When it comes to clinical research, the cornerstone of ethical practice lies in the concept of informed consent. Informed consent establishes a transparent and respectful partnership between researchers and study participants. At the heart of this collaboration is the informed consent form, a document that encapsulates the rights, responsibilities, and potential risks associated with participating in a research study.
The informed consent process represents an important agreement between researchers and human subjects, so understanding the key elements and considerations is essential. If you’re working with research subjects, then creating an Informed Consent Form (ICF) for clinical research is a skill you must have under your belt.
Let’s start with our basic understanding of consent– 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 of our property, bodies, etc. Consent changes an action that is not permitted to an action that is permitted.
Informed Consent in medical research is a bit different from consent in other settings. Informed consent relies upon researchers providing participants with clear and detailed information regarding the study. In other words, even though participants may not have a medical or scientific background, they should understand the study in full, including but not limited to their role in the research. From there, informed consent allows patients to then authorize (give consent) to the research and activities based on their full understanding of what that entails and what is expected of them..
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 in writing. 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 Report, which dictates that a person has the right to decide for themselves what they do with their own body. Even research participants have autonomy and researchers need to have respect for people’s individual decisions.
Informed consent in medical research is important because when it comes to medical research, the main goal is different from the goals of clinical care. Clinical care providers are working to get individuals/patients better. In medical research, the goal is to produce general knowledge (that might not even benefit the subject of the study). Understanding this difference is a core component of informed consent in clinical research.
In fact, it’s so important that multiple regulations specifically discuss the obligation and role of informed consent. Those regulations include:
It is important to note that if two regulations have conflicting views on a certain aspect of research and consent, the clinical trial must follow the regulation that provides greater protection for the participant.
Informed Consent is only part of the framework that creates clinical research. In order to ensure the needs of researchers and participants are met, there are multiple guidelines in place, including informed consent and study protocols.
More specifically, clinical trials are used to answer questions related to new devices, therapeutics, techniques, or drugs. To help support those goals, study protocols are developed to give a detailed overview of what researchers will do throughout the study, in order to answer your main research questions.
In some cases, protocols can be very technical; there is a device section, a statistical analysis section, and more. However, 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.
Informed consent, on the other hand, should be designed for an everyday reader. It is essentially explaining the role a subject will play when 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. This is done through an informed consent form (ICF).
Unlike study protocols (the protocol), informed consent forms for clinical research must be written in a very specific way. Not only are there regulatory requirements regarding what you must tell participants and how much information you must provide, but you also must remember a few other essential components.
When writing an informed consent document, your audience is the participant who will sign it. The document needs to be clear and complete, assuming the participant does not have any background knowledge on the subject.
Remember, most people, including participants, are not as 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? What can participants expect? Questions such as these help the participant make an informed decision and help them understand whether or not it is realistic to participate.
You might also want to survey the general population in the area where you plan to complete your study for their comprehension level. According to the Center for Plain Language, the average American reads at a 7th to 8th grade reading level. While the doctor's office or the hospital where you complete the study may have additional information regarding regional demographics, going into the writing understanding that keeping language simple and straightforward is essential to . ensuring everyone in the sample population can read and comprehend the informed consent 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 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 for clinical research should include a section outlining possible risks or discomforts for the subject. Risks can be physical, emotional, and even financial. Physical risks include things like blood clots; physical discomforts may be skin irritation or a needle poke.
You can also include some data from your pre-clinical trials which might help potential participants 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.
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.” Do not give false information to a potential study participant.
This section outlines any potential benefits of being in this study. It is important to highlight that the benefits cannot be guaranteed.
This section should also include any 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 into 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 for clinical research 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 their data is codified and anonymized 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 or conditions 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. Further, because they are likely new to this, you’ll want to help them steer any questions to the appropriate contact. 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.
Now that you know what you must include in your ICF for clinical research, it’s equally important to understand what you want to avoid. Much like you want to include clear and detailed information for study participants, there are other language pitfalls you want to avoid including:
Prior to obtaining informed consent and presenting your study participant with an ICF, study staff should make sure to do a few things with participants. First, provide time for participants to read the consent document and allow participants to ask for questions. If desired, participants should be allowed 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 assess a patient's comprehension to ensure they truly understood the document.
It may be useful to create a script for study staff to utilize when presenting an ICF to clinical study participants. This 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 and help ensure your team conveys everything the participant needs to know.
As clinical researchers, we sometimes tend to put research before all else and focus on the outcomes. Informed consent forms in clinical research ask us to consider the participants who will help us get there. For that reason, they are essential for a successful and ethical research study.
ICFs are 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. Further, they provide an excellent opportunity to get buy-in from participants on your research goals.
In short, ICFs in clinical research are more than a procedural document. They should be crafted with participants and their role in your research in mind. When writing an ICF, consider these factors as well as federal regulations and you can ensure you’re starting your research with best practices at the forefront.
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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