What you need to know about the Informed Consent Process
Participating in clinical research is voluntary. Informed consent involves providing a potential participant with adequate information to allow for an informed decision about clinical study participation, facilitating the participant’s understanding of the information, obtaining a voluntary agreement to participate, and continuing to provide information as the study progresses.
The Food and Drug Administration (FDA) outlines the following criteria that must be given to each potential research subject:
- A statement explaining that the study involves research
- An explanation of the purposes of the research
- The expected length of time for participation
- A description of all procedures that will be completed during enrollment on the clinical trial
- A description of any predictable risks
- Any possible discomforts such as injections, frequency of blood test, etc. that could occur as a result of the research
- Information about any alternative procedures or treatment (if any) that might benefit the research participant
- Any possible benefits that may be expected from the research
Need Additional Information about Informed Consent?
Visit the UW Human Subject Division website