Informed consent is the term that signifies a person has been given information regarding all possible consequences for a treatment, including both potential risks and benefits. While informed consent frequently is applicable in any medical procedure or treatment, it is especially important in clinical trials. The U.S. Department of Health and Human Services has established regulations that require any research trial to obtain informed consent from any human subject.1
Before taking part in a clinical trial, you will be provided with an informed consent form, which includes important information about the trial, including its purpose, how long it is expected to last, any tests or procedures that are expected, and potential benefits and risks (like side effects). The informed consent form must be signed before you can take part in a research trial, and your signature confirms that you have been given and understand the information contained in it. In addition, informed consent continues throughout the research trial, as new information about the treatment becomes available, and you have the right to leave the trial at any time.2
While you may receive benefit for your health condition by participating in a clinical trial, there is also a chance that you will not receive any benefit, and you may be exposed to unplanned risks. Informed consent aims to give you all the information you need to make a decision about participating in the research trial.3
What are your rights in a clinical trial?
When you sign an informed consent form, it means you have been given the required information about the trial and that you understand it. Your signature does not bind you to participation in the research trial, and you have the right to discontinue or leave the trial at any time for any reason.
In addition to your rights before beginning in a research trial, you have the right to be informed throughout the trial as new information becomes available, such as when new risks or findings emerge during the course of the study.
Children who participate in clinical trials also have special protection. In most cases, both parents must provide legal consent for the child to participate, and many trials allow children aged 7 years or older to also provide their agreement to participate.4
Questions you may want to ask
As a potential participant in a clinical trial, you will be given the opportunity to ask questions. Some questions you may want to consider include:
What is the purpose of this study?
What tests or procedures will be performed on me?
What are the expected outcomes or benefits for this treatment?
What are the possible risks, side effects, or complications?
How might my participation in this trial impact my life?
Are there other treatments that are options for me?4,5
Informed Consent FAQs, U.S. Department of Health and Human Services. Available at https://www.hhs.gov/ohrp/regulations-and-policy/guidance/faq/informed-consent/index.html. Accessed 10/23/17.
Clinical Research Trials and You, National Institutes of Health. Available at https://www.nih.gov/health-information/nih-clinical-research-trials-you/basics. Accessed 10/23/17.
Informed Consent for Clinical Trials, U.S. Food and Drug Administration. Available at https://www.fda.gov/forpatients/clinicaltrials/informedconsent/default.htm. Accessed 10/23/17.
How Do Clinical Trials Protect Participants? National Heart, Lung and Blood Institute. Available at https://www.nhlbi.nih.gov/studies/clinicaltrials/protect. Accessed 10/23/17.
What questions should I ask during informed consent? American Cancer Society. Available at https://www.cancer.org/treatment/finding-and-paying-for-treatment/understanding-financial-and-legal-matters/informed-consent/questions-i-should-ask.html. Accessed 10/23/17.