Developing a strong informed consent form (ICF): Essentials and suggestions to adequately inform your participants

By Suruchi Batra 

Seeking informed consent is an important component of any research activity involving human subjects, including usability tests. “Informed consent” is more than asking participants to sign an agreement; the consent process verifies that participants understand the purpose of the activity they will partake in and ultimately agree to participate based on the outlined terms. 

While you might not necessarily seek an Institutional Review Board (IRB) review of your study, it is still important to have participants’ consent and sign an ICF. According to FDA’s 2023 guidance on informed consent, “no investigator may involve a human being as a subject in FDA-regulated research unless the investigator has obtained the legally effective informed consent of the subject or the subject’s legally authorized representative (LAR).” 

What steps should you take with your consent forms to inform participants appropriately? Below we outline 5 important steps to developing strong ICFs. 

1. Outline critical information, particularly related to human subjects’ protection. Include the activity’s purpose, possible risks and benefits, total compensation, anticipated time commitment and confidentiality and voluntary participation statements. These important elements provide participants with enough details to inform their decision on whether to participate. 
2. Activity purpose. The ICF should clearly describe the reason(s) that participant type (e.g., patients, lay caregivers, HCPs) is part of the study population. 

Example text: You have been asked to participate in this study because you have been diagnosed with Type 2 Diabetes and might have experience administering insulin. 

2. Risks and benefits. Participants must be provided with any foreseeable risks to their participation, including mental, emotional and physical risks. Typical risks might include general fatigue or annoyance (from a long session or answering lots of questions, for example) but should also include any risks specific to your study, such as a needlestick or potential side effects if interacting with an injection device containing actual medication. 

Example text: You might encounter a needle stick injury, potentially resulting in pain, minor bleeding, or infection. First aid will be available in the unlikely event of a needlestick. 

3. Total compensation. It is important to indicate total compensation participants will receive upon completion of which activities they will receive compensation (if the study contains multiple stages, like training and a usability test session) and how they will receive the compensation. 

Example text: You will be compensated $100 upon completion of your 30-minute interview via a digital gift card. 

4. Anticipated duration. Participants should be made aware of the number of sessions they are expected to participate in and the anticipated duration of each activity. 

Example text: You will participate in a 2-hour training session, followed by a 1-hour break and then a 3-hour test session. 

5. Confidentiality. It is important that participants know who might have access to their information and that they are aware of any confidentiality procedures in place.  
   Example text: Study information collected about you may be given to the U.S. Food and Drug Administration (FDA). 
6. Voluntary participation. It is essential that participants understand they are participating of their own free will and that there is no hint of coercion or undue influence in any way. Particularly, it is important that participants understand they can end their involvement at any time and for any reason without forfeiting their agreed upon benefits (e.g., compensation, medical care). 
   Example text: Your participation in this study is voluntary. You may decide not to participate, or you may leave the study at any time.  
7. Include activity-specific information. While many research activities share similar key elements, consider if there are any unique details that should be explicitly described in your ICF. For example, will your study involve an injection device? If so, document any related details and procedures (e.g., if the device will contain actual medication, the risks involved with using real needles, how participants will simulate injections). Will you record the study session? If so, collect consent for video and audio recording. 
8. Review language for readability and comprehension. Consider applying FDA’s guidance on product labeling to ICFs. One guidance document cites that the average reading level in the United States is estimated to be 8^th grade and that medical information should be written at a 4-5^th grade level. 
9. Tweak and develop forms specific to user groups. Some research activities might involve more than one user group. If there are key differences in participation amongst user groups, such as the activities they will perform, the expected time commitment, or compensation amount, then you should create tailored ICFs that are specific to each user type to clearly present only the relevant information. For example, your research activity might involve adult patients, adult caregivers and healthcare professionals (HCPs). In this case, it might be possible to develop a single ICF for adult patients and caregivers, but you should consider creating a separate ICF for HCPs. This is because many of the procedures and ICF content are likely to be similar for adult patients and caregivers but might differ for HCPs (e.g., session length, evaluation activities). 
10. Provide opportunities for participants to ask questions. It is important that participants have enough time to first thoroughly review the ICF and then ask any lingering questions. Consider sending the ICF to participants digitally beforehand so they can review the ICF content at a time convenient for them. Alternatively, ask participants to arrive onsite at least 15 minutes early to allow them time to fully read through the ICF. Later, once you invite participants into the session room, (A) confirm participants had enough time to fully review the ICF and (B) ask whether or not they have any questions. 

FAQs 

• What if my study involves adolescents? Adolescents cannot legally provide consent, but they should still be a part of the informed consent process. Instead of having them read and sign a consent form, have their LAR (i.e., parent or guardian) review the consent form and develop an assent form for the adolescent to read and sign. The assent form should contain the key information from the consent form, but you should adjust the language to be more suitable for younger participants. For example, “Purpose of the Study” in a consent form could be updated to “Why are you here?” in the assent form. 
• What if participants within the same user group will receive different compensation rates? This might be the case if you are including HCPs at different professional levels (e.g., primary care versus specialized physicians) or if your study will take place in different locations with significantly different costs of living (e.g., New York City versus Cleveland). Consider taking one of the following two approaches: 

1. Duplicate the ICFs and replace only the compensation rate in each form. Consider labeling them (e.g., by HCP type, study location) to avoid mix-ups. 
2. Create a table in each ICF that outlines the compensation rates. 

• How can I make sure I have all essential components in the ICF for my specific study? Consider submitting your ICF(s) along with your test protocol and other relevant documentation to an IRB for their assessment and feedback. 

Contact our team to learn more about collecting participant consent. Or, sign up for a complimentary account with OPUS, our team’s software platform that provides HFE training and tools.  

Suruchi Batra is a Senior Human Factors Specialist at Emergo by UL.