Informed Consent: What You Should Expect
If you’re considering participating in a clinical trial or have participated in one before, you should be familiar with an important process called informed consent.
The phrase “informed consent” may sound formal, but the idea is straightforward. You should have the information you need to understand a clinical trial and decide if participating is right for you.
An informed consent form explains the purpose of the study, what you will be asked to do, potential risks and benefits, available alternatives, compensation (if available), and your rights as a research participant.
Understanding informed consent can help you feel more comfortable asking questions and making an informed decision about participating in clinical research.
What Is Informed Consent in a Clinical Trial?
Informed consent is a conversation, a process, and a written document (Informed Consent Form (ICF)).
Before enrolling in a clinical trial, the research team will review information about the study with you. This is a good opportunity to ask questions, discuss anything you don’t understand, and take the time you need to decide whether you want to participate.
Just because you started the informed consent process does not mean you cannot stop and lose your chance at participating. You can take your time to review and share the information with your physician, friends or family.
Importantly, signing an informed consent form does not mean you are giving up your rights. Clinical trial participation is voluntary.
Why Is Informed Consent Important?
Clinical trials help researchers study potential new treatments, devices, procedures, and approaches to managing diseases and medical conditions.
Because clinical research involves more than routine medical care, it is important for participants to understand what they are being asked to do.
Informed consent is designed to help answer questions like:
- Why is this clinical trial being conducted?
- What will happen if I participate?
- How long will the study last?
- What are the potential risks?
- Could I benefit from participating?
- What alternatives do I have?
- What happens to my personal information?
- Can I leave the study if I change my mind?
In the United States, FDA-regulated research involving human participants is subject to informed-consent requirements. An Institutional Review Board (IRB) also plays an important role in reviewing research and protecting the rights and welfare of participants.
What Is Included in a Clinical Trial Informed Consent Form?
The exact contents of an informed consent document can vary depending on the clinical trial and the regulations that apply. However, FDA regulations identify eight basic elements.
Let’s take a closer look at what those elements mean in everyday language.
- The Study Purpose and Procedures
It should explain:
- The purpose of the clinical trial
- How long you are expected to participate
- What procedures will take place
- Which procedures or treatments are experimental
- Potential Risks and Discomforts
Every clinical trial has potential risks, although the specific risks vary from study to study.
The informed consent should describe the risks and discomforts associated with participating. For later phase studies, these usually include known side effects and other risks.
The goal is to give you enough information to understand what could happen before you decide whether to participate.
- Potential Benefits
The informed consent should also explain the benefits that may reasonably be expected from participating.
It’s important to understand that a clinical trial may not provide a direct medical benefit to you.
For example, an investigational treatment may not work, or you may receive a placebo if the study design includes one.
- Alternatives to Participating
You should be informed about appropriate alternative treatments or procedures, when they exist.
Understanding your alternatives is an important part of making an informed decision.
Participating in a clinical trial is a choice, not something you should feel that you have to do.
- How Your Information Will Be Protected
Clinical trials require researchers to collect information about participants.
The informed consent should explain the extent to which records that identify you will be kept confidential and who may have access to your research records.
Depending on the study, information may be reviewed by members of the research team, the study sponsor, an IRB, or regulatory authorities.
- Compensation and Treatment for Research-Related Injury
For research involving more than minimal risk, informed consent requirements include information about whether compensation is available and whether medical treatment is available if a research-related injury occurs.
Some clinical trials may also provide compensation for a participant’s time, travel, or other study-related expenses. If compensation is offered, the research team should explain the details before you enroll.
- Who Can Answer Your Questions?
Your informed consent should explain whom you can contact if you have questions about:
- The clinical trial
- Your rights as a research participant
- A research-related injury or concern
Don’t be afraid to use these contact numbers or email addresses. It’s also important to note that the informed consent discussion is not the only time you can ask questions. You are encouraged to ask questions at any time during your participation in a clinical trial.
- Participation Is Voluntary
Perhaps one of the most important things to understand about informed consent is that participation is voluntary.
FDA regulations require the consent process to include a statement that:
You can choose not to participate.
Refusing to participate should not result in a penalty or loss of benefits to which you are otherwise entitled. You may discontinue participation without penalty or loss of benefits to which you are otherwise entitled.
Additional Information That May Be Included
Depending on the clinical trial, your informed consent may contain additional information:
- Risks that are currently unforeseeable
- Circumstances under which the investigator may end your participation
- Additional costs that may result from participating
- What happens if you withdraw and how your withdrawal will be handled
- A statement that significant new findings that could affect your willingness to continue will be provided to you
- The approximate number of participants in the study
Frequently Asked Questions About Clinical Trial Informed Consent
Does Informed Consent Happen Only Once?
- Not necessarily. Informed consent is an ongoing process. If researchers learn important new information during a study, the research team may need to provide that information to participants.
Can I leave a clinical trial or change my mind after signing informed consent?
- Yes. Signing an informed consent form does not mean you are required to remain in a study indefinitely. Your consent document should explain what happens if you decide to withdraw, and the research team can explain the appropriate process for leaving the study. If you change your mind about participating, talk with your research team. They can explain the appropriate steps for withdrawing from the study.
What if I don’t understand something in the consent form?
- Ask the research team to explain it in simpler language. Federal requirements call for consent information to be presented in language understandable to the participant.
Will I receive a copy of my informed consent form?
- A copy of the signed consent form is generally provided to the person who signs it.
Interested in Learning More About Clinical Trials?
If you’re considering a clinical trial, check out Ora’s find a trial webpage. If a study interests you, you can contact our study team or fill out an online form. We are happy to take the time to speak to you so you may ask questions, and discuss whether a study may be appropriate for you.
At Ora, our goal is to make the clinical trial experience easier to understand and more patient-centered.
