What questions should I ask the clinical investigator or the study staff member before deciding to participate?
You should ask any question you believe will help you in the decision making process. Before meeting with the clinical investigator or study staff member, write your questions down, and feel free to take notes of the responses you are provided during the discussion. Some questions that you may want to ask include:
- What is the purpose of the study?
- What side effects may occur if I participate in the study?
- Has anyone been injured during participation in this study?
- Why does the clinical investigator or study staff member believe the study product may be effective or beneficial?
- Will I get the product being studied, and if not, why?
- How many people has the clinical investigator enrolled in this study?
- How many people are enrolled in this study in the U.S.? In the world?
- What tests, procedures, and medications are involved in this study?
- What are the alternatives to participation in this study?
- What are the possible downsides of participating in this study?
- What costs will I be responsible for in connection with this study?
- Will my insurance cover any costs associated with this study?
- Will I be paid for participation in the study?
- How long will I be in this study?
- Whom should I contact if I experience a side effect or complication?
- Whom should I contact if I have a question about the study?
- Whom should I speak with if I decide to end my participation in the study?
You should feel free to take the time you feel is necessary to decide whether to participate in a clinical research study. This may mean several discussions with the clinical investigator or study staff member. That is okay, because in the end, it is your decision whether or not to participate, and you need to feel comfortable with that decision.