|Year : 2018 | Volume
| Issue : 1 | Page : 62-68
Picture versus words: A comparison of pictorial and verbal informed assent formats
Siddharth Dutt, Bangalore N Roopesh
Department of Clinical Psychology, National Institute of Mental Health and Neurosciences, Bengaluru, Karnataka, India
|Date of Web Publication||29-Mar-2018|
Bangalore N Roopesh
Department of Clinical Psychology, National Institute of Mental Health and Neurosciences, Bengaluru - 560 029, Karnataka
Source of Support: None, Conflict of Interest: None
Background for the Study: Informed consent is a process of obtaining permission from the participant to participate in research. Involving children in a research requires them to give their “assent” for participation. Informed assent is obtained from children even after their guardians have given consent for participation. Studies have shown that children have difficulty understanding the key elements of research process such as right to withdraw from the study or the meaning of “harm” involved in the research process. Further, the studies have also propounded that using child-friendly methods such as using pictures and simple language would facilitate children's understanding. Objectives: In this study, pictorial and verbal assent formats were compared find out which format is suitable for children's understanding of informed assent with respect to research. Methods: A sample of 389 school going children and adolescents of both the gender, ranging from 7 to 16 years were considered for the study. The sample was randomly divided into two groups, where for one group (n = 197), pictorial assent format was administered and another group (n = 192), verbal assent format was administered. The pictorial assent format was developed for the study by the corresponding author. Results and Conclusions: Analysis revealed that there was a significant level of interaction between gender and the two assent formats. Males were able to understand pictorial assent format better compared to the females, whereas females were able to understand verbal assent format better than the males, when age and education were considered as covariates. Further, it was found that as age increases there is better understanding of research processes in both the formats. Hence, while the process of obtaining assent for participation in research, age of child must be considered and with respect to gender differences males tend to prefer pictorial formats whereas females tend to prefer verbal formats.
Keywords: Ethics, informed assent, pictorial assent format, verbal assent format
|How to cite this article:|
Dutt S, Roopesh BN. Picture versus words: A comparison of pictorial and verbal informed assent formats. Indian J Soc Psychiatry 2018;34:62-8
|How to cite this URL:|
Dutt S, Roopesh BN. Picture versus words: A comparison of pictorial and verbal informed assent formats. Indian J Soc Psychiatry [serial online] 2018 [cited 2021 Jan 18];34:62-8. Available from: https://www.indjsp.org/text.asp?2018/34/1/62/228780
| Introduction|| |
Participation of individuals in any research process should be clearly on voluntary basis, hence to agree or disagree to participate in the research process, one must have clear understanding of the research procedure involved, and must be aware of the granted autonomy to make a decision to participate in it. The process of obtaining permission from the participants to participate in the research is called informed consent. The researcher while taking consent must ensure that a prospective participant is well aware of his/her rights  has a complete understanding of the research process, knowledge about whether there are any risks involved, and aware of benefits for participation if any. The process of taking consent must address the issue of confidentiality, right to withdraw, state the method of how data will be obtained, stored, and to where and to whom it will be shared. The participants must also be thoroughly informed about how confidentiality agreement can be breached under certain conditions such as where there is indication of harm to self or others or disclosure in legal proceedings.
The US Department of Health and Human Sciences  recommends as well as specifies eight elements to be disclosed in the informed consent forms: (1) A statement stating that process or activity involves “research,” along with description of the research purpose, duration of participation, study procedures, and identification of any procedure that are experimental; (2) Detailed description of any foreseeable risk and discomforts; (3) Expected benefits (if any); (4) Alternative procedures or treatment other than those which are involved in the study; (5) Issues related to confidentiality; (6) Compensation and available treatment in case of injury or any harm; (7) Contact details in case of questions; and (8) A statement that participation is voluntary and refusal to participate or subsequent withdrawal from research participation would entail no penalties or loss of benefits to the participants.
Informed assent is a process which can be conceptualized as where children are informed about the research and are allowed to take a decision to whether to participate in the research processes even after the permission from the legal guardian is obtained. The purpose of obtaining additional permission from parents or guardian is because children are developmentally not capable of analyzing potential risks and benefits of the research process. The assent is similar to the process of consent, but the information is presented in a simple and noncomplicated language so that the children can comprehend the entire research process.
The process of involving children in research and obtaining their consent becomes intricate and challenging when it comes to matters such as their ability to provide assent and their capacity to understand their rights in the research process. In the Declaration of Helsinki guidelines , it was specified that parental permission/consent and assent from children who are capable of making decision is mandatorily required. The International Ethical Guidelines for Biomedical Research Involving Human Subjects  commented that “older children, who are more capable of giving assent, should be selected before younger children or infants, unless there are valid scientific reasons for involving younger children first.” Hence, the process of obtaining consent/assent depends on the age of the child and their ability of the child to understand the processes and procedures involved in research. Further, it also depends on their understanding that it is voluntary participation, and that they can refuse to participate and/or withdraw from the research whenever they want.
Age is an important influential factor in determining the ability to consent for participation in research. According to Ondrusek et al., understanding of research process and conditions of participation is incomplete till 9 years of age and suggested that it is developmentally and ethically inappropriate to obtain assent from children below 9 years. Authors have also found that children of all ages believed that the researcher(s) would be unhappy if they withdrew from the study and this possibly prevented them withdrawing from the study. Children younger than 14 years have difficulties in understanding key elements of research which does not involve any intervention, and hence consent ethically cannot be obtained  and also there might be perceived stigma in admitting that one does not understand what was told and asked or needs further explanation regarding research process. Further, children may agree to participate in the research merely to please and/or they have been taught to obey adults ,,, and refusal to participate may be perceived as distancing from there peer group. Younger children's understanding of “harm” might be completely different than older children, where younger children might interpret “harm” as fall or injury or something else entirely.
Younger children between 6 and 15 years are capable of understanding the basic purpose and procedures involved if the information is provided in age appropriate manner. According to Lambert and Glacken, other factors which affect the understanding of research process are intelligence level of the child, reasoning ability, preference for involvement, emotional state, prior experience with research, presence of parents, support, and beliefs.
To enhance the understanding of the research process for participants, factors such as developing good rapport initially before explaining the processes where the researcher introduces him/herself, adequate time spent in explaining and obtaining assent, readability of assent forms, simple wording, with proper formatting, and organization helps in facilitating it. In this regard, Vitiello  suggested that new ways that facilitate and enhance the understanding of research processes could be done using diagrams, flipcharts, using interactive electronic or computer devices which provide additional support in explaining process, procedures involved, risks and benefits involved, and terms of confidentiality.
Research reveals better understanding among the children when the prose material is presented orally.,, Studies have also found that pictures facilitate recall of information better both in picture and prose format and this can be explained by repetition effect where in prose-plus-picture condition involves two presentations of same information in comparison to prose where it is presented only once. This has been attributed to the process of dual coding where information in prose-plus-picture condition is encoded both visually and verbally, whereas in prose condition information is encoded only verbally. Information thus encoded and stored in dual format (verbal and visual) increases the probability of recall.
Spatial ability which is found to be better in males than females  facilitates the difference in learning or understanding of material. Males tend to prefer learning through visual material than females, whereas females learn better through verbal material.
Studies previously done , indicate that children may not adequately understand the oral or verbal method of taking consent for voluntary participation of research and pictorial methods can enhance their understanding. Furthermore, there have been no studies that have tried to compare effectiveness of using a pictorial assent format in comparison with verbal assent format for research. In addition, based on the review there were no literature available pertaining to the informed assent process done with children in the Indian context. Hence, this study has compared pictorial and verbal assent formats, to find out whether which format is suitable for children's understanding of informed assent with respect to research.
| Methods|| |
Sample consisted of 389 typically developing children and adolescents (7–16 years; grade two to tenth). Initially, five private English medium schools in Bengaluru were approached and out of which, 4 schools gave permission to conduct the study. The schools belonging to different areas and cater to different socioeconomic strata were approached. The children belonged to the lower to higher socioeconomic status and urban background. The sample was divided into groups, pictorial and verbal format groups. Participants were divided into groups alternatively according to the class sections that they were in. For example, if section A was taken for pictorial assent format, section B was taken for verbal assent format, and section C for pictorial assent format and so on. Pictorial assent format was administered on 197 children (girls = 86) and verbal assent format was administered on 192 children (girls = 79).
Description of tools
Sociodemographic data sheet
Sociodemographic details such as age, gender, and education were obtained using sociodemographic data sheet.
The pictorial assent format consisted of 12 pictures depicting the informed consent/assent process in research which were shown sequentially. The themes for the pictures were derived from the standard Informed Assent Guidelines for the sequence. Initially, 14 pictures were drawn by a professional artist belonging to the Department of Mental Health Education, NIMHANS, Bengaluru. The pictures were drawn keeping in mind the relevance of the characters in Indian culture such as dress code, hairstyle, makeup, and the social/environmental setting. The pictures depicted characters involved in explaining the process of psychological research and obtaining assent from children. These pictures were then shown five mental health professionals with minimum qualification of M. Phil. and who have done research with children. Based on their suggestion, pictures were modified/redrawn and finally, 12 pictures were chosen for the study. Sample of pictorial assent form is shown in [Figure 1], [Figure 2], [Figure 3], [Figure 4], [Figure 5].
The verbal assent format had a written paragraph explaining the informed consent/assent process in research which was read out orally. The written paragraph was developed based on the sequence of the standard Informed Assent Guidelines. Similarly, this was again shown to the same five mental health professionals for content validation. Based on their suggestion, the format was modified accordingly.
Both format had information about a researcher need for selecting few children; children asking the reason for the same; researcher explaining the need as to obtain a research degree; what might happen in the research, such as administering paper-pencil tests, computer tests, maintaining confidentiality; right to refuse participation before starting and/or after the research started; their decision not affecting how they will be treated by the researcher; and further clarification needed.
The pictorial and verbal assent formats were presented to the children after obtaining informed consent and informed assent from them. After the presentation of either format, the children were asked 15 questions about various aspect of the research, such as research participation, their rights to participate, and right to reject/withdraw and were asked to indicate there level of understanding for each question. Some of the questions are “Who will benefit from this study? “Who can decide when to stop this study?” “Even if you do not want to participate, can we force you to participate?” and “What will happen if you refuse to participate in this study?” Written informed consent was obtained from the parents and school authorities and written informed assent was obtained from the children. For the younger children, pictorial assent forms had to be shown for longer duration, and verbal assent form had to be read out slowly for better understanding.
This study was approved by the Ethics Committee of the National Institute of Mental Health and Neurosciences, Bengaluru, India.
The answers given by the children for the 15 questions were rated as “adequate,” “somewhat adequate,” or “inadequate.” Initially, for the few responses of the children, the first author carried out the ratings and it was cross-checked by the second author for consistency. Any discrepancy was corrected and recoded. This process continued till both the authors achieved consistency in ratings. Each “adequate” response was given a score of “2,” “somewhat adequate” response were given a score of “1,” and “inadequate” response were given a score of “0.” To arrive at a total score, all the points obtained (total number of “adequate” responses, and “somewhat adequate” responses) were summed up. The data were analyzed using SSPS 15 software (SPSS Inc, USA). For descriptive statistics, mean and standard deviation (SD) was calculated. Pearson's correlation analysis was done to assess the degree of association between age, education, understanding of pictorial assent format, and understanding of verbal assent format. Multivariate analysis was carried out for each of the 15 questions as well as the total score to find out whether there was any interaction between two groups of stimuli (verbal and pictorial) and gender, keeping age and education as covariates.
| Results|| |
The mean and SD for males who were administered pictorial assent format was found to be mean = 21.54 and SD = 5.4, whereas the mean and standard for males who were administered verbal assent forms was found to be mean = 20.46 and SD = 6 [Table 1].
|Table 1: Mean and standard deviation and F values for boys and girls in pictorial and verbal informed format|
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The mean and SD for females who were administered pictorial assent forms was found to be mean = 20.12 and SD = 5, whereas the mean and SD for females who were administered verbal assent format was found to be mean = 21.15 and SD = 5.2 [Table 1].
Multivariate analysis revealed that there was significant level of interaction between gender and two types of assent forms (F = 3.4, P = 0.06) when age and education were considered as co-variants; males were able to understand pictorial assent format better compared to females, whereas females were able to understand the verbal assent format better than pictorial assent format [Figure 6]. In addition, the results of the separate analysis of the 15 questions showed significant gender differences for questions, “Why this study is being done?” (P = 0.017) and 'Why are you selected for this study?” (P = 0.005), where boys scored more than girls; significant differences in type of stimuli for questions, “Why this study is being done?” (P = 0.032), and “Who can decide when to stop this study?” (P = 0.035), where pictorial presentation showed more scores compared to verbal presentation. There was no significant interaction effect observed, however, question “If you do not want, can you refuse to answer?” showed tendency toward significant level (F = 3.654, P = 0.057), where boys did better in pictorial and girls did better in verbal presentation.
|Figure 6: Interaction effect for boys and girls in pictorial and verbal informed assent formats|
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The correlation analysis [Table 2] showed that there was a strong significant level of association between age and understanding of pictorial assent format (r = 0.34, P = 0.00), indicating as age increases the understanding improves. Further, there was significant level of association between age and understanding of verbal assent form, indicating as age increases the understanding improves (r = 0.15, P = 0.03).
|Table 2: The correlation between age, education, and score on assent formats|
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| Discussion|| |
This study was done to explore whether using pictorial assent format would improve the understanding of research process in children in comparison to verbal assent format and whether there are any gender differences in understanding of the same with respect to pictorial versus verbal assent formats.
The results showed that age played a major factor in understanding the various elements of research processes; as there is increased understanding of the informed assent process with respect to research in children with age. This result is consistent with literature, where understanding is continued to grow when children reach adolescence, where it helps in facilitating the understanding of research process and making the participation voluntary. Further, Ondrusek et al. found that children below 9 years have difficulty understanding the research process. Substantiating this, Vitiello  asserted that research is not an “all or none” phenomena, but the ability to understand increases with age. He concludes that as age increases, ability to understand the consequences of one's own actions, cost and/or benefits of behavior increases, and this enhances children to make better judgment related to evaluation of harm, risks involved, and the right to withdraw from the research. Lambert and Glacken  also concluded that age is an influential factor which determines the competence of the child to consent which is based on their vulnerability, limited social power, and developing cognitive ability.
Gallagher et al. found that younger children were more interested in knowing immediate facts such as name of the researcher, age, from where and why have they come rather the abstract concepts of research process such as experimental aims, purpose, and the risks involved.
Findings further showed that there was significant sex difference with respect to understanding of the research process; boys seemed to have more adequate understanding of the aspects of research in the pictorial format whereas this was found to be the opposite with respect to the girls [Figure 5]. In the pictorial assent format, boy's scores indicate that they tend to gain adequate understanding through pictorial presentation, whereas the girls tend to gain adequate understanding through verbal assent form. Linn and Petersen  in meta-analytic study found that boys were better at spatial ability than the girls; Johnson and Meade  found that there is apparent difference in spatial ability in boys around the age of 10 and remains constant throughout in comparison to girls. Thus, enhanced spatial ability could explain why boys were able to comprehend better through pictorial format. Preference to learn through pictorial formats for boys could be also due to gender-related beliefs which developed by the interaction in the society through implicit and explicit ways. Hyde and Linn  found that the girls were better than the boys in verbal ability and Mittal et al. found that there was gender difference in cognitive abilities where girls found to have better memory for language than boys. This could explain why the girls in the current study were able to understand the assent forms in verbal format better. Separate analysis for each of the 15 questions showed that boys compared to girls had better understanding about the purpose of the study and why they were selected for the study. Further, with respect to the type of stimuli, pictorial presentation compared to the verbal presentation shown to help in understanding the purpose of the study and who can decide when to stop the study.
| Conclusions|| |
This study shows that during the process of obtaining assent from children for research participation, age of the child must be considered as it tends to influence obtaining assent process to a large extent. With respect to boys, the current study shows that they tend to have a better understanding of the pictorial assent format better than the verbal format, whereas the girls tend to have a better understanding the verbal assent format of the research process.
This study showed that older the children, better the understanding of the research purpose and their rights with respect to participation in research. Given this, for younger the children there need to be a detailed explanation of the research process along with their rights for participation. Further, the researcher can ask questions regarding how much the children have understood about the research process and if the children have less awareness, they need to be explained again, with better examples. This study has shown that the pictorial format of presentation can help in better understanding why the particular study is being done and that children have a say in the participation in the study. Further, in India, usually adults decide for the children and usually do not consider their opinion. In addition, in general, there is also less awareness about research ethics. Compounding the difficulties, in India, children speak various languages and dialects in their homes and also in schools. Although they might be in English medium schools, not all children are able to speak and understand it adequately. Given these conditions, pictorial assent formats can act as a main or as an adjunct to verbal informed assent forms.
Although the children in the study belong to different socioeconomic status, they were all from English medium schools and urban background. The both pictorial and verbal assent format were for participating in a hypothetical research situation and did not match actual research setting there they need to participate for real. Further, the assent formats had content that listed procedures for research akin to using psychological variables, such as paper-pencil and computer tests. The content did not include procedures used in medical or other scientific researches, such as taking medications, imaging, and/or surgical procedures.
We acknowledge Late Prof. Jayashree Ramakrishna and the artist Mr. Shripathy Acharya for their assistance in developing visual stimulus for this study.
Financial support and sponsorship
Conflicts of interest
There are no conflicts of interest.
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[Figure 1], [Figure 2], [Figure 3], [Figure 4], [Figure 5], [Figure 6]
[Table 1], [Table 2]