This article will provide an overview and discussion on the key elements of informed consent, and considerations for creating an Informed Consent Form (ICF) for clinical studies.
Consent is when a person agrees or gives permission to do something. Consent is about communicating the activity and a person deciding whether they want to participate or not. It is a legal and moral protection for unauthorized invasion on our property, bodies, etc. Consent changes an action that is not permitted to an action that is permitted.
Consent in medical research is different from consent in many other settings. That being said, informed consent is slightly different from traditional consent. Informed consent is the authorization of an activity based on the understanding of an activity and what it entails. In medical research, informed consent is essential because it allows patients/subjects to completely understand what they are signing up for, even if they do not have a medical or scientific background themselves.
Informed consent is a clear and standard process, not just a piece of paper. Your informed consent process should explain all that is needed to make an informed decision, both orally and written. The written format is there so that a signature can be obtained from the patient. Oftentimes the informed consent process needs to be approved by your Institutional Review Board (IRB).
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Informed consent is a key founding principle of research ethics. It is based on the Belmont Reports, which dictate that a person has the right to decide for themselves what they do with their own body. This ties into autonomy and the idea that researchers need to have respect for people’s individual decisions.
Within medical research, the main goal is different from the goals of clinical care. Clinical care providers are working to get you, as an individual, better. In medical research, the goal is to produce general knowledge (that might not even benefit the subject of the study).
Some regulations that touch upon this topic are listed and linked below:
It is important to note that if two regulations have conflicting views on a certain topic, the clinical trial must follow the regulation that provides greater protection for the participant.
Trials are used to answer questions related to new devices, therapeutics, techniques, or drugs. Protocols are developed to give an overview on what you are going to be doing throughout the study, in order to answer your main research questions. Protocols can be very technical; there is a device section, a statistical analysis section, and more. The protocol as a whole is not designed for the everyday reader. It's usually designed for members of the clinical team and for regulatory bodies.
A clinical trial is designed to study a new medical product in humans specifically. Informed consent is essentially explaining the role of a subject participating in a trial. In order to make an informed decision to participate, subjects need to be informed about what will be done, the protocol, risks, discomforts, and finally that participation is voluntary.
When writing an informed consent document, your audience is the participant who will sign it. The document needs to be clear and complete, assuming that the participant does not have any background knowledge on the subject. Most are not involved in medical studies the way you are! It should also not be written as a sales pitch but instead as a way to convey important information about the study. How much time do they need to commit? What type of tests will be performed throughout the study? Questions such as these help the participant make an informed decision and help them to understand whether or not it is realistic to participate.
You might also want to survey the general population in the area you plan to complete your study for their comprehension level. This might be provided by the doctors office or the hospital you complete the study at. Knowing their comprehension level is important to ensure everyone in the sample population can read and comprehend the document correctly.
In short, writing a consent document in a research study boils down to 3 major elements:
The Informed Consent Form (ICF) is the document that contains all of the information a subject needs to decide about participation. The FDA does not dictate specific language required for the ICF but does require certain basic elements to be included. Here is a list of some of the required elements:
Many of these elements will be taken from the study protocol, but need to be shortened and more digestible for the study participants to understand.
Some studies might have special considerations that go beyond the required elements above. Here is a list of some of those special circumstances:
The beginning of an ICF should give a general overview and description of the clinical study. This is a great place to add a picture or an infographic in order to convey your message better. The take home message of the ICF should include the purpose of the study, the role of the subject, the length of the study, and the procedures that will occur as part of a study. Below we will dive deeper into some of the specific parts of an ICF.
The ICF should include a section that outlines possible risks or discomforts for the subject. Risks can be physical, emotional, and even financial. Physical risks are things like blood clots; physical discomforts are things like skin irritation or a needle poke. You can also include some data from your pre-clinical trials as that might help them make an informed decision on whether or not they believe the risks are a problem for them. For example, you might include that less than X% of our preclinical data indicated skin irritation problems, and Y% of the skin irritation was clear in 2 days. You should also add the cost of participation, whether there is a monetary cost, if they will need to take time off of work, etc.
Of course, do not give false information to a potential study participant. If you or the trained worker giving this briefing does not know an answer, it is ok to say, “I will get back to you.”
This section will outline the potential benefits of being in this study. It is important to highlight that the benefits cannot be guaranteed! This section should also include the compensation for participation and include an individual breakdown for study related procedures. For example, if a participant does not show up for half of the clinic visits, they should not expect to receive the full compensation for the study.
This section should also explain the impact on future patients and the general population. Having a subject buy in to what you are trying to achieve in the beginning helps you increase your chance of compliance throughout the study.
Here you want to discuss what the other possibilities are for potential participants. The first option is to not participate, especially if they are not comfortable with the risks and discomforts. If you are completing the study as part of their treatment, you can provide their other options, the most common being sticking to the standard of care.
You should also explain that they can decline participation at any point in the study and it will not cause them to lose their patients rights.
Confidentiality is very important to many patients, particularly when it involves their Personal Health Information (PHI). The ICF should include who has access to their PHI, how data will be monitored, how the monitoring works, sponsor data that will be shared, and the possibility for an inspection by the IRB or the FDA.
You need to explain the de-identification of their PHI and what will happen to ensure that their data is codified when shared. You also need to let the patient know the possibility for publication and how their data will be handled if that does happen.
In any clinical study in the US the participant has the right to withdrawal at any point, even after they have signed the ICF. In addition, the investigator has the right to withdraw the subject during the trial. This could be due to a variety of reasons but is most often associated with lack of compliance, awareness of better treatment options, or if the treatment is causing harm to the participant. This should be added to the consent form so the participant has knowledge of this possibility before the study starts.
The compensation and costs section is a more detailed benefits and risks section, but only concerning the financial impacts of the study on the participant. Here you can outline the compensation, broken down into time points if relevant.
In general it is not good to overcompensate, as this could be considered coercion. The ICF should give full disclosure on how the payment will work (gift cards, cash, check, snacks, etc).
This section should also disclose potential costs. For example, the trial might not compensate for travel time. You should also inform them about taxes. If a subject earns over $650 from a clinical trial annually, they need a 1099 and will have to pay taxes on that amount.
You should also separate costs of what is being billed to insurance and what the patient has to pay for, if applicable. A table is a great way for the participant to visualize this data.
Make sure the participants have a physical copy of this form to take home with the most important contacts on it. There could be multiple contacts on the form. For example, the principal investigator (PI), study staff, doctor, IRB, the sponsor, etc. Here is a list of which problems should go to which people:
If your study involves the collection of biospecimens, the ICF should have a section explaining your study’s plan for maintaining them. You’ll need to answer the following questions, if applicable:
You should also distinguish which specimens are being collected for the study and which are collected as part of the patient's standard of care.
Here is a helpful list that details what NOT to do when writing your ICF.
While the subject is with the study staff, the staff should make sure to do a few things before obtaining consent. First, they need to read the consent document and make sure to allow time for questions on things the subject doesn't understand. The staff should allow the potential subject to take the ICF home so they can review it with others.
An investigator should only get consent from a potential subject if proper time was given, the staff did not influence the subject, and if the information was understood by the patient. The staff can also perform an assessment of a patient's comprehension to ensure that they truly understood the document.
The script should be created in conjunction with the ICF. While writing the script, keep in mind the main purpose of why the patient is in the clinic, and the value of their time. It should be conversational, informative, but concise.
Informed consent is essential for a successful and ethical research study. It is about giving potential subjects the pertinent information they need to make an informed decision about participating in a clinical study. Consent is also a process that includes a give and take exchange between the subject and the study personnel. When writing an ICF, it is important to take these factors as well as federal regulations into account.
This information comes from a talk with Tala Harake, in partnership with University Lab Partners. Access the video here.
Tala Harake is a Managing Partner at Vigilant Clinical Trials Consulting. After completing her undergraduate studies in Biology and Mathematics, Tala went on to earn a graduate degree in Biochemistry. She then began her career at Masimo, where she headed their clinical research department. In 2020, Tala departed Masimo to start her consulting company Vigilant Clinical Trials Consulting, LLC. Since starting VCTC, her clients have included medical device start-ups, university research centers and medical societies. Throughout her career, Tala has been driven by a passion for medical devices and an underlying desire to help get these incredible devices to market and into the hands of healthcare workers.
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