Use of incomplete or developmentally inappropriate materials in the assenting process might result in selection bias, insufficient sample size, under- or over-representation of certain groups of youth, costly delays in recruitment, or even high rates of attrition in studies over time. However, many researchers struggle to find materials to use in their assenting process that are comprehensive and developmentally appropriate for their target participant population.
DigiKnowIt News is an educational website that you can seamlessly integrate into your assenting process to recruit more children and adolescents for your research and minimize attrition.
Why should you consider changing your current assenting process?
The importance of informed assent in pediatric research cannot be understated. Not only is the informed assent process vital for respecting participants’ autonomy and complying with good clinical practice guidelines, but it is also a key opportunity for researchers to achieve their recruitment and retention goals.
Children and adolescents may feel too nervous or unprepared to participate in research if they are not adequately informed about their rights as participants and what they may be asked to do as part of your research study or clinical trial. In addition, participants who are not well-informed about the purpose and methods being used in a study may have unrealistic expectations about their participation, which can cause them to lose motivation to participate over time, especially when met with any unexpected challenges or discomfort.
Therefore, if you are experiencing low participation rates or high attrition rates, it may be because your participants are not adequately informed about your study’s goals and methods. Modifying your informed assenting process to effectively inform potential participants may help them feel more comfortable and motivated to participate fully in your research, so you can meet your goals.
Why is your current informed assent process not working?
Pediatric researchers face a unique challenge to educating their potential participants. Properly informing participants should look different for pediatric research studies than studies for adults, but popular informed assent practices do not reflect that. Children are usually not involved in the process of choosing the design or methods of delivering information about clinical research to children, so many potential participants end up receiving information that is neither engaging, comprehensible, nor appealing to them.
Assent forms and in-person meetings with health care providers are the most common ways children and adolescents are informed about clinical trials and their rights before participating. However, health care providers have reported that they find it difficult to maintain young people’s attention and provide balanced information to families during informed consent meetings.1 In addition, research has shown that assent forms and participant information sheets are often long and difficult for young people to understand.2
Therefore, just because you have provided information to your potential participants about their rights, and the goals and methods being used in your study, does not necessarily mean children were able to understand or retain the information well enough for them to remember it, to decide if they think your study will benefit them, and to decide whether they want to participate in it.
How can you elevate your assenting process for better results?
Research has shown that delivering information about study participation to children and adolescents in a multimedia, digital format may improve potential participants’ knowledge about clinical trials. These methods also may be more understandable for young people than delivering the same information in paper format.3
By delivering information in a way that is entertaining and appeals to multiple different learning styles, you may be able to help potential participants better understand and retain information about study participation, so they feel comfortable beginning and continuing participation in your research.
Creating an engaging and developmentally-appropriate informed assent process for potential participants does not have to be expensive or time consuming. DigiKnowIt News is an engaging, developmentally-appropriate, multimedia website containing the information that children and adolescents need to understand what clinical trials are, what might be involved if they participate, and what their rights are as a participant. When you purchase access to DigiKnowIt News for your study, you get access to a web application that cost over $2 million to develop and evaluate.
DigiKnowIt News was designed to help researchers upgrade their informed assent processes to improve their participant recruitment and retention rates without each researcher having to spend all of the time, money, or resources that were needed to create these interactive, flexible, and multimedia resources.
If you are looking for research-based, cost-effective ways to educate potential participants for better participation rates in your research, DigiKnowIt News can help.
To learn more about how DigiKnowIt News can help you, visit https://digiknowit.com/.
- Barakat, L. P., Schwartz, L. A., Reilly, A., Deatrick, J. A., & Balis, F. (2014). Perceived barriers and benefits of Phase III clinical trials participation for adolescents and young adults with cancer (AYA): A qualitative study of AYA decision making experiences. Journal of Adolescent and Young Adult Oncology, 3(1), 3–11.
- Ménoni, V., Lucas, N., Leforestier, J. F., Doz, F., Chatellier, G., Jacqz-Aigain, E., Giraud, C., Tréluyer, J . M., & Chappuy, H. (2011). Readability of the written study information in pediatric research in France. PLoS One, 6(4), e18484.
- Tait, A. R., Voepel-Lewis, T., & Levine, R. (2015). Using digital multimedia to improve parents’ and children’s understanding of clinical trials. Archives of Disease in Childhood, 100(6), 589–593.