Understanding the Informed Consent Process

Taken from CenterWatch Pamphlet

Your Rights as a Clinical Trial Volunteer
Informed Consent

Any volunteer who gives his or her consent to participate in a clinical trial or who is asked to give his or her consent on behalf of another has the following rights:

1. To be told the purpose of the clinical trial.
2. To be told about all the risks, side effects or discomforts that might be reasonably expected.
3. To be told of any benefits that can be reasonably expected.
4. To be told what will happen in the study and whether any procedures, drugs or devices are different than those that are used as standard medical treatment.
5. To be told about options available and how they may be better or worse than being in a clinical trial.
6. To be allowed to ask any questions about the trial before giving consent and at any time during the study.
7. To be allowed ample time, without pressure, to decide whether to consent or not to consent to participate.
8. To refuse to participate, for any reason, before and after the trial has started.
9. To receive a signed and dated copy of the informed consent form.
10. To be told of any medical treatments available if complications occur during the trial.