Informed consent is the exercise of a free power of choice without undue inducement, force, fraud, deceit, duress or other form of constraint or coercion. If the subjects are minors or are not capable of giving consent, parental, guardian or other legal representative consent is required.
- Use of a written consent form that includes all of the basic elements.
- The process of learning the key facts about a research study.
- A process by which a subject voluntarily confirms his or her willingness to participate in a particular research project.
- Informed consent is documented by means of a written, signed, and dated informed consent form unless such documentation is waived by the IRB. (45 CFR 46.116)
- In giving informed consent, subjects may not waive or appear to waive any of their legal rights, or release or appear to release the investigator, the sponsor, the institution or agents thereof from liability for negligence (21 CFR 50.20 and 50.25).
- It is a continuing process throughout the study to provide information for participants.