Abstract

The case of a specialist physician who is invited to participate in a multicenter, pharmaceutical laboratory-sponsored study intended to establish the effectiveness and safety of a new drug for diabetes mellitus is presented. The doctor has a very successful private practice due to high patient demand and also holds an institutional position as an employee of a public hospital in the city where he resides.

The pharmaceutical company offers to pay the doctor a substantial amount for including in the research patients from both his private consultation and the public hospital who meet the eligibility requirements. The physician accepts the proposed compensation and decides to admit patients who meet the requirements without explaining the characteristics of the research or inviting them to participate by signing of an informed consent.

The research continues for two years, during which the physician submits the required reports to the contracting laboratory and agrees that if the laboratory wishes to publish the results, his name, medical specialty, and the institutions where the research was conducted shall be included in the respective article submitted for publication in a high-impact medical journal.

A colleague of the physician conducting the research learns about the conditions under which the study was conducted at the public hospital’s consultation and reports this situation to the institution’s research Ethics Committee (REC).

The case is analyzed from the perspective of ethical principles guiding research involving human beings.