Do you know the difference between informed consent in healthcare, and informed consent in clinical trials?
Informed consent is much more than just signing a form, it is one of the founding principles of ethics in medical care and research. It implies ongoing communication between you person and your healthcare provider or investigator, in the case of clinical studies. From the first time you receive information about the treatment, to your right to take time to ask questions, consider your options, continue to receive relevant information even after signing the consent form, or even change your mind and revoke consent, it is all part of the informed consent process.
In a clinical trial, the Informed Consent Form (ICF) is the main source of information for those considering participating and serves as a legal document to ensure that, as a participant, you have enough information about the study, you understand it, and agree to participate in a specific study, with all that it entails.
What is informed consent in healthcare
The main purpose of the informed consent process is to protect you as a patient and allow them to make informed decisions about their health. Consent in this sense means as an individual, you must give permission before receiving any type of medical treatment, test or examination, and this must be done after receiving an explanation or based on an understanding of what it implies.
There are three key aspects for consent to be valid:
- Willingness: the decision to accept or refuse treatment should be voluntary, and it should be made by the patient, without being pressured by medical staff, friends, or family.
- Information: the person must have received information about their condition or illness, treatment options, and the risk and benefits of each one, including not getting any treatment at all.
- Capacity: the person must have the ability to understand the information given to them and use it to make an informed decision.
When it comes to healthcare, consent is usually given in writing, and in some cases can be given verbally, but there is always some form of documentation involved. Informed consent is required for most medical procedures, from blood tests to major surgeries. In the latter case, consent is only valid for a specific one-time procedure, and if another procedure is needed, even if it is the same type of procedure, another consent form must be signed.
When done correctly, the process of informed consent allows you to participate in your own medical care, enforcing your rights. It should also reassure you and ease your concerns, while also allowing physicians to understand and respect your wishes.
Purpose of the ICF in clinical research
In clinical research, the basic principles of willingness, information, and capacity still apply, as well as the right to revoke consent at any time. However, in this case the requirements of the informed consent form are very strictly regulated, and the process is much more thorough. It involves giving a potential participant not only information, but also the time they need to truly understand the study and make the decision to participate or not. Another key difference is that signing an ICF for a clinical trial means the participant consents to all the procedures, tests, visits, and anything else the study might involve, whereas in regular health treatments, the ICF normally only convers a single, specific procedure.
The main goal of any study is to improve treatment options by testing a drug or regimen, and for that, volunteers are essential, but there are important differences between being a subject or participant in a clinical trial and being a patient receiving standard care. The experimental nature of clinical trials means that participants may be exposed to treatments and risks that are different from the standard medical practices, and they may not always experience a benefit when taking the treatment or drug being tested. It is very important that you completely understand what the study entails before agreeing to be a participant, and the ICF plays a key role in this.
The aim of incorporating an ICF into clinical trials was born out of the need to uphold the rights of participants. First established in the Nuremberg Code of 1947, its purpose continues to be to respect the autonomy and rights of participants, as well as protect them from potential harm. Therefore, investigators are legally required to provide verbal and written details about the study to anyone interested in participating.
Informed consent process in clinical research
Because the ICF is a medical document used to give potential participants information about a specific study, it is vital that it is written clearly and is easy to understand. One of the key elements of informed consent is understanding what you are consenting to, which is why it is so important that if you want to participate in a clinical trial, you ask any questions you might have, and ask the medical team to explain anything that isn’t clear, or you don’t quite get.
To this day, not everyone that signs an ICF for a clinical trial fully understands the document they are signing. An article published by the Bulletin of the World Health Organization describes a three-decade-long analysis on participant’s understanding of informed consent in clinical trials, showing that for each different part of the ICF, between 52% to 75% of participants understood them. This needs to be remedied. For informed consent in clinical trials to be valid, investigators and participants must take as much time as necessary to discuss and share any concerns or questions about the trial. Otherwise, potential participants may be overwhelmed by the amount of information and can feel pressured.
Normally, there are three important steps leading up to signing the ICF that you should be aware of:
- The Recruitment phase begins after regulatory approval of the trial design. This is when investigators start looking for potential participants for the study. If you show interest in participating in the study, and agree to receive more information, you will go into Pre-Screening.
- During Pre-Screening, the investigator might ask you as a potential participant some questions to see if you would be a good fit for the study. They will sit down with you and go over all aspects of the study, answering any questions you may have. The investigator will discuss with you how the protocol works, what the risks are, and make it clear that participation throughout the process is completely voluntary. Here, the key is that you can easily understand the information, therefore the researcher’s ability to explain the process is very important.
- Lastly, you should be given sufficient time to discuss your participation in the study with your friends, families, and physicians. If you decide to do so, by signing an informed consent form for the clinical trial, you voluntarily agree to participate in the clinical trial, and everything that it involves. Once the ICF is signed, you will be officially in the Screening phase, where the investigator will ask questions, and some tests may be needed to confirm you meet the requirements to participate in the study.
What does an informed consent form include?
According to guidelines and recommendations, ICFs for clinical trials should include:
- Statement explaining the purpose and objectives for the research.
- Indication that participation is voluntary, and that consent may be withdrawn at any time.
- A summary of the procedures of the study. What will be done during the study, including treatments, assessments, and interventions.
- What is expected from the participant (e.g., filling out a daily diary, reporting any adverse events to the medical team), and information on how the medication is to be taken.
- Risks and benefits of participating in the study. This can range from a list of side effects to possible health improvements related to the study drug.
- The duration of the study.
- Disclosure that the study will provide medical care in the event of injury.
- Details on data confidentiality and privacy.
- Contact information for questions or concerns.
And when applicable:
- The possibility of unexpected or unknown risks.
- The likelihood of not receiving the study drug or treatment being tested when there is more than one treatment option in the study.
- Any reasons why your participation may be ended.
- The process of leaving the trial before its completed and how to do so.
If you are ever interested in participating in a clinical trial, the ICF will serve as your guiding document to understand the study you will potentially enroll in, your rights as a participant and your responsibilities, so it is not something you want to rush through. Read it carefully and never hesitate to express your doubts or concerns to the investigators.