medical education sessions. This faculty member is on the “Speakers Bureau” of both one of the largest pharmaceutical companies and one of the main medical device companies. You note that a new clinical research protocol of his, sponsored by a drug company, now is looking for patients with acute coronary syndromes (ACS) and he is clear about his desire to identify such patients for the study. As the months go on, there is rather slow recruitment and your supervisor is apparently getting more anxious about finding patients. New and old patients seen in clinic are given special scrutiny as potential study candidates and you are asked to keep a sharp look-out for patients for this protocol. Your supervisor identifies 2 patients in clinic today and talks to them briefly about joining the study. You had thought these patients did not have an ACS when you did the initial interview and presented them to your supervisor. He is quite certain in his feedback to you that you missed the significance of their symptoms and they have an ACS.

  • What should you do in your interaction with each patient as you are left to explain the protocol and have the informed consent forms signed?
  • Does it affect your judgment about enrolling such patients if the study is sponsored by the NIH versus the maker of the trial drug (who also employs your supervisor on a Speakers Bureau)?
  • What should the informed consent form say about your supervisor’s relationship to the sponsor of the study?
  • What should you say to the patients who ask you whether you think they should join this double-blind placebo-controlled study?
  • What should you say to your supervisor if this pattern of identifying patients continues, meaning you don’t agree with inclusion of your/his patients?
  • Whom can you go to if you feel there is something wrong in the situation you are witnessing and becoming party to?
  • Are you aware of any Medical Center or Medical School policies that apply to any part of this situation?