Informed consent is both a document and a process. It must be documented (unless waived) and must include the required elements in 45 CFR 46.116 and, for FDA studies, 21 CFR 50.25.
Required elements include
- A statement that the study involves research and its purpose
- Reasonably foreseeable risks and discomforts
- Benefits, alternatives, and confidentiality protections
- Compensation and treatment for injury (if applicable)
- Contacts for questions and a statement that participation is voluntary
The 2018 Common Rule revisions added a concise 'key information' section at the top of the form to help prospective subjects make an informed decision.