How is informed consent for a clinical trial or research study different from consent for standard treatment?
Informed consent for a clinical trial or investigational drug or procedure (where new treatments are compared to the current standard treatment) usually includes more information than the consent for standard treatment. The informed consent process should tell you:
- What the clinical trial is set up to find out
- What is expected of you – what will be done and how long you will take part
- Expected benefits
- What’s known and not known about the new drug or procedure
- Any possible risks to you (if known)
- Whom you should contact with questions about or problems with the study
- Other possible treatment options
- That you can leave the study with no penalty and opt for standard medical care at any time
- How your personal information will be protected
The informed consent process is meant to give you ongoing explanations that will help you make educated decisions about whether to start or stay in a clinical trial. The most important part of this process is your everyday interaction and discussions with the research team and other medical staff before, during, and after the trial. The consent form can be a great tool to help get this conversation started.
This is all done so that you can make the best decision for yourself, and to be sure that you are able to choose freely whether to enroll in or stay in the study. Much of this information may be on the consent form itself, which also usually explains that you can withdraw from the study at any time without penalty. The doctor or nurse may encourage you to take extra time to think it over and come back with any questions. If you are giving consent for your child, both parents may be required to sign the form in order for the child to take part in the clinical trial.
Before you decide, the research team will talk with you about the clinical trial’s purpose, procedures, risks, possible benefits, and your rights as a participant. If you decide to take part, the team will keep you up to date on any new information that may affect you and your situation. Before, during, and even after the clinical trial, you will have the chance to ask questions and talk about your concerns. Informed consent for clinical trials goes on for as long as the research lasts, and even afterward.
The process varies among different research institutions and clinical centers, but normally informed consent for a clinical trial includes these steps:
A first meeting. This is when you meet with a member of the research team who gives you the informed consent document and explains it to you. This discussion may also include your oncologist (cancer specialist), primary care doctor, and a nurse. Sometimes a social worker, patient representative, or staff psychologist may be there, too. You can bring along a family member or friend for support, and to help you keep track of the information. The information should be given in a way you can understand. It should also be given at a comfortable pace, with time allowed for you to think it over and ask questions. Some centers offer a video, audio recording, or an interactive computer module to help you better understand the information in the consent form.
Time to take in the information. It can be hard to absorb so much new information in one sitting, especially at a time of emotional stress. You should be given a copy of the consent form so that that you can take it home; review it as many times as you need; and talk it over with family, friends, clergy, counselors, therapists, patient representatives, or other trusted advisors.
A check of your understanding of the information. The research team should make every effort to be sure that you understand the information they give you. They can do this by having you fill out a questionnaire, asking you questions, or having you tell them about the clinical trial in your own words. You also should tell team members about anything you don’t understand. If you find that the consent form or other information is written in words that are too technical for you, let them know. Otherwise they will assume that you understand when you really don’t.
Chances to ask questions. During the first meeting and in later discussions, you should be given the chance to ask questions and raise concerns. Keep asking questions until you feel you know enough to make your decision.
Continued updates on new information. As the clinical trial goes on, the research team may make new discoveries that could affect your health, well-being, or willingness to stay in the study. They will share this with you and might ask you to sign a new consent form. Of course, you are free to leave the study if this information leads you to have doubts about staying in it.
A contact person and phone number for more information should be given to you at the first meeting. While your doctor will likely be a helpful source of information, only you can make the decision about being in a study. Not even the best medical experts can predict whether a method being studied in a clinical trial will work for you. The informed consent process is designed to help you weigh all of the pros and cons and make the best choice.
Tips about clinical trials
- Keep a copy of the consent form. Ask for a copy if one isn’t offered to you. You may also request a copy of the protocol (full study plan) that describes all the details of the clinical trial.
- According to US regulations, no informed consent document may say anything that asks or seems to ask you to give up (waive) any legal rights. It also may not include anything that releases or appears to release the investigator, doctor, sponsor, or facility from liability if they are negligent or careless.
- If you cannot understand the forms you are asked to sign, don’t be afraid to let someone know that you are having trouble. Many people feel nervous about signing consent forms and talking with doctors. Take your time, and ask for help when you need it.
We have more information that can help you understand clinical trials. Call us or visit our Clinical Trials page online to find information, worksheets, and videos that can help you decide if a clinical trial is right for you.
- Informed Consent
- What is informed consent and what does it mean?
- Why does the doctor need me to sign a consent form?
- What are the legal requirements of informed consent?
- Who besides the patient is allowed to consent?
- Are there times when the usual consent requirements do not apply?
- How will I be given information for informed consent?
- What questions should I ask during informed consent?
- Can I change my mind after I’ve signed the consent?
- What if I don’t want the treatment that’s being offered?
- How is informed consent for a clinical trial or research study different from consent for standard treatment?
- How is shared decision-making different from informed consent?
- What if I want my doctor to make the decisions about my care, and I don’t want more information?
- How can I find out more?