Informed Consent Process (US FDA)

Clinical trials are experiments. As such, they may involve risks, often serious ones. You have no guarantee how the trial will turn out if you choose to enroll. You also may undergo discomfort, inconvenience, and expense that you would not have had otherwise. Only you can decide whether joining a clinical trial is worthwhile or not, based on how you value the possible benefits and risks. For all these reasons, you should evaluate the details of a clinical trial carefully before making any decision. The following are some additional questions that you should ask yourself before you consider a clinical trial:

QUESTIONS SPECIFIC TO THE CLINICAL RESEARCH TRIAL:

• How will enrolling in this clinical research trial benefit me?
• Are there other ways I could get the same benefits without enrolling in this clinical research trial?
• What adverse effects might this particular clinical research trial have on my health?
• Has a study researcher answered all of my questions to my satisfaction?
• Whom should I call if I have new questions?

QUESTIONS SPECIFIC TO YOU AND YOUR PARTICIPATION:

• What is the actual medical intervention being tested? If it is a pill, am I willing to take pills as often as the trial requires?
• Will there be tests that make me nervous or uncomfortable?
• What private information about me do the study researchers need to know? Am I comfortable with that? How will they protect that information?
• How much time will I need to spend as part of the trial? How many visits will I need to make, and how long will those visits last?
• What expenses will the study have? Will I miss time from work? Will I have to pay for travel, parking, and meals?
• Am I comfortable with the idea of participating in a clinical research trial?

Only you can decide whether a clinical trial is right for you. Only you can balance the benefits and risks and determine which are more important to you.