Conflicts of Interest and Informed Consent?
A scenario meant to stimulate discussion about the ethical issues that arise when a researcher is unsure if a study participant is too incapacitated to actually give informed consent.
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.
- 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?
Caroline Whitbeck introduced methods and modules for discussing numerous issues in responsible conduct of research at a Sigma Xi Forum in 2000. Partial funding for the development of this material came from an NIH grant.
You can find the entire sequence on the OEC at Scenarios for Ethics Modules in the Responsible Conduct of Research. Some information in these historical modules may be out-of-date; for instance, there may be a new edition of the professional society's code that is referred to in an item. If you have suggestions for updates, please contact the OEC.