The process of obtaining informed consent must comply with the requirements of 45 CFR 46.116 and ISU policy. The documentation of informed consent must comply with 45 CFR 46.117. The following resources are provided to assist with the development of the consent process.
A compilation of the consent requirements are provided in the checklist.
Below are general tips on how to design informed consent. The order of the tips, follow the headings of the consent template.