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Questions to ask before consenting to participate in a clinical trial

Before participating in a clinical trial, you need to make an effort to know as much about the trial as possible. Use these questions below as a guide when you are discussing the trial with your doctor or caregiver.

  • Who is doing the study and what questions might it answer?
  • Will the study help in understanding my condition? How?
  • Who is going to be in the study?
  • Why do researchers believe the new treatment being tested may be effective? Has it been tested before?
  • What kinds of tests and treatments are involved?
  • What other options or choices do I have if I decide not to participate?
  • How do the possible risks, side effects, and benefits in the study compare with my current treatment?
  • How can I end my participation in the study if I change my mind?
  • Who has reviewed and approved the study?
  • Who will find out that I am participating in the study?
  • How might this trial affect my daily life?
  • How long will the trial last?
  • Will hospitalization be required?
  • Who will pay for the treatment?
  • Will I be reimbursed for other expenses?
  • What type of long-term follow up care is part of this study?
  • How will I know that the treatment is working? Will results of the trials be provided to me?
  • Could my condition become worse during the study? What will happen if it does?
  • Whom do I contact for questions and information about the study?

 

 

Checklists to inform decisions about entering a clinical trial

- from ECRI

What should a protocol description for a trial tell me?

Information that should be included in study recruitment ads

What should a consent form include?

What should I know about the place and people conducting the clinical trial?

What should I ask about conflicts of interest?

What to discuss with the researchers and close family and friends during the consent process

 
 
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