THE NATIONAL ACADEMY OF ENGINEERING

Conflicts of Interest and Informed Consent?

Author(s): Stuart Youngner, M.D.

You are the principle investigator of a phase II study of refractory depression funded by a large pharmaceutical company. Mr. Smith has been unsuccessfully treated by a psychiatrist in the community. This psychiatrist has referred Mr. Smith to you at the academic medical center where you work and are conducting the study.

The study involves hospitalization, a washout period of four weeks, and assignment to a placebo or treatment arm. Mr. Smith agrees to the study saying, "I don't care anymore. I don't care if I get the medicine or the placebo. What difference does it make?"

Mr. Smith's wife confides to you that her husband is so depressed that he really can't make a rational decision, but she wants very much for him to participate in the drug study. After all, nothing else has worked. You agree that Mr. Smith has little to lose.

John, a psychiatric resident, wonders if you are the best person to assess Mr. Smith's competency to give informed consent to participate in this study.

Discussion Questions

• How should Mrs. Smith's comments influence your decision?
• What about John's opinion - is there a conflict? Are you able to adequately assess Mr. Smith's competency given your multiple roles?
• Who might be in a better position to obtain informed consent?

• Return to Research Ethics Module Supporting Pages

• If You Were an IACUC Committee Member

• Conflicting Obligations: Part II

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