IRB: Ethics & Human Research
A Tool Kit to Enhance the Informed Consent Process for Community-Engaged Pediatric Research
Effective communication of informed consent is challenging for individuals with low health literacy. The existing literature in this field highlights that research participants often do not adequately comprehend informed consent. While effective communication strategies have been well validated in clinical settings for patients with low health literacy, these same strategies have not been implemented in the setting of informed consent. We provide a tool kit for an enhanced informed consent process that is based on principles of effective low health-literacy communication. This approach was developed and implemented in two ongoing studies that are community-based interventions to prevent pediatric obesity among underserved populations. We also suggest areas for targeted next steps for informed consent research to improve patient understanding. This new method lays the groundwork to then test the efficacy of this approach as we strive to include more diverse populations in research.
Key words: informed consent, health literacy, pediatric obesity
The informed consent process for research should ensure that research participants receive sufficient information regarding the details of their involvement, comprehend the provided information, and grasp the voluntary nature of their participation.1 An unsurprising consequence of the sometimes lengthy, complex, and burdensome process is that individuals who consent to participate in research often do so without truly being “informed.”2 In a recent systematic review of articles about informed consent for surgery and clinical research, Falagas and colleagues identified gaps in how well research participants understood various components of the informed consent process. They noted that for a third of the clinical trials included in their review, research participants did not have adequate understanding in the areas of research risk and benefits, randomization, study aims, right to withdraw from research, and voluntarism.3 Other studies suggest that education level, literacy, and a participant’s primary language are all associated with understanding the elements of informed consent.4
Because there are numerous reasons that people can misunderstand the various components of informed consent, there have been some attempts to improve the consent process. A recent systematic review identifying 42 trials that developed enhanced approaches to informed consent organizes the approaches into four categories: multimedia technology, modifying consent forms, extended discussion with educators, and test or feedback.5 When modifying the consent forms, investigators used four basic strategies: condensing the form (i.e., making shorter sentences), revising content for readability (e.g., from 16th- to 6th-grade reading level), improving formatting (using larger font), or including graphics. The findings of these approaches did not suggest that one method was superior to others in increasing comprehension.6 Another systematic review and meta-analysis found that enhanced consent forms and extended discussions were the most effective in improving participant understanding compared to multimedia approaches.7 Notably, there was significant variability among the populations studied (such as elderly, mentally ill, and some healthy participants), with various education or reading levels, making it difficult to draw universal recommendations for developing an improved approach to the informed consent process.
An important concern is that low health-literacy skills may influence one’s ability to accurately interpret consent forms, correctly ascertain risk-benefit ratios, and grasp the concepts of voluntarism and withdrawal.8 Health literacy represents an individual’s ability to receive, process, and use information to make appropriate health-related decisions, including whether or not to participate in research. Health literacy includes more than just writing and reading skills (print literacy) or listening and speaking skills (oral literacy); it also involves quantitative skills (numeracy) and cultural and conceptual knowledge.9 Millions of Americans have low health-literacy skills with notable disparate trends among certain racial or ethnic groups and those with lower income or lower educational attainment.10 Furthermore, participants with higher health literacy have been shown to have better comprehension of the informed consent process.11 Yet without clear guidance from the literature, researchers are often left without practical guidance for developing appropriate informed consent approaches for low-literacy populations. Here, we describe the development of a theory-based enhanced informed consent process that integrates health-literacy approaches into the presentation of the elements of informed consent and into the overall informed consent process. We also provide recommendations for how future studies could test the efficacy of an enhanced approach to informed consent.
Enhanced Informed Consent Process in Pediatric Obesity Trials
The Consortium for Obesity Prevention and Treatment Research (COPTR) is a National Institutes of Health–funded collaboration among multiple academic institutions designed to implement community-based clinical trials to support healthy weight among underserved children. While four studies implement a unique protocol to test unique behavioral interventions aimed at childhood obesity prevention or treatment, there are several unifying features across the studies, including a foundation in behavior-change theory and a multilevel approach to understanding the determinants of obesity.12 Each of these trials is a three-year behavioral intervention with methods previously published.13 These studies are based in behavior-change theory and were developed and piloted prior to implementation. Many of the participants in these trials are Spanish speaking; all of the participants are from underserved populations and are traditionally underrepresented minorities with elevated risk for low health literacy. The informed consent process focused on providing information to parents and carefully evaluated dissenting behavior in young children (ages two to five years). In this report, we describe the approach to developing and implementing a multipronged enhanced informed consent process for parent and child dyads for two COPTR studies, the University of Minnesota’s Now Everybody Together for Amazing and Healthy Kids (NET-Works) trial and Vanderbilt’s Growing Right onto Wellness (GROW) trial.
Development and components of the enhanced consent process. The enhanced informed consent process was intended to supplement but not replace the traditional process and included careful attention to four domains, each of which utilized low health-literacy approaches, while maintaining careful fidelity to the required components of informed consent. These low-literacy components included writing the consent form at less than an 8th-grade reading level, explaining the written document using low health-literacy techniques (including avoiding jargon, highlighting key areas, and maintaining eye contact), developing visual aids to enhance participant understanding of each key component outlined in the consent form, and using teach-back techniques to gauge participant understanding prior to enrollment in the study. These low-literacy approaches have been well validated in clinical encounters and have demonstrated efficacy at improving participant understanding.14 The visual aids were developed using a similar approach to the intervention materials, which have been published.15 Because the studies enroll parents and their young children, the research staff was aware of potentially dissenting behaviors from children that would indicate their desire to withdraw from the study. The process of informed consent was not identical for NET-Works and GROW; however, the studies shared a common approach to key components, and we report those shared components. The institutional review boards at both the University of Minnesota and Vanderbilt University were supportive of using the enhanced approach described.
Data collector training. The study coordinator trained bilingual data collectors to obtain informed consent using the consent document (in the participant’s language of choice) and an explanation guide summarizing the key components of the informed consent process. Data collectors underwent four hours of training, along with four to six hours of mock-consent practice time, and then certification with the study coordinator. Training consisted of an extended discussion of the goals of informed consent, methods of the consent protocol, use of (and practice with) a consent script, and use of visual aids resulting in certification for each data collector. Training was performed in English; the bilingual data collectors practiced obtaining informed consent in English and Spanish to become proficient at this in both languages.
Implementing an Enhanced Informed Consent Process
Verbal discussion of the informed consent form. Data collectors obtained informed consent in each participant’s home or at a community-based data collection site. Attempts were made to minimize distractions (e.g., turning off the television if at a home or having one person play with the children while the data collectors discussed consent). The informed consent process was conducted in either English or Spanish, as requested by the participant. Participants were given a copy of the consent form when the informed consent process began.
Data collectors used the consent form, visual aids, and an accompanying explanation guide to verbally explain the study’s purpose, duration, procedures, randomization, compensation, and participant eligibility. The explanation guide provided a bulleted list of key points to be discussed about the research study. Avoiding jargon, data collectors verbally reviewed risks and benefits of participation, described randomization, discussed confidentiality and privacy issues, and explained how to withdraw from the study. The data collectors were trained to use low-literacy communication techniques to guide the potential participant through the informed consent form by reading the section heading, periodically pointing to sections of the consent form, and turning the pages of the consent form for the participant to follow along. The data collectors also used additional low-literacy communication methods including positioning themselves close to the potential participant, sitting at a table when possible, speaking slowly, making eye contact with individuals, listening carefully to questions and concerns, and asking questions themselves to facilitate a conversational method.16
The consent process began with asking the potential participant what interested him or her about the study. This provided the data collector with insight into the person’s original understanding of the study and helped flag any questions or concerns up front. The potential participant was given one copy of the consent form, and the data collector retained the other. Data collectors were encouraged to stop from time to time to ask if the individual had any questions and to read the individual’s body language and facial expressions to get a sense of overall understanding.
The three-year duration of the study was emphasized, and data collectors explained the annual measurement visits according to the age of the index child as they progressed through the study. Example language included, “We are here visiting with you now and your child is three years old [pointing to the corresponding visual aid baseline measurements icon]. We will come back again next year when s/he is four years old [pointing to Year 1 measures], again when s/he is five years old [pointing to Year 2 measures], and for the last time when s/he is six years old [pointing to Year 3 measures].” Linking annual measurements to the child’s age allowed potential participants to think of the future and determine if the study was appropriate for their family.
Privacy and confidentiality were emphasized in an ongoing conversation with potential and later actual participants, beginning with the telephone screening, throughout the informed consent process, and during all data collection time points.
Visual aids. In addition to the written consent form with verbal review, the study team used visual aids developed by a graphic designer to enhance understanding by potential participants. The graphic designer and study teams were responsible for choosing appropriate symbols. These colorful, laminated visual aids depicted the study timeline, random assignment to study groups, and study logo to introduce and state the purpose of the study. The visual aids were designed to supplement, not substitute, the consent form and to help facilitate comprehension. Each key idea was identified (e.g., randomization, incentives, data collection), and an appropriate simple graphic was developed to communicate that idea. We adhered to simple sentence structure and used short phrases and captions when written language was necessary. Finally, a high percentage of white space was preserved on the page to help focus the potential participant on key concepts.
Principles of effective health communication served as the foundation for the development of the visual aids. Previous literature has shown that use of visual aids can improve patient comprehension for a variety of factors including understanding numerical or graphical data, recall of medical dialogue, and engaging in medication management.17 Although there is limited evidence directly comparing the utility of visuals for patients with adequate versus inadequate literacy skills, these approaches have been shown to be universally accepted by and independently beneficial for patients of all literacy levels.18 Seminal work published by Doak and Doak emphasized several key principles of effective visual development, including the use of pictures to communicate ideas, optimal use of white space on the page, the sizing and positioning of text and graphics, and the use of simple language and avoidance of jargon.19 We paid special attention to the structure and layout of the visual aids to give potential participants a broad overview of the study and its components. Text headers were emboldened, and any written text was limited to short phrases, using the active voice.20 There are slight differences between the visual aids used for each study, with a full description below.
For both studies, the study arms were described in detail, delineating the differences between the intervention and control groups. The randomization procedure was described as an electronic flip of a coin with emphasis placed on the point that participants and data collectors were not allowed to choose the study arm. Given the longitudinal nature of these interventional studies, the schedule and importance of yearly measurement visits were discussed, with an explanation that regardless of study group assignment, all study participants would be asked to complete the annual measures. Along with describing the voluntary nature of the study, data collectors explained various techniques that would be employed to try to keep participants engaged for the entire three years of the study, including periodic mailings, requests for current phone numbers and email addresses, and offering flexible scheduling of visits—all in an effort to help participants understand the commitment level in advance, should they choose to sign the consent form.
The University of Minnesota NET-Works Study used two visual aids to supplement the consent process (Figures 1 and 2, English version; all figures for the article are available through the IRB: Ethics & Human Research web page). The first visual aid was a timeline and randomization guide (Figure 1). It depicted a general overview of the study’s timeline, sequence of annual visits, incentives, and two study arms. A consent script was written for data collectors to practice and use during the initial recruitment phase to help guide the conversation with full explanations of each section of the consent form.
A second visual aid, “Measure-Me” (Figure 2), that describes the procedures for participating was then shown to the potential participant. Each measurement had a corresponding image on the visual aid. For instance, the “Height & Weight” measurement had a picture of a scale; “Food Recall,” a picture of a child eating; “Home Food Inventory,” a picture of a refrigerator; and “Hair Sample,” images of a comb and scissors. A house or phone icon indicated if the visit would be performed at the house or over the phone. Data collectors described each measurement in detail while pointing to the corresponding image on the visual aid and answered questions as they arose. It was explained that measurements and devices utilized were being used only for the purposes described. For example, the “activity monitor” (accelerometer) was described to individuals as monitoring the levels of intensity of physical activity only; it was also explained that there was no global positioning system attached to this measurement. Similarly, the hair sample was described as analyzing only levels of cortisol.
In addition to the timeline-and-randomization and “Measure-Me” visual aids, a laminated “Certificate of Confidentiality” was used to reiterate what was discussed in the confidentiality portion of the written consent form to highlight the importance of privacy and confidentiality in research practices.
The Vanderbilt University GROW Study used four visual aids to supplement the informed consent process (Figures 3-6). These documents contain information that corresponded to the implementation, compensation, and benefits sections of the written informed consent document. The first aid was an overview of study procedures (Figure 3).21 It briefly detailed the primary focus of each arm of the study, the data collection time points, and potential compensation. The second aid (Figure 4) gave a detailed account of data collection. In this document, the focus was on what participants could expect at each data collection session, with a picture that corresponded to each measurement station, including a scale to depict anthropometrics and a refrigerator with a phone to depict the approaches used for measurement of dietary intake.
The third aid (Figure 5) provided a pictorial representation of the intervention arm of the study. Each phase of the intervention, focusing on the time commitment and activities at each point in the study, was briefly described with the use of images and symbols. A final visual aid was used to give more detail to the control arm of the study (Figure 6), including the time frame for subsequent data collection and control sessions.
At the end of the consent form discussion, data collectors asked two open-ended questions to ensure the potential participant’s understanding, using the teach-back technique.22 The teach-back technique is a well-studied communication strategy that improves understanding by asking potential participants to “teach back” key concepts. In this setting, potential participants were asked to describe the difference between the two study groups, ensuring knowledge of the components of the intervention group and the control group. Individuals were asked to describe some of the study measurements being conducted using the images on the visual aid that represented procedures. If the individual answered incorrectly, struggled to answer, or could not answer, the data collector assisted by explaining once again the components of both study arms and by describing procedures and requirements.
The Tool Kit for an Enhanced Informed Consent Process
We developed and implemented a tool kit for a comprehensive enhanced informed consent process that is based on principles of effective low health-literacy communication techniques that had previously been tested to enhance health communication. In our view, the use of low health-literacy strategies to gauge understanding by potential participants should be a standard part of the informed consent process. Some researchers may express concern that individuals with adequate health literacy will be less receptive of such inquiries and of low-literacy approaches in general; however, low-literacy communication techniques have been well studied in the clinical setting, with evidence supporting that both highly and less literate patients appreciate and benefit from targeted efforts to communicate more clearly and effectively.23 To that end, the Agency for Healthcare Research and Quality has published a set of “standard precautions” when working with patients across all literacy levels.24 The most tested of these approaches in the clinical setting is the teach-back method. This allows those conducting the consent process to tailor further information to the patient’s level of understanding. While specific trials testing the effectiveness of the teach-back approach to improve the informed consent process for research in low-literacy populations are lacking, the efficacy in clinical practice warrants its inclusion.25
There have been some efforts to improve the consent process particularly for patients with low health literacy.26 Targeted approaches have included alterations to consent documents to enhance their readability, the addition of multimedia tools to increase comprehension, and extended discussions for patients regarding study details. For example, in a study by O’Lonergan et al., parents who were randomized to a multimedia consent process showed greater understanding of a hypothetical procedure than parents who completed a traditional paper consent process.27 Our tool kit and approach to the informed consent process build on the successful techniques identified in these studies. With the aim of improving research participants’ understanding of the elements of informed consent, we suggest that the essential components of an enhanced informed consent process should include extensive training for data collectors in the use of low-literacy communication strategies, the development and implementation of visual aids to augment the traditional informed consent process, and the use of the teach-back technique to gauge an individual’s understanding before moving forward with the informed consent process.
Although we did not conduct a systematic, validated assessment of the use of this tool kit (either by conducting understanding tests before and after use of the tool kit or by conducting a randomized controlled study), we did use the teach-back technique during the consent process to gauge individuals’ understanding of the elements of informed consent. We also conducted semistructured interviews with the six data collectors who conducted the consent process to obtain their perspectives about the effectiveness of the enhanced approach. They universally agreed that the enhanced approach improved potential participants’ understanding and reduced the time needed for potential participants to gain an appropriate understanding, though it may have increased total consent time. The main advantages were that the visual informed consent aid served as a road map for individuals to understand the key requirements of the study, while helping to make the process more interactive. In their view, the visual aids were most helpful in addressing condition assignment and detailing requirements of the study but less helpful in emphasizing the voluntary nature of the research or in detailing the risks and benefits of the research. They also thought that the visual aids allowed for the formulation of questions and further discussion about particular activities, timelines, group assignments, and other components of the study. This gave individuals an opening to ask their questions prior to officially signing the consent form. When asked further about how the enhanced informed consent process addressed all necessary consent components, the data collectors highlighted the importance of the teach-back technique that was used at the end of the consent process and prior to when the individuals signed the consent form.
Our work lays the foundation for future research directions. Specifically, we would suggest that randomized trials be conducted to determine if the type of enhanced informed consent approach we implemented could potentially replace the traditional informed consent approach while maintaining individuals’ adequate understanding of the elements of informed consent and the nature of the study for which they are being recruited to participate. We suggest that these trials be conducted with a broad range of individuals from diverse backgrounds, including individuals with low and adequate health literacy. Future efforts should also focus on how the use of visual aids could augment both the parental consent and child assent processes.
All five figures for this article are available through the IRB: Ethics & Human Research webpage, part of The Hastings Center website.
William J. Heerman, MD MPH, is an assistant professor in the Division of General Pediatrics at Vanderbilt University Medical Center; Richard O. White, MD MSc, is an assistant professor in the Department of Community Internal Medicine at the Mayo Clinic in Jacksonville, Florida; Annie Hotop, MS MA, is a senior coordinator in the Division of Epidemiology & Community Health at the University of Minnesota; Karen Omlung, BA, is a community program specialist in the Division of Epidemiology & Community Health at the University of Minnesota; Sharelle Armstrong, BA, was a research assistant in the Division of General Pediatrics at Vanderbilt University Medical Center when this article was written; Irène Mathieu, BA, was a student in the School of Medicine at Vanderbilt University when this article was written; Nancy E. Sherwood, PhD, is a senior investigator and the director of scientific development in the HealthPartners Institute for Education and Research; and Shari L. Barkin, MD MSHS, is a professor in the Division of General Pediatrics at Vanderbilt University Medical Center.
- National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research. The Belmont Report: Ethical Principles and Guidelines for the Protection of Human Subjects of Research, 3 vols., DHEW Publication No (OS) 78-0012- 78-0014.Bethesda, MD: The Commission, 1978.
- Infectious Disease Society of America. Grinding to a halt: The effects of the increasing regulatory burden on research and quality improvement efforts. Clinical Infectious Diseases 2009;49(3):328-355; Wipke-Tevis DD, Pickett MA. Impact of the Health Insurance Portability and Accountability Act on participant recruitment and retention. Western Journal of Nursing Research 2008;30(1):39-53.
- Falagas ME, Korbila IP, Giannopoulou KP et al. Informed consent: How much and what do patients understand? American Journal of Surgery 2009;198(3):420-435.
- Sherlock A, Brownie S. Patients’ recollection and understanding of informed consent: A literature review. ANZ Journal of Surgery 2014;84(4):207-210.
- Flory J, Emanuel E. Interventions to improve research participants’ understanding in informed consent for research: A systematic review. JAMA 2004;292(13):1593-1601.
- See ref. 5, Flory and Emanuel 2004.
- Nishimura A, Carey J, Erwin PJ et al. Improving understanding in the research informed consent process: A systematic review of 54 interventions tested in randomized control trials. BMC Medical Ethics 2013;14:28.
- Nutbeam D. The evolving concept of health literacy. Social Science & Medicine 2008;67(12):2072-2078; Baker JL, Olsen LW, Sorensen TI. Childhood body-mass index and the risk of coronary heart disease in adulthood. NEJM 2007;357(23):2329-2337.
- Nielsen-Bohlman L, Panzer AM, Kindig DA, eds. Committee on Health Literacy, Board on Neuroscience and Behavioral Health, Institute of Medicine. Health Literacy: A Prescription to End Confusion. Washington, DC: National Academies Press, 2004.
- Kutner MA, United States Department of Education, National Center for Education Statistics. The Health Literacy of America’s Adults: Results from the 2003 National Assessment of Adult Literacy. Washington, DC: United States Department of Education; National Center for Education Statistics, 2006. National Center for Education Statistics series.
- Ownby RL, Acevedo A, Goodman K, et al. Health literacy predicts participant understanding of orally-presented informed consent information. Clinical Research and Trials 2015;1(1):15-19.
- Huang TT, Drewnosksi A, Kumanyika S, et al. A systems-oriented multilevel framework for addressing obesity in the 21st century. Preventing Chronic Disease 2009;6(3):A82.
- Pratt CA, Boyington J, Esposito L, et al. Childhood obesity prevention and treatment research (COPTR): Interventions addressing multiple influences in childhood and adolescent obesity. Contemporary Clinical Trials 2013;36(2):406-413; Robinson TN, Matheson D, Desai M, et al. Family, community and clinic collaboration to treat overweight and obese children: Stanford goals—A randomized controlled trial of a three-year, multi-component, multi-level, multi-setting intervention. Contemporary Clinical Trials 2013;36(2):421-435; Sherwood NE, French SA, Veblen-Mortenson S, et al. Net-Works: Linking families, communities and primary care to prevent obesity in preschool-age children. Contemporary Clinical Trials 2013;36(2):544-554; Moore SM, Borawski EA, Cuttler L, et al. Impact: A multi-level family and school intervention targeting obesity in urban youth. Contemporary Clinical Trials 2013;36(2):574-586; Po’e EK, Heerman WJ, Mistry RS, et al. Growing Right onto Wellness (Grow): A family-centered, community-based obesity prevention randomized controlled trial for preschool child-parent pairs. Contemporary Clinical Trials 2013;36(2):436-449.
- Dewalt DA, Broucksou KA, Hawk V, et al. Developing and testing the health literacy universal precautions toolkit. Nursing Outlook 2011;59(2):85-94.
- White RO, Thompson JR, Rothman RL, et al. A health literate approach to the prevention of childhood overweight and obesity. Patient Education and Counseling 2013;93(3):612-618.
- See ref. 14, Dewalt et al. 2011.
- Houts PS, Witmer JT, Egeth HE, et al. Using pictographs to enhance recall of spoken medical instructions II. Patient Education and Counseling 2001;43(3):231-242; Katz MG, Kripalani S, Weiss BD. Use of pictorial aids in medication instructions: A review of the literature. American Journal of Health-System Pharmacy 2006;63(23):2391-2397; Houts PS, Bachrach R, Witmer JT, et al. Using pictographs to enhance recall of spoken medical instructions. Patient Education and Counseling 1998;35(2):83-88.
- See ref. 17, Houts et al. 2001; Houts et al. 1998; Smith SK, Trevena L, Nutbeam D, et al. Information needs and preferences of low and high literacy consumers for decisions about colorectal cancer screening: Utilizing a linguistic model. Health Expectations 2008;11(2):123-136; Kandula NR, Nsiah-Kumi PA, Makoul G, et al. The relationship between health literacy and knowledge improvement after a multimedia type 2 diabetes education program. Patient Education and Counseling 2009;75(3):321-327.
- Doak CC, Doak LG, Root JH. Teaching Patients with Low Literacy Skills, 2nd ed. Philadelphia: J.B. Lippincott, 1996.
- See ref. 15, White et al. 2013.
- Heerman WJ, White RO, Barkin SL. Advancing informed consent for vulnerable populations. Pediatrics 2015;135(3):e562-e564.
- Dewalt DA, Callahan LF, Hawk VH, et al. Health literacy universal precautions toolkit. Rockville, MD: Agency for Healthcare Research and Quality, 2010. https://www.ahrq.gov.
- See ref. 7, Nishimura et al. 2013.
- See ref. 14, Dewalt et al. 2011.
- Tamariz L, Palacio A, Robert M, et al. Improving the informed consent process for research subjects with low literacy: A systematic review. Journal of General Internal Medicine 2013;28(1):121-126.
- See ref. 7, Nishimura et al. 2013; see ref. 25; see ref. 5, Flory and Emanuel et al. 2006.
- O’Lonergan TA, Forster-Harwood JE. Novel approach to parental permission and child assent for research: Improving comprehension. Pediatrics 2011;127(5):917-924.