BILL OF RIGHTS

what you need to know before participating in a clinical study

• Be told the purpose of the trial of the investigation

• Be informed of all the risks, plausible side effects or discomforts that any normal person could expect

• Be informed of the sought benefits

• be told what will happen in the study, and whether any procedures or drugs (medications) or devices are different from those considered the standard of care

• be informed of existing options to the standard of care that are considered reasonable, and could be better or worse than participating in a clinical trial

• Be provided informed consent ahead of time, so you can evaluate in a non stressful manner

• Be allowed ample time to ask questions before signing consent and any given time afterwards

• Be given reasonable time to decide whether you want to participate or not

• Be told of any medical treatments available if complications or adverse events occur during the duration of the clinical trial

• Understand well that you have the right to refuse to participate for any reason before or after the initiation of the clinical trial

• Receive a signed copy of the informed consent

• Receive contact information from the principal investigator conducting the clinical trial