How to Write Participant Consent Forms

Writer(s): 
Wendy Gough, Bunkyo Gakuin University; Caroline Handley, Asia University

Researchers who conduct studies involving human participants should always obtain informed consent beforehand to ensure ethical practices. This is typically done by creating a participant consent form. These forms provide sufficient background information on a study to enable an informed decision about whether or not to participate. Regarding classroom-based research, students should always be asked to provide consent for their data, even if it will be anonymised prior to analysis. If findings are not reported anonymously, additional consent will be required for naming participants in a paper or presentation, or for including any information which makes participants identifiable. Fortunately, creating an informed consent form becomes easier once their importance, key features, and relevant issues are understood.

Why Informed Consent is Important

When conducting research involving human subjects, it is imperative to ask for consent to participate in a project. Informed consent is important because it explains the research project, ensures transparency that the researcher is following ethical practices, and gives participants the option to drop out at any time. Informed consent is typically obtained by asking participants to sign a form that outlines the nature of the project, activities involved, timeframe, expectations of both the researcher and participants, data collection and storage methods, how the data will be used, and whether there will be any risk or benefit to the participants. A well-written form also lists the researchers involved in the project. Therefore, it should also help avoid issues related to data ownership.

In Western countries, universities usually have some kind of an institutional review board (IRB) or research ethics review committee (REC) that oversees all research conducted. Teachers and researchers must obtain permission from the IRB before beginning any research process. The IRB reviews and oversees the research and ensures it is being conducted in an ethical manner. Originally, the IRB was intended for scientific and medical research, but it also applies to educational and other research involving human subjects. Japanese universities, unlike their Western counterparts, often have not required such strict research oversight. However, because Japanese universities are struggling to maintain status on the world stage, the Japan Society for the Promotion of Science Editing Committee published For the Sound Development of Science -The Attitude of a Conscientious Scientist in 2014. This book outlines responsible research activities, methods for planning, conducting, and presenting research results, how to conduct joint research, use research funding, and contribute to quality improvement. It also provides guidelines for scientific research that are applicable to educational inquiry in the Japanese context.

Despite growing concern for stricter guidelines at Japanese universities, many still do not have an IRB process or a committee that oversees the research process. Likewise, language schools and other public or private educational institutions might also not have guidelines for conducting research. Therefore, when planning a project, it is important for you, the teacher/researcher, to first find out what kind of research protocols the institution has by asking a senior colleague or staff member. If the institution does not have any guidelines, you should still follow ethical research protocols by asking for informed consent from the participants. Informed consent can be obtained orally, but to avoid miscommunication between you and the participants, written consent is preferable. Informed consent forms should be provided in Japanese to ensure the participants understand what they are consenting to. Likewise, the forms can be in English if you anticipate that some participants will not be fluent in Japanese. If you are not proficient in Japanese, have a Japanese-speaking colleague on hand to explain the research project to the participants before they are asked to sign the informed consent form.

Components of a Participant Consent Form

Many institutions provide consent form templates which can be filled in with the details of your study. If such forms are available, it is generally preferable to use them. If there is no template, or the template does not provide sufficient information to participants, English-language templates from various universities can be found online which can be adapted to meet your needs. There are minimum elements which need to be included on any consent form. TESOL provides conditions for informed consent for their publications, which could be used as a checklist when writing your form (TESOL International Association, n.d.).

The consent form should clearly state who is conducting the research and provide contact details (email address) for the lead researcher as well as one other person of authority who is not connected to the study, such as the department head or supervisor. It should also clearly state the aims of the study or how it is expected to contribute towards knowledge within the field. This does not mean it should state the hypothesis being investigated, as such information could influence the results. Rather, participants should understand the significance of the research and general aims, as well as the intention to publish the findings. A clear description of the study should be given, including the activities participants will be asked to complete and the amount of time this will require. The consent form should also explain that participants can withdraw consent at any time while the study is being conducted. Students must understand that such withdrawal will not result in any penalties or negative consequences for their studies. The consent form should also outline how data will be stored. The original data (essays, test papers, interviews, etc.) should be stored securely for a fixed number of years, after which it will be destroyed. Digital data extracted for analysis should also be kept securely. The amount of time data is required to be stored and how to dispose of it after the storage period ends varies by institution, so it is important to check your institution’s policies in regard to data storage and disposal. You should also decide whether to store the data anonymously. If so, the consent form should be separated from the original data, and participants should only be identified by a numerical code. In such an instance, it may be impossible for participants to withdraw consent after the data has been collected, so they should be informed as such. Finally, any risks to participants should be explained.

The idea of risk is grounded in medical research and is often considered in terms of physical consequences. However, within social and behavioral research, physical risks are often not greater than those of daily life, so special consideration is not required. Nonetheless, psychological and informational risks may be greater and should be considered (National Research Council, 2014). For example, if the participants will be doing activities involving potentially sensitive cultural, political, or social topics, this should be explained in the form because the participants might feel uncomfortable with the topics or worry about being bullied if they disagree with the opinions of other participants. Explaining this potential risk on the consent form will give everyone the choice of opting out if they do not want to communicate with others about sensitive topics. Another potential risk might arise if the materials used in the study are above the participants’ current English level. This might pose a psychological or informational risk if participants feel their English is inadequate. Though rare in educational research, any potential physical risks should also be explained. For example, if the participants are doing fieldwork activities outside of the classroom or school setting, physical risk might include factors related to travel, the weather, equipment used, or with people at the research site. Regarding fieldwork, remember to also enquire with your institution about the need for insurance to cover any possible physical injuries that could occur when the participants are off campus.

Issues with Obtaining Informed Consent

The main issue with obtaining informed consent is ensuring it truly is informed. In other words, participants must have a clear understanding of what they are being asked to do and why, as well as their rights not to participate. For this reason, since minors are not considered able to give informed consent, consent of their legal guardian is required. In Japan, the age of adulthood is 20, although this will be lowered to 18 in 2022. Japanese universities might also have their own guidelines regarding when adulthood begins. For example, a university might deem any 2nd-year or above student to be an adult, or any student in the first year to be a minor, regardless of their age. Therefore, you need to decide whether it is ethical to treat any participants aged 18 or 19 as adults, capable of giving informed consent, or as minors, requiring consent from a guardian. Check with your institution on what is required in its specific context. In general, studies involving students under 18 should only be conducted with guardian consent.

A further consideration when conducting research involving students is power relations. Your own students may not feel able to withhold consent because they might feel as though they cannot say “no” to you, their teacher. If ethical permission is granted to conduct research with your students, it is particularly important to promote the option to decline and let everyone know there will be no negative consequences for not participating. If an activity related to the research project takes place during class time but is not part of the curriculum, alternative activities need to be provided for the students that have declined. In addition, if other students are unaware of who has declined participation, the risk of social stigmatization for not complying with the teacher’s request for help decreases.

Finally, if the institution in which the study will be conducted does not provide ethical oversight, it might be useful to ask a colleague to check the consent form for any issues. Even when acting with the best possible intentions, it is not always easy to ensure all possible risks have been considered, or that the study explanation is completely comprehensible to a participant with no knowledge of the research area. Obtaining a second opinion before getting started may prevent uncorrectable problems that render the entire study unpublishable. Non-native Japanese or English speakers should also have the Japanese and English text of the consent forms checked by native-speaking colleagues to ensure the language will be understandable and that all necessary components have been included.

Conclusion

Informed consent is vital for conducting research with human participants. It ensures your research is being conducted ethically with the intention of advancing knowledge that will hopefully benefit humanity. Rather than viewing it as time-consuming paperwork, informed consent forms should be approached as powerful tools for producing higher quality research. It is not only ethically important—by dictating what information will be collected and how it will be handled, informed consent forms can also assist researchers in designing studies, planning data analysis, and clarifying data ownership.

References

European Union Agency for Fundamental Rights. (n.d.). Child participation in research. Retrieved from https://fra.europa.eu/en/theme/rights-child/child-participation-research

Health Research Authority (n.d.). Consent and participant information guidance. Retrieved from http://www.hra-decisiontools.org.uk/consent/principles-children-EngWales...

Japan Society for the Promotion of Science Editing Committee. (2014). For the sound development of science -The attitude of a conscientious scientist. Retrieved from https://www.jsps.go.jp › j-kousei › data › rinri_e

National Research Council. (2014). Proposed revisions to the common rule for the protection of human subjects in the behavioral and social sciences. Washington, DC: The National Academies Press. https://doi.org/10.17226/18614.

TESOL International Association (n.d.). Informed consent policy statement and release. Retrieved from https://www.tesol.org/readand-publish/journals/tesol-quarterly/tesol-qua...