What is Meant by “Informed Consent”?

Unless you have participated in a clinical trial, you might not be familiar with the term “informed consent,” commonly used to refer to the document that patients are given when they are considering signing up for a trial. This document contains information about the trial, discusses risks of participating, and includes details about the experimental treatment and required tests. Patients need to sign the document before beginning a clinical trial.

What is informed consent?

The National Cancer Institute (NCI), however, defines informed consent as “a process in which patients are given important information, including possible risks and benefits, about a medical procedure or treatment, genetic testing, or a clinical trial. This is to help them decide if they want to be treated, tested, or take part in the trial. Patients are also given any new information that might affect their decision to continue. Also called consent process.”¹ This leads to an important question: Is informed consent a process, as the NCI definition indicates, or is it merely a document?

In an ideal world, informed consent should always include a detailed conversation between a patient and a physician; much more should be involved besides sharing a document. However, in reality, these discussions might be brief summaries, with potential participants given informed consent documents to read for specifics. This can lead to gaps in understanding. While the NCI recommends that informed consent documents shouldn’t be longer than six to nine pages, these documents are often two or three times as long. Since patients are reviewing such documents at stressful periods in their lives, they are often difficult to fully comprehend.

Tips for understanding informed consent documents

I’d like to share a few helpful suggestions if you are presented with an informed consent document for a clinical trial:

• Do not sign the document as soon as you receive it. Take it home so that you can look at it more carefully. Make a list of any questions that you might have or any points that you do not understand to discuss with your doctor or clinical trial coordinator. While informed consents are supposed to be written in lay language that is easy for patients to understand, terms are still frequently included that are confusing.
• Understand what kind of treatment you would likely receive if you didn’t participate in this clinical trial (usually called “standard of care” or SOC). The SOC treatment should be described clearly in the informed consent, along with the risk profile and potential benefits of the clinical trial treatment. If you cannot find all the information you need in order to make your decision, ask for clarification!
• Ensure that you fully understand what your schedule will entail if you participate in the trial. The document should include detailed information about how often you will receive treatments and need tests. If this is not made transparent, request more specifics in order to make sure you will be able to manage any additional burden of participation. Sometimes clinical trials include “randomization,” meaning that one group of patients will receive the experimental drug and others will receive the SOC. Other trials might give different doses of the trial medications to participants depending on their order of enrollment. Gather as much detail as you can.
• Make sure you know which costs will be covered by the trial and which costs you and/or your insurance company will need to fund. Often, clinical trials cover the expenses of the experimental drug and any testing in addition to what would be typical with standard of care treatment. Other costs are your responsibility. However, some trials are becoming more patient-friendly and including forms of reimbursement for meals, parking, and/or transportation.
• Confirm that you understand whether you will be given the results of all biopsies, blood tests, and other procedures or if any of these are being done for research purposes only. In some situations, you may not receive your individual results if a test is not intended to impact your own care. Sometimes, such tests performed to gather additional data for research are listed as optional; if this is the case, you will be asked for an extra signature if you agree to undergo these. If you choose not to be part of an optional portion of the trial, you will not be penalized in any way.

As you can see, there are many things to consider when investigating a clinical trial. I hope you find the suggestions above helpful. Many advocates, myself included, are working with researchers and pharmaceutical companies in order to simplify clinical trial informed consents and make the contents clearer to potential participants like yourselves.

Editor’s Note: We are extremely saddened to say that on June 23, 2024, Ivy Elkins passed away. Ivy’s advocacy efforts and writing continue to reach many. She will be deeply missed.