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What is informed consent?

Informed consent is a written contract you sign agreeing to your clinical trial participation. This agreement is signed either by you or by your representative as a confirmation of your willingness to participate in research and is only signed after you have been fully educated on the clinical trial. The Food and Drug Administration (FDA) requires informed consent for every participant in any clinical trial, outlining that you understand and comply with the potential risks.

You should only provide your consent if you have thoroughly considered participating in a clinical and are ready and willing to participate. Likewise, the agreement cannot include any language that seems to free the drug manufacturer, research physician or institution from the care for your well-being.

Providing your informed consent is much more than just signing a contract. The process should involve you asking many questions about the trial so that you are fully educated and prepared to participate. It is your right and responsibility to provide informed consent prior to participating in any clinical trial.

Common Questions:

What is a Clinical Research Trial?
Why Participate in a Clinical Research Trial?
Is there a difference between Clinical Trials and Treatment?
How are New Drugs Tested?

Learn More About Clinical Trials:

What Types of Clinical Trials are Available?
Phase I Clinical Trials
Phase II Clinical Trials
Phase III Clinical Trials
Phase IV Clinical Trials
Glossary of Clinical Trial Terminology
Alabama Health Resources
Brief History of Clinical Trials
Find Clinical Trials

Know Your Rights as a Participant:

Your Patient Rights
Patient Privacy Rules
NIH Patient Bill of Rights
Legal, Ethical, and Safety Issues