What is Informed Consent?
If you decide are interested in participating in a clinical trial, the first step is Consent.
Through the Informed Consent discussion, the research site provides information about your rights as a volunteer as well as the study
requirements, before any procedures related to the clinical trial are initiated.
Participation in a clinical trial is voluntary only. A research volunteer can stop participation at any time – with no recourse.
Informed Consent may occur during a stand-alone visit or may be combined with the Screening Visit.
21CFR50 identifies requirements for consent that must be met:
- Sufficient time or opportunity must be given to the potential volunteer to determine whether or not they want to participate.
- The potential volunteer should take all the time they need – ask questions of the staff, doctor, etc. if needed. The potential volunteer can also go home to think it over and discuss with family if they choose to do so.
- The potential volunteer should not note any coercion or undue influence from the research staff
- All information provided to the volunteer or legally authorized representative must be understandable. All documents must be at an acceptable language level and in a language understood by the volunteer or representative.
- The consent must not include any exculpatory language (wording that waives or appears to waive any legal rights)