What is informed consent in clinical trials?
If you’re considering different treatment options available to you, chances are you may be considering a clinical trial. Clinical trials can provide you with an alternative treatment pathway, potentially giving you access to investigational drugs you wouldn’t normally be able to receive.
If you’ve found a clinical trial that may be suitable for you, you will need to know what the potential benefits and risks may be as a result of participating. To make sure it is clear you understand the decision to take part in a trial, you must give informed consent. Here we explain what’s meant by informed consent, how you give it and what’s covered in the process.
Informed consent for clinical trials
Clinical trials are a vital part of developing new treatments. They allow researchers to understand how effective a potential new “investigational” drug is, the nature of any side effects, and what happens to the investigational drug in the body. Every single approved drug available today will, by law, have undergone testing in in clinical trials.
For clinical trials to be run, sufficient numbers of people need to take part. However, it’s important that everyone, including clinicians and participants, are fully aware of and understand what will happen in the trial. We recently posted about understanding clinical trials, but as each clinical trial has different purposes, you should know what benefits and risks are associated with the one you are considering.
You must give informed consent to participate so that the team performing the trial is confident you know what’s involved in the clinical trial, what will be expected of you, what the risks are and the procedures for the trial.
Agreeing to participate in a clinical trial is more than signing a form; you need to know all about the study and any other available options to make your decision. Informed consent means that you understand the purpose of the research, what your role in the trial is, and how the clinical trial will work, and should be carefully considered with the support of your friends, family, patient advocacy group, or others you may consult with about participating in a trial, including your healthcare provider(s).
The importance of informed consent
The main purpose of providing informed consent is to give you protection. Informed consent requires a legal document to be signed showing that the healthcare provider has fully explained to you what your available treatment options are, and what to expect from the trial. This means that you will be given enough information to make sure that you’re comfortable with the decision you make.
The team conducting the study, including the lead physician(s) has a responsibility to make sure that you fully understand the procedures involved in the clinical trial before you take part. To be able to provide informed consent, you will be given an informed consent document to review. The document will cover what happens in the trials, which you can then sign if you agree. You will also be given a copy of the document for future reference.
What does an informed consent document cover?
Some key areas covered in an informed consent document include:
- The purpose of the research
- How the trial works - this can cover expected length of time, and what procedures you will undergo
- Any possible benefits, known risks or discomforts you may experience due to the study
- Alternative procedures or treatments you may benefit from
You will also be informed that participation is voluntary. This means you have the right to refuse treatment, and you can withdraw from the study at any time.
You may have questions about what informed consent means for your confidentiality. As part of the informed consent process, you will be told what happens with any information about you that is collected as part of the clinical trial. This includes an explanation of how any records that identify you will be kept, and who will be allowed to access the records (for example, health regulatory agencies may inspect the records).
How will I be informed?
How you are informed will vary, depending on the study team and physicians involved. You may be given the information verbally or be provided with written documents such as leaflets. You may even have informational videos to watch, or computer modules to complete.
The information you are provided needs be easily understandable, in terms of the language that the information is given and in the way it’s written, for you to give informed consent. If there are any words or terms you’re unfamiliar with, ask the team conducting the study, including the lead physician to clarify or for more information. You should ask as many questions as you need to feel comfortable and to fully understand the information that is being presented.
To make sure you appreciate what’s involved, take your time to process the information, and carefully review any materials that you are given. If there’s anything you don’t understand, go over it again with the team conducting the study or your healthcare provider. And finally, have a conversation with your friends, family, and any patient advocacy group you’re a part of about the clinical trial.