Informed Consent in Clinical Trials
Clinical trials offer the opportunity for patients to try potentially life-saving, innovative treatments. However, there may also be drawbacks, as these medications and therapies have yet to be fully tested on humans. Additionally, patients have the right to ask questions and receive information about any treatment they receive, whether in a clinical trial or not.
Informed consent is legally and ethically required in all healthcare, but is especially important when it comes to experimental treatments. This article will guide you through an overview of informed consent in clinical trials so that you can feel comfortable when deciding whether a clinical trial is the right choice for you.
What is Informed Consent?
To understand informed consent, we must first learn what clinical trials are. Clinical trials allow medical teams to determine how new treatments work. If a treatment meets certain standards in animal testing, it makes it to the final stage of testing – human clinical trials. Clinical trials help us determine the safety of a treatment, dosage, frequency of treatment, and effectiveness in terms of relieving symptoms or curing a condition. Since researchers don’t know exactly how well the treatment will work or how it will impact the body, there are some risks involved.
Clinical trials allow medical professionals to study the treatment as it affects humans, so it’s important for the participants to understand their role. In this context, they’re the subject of research – not a patient. Although they may get the benefit of treatment, it’s important that participants also understand that there could be no benefit, as well as unknown risks.
As such, it’s critical for participants to make an informed decision as to whether participating in a clinical trial is right for them. They need information about:
- What discomforts and risks they can experience
- What treatments or therapies will be done to them
- How the research process will work
- How participation in the study is completely voluntary
The process of informed consent ensures that this information is given to study participants before research begins. They must sign a form to signify that the purpose and plan of research were explained to them, including what their role entails.
The Informed Consent Form (ICF)
Informed consent is more than verbally asking a person if they’d like to participate in a clinical trial. The informed consent form, or ICF, details the design of the clinical trial and the role of the patient – or potential research subject. The ICF should include:
- The purpose of the clinical trial and research
- The expected duration
- A statement that the study includes research
- A statement that participation is voluntary and that the participant can refuse treatment without the consequence of losing the care that they need
- All potential risks and benefits related to the research
- All potential discomforts (such as blood tests and injections)
- A list of all procedures that are included in the treatment
- Alternative treatments or procedures (if any) that could benefit the participant
- Details on how the participant’s information will be maintained and kept private
- A statement that the FDA may inspect the records of the research at any time
- The participant’s rights, like refusing treatment
- Information about compensation
- Information about medical treatments in the event that an injury occurs
- Contacts that the participant can use for any additional questions related to the clinical trial
How to Carefully Read an ICF
When you sign up for a clinical trial, you are considered a research subject. Taking part in the trial is referred to as enrollment in the study. As a potential research subject, you’ll be given the opportunity to read the ICF in full, as well as ask questions. It’s important that you read the form carefully and check to confirm that all the above points are covered in the form.
You can bring a family member or friend with you when you’re presented with the consent form. They can help you take notes and keep track of information. Be sure to ask questions about any terms or points that you don’t understand. The study representative is there to answer your questions and make sure you feel comfortable with the details of the clinical trial. Remember that many people feel nervous when talking with health care professionals or reviewing consent forms, so don’t be afraid to let someone know if you need help. You can also ask for extra time to review the form and bring a copy home with you where you might feel more comfortable looking through it.
After signing the ICF and proceeding to the clinical trial, you should still keep a copy of the ICF. You can also ask for a copy of the protocol (the detailed plan for the study). Be sure to review both throughout the study. If, for some reason, the study isn’t following the protocol you signed up for, you are free to opt-out at any time. Even if the clinical trial is on track as designed, you remain free to refuse treatment without consequence.
Ultimately, deciding to join a clinical trial can be a nerve-wracking but potentially rewarding decision. The informed consent process exists to help you weigh the benefits and drawbacks. It’s important that you make the best decision for yourself and your needs above all else. If you want to learn more about clinical trials, check out our informative guide here. If you or a loved one is interested in taking part in innovative research, you can read more about open opportunities with Triad Clinical Trials by clicking here.