As a participant in a clinical research study, you have certain rights, including access to high-quality healthcare and certain information. If you've been accepted to a trial, before you begin, you'll be given information on what the trial entails, what the benefits and risks of the trial might be, how long the trial will last, and what you need to know about the treatment.
This process of learning about the trial is called "informed consent." Basically, "informed consent" means you have the right to know all of the benefits, risks, and necessary details of the trial before you opt to participate. Informed consent lasts even after the trial is over, when you still have the right to have any questions answered. (In many cases, "informed consent" is also the name of the form you sign to indicate that you have received all the information you require and give your consent to participate in the trial.)
A clinical research study has to compare the test treatment to existing treatments, which is why control groups are important. Control groups are composed of participants who receive established medical treatments during the trial. On occasion, this group may be given a placebo--a pill or treatment similar in appearance to the drug compound under study, but without the active ingredient.
To keep the test results as fair as possible, you may not be told whether you're in the control group or the experimental group. Be assured, however, even if you're in the control group, you'll still be closely monitored by the doctors and researchers conducting the study.
You have the right to know what will happen to you during a clinical trial. However, asking the questions is up to you. Here are some questions to consider asking the investigators before committing to a clinical trial:
A child enrolled in a pediatric clinical trial is granted all of the rights and privileges of any participant in a medical trial. The main difference is that you, as the parent or guardian, will be the one asking the questions and making decisions for the child. You have a right to informed consent concerning your child's involvement in any pediatric clinical trial.
Here are a few questions to ask before signing your child up for pediatric clinical trials:
You can withdraw from a clinical research study or have your child removed from a pediatric clinical trial at any time.
You should note, however, that a clinical study would be in jeopardy if a substantial percentage of participants withdrew before its end. It's generally better to make the decision to participate or not before the clinical research study starts. If you must withdraw from a study, researchers appreciate knowing your reasons for leaving.
National Institutes of Health staff. (2008). Glossary of clinical trials terms. Retrieved January 15, 2019, from the ClinicalTrials.gov Web site: http://www.clinicaltrials.gov/ct2/info/glossary.
FDA staff. (2009). Basic questions and answers about clinical trials. Retrieved January 15, 2010, from the US Food and Drug Administration Web site: http://www.fda.gov/ForConsumers /byAudience/ForPatientAdvocates/HIVandAIDSActivities/ucm121345.htm.
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