Clinicaltrials Your Rights

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.)

Control Groups

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.

Questions to Ask Before Joining a Clinical Trial

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:

  • Can I still see my own doctor during this study?
  • Does the experimental medication or treatment have any known side effects?
  • Is there pain involved with any of the treatments? If so, how will the pain be managed?
  • What is the time commitment for this trial (total, per visit, and outside visits)?
  • What is required during the course of this study?
  • What credentials do the people conducting the study hold?
  • What are the expected benefits of the experimental treatment for my condition?
  • Where will I receive treatment?
  • Will I find out the results of the study?
  • Will I know if I am in the control group?
  • Will I be limited in my activities while participating in this clinical trial?
  • Will I incur any costs by participating in this study?

Pediatric Clinical Trials

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:

  • Is the procedure painful?
  • Can my child still attend school during the trial?
  • Will my child be able to participate in his or her regular activities?
  • Will my child have to stop taking current medications?

Withdrawing from 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.

Resources

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.