One of the most critical but often overlooked aspects of conducting research is communicating with the participants. Researchers are usually laser-focused on study design, data collection methods, and perfection of detail for publication. But first, there is a crucial hurdle to clear: approval from the Institutional Review Board (IRB).
The IRB for researchers plays a vital role in protecting the rights and well-being of all participants. According to the Belmont Report, which lays the ethical foundation for IRB guidelines, the primary principles guiding human research are respect for persons, beneficence, and justice (Sims, 2010). To ensure a clear path in aligning with these principles, researchers must submit detailed documentation, including research forms that explain the study, its risks, and the expectations of participants. Here’s where things can get tricky; while it’s essential to include all the required legal and ethical information, without expertise and care in handling the process, these forms can easily become dense, confusing, and overwhelming for the very people they’re meant to protect and inform.
Imagine you are a participant, and you are handed a research consent form that’s packed with technical jargon, legalese, and dense text. Even if you’re eager to participate, trying to wade through all these formalities can feel like an impossible task. Research has shown that overly complex consent forms can significantly reduce participants’ understanding and willingness to take part in the research (LeCompte & Young, 2020). What’s clear and logical to the researcher might be utterly bewildering to someone outside the field of specialization. This disconnect can impact the IRB process and lead to misunderstandings, lower participation rates, and, ultimately, compliance issues—both from a legal standpoint and the participants themselves.
Common Pitfalls in Traditional Research Forms
Let’s be honest, research forms have a bit of a reputation and aren’t exactly user- friendly. Ask most people how they feel about reading a research consent form, and you’ll likely get a few groans or eye-rolls. Unfortunately, this reputation isn’t entirely undeserved. Traditional research forms often suffer from a few key pitfalls that can turn what should be a straightforward process into a confusing and frustrating experience for participants.
Overly Technical Language
First off, let’s talk about language. As researchers, we are accustomed to dealing with complex concepts, specialized terminology, and the kind of language that fits perfectly in an academic journal. The problem is that what makes sense in a scholarly article does not always translate well to a general audience and human subject review boards are usually very keen to ensure that this is well considered.
When research forms are loaded with technical jargon, participants may struggle to understand even the basic premise of the study, let alone the specifics of what they’re accepting. A study by McMillan (2020) emphasizes that “the use of complex, discipline-specific language can hinder the informed consent process, as participants may not fully grasp the implications of the study due to unfamiliar terminology” (p.25).
Words and phrases that seem perfectly normal to you, like “randomized control trial,” “placebo,” or “double-blind”, can be baffling to someone who isn’t steeped in research methodology. This isn’t just an issue of clarity but an ethical concern that does not foster collaboration. Participants need to fully understand what they are getting into before they can give truly informed consent. Eaton (2020) argues that language clarity is not merely a procedural necessity but a moral obligation. Without comprehensive support from the IRB, researchers can find the language of the form a barrier to understanding, which might undermine the entire process.
Lengthy and Overwhelming Documents
Another common pitfall is the sheer length of these forms. It’s not unusual for a consent form to run several pages long, packed with dense blocks of text. While there is a lot of essential information to convey, most people’s eyes glaze over when they’re handed a long, legal document. They might skim it at best, or worse, just sign it without really reading it. Research supports this concern.
A study by Krieger et al. (2017) discussed that participants are less likely to read and fully comprehend research consent forms that exceed four pages. A common challenge researchers find with institutional review boards is the lengthy and overwhelming forms, which can lead participants to miss important details, feel confused about expectations, or even decide not to participate. The goal should be to inform, not defeat. An independent review board can eliminate such obstacles by offering a concise, well-organized form that can communicate the same essential information without bogging participants down in pages of text.
Ambiguity and Confusion
Then there’s the issue of clarity. Even when the language is relatively straightforward, research forms can still be confusing if they’re not clearly organized or if key details are buried in the fine print. Participants might not be sure what they agree to, the potential risks, or even what they need to do next. This ambiguity can lead to misunderstandings that affect the quality of your research and the safety and comfort of your participants.
For example, a consent form might vaguely mention “possible side effects” without clarifying what those could be, or it might outline procedures in a way that’s hard to follow. “Ambiguity in consent forms can lead to significant misunderstandings,” as discussed by the review by Brehaut et al. (2012), which highlighted the need for clear, precise language in consent forms to ensure participant understanding and compliance. When participants are left with questions, they might hesitate to ask for clarification, either because they’re embarrassed or because they assume they should already understand. This can lead to a situation where participants aren’t fully informed and might eventually derail the IRB process.
The Impact of These Pitfalls
The common pitfalls, such as technical language, lengthy documents, and ambiguity, aren’t just minor annoyances. They can have serious implications for researchers trying to find an IRB. Participants who don’t fully understand the forms they are signing might not follow study protocols correctly, might drop out of the study altogether or might feel anxious and distrustful of the research process.
This can lead to incomplete data, skewed results, and a whole host of other problems that ultimately compromise the validity of your research. Moreover, if the IRB service sees that your protocol templates and forms are unclear or confusing, you might face delays or rejections in your approval process. The clarity of consent forms is a critical factor in IRB review outcomes, according to an analysis by Hammerschmidt and Keane (1992).
An independent IRB that offers a comprehensive, bespoke approach can guide you to “yes” by ensuring that your research forms are as clear, concise, and user-friendly as possible. In the next section, we’ll explore how to avoid these pitfalls by designing forms that communicate effectively and enhance participant understanding.
Principles of Designing User-Friendly Research Forms
Creating research forms that are both IRB-compliant and easy for participants to understand might sound like a tall order, but it’s definitely achievable. The key is to focus on a few core principles that make the information more accessible and engaging. When you design with the participant in mind, you make the process smoother for them and yourself—leading to better data collection, higher participation rates, and a stronger foundation of trust. Let’s break down these principles and see how they can transform your research forms.
Simplicity and Clarity
The first rule of thumb is to keep it simple. That doesn’t mean dumbing down your content or cutting out important details, but rather making sure everything you include is straightforward to understand. This aligns with the recommendation from the National Institutes of Health (NIH) that “Research consent documents should be written at an eighth-grade reading level or lower” to ensure comprehension across a broad audience (NIH, 2013). Start by using plain language wherever possible.
Imagine you’re explaining the study to a friend with no background in your field; how would you phrase things to foster collaboration? Avoid technical jargon; if you must use specialized terms, explain them in plain English. Dr Rima Nakkash notes, “Researchers often use technical terms that are second nature to them but confusing to laypersons, which can lead to misunderstandings about what participation entails” (Nakkash et al., 2017).
Short, clear sentences are your friend here. Long, complex sentences with multiple clauses can confuse readers, especially when they’re already trying to grasp new concepts. IRB services will normally offer expertise and care in handling the process of consent form creation by recommending that you break information down into digestible pieces and use direct, active language.
Instead of saying, “Participants will be randomized into different treatment groups as determined by the study protocol,” say, “We will randomly assign you to one of the treatment groups.” Remember, the goal is to ensure that participants understand what they agree to without having to re-read sentences multiple times or look up definitions. Clarity builds confidence and trust, both essential for obtaining informed consent.
Logical Structure and Organization
A well-structured form guides participants through the information in a logical, easy-to-follow way, helping them understand each part of the study without feeling lost or overwhelmed. To ensure a clear path, start by outlining the key sections of your form: an introduction to the study, details about procedures, potential risks and benefits, confidentiality assurances, and what’s expected of participants. The human subject review board checks to ensure each section is clearly labeled with a heading that tells participants exactly what they’re about to read.
According to the World Health Organization (WHO), “Well-organized consent documents improve participants’ ability to follow the narrative and retain critical information” (WHO, 2019). Within each section, use bullet points, numbered lists, and subheadings to break down information further. This makes the form easier to scan and fosters collaboration by helping participants find specific details quickly if they need to refer back to something at a later time.
Also, consider the overall flow of the form. Present information in the order that makes the most sense for someone who’s new to the study. Start with a broad overview and then move into the specifics. Avoid jumping back and forth between topics, as this can confuse readers and make it harder for them to retain important details, which eventually will hinder your IRB process. This advice is echoed by Dr. Christine Grady, who emphasizes, “The sequencing of information should mimic the logical flow of a conversation, beginning with the most critical concepts and gradually moving into detailed specifics” (Grady, 2015).
Accessibility Considerations
It’s crucial to remember that not all participants will approach your form with the same background, abilities, or language skills. A comprehensive, bespoke IRB approach should ensure that accessibility is a top priority when designing your forms, ensuring that everyone who wants to participate can be comfortable and fully informed.
For participants with visual impairments, ensure your form is compatible with screen readers and consider offering large-print versions. Use a high-contrast color scheme and a readable font size to improve readability for everyone. For those with cognitive disabilities, breaking information down into simple, clear sections, as mentioned earlier—can make a big difference in their ability to understand and engage with the content. Language barriers are another important consideration.
If you expect to have participants who speak different languages, provide translated versions of your forms. But don’t just run your document through an online translator or AI automation—work with a professional who offers top-tier services and can offer comprehensive support to ensure the content is accurately conveyed in each language. Emanuel et al. (2008) advises that translations should maintain the original intent and clarity of the content, with particular attention to culturally sensitive concepts.
Finally, think about the format of your form. If it’s digital, is it mobile-friendly? Can participants easily fill it out on their phone or tablet, or is it only accessible on a desktop computer? Offering multiple formats—printable PDFs, online forms, etc.—can help ensure that your forms are accessible to the widest possible audience. As noted in a study by Emanuel et al. (2008), “Providing multiple formats of consent forms increased accessibility and participant inclusion, particularly among underrepresented groups” (p. 129).
The Power of Thoughtful Design
By prioritizing simplicity, clarity, logical structure, and accessibility, you can create research forms that comply with IRB requirements and are truly user-friendly. These principles are the foundation of effective communication with your participants. With the comprehensive support of Institutional or independent IRB, following these principles can help demystify the research process, reduce anxiety, and ensure that participants are fully informed and comfortable with their involvement.
In the end, thoughtful design isn’t just about making your forms look good—it’s about respecting your participants’ time, intelligence, and willingness to contribute to your research. When participants feel valued and informed, they’re more likely to engage with your study meaningfully, leading to better outcomes for everyone involved. Next, we’ll look at some practical strategies you can use to put these principles into action, ensuring that your research forms are as effective as they can be.
Strategies to Enhance Participant Understanding
Designing research forms that are clear and accessible is only half the battle. To truly ensure that participants understand what they’re signing up for, you need to go a step further to foster their collaboration. This is where thoughtful strategies come into play, approaches that clarify the content and engage participants, making the information stick. By employing a few critical tactics with the assistance of IRB services, you can significantly boost participant comprehension and, in turn, improve the overall quality and effectiveness of your research and turn challenges into victories. Let’s explore some of the most effective strategies supported by scholarly research.
Pre-Testing Forms with Target Audiences
One of the most effective ways to ensure your research forms are understandable is to test them with people who resemble your study participants. This step is often overlooked, but it can provide invaluable insights into how your forms are perceived and understood by those outside of your research team. Pre-testing involves sharing your draft forms with a small group of potential participants or individuals similar to your target audience.
According to Creswell and Creswell (2017), “pilot testing helps in refining the instruments and ensuring the language and format are appropriate for the study population” (p. 146). By gathering feedback on their experience, you can identify any problematic areas in your forms and make necessary revisions before you submit them to the IRB or present them to actual participants. Direct engagement with independent IRB can offer a guide to “yes” and help predict and eliminate such problems. This is a proactive way to catch issues early on, ensuring that your forms are as participant-friendly as possible right from the start.
Incorporating Visual Aids and Examples
Sometimes, a picture is worth a thousand words. While text is essential for conveying detailed information, visual aids can help illustrate complex concepts more clearly and quickly than just words. Incorporating images, diagrams, and examples into your research forms can make them more engaging and easier to understand. Research supports the effectiveness of visual aids in improving comprehension.
A study by Flinn (2008) found that “visual aids, such as diagrams and flowcharts, can significantly enhance participants’ understanding of study procedures and risks” (p. 379). For instance, if your study involves a particular procedure or equipment that participants might be unfamiliar with, a human subject review board would recommend you include a simple explanatory diagram or photo with labels. If the consent form details a complex process, like the steps participants need to follow during the study, a flowchart can help clarify the sequence of actions better than text.
Examples are another powerful tool. If you ask participants to complete questionnaires or record certain behaviors, provide a completed example showing precisely what you’re seeking. This reduces ambiguity and helps participants feel more confident in complying with study requirements.
Interactive Digital Forms
In today’s digital age, more and more research is conducted online, and digital forms offer unique opportunities to enhance participant understanding. Some independent IRBs offer comprehensive support with interactive forms that allow participants to engage with the content dynamically, significantly improving comprehension and making the process more user-friendly.
For example, consider using digital forms that include pop-up explanations or hover-over definitions for technical terms to foster collaboration. Research by Faden et al. (2014) suggests that “interactive consent forms can improve understanding and retention by providing immediate, context-specific information when participants need it” (p. 12). When participants encounter a word or phrase unfamiliar, they can simply hover over it or click to see a plain-language explanation. This keeps the form itself clean and readable while providing the necessary detail when needed.
Progress bars are another helpful feature of digital forms. A human subject review board would recommend such forms, as they help participants track their progress, reducing the stress and confusion that can come from lengthy documents. This can help keep participants engaged and motivated to complete the form. Additionally, digital forms can include built-in checks to ensure participants don’t accidentally skip important sections or questions.
Lindegger and Richter (2000) noted that using digital tools in informed consent can lead to more accurate data collection and higher levels of participant satisfaction. Therefore, using progress bars helps ensure that all necessary information is collected and guides participants through the form in a logical, step-by-step manner.
Emphasizing Key Information
While every part of your research form is important, some information is critical for participants to understand. This includes details about risks, benefits, participant responsibilities, and their rights (including the right to withdraw from the study at any time). To make sure this key information isn’t missed, it’s essential to highlight it effectively.
One strategy is to use formatting to your advantage. Another approach IRB services often recommend is placing critical information in a separate box or sidebar on the page, making it stand out from the rest of the text. You can also use plain-language summaries or FAQs at the end of each section or the end of the form. These recaps foster collaboration and give participants a second chance to absorb the most vital information in a simplified format.
Some researchers also opt to include a “key facts” section at the beginning of the form, providing a brief overview before diving into the details. Reiterating such essential points helps reinforce understanding and ensures no critical detail is overlooked.
Providing Opportunities for Questions and Clarification
Always make it clear that participants can ask questions at any time. Sometimes, even the best-designed form won’t cover everything a participant wants to know, or they may still feel uncertain about certain study aspects. Encouraging questions fosters collaboration, shows that you value their understanding, and are committed to ensuring they feel fully informed. If possible, include a contact number or email address directly on the form so participants can ask any questions.
Consider adding a live chat option or a “submit a question” feature for digital forms. During in-person consent processes, make time for participants to ask questions and provide a clear path with reassuring answers. According to Beskow et al. (2010), “facilitating open communication between researchers and participants is critical for fostering trust and ensuring truly informed consent” (p. 289).
Reassuring participants that it’s okay not to sign immediately and that they can take the form home to review before making a decision can also enhance their comfort and understanding. The goal is to show expertise and care in handling the process and foster an environment where participants feel supported, respected, and well informed.
By using these strategies with the help of institutional or independent IRBs that offer comprehensive, bespoke approaches in the IRB process, you can significantly enhance participant understanding of your research forms. This helps ensure that your study is conducted ethically and responsibly and builds trust between you and your participants—laying the groundwork for a successful research project. In the following section, we’ll examine how these principles and strategies come together in real-world examples and how you can apply them to your work.
Enhancing Participant Compliance Through Better Design
Participant compliance is a cornerstone of successful research. If participants don’t follow the study procedures or drop out partway through, it can jeopardize the validity of your data and lead to ethical concerns. Fortunately, one of the most effective ways to boost compliance is through better design of your research forms, which are clear, understandable, engaging, and reassuring. By focusing on trust, simplicity, and support, you can create a research experience that fosters collaboration and encourages participants to stay committed from start to finish. Let’s explore how thoughtful design can make a real difference, supported by insights from scholarly sources.
Reducing Barriers to Completion
Even the most well-intentioned participants can struggle with compliance if participating is too difficult, time-consuming, or confusing. This is where design is critical in increasing barriers to completion, making it difficult for participants to stick with the study. Independent IRBs can help turn such challenges into victories by streamlining your forms and processes.
As Dillman et al. (2014) suggest in their book Internet, Phone, Mail, and Mixed-Mode Surveys: The Tailored Design Method, “simplifying questions and reducing the cognitive load on participants can significantly improve response rates and compliance.” This means cutting out unnecessary steps, keeping questions and tasks simple, and ensuring instructions are straightforward and easy to follow. For instance, if participants must complete a daily journal, providing a straightforward template with specific prompts can make the task less daunting and more likely to be completed consistently.
Another barrier to compliance can be the length and complexity of the forms themselves. If participants have to fill out lengthy questionnaires or read through pages of dense text, they might feel overwhelmed or frustrated, leading to non-compliance. Through direct engagement with your institutional review board, simplifying these forms using bullet points, clear headings, and concise language can make the experience more manageable.
According to Beskow et al. (2010), “shorter and more focused consent forms have been shown to improve participant comprehension and willingness to participate,” highlighting the importance of brevity and clarity. Digital tools can also help reduce barriers. For example, sending automated reminders to participants about upcoming tasks or deadlines can keep them on track without feeling nagged. Similarly, offering digital forms that can be filled out on a smartphone or tablet allows participants to complete them at their convenience, increasing the likelihood that they’ll follow through.
The Impact of Good Design on Compliance
When participants feel informed, supported, and respected, they’re far more likely to comply with study protocols and complete the study. Good design isn’t just about making your forms look nice—it’s about creating a participant experience that is as seamless and positive as possible. As Yu et al. (2020) note, “attention to the participant experience in study design can have profound effects on compliance and retention, ultimately enhancing the quality of research outcomes.”.
As a researcher, you might face challenges in participant recruitment, which could be due to forms that don’t effectively foster trust or ensure compliance among participants. Do not fret; some top IRB boards with expertise and care in handling the process can help turn challenges into victories by ensuring your forms are user-friendly and foster participant compliance. You can cultivate a strong, cooperative relationship with your participants by reducing barriers, building trust, maintaining communication, and addressing concerns. In the long run, these efforts lead to more reliable data, fewer dropouts, and a smoother research process.
Conclusion
Creating user-friendly research forms that enhance participant understanding and compliance is not just a box to check on your way to IRB approval but a critical aspect of ethical and effective research. By prioritizing simplicity, clarity, and accessibility in your form design, you can build trust with your participants, reduce barriers to their involvement, and ensure they feel informed and respected throughout the study. The strategies we’ve discussed, pre-testing forms, incorporating visual aids, utilizing interactive digital tools, maintaining open communication, and addressing participant concerns, are all about putting yourself in the shoes of your participants.
When you design with their needs in mind, you create an environment where participants are more likely to engage fully and adhere to study protocols, resulting in better data and a more effective research process. In the end, thoughtful design is about not just meeting IRB requirements but also fostering a collaborative relationship with your participants, where they feel confident in their role and valued as contributors to the research.
If you need the services of an independent review board, consider BeyondBound. Our approach to IRB is comprehensive and bespoke, designed to eliminate obstacles that might otherwise hinder participant engagement and jeopardize your research. We focus on providing no roadblocks, just support, offering an efficient, stress-free service that paves the way for fast, confident approval. By investing in our services to create clear, accessible, and supportive research forms, you’re setting the stage for successful studies that benefit everyone involved.
We can design your research forms with these principles in mind, ensuring that you’re not just meeting IRB requirements but also providing a clear path to a positive, stress-free research experience for everyone involved. So, take these principles to heart, and let your research forms reflect your commitment to ethical standards and participant well-being.
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