Module 4 Examples: “Approval process”
Example 4.1
Adapted from: University of Minnesota, "Informed Consent."
A graduate student in psychology informs her participants about the purpose and procedures of her study on visual creativity and mentions that there are some risks and benefits.
Has she apprised them of all the required information according to the consent process?
No. The student must tell her participants about the specific risks and benefits of being in the study. In addition, from this brief description of the consent process, you cannot tell what the description of the study covers. In general, an informed consent process must address all eight elements of consent as identified in the Common Rule.