Module 4 Examples: “Approval process”
Example 4.2
Adapted from: University of Minnesota, "Informed Consent."
A principal investigator outlines the risks and benefits of a study to a potential participant. The participant wants to know of his other options. The investigator does not know of any other options.
What should the investigator tell the participant?
The answer to this question depends on the kind of research the investigator is conducting. In treatment studies, the consent document must describe "appropriate alternative procedures or courses or treatment, if any" (45 CRF 46.116(a)(4). If there are no clear alternatives to participation, the investigator should simply note nonparticipation as an alternative. For non-treatment studies, the consent document could incorporate similar language about nonparticipation, but a UW-Stout IRB would not usually require such language.