Before the trial: informed consent
When you first meet with the research team, they will walk you through a process called "informed consent" to discuss:
- The purpose of the study
- Tests and procedures involved
- Possible risks and benefits
- If there will be any costs to you
- How the researchers will protect your privacy
- Your rights as a participant in the trial
- Any concerns you may have
You will be informed about new benefits, risks, or side effects that may be discovered during the trial. You may also be asked to sign a new consent form that identifies these updates to the study.
Short-term risks are usually easy to identify. You'll see them outlined on your consent form. Long-term risks are often not well known because the drug or device hasn't been around long enough for the data to be available.
During the trial: your care
When you volunteer for a clinical trial, some visits and procedures collect information related only to the study. Other visits and procedures are part of the usual care, often referred to as "standard care,” for your condition which would be provided even if you were not in a clinical trial.
Being part of a clinical trial is not the same as being treated for a specific disease. Your routine care will continue with your regular health care providers while you take part in the research study. The important thing to remember is that the choice of whether or not to enter a clinical trial is completely up to you.
After the trial: learning results
Ask your research team if they know when the study will be completed and the results published. You can also see results of completed clinical trials at clinicaltrials.gov, a database run by the National Institutes of Health.
Keep in mind, though, that sometimes a trial needs to end before it is completed, or the trial is ongoing and does not have a specific end date.
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