When Should We Accept 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 principal 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?"
- Do you think Mr. Smith should be allowed to participate in the study? Why or why not?
- What other information would you want to help you make this decision?
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 Some information in these historical modules may be out-of-date; for instance, there may be a new edition of the professional society's code that is referred to in an item.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.