Our primary concern is the health and safety of our volunteers.
All of our studies are conducted under guidelines set down by the US Food and Drug Administration (FDA). Each study is reviewed by an Independent Review Board (IRB) which is responsible for ensuring that your safety has been thoroughly considered, that the information provided to you is fair, balanced and accurate and that your rights as a volunteer are maintained.
Knowing Your Rights - the Informed Consent Process
If you've had a procedure in a hospital, you may have had to sign a consent form. An informed consent for a clinical trial is a more specialised consent and it has a very distinct purpose: it is designed to protect you, not the research staff.
You will be given an Informed Consent Form (ICF) as part of a conversation you have with the research staff before you participate in a trial. The informed consent will explain:
- The purpose of the trial
- What treatments or procedures you will undergo during participation
- A schedule
- An explanation of the risks
- Potential benefits of the trial
- Your rights as a participant
Use the written informed consent as a basis for asking any questions you may have about the clinical trial process.
Signing an informed consent does not obligate you to participate in the clinical trial. Even though you sign the consent,you can change your mind and leave a study at any time.