• 1. Should I take part in a clinical trial?

    Ultimately, it is your decision whether or not to participate in a clinical trial. It’s important that you feel comfortable to ask questions about the research being conducted at any time. You should have as much information as possible to make an informed and educated decision on participating. Some questions to consider before making your decision:

    • What is the purpose of the study?
    • Who is going to be in the study?
    • Who is in charge of the study?
    • What kinds of tests and treatments are involved?
    • What are the possible risks or side effects?
    • What are the potential benefits?
    • How long will I be expected to participate in the study?
    • How much does it cost to participate?
    • Will I be reimbursed for other expenses?
    • How will I know that the treatment is working?
    • Will the results of the study be provided to me?
    • Who should I contact if I have more questions?

    2. Who is eligible to participate in a clinical trial?

    Each study has its own set of eligibility criteria, or inclusion/exclusion criteria; these criteria state who can and cannot participate in a particular study. Generally, participants within a study are alike in significant ways such as type of disease or illness, age, gender, previous or current treatments, or other medical conditions. The criteria for a particular study help define the appropriate population, as well as keep people who are not appropriate for the treatment safe. While some clinical trials enroll people with a specific illness or disease, others enroll healthy participants. To find out if you are eligible for a particular study, contact the project coordinator or nurse in charge of participant enrollment.

    3. What is the informed consent?

    Informed consent is a process in which you learn more about the important facts related to a clinical trial in order for you to make an informed decision about whether or not to participate. During the informed consent process you should learn more about the procedures for the evaluations and treatment of the clinical trial, the known benefits, the known risks, alternative treatments, confidentiality of records, compensation, and the ability to withdraw at any time without penalty. During this time, you should also feel free to ask any questions you may have about the study in which you may be participating.

    4. How are participants protected?

    Clinical trials within the U.S. must be approved and monitored by an Institutional Review Board (IRB). The IRB is an independent committee of physicians, statisticians, community advocates, and others. They are responsible for ensuring that the risks are as low as possible and out-weighed by potential benefits, and that the clinical trial is ethical. They are also responsible for verifying that the rights of the participant are protected.

    5. Can a participant leave a clinical trial after it has begun?

    Yes. As a participant, you have the right to withdraw from a clinical trial at any time. However, it’s important for the research staff to know that you are leaving the study and why.