Millions of volunteers participate in government- and industry-sponsored clinical trials each year. Prior to agreeing to participate, every volunteer has the right to know and understand what will happen during a clinical trial. This is called informed consent and it is a process that can help you decide whether or not participating in a trial is right for you.
If you have given consent to participate in a clinical trial, or if you have given consent on behalf of another person, you both are entitled to the following rights:
When you give written consent to participate in a clinical trial, you are acknowledging that you understand and accept all aspects of the research study-including any risks or benefits involved. However, informed consent is not strictly about signing a document. It is a process that involves ongoing conversations between the research staff and you before, and even after, you decide to become a study volunteer.
To begin, the research staff is obligated to discuss all the pertinent information about the trialâ€”its purpose, the procedures involved, the potential risks and benefitsâ€”with you. It is your responsibility to ask questions if there is something you do not understand.
If you do not understand any part of the process, ask the researcher to repeat the information or to explain it in another way, using everyday words. If English is not your first language, inform the researcher that you are not comfortable speaking about a clinical trial in English. Upon request, research centers can and should produce documents that explain every aspect of the study and study personnel should be able to explain the information to you in your preferred language. If this is not possible, you should not participate in the study.
It is the responsibility of the research staff to help you understand the information they provide you and to give you enough time to ask any additional questions you may have. In some instances, this may not be possible to accomplish in a single visit, therefore it is essential to take the time you need to make an informed decision. You may discover important concerns that you did not think about during the first visit.
The following represents a sample list of questions that you should ask during the informed consent process:
About the clinical trial
About your care
About personal matters
About compensation and costs
A recent CenterWatch survey of 672 study volunteers offers insight into the informed consent process and whether or not it is working to help volunteers understand their roles and responsibilities. Some key takeaways from the study are:
Research studies are very involved so it is important to learn as much as possible about the study you may participate in before you consent. The U.S. Food and Drug Administration (FDA) guidelines state that study volunteers should understand the risks they are taking, which may mean spending additional time with the research staff to make sure you get the information you need. If you want to know details, such as any documented side effects of a particular drug observed in earlier clinical trials, you must ask for that information as well as any other information you may want to know.
The decision to participate in a clinical trial is a personal one and one that you are entitled to make freely, without influence or coercion. Being properly informed so that you fully understand the responsibilities of becoming a study volunteer is the best way to ensure that you are making the right decision for you.
For information about volunteering for a clinical trial, click here.