People should know as much as possible about the clinical trial and feel comfortable asking the members of the health care team questions about it, the care expected while in a trial, and the cost of the trial.
The decision to participate in a clinical study should not be taken lightly. If you would like to participate, you should have a clear understanding of the nature and aims of a study and your role in it. Ask the research team questions about anything that is unclear.
Points to consider before agreeing to participate:
- The purpose of the study
- Your rights as a participant, including your right not to participate or to drop out at any time
- Your duties and obligations as a study participant
- How long the study will last and how much of a time commitment will be expected
- Any possible effects of the study, including potential benefits and risks
- Whether you will be reimbursed for expenses
If it is a study with an intervention -- any drug or therapy that produces an effect -- you should also be given information about the following:
- Your chances of being in the intervention group versus the control group
- How you will be assigned to one group or the other (this is often done by randomization)
- The chance of an adverse reaction or other risks from being in the intervention group
- Alternatives that you may want to consider rather than participating in a clinical study
Questions to ask:
- Who is going to be in the study?
- Why do researchers believe the experimental treatment being tested may be effective? Has it been tested before?
- What kinds of tests and experimental treatments are involved?
- How do the possible risks, side effects and benefits in the study compare with my current treatment?
- How might this trial affect my daily life?
- Will hospitalization be required?
- Who will pay for the experimental treatment?
- What type of long-term follow up care is part of the study?
- How will I know that the experimental treatment is working?
- Will results of the trials be provided to me?
- Who will be in charge of my care?