WHAT SHOULD I KNOW BEFORE PARTICIPATING IN A RESEARCH STUDY?

You should know as much as possible about the research study before you participate. It is important that you feel very comfortable asking questions and that the staff answers them in a way you can understand. When preparing for a meeting with the study coordinator or doctor you should plan ahead and write down the questions you want to ask. Review the study website to help you prepare questions to ask. You might ask a friend or relative to come with you for support and to hear the responses to your questions. You may want to ask the following questions when deciding whether to participate in a clinical trial:

  • Why is this research being done?
  • What is the purpose of the study?
  • Who is sponsoring the study?
  • Who has reviewed and approved this study?
  • Why does the research team think the treatment, drug, or medical device will work?
  • What kinds of therapies, procedures, and/or tests will I have during the trial?
  • Will they hurt? If so, for how long?
  • How will the tests in the study compare to tests I would have outside the study?
  • How long will the study last?
  • How often will I have to go to the study site?
  • Will I be able to take my regular medications during the trial?
  • What medications, procedures, or treatments must I avoid while in the study?
  • What are my responsibilities during the study?
  • Will I have to be in the hospital during the study?
  • Will the study researchers work with my doctor while I am in the study?
  • Can anyone find out that I am participating in a study?
  • Can I talk to other people in the study?
  • Will I be able to find out the results of the trial?
  • Questions about risks and benefits include:
  • How do the possible risks and benefits of the study compare with approved treatments for me?
  • What are the possible immediate and long-term side effects?
  • Will I have to pay anything to participate in the study?
  • What are the charges likely to be?
  • Is my insurance likely to cover those expenses?

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