Questions to Ask

A clinical research study involves testing or studying a drug or medical treatment to see if it is a safe and effective treatment for people. The FDA has rules on how clinical trials are conducted. These rules are designed to ensure the safety of those who participate. One of these rules is that the researcher must provide an Informed Consent Form for you that explains the pros and cons of being in the study.

Read the Informed Consent. Feel free to take it home and discuss it with people you trust. Make sure all your questions are answered before you sign.

Whether or not to be part of a clinical trial is your choice. It is in everyone’s best interests to make sure participants feel comfortable asking the research team questions about the study, related procedures, and any expenses or reimbursements. In deciding for yourself or your child, consider the following:

  • What is being studied?
  • Why do researchers believe the intervention being tested might be effective? Why might it not be effective? Has it been tested before? 
  • What are the possible treatments that I might receive during the trial?
  • Is there a control group that receives a placebo or no treatment?
  • Who will know which treatment I receive during the trial? Will I know? Will members of the research team know?
  • How do the possible risks, side effects, and benefits of this treatment compare with my current treatment?
  • What will I have to do?
  • What tests and procedures are involved?
  • How often will I have to visit the hospital or clinic?
  • Will hospitalization be required?
  • How long will the study last?
  • Who will pay for my participation?
  • Will I be reimbursed for other expenses? When?
  • What type of long-term follow-up care is part of this trial?
  • If I benefit from the treatment, will I be allowed to continue receiving it after the trial ends?
  • Will results of the study be provided to me?
  • Who will oversee my medical care while I am in the trial?
  • What are my options if I am injured during the study?

Sources: www.clinicaltrials.gov; www.genome.gov; www.cancer.org