2026-05-19 カリフォルニア大学サンディエゴ校（UCSD）
Informed consent means making sure prospective participants understand what they are agreeing to before they choose whether to share their data or take part in research. Photo credit: iStock/nito100
＜関連情報＞
- https://today.ucsd.edu/story/in-the-digital-health-era-can-we-do-better-than-a-consent-form
- https://academic.oup.com/jamia/article/32/4/712/7998588?login=false
- https://www.jmir.org/2025/1/e63349/
- https://dl.acm.org/doi/10.1145/3637330
- https://journals.sagepub.com/doi/10.1177/15562646241290078
- https://www.frontiersin.org/journals/digital-health/articles/10.3389/fdgth.2021.690901/full
研究におけるインフォームド・コンセントに基づくデータ管理コミュニケーションを支援するためのデータフロー図の活用：参加者の視点 Using dataflow diagrams to support research informed consent data management communications: participant perspectives
Brian J McInnis, PhD;Ramona Pindus, BS;Daniah H Kareem, BSPH;Julie Cakici, PhD, RN;Daniela G Vital, MPH, BSPH;Eric Hekler, PhD;Camille Nebeker, EdD, MS
Journal of the American Medical Informatics Association Published:04 February 2025
DOI:https://doi.org/10.1093/jamia/ocaf004
Abstract
Objectives
Digital health research involves collecting vast amounts of personal health data, making data management practices complex and challenging to convey during informed consent.
Materials and Methods
We conducted eight semi-structured focus groups to explore whether dataflow diagrams (DFD) can complement informed consent and improve participants’ understanding of data management and associated risks (N = 34 participants).
Results
Our analysis found that DFDs could supplement text-based information about data management and sharing practices, such as by helping raise new questions that prompt conversation between prospective participants and members of a research team. Participants in the study emphasized the need for clear, simple, and accessible diagrams that are participant centered. Third-party access to data and sharing of sensitive health data were identified as high-risk areas requiring thorough explanation. Participants generally agreed that the design process should be led by the research team, but it should incorporate many diverse perspectives to ensure the diagram was meaningful to potential participants who are likely unfamiliar with data management. Nearly all participants rejected the idea that artificial intelligence could identify risks during the design process, but most were comfortable with it being used as a tool to format and simplify the diagram. In short, DFDs may complement standard text-based informed consent documents, but they are not a replacement.
Discussion
Prospective research participants value diverse ways of learning about study risks and benefits. Our study highlights the value of incorporating information visualizations, such as DFDs, into the informed consent procedures to participate in research.
Conclusion
Future research should explore other ways of visualizing consent information in ways that help people to overcome digital and data literacy barriers to participating in research. However, creating a DFD requires significant time and effort from research teams. To alleviate these costs, research sponsors can support the creation of shared infrastructure, communities of practice, and incentivize researchers to develop better consent procedures.
デジタルヘルス研究におけるインフォームドコンセントの選択に影響を与える要因：参加予定者を対象とした調査研究 Factors Influencing Informed Consent Preferences in Digital Health Research: Survey Study of Prospective Participants
Brian J McInnis; Ramona Pindus; Daniah Kareem; Daniela G Vital; Eric B Hekler; Camille Nebeker
Journal of Medical Internet Research published: 18.Jun.2024
DOI:https://preprints.jmir.org/preprint/63349
Abstract
Background:Readability is important to consider when developing informed consent communications for prospective research participants, but not the most important consideration. Other factors to consider relate to learning preferences and literacy needs of people recruited to participate in research, as these factors can influence understanding of consent communications. To promote understanding among prospective participants, researchers should take a human-centered approach to develop consent communications.
Objective:This study aims to explore how factors related to readability, topic, and participant demographic characteristics play into preferences for digital health research consent material. These factors are important to consider as not attending to some details that matter to a specific subgroup of prospective participants may systematically exclude people from research.
Methods:People eligible to participate in a digital health study were recruited to review 31 paragraph length sections of a consent form, referred to as “text snippets,” for an existing institutional review board–approved digital health study. Participants (N=79) were surveyed and asked to choose between 2 variations of the text snippets, either indicating a preference for the institutional review board–approved original or a version that was modified to improve readability.
Results:A slim majority of participants provided feedback about the snippets (n=44; 55%). Our qualitative analysis of the feedback found that participants preferred shorter snippets, in general, but the snippets also elicited new questions not addressed by the original consent material. This observation is supported by our quantitative analysis, which found that when the character length of the original was longer, participants were less likely to prefer the original (P<.001) and more likely to prefer the modified text by a factor of 1.20 times (P=.04), and particularly for snippets explaining study risks (P=.03). Our analysis also found significant differences in participant demographic characteristics. For example, older participants tended to prefer the original more than younger participants, by a factor of 1.95 times (P=.004). The results present illustrative examples of how factors related to sex, age, physical activity, and ethnicity all play into preference for consent communication.
Conclusions:The findings point toward new ways of evaluating informed consent communication: (1) for responsiveness to specific prospective participant populations, and (2) effectiveness at eliciting informed questions from people considering participation. We discuss how creating partnerships with prospective participants to prototype informed consent materials, specifically study procedures and risks, can be a way to identify those details before launching a study. Furthermore, future research should go beyond “readability” to explore alternate measures of evaluating consent materials, such as the likelihood that the consent material and communication procedures will elicit “informed questions” for the research team.
インフォームド・コンセントの未来を探る：サービスデザインアプローチの適用 Exploring the Future of Informed Consent: Applying a Service Design Approach
Brian James McInnis, Ramona Pindus, Daniah Kareem, Savannah Gamboa, Camille Nebeker
Proceedings of the ACM on Human-Computer Interaction Published: 26 April 2024
DOI:https://doi.org/10.1145/3637330
Abstract
Informed consent is a cornerstone of ethical human subject research. This practice demonstrates the ethical principle of “respect for persons.” Our study was designed to imagine an informed consent future, specifically in a digital health context in which informed consent processes are mediated by sociotechnical systems. Design speed-dating workshops were conducted to explore dimensions of the consent communication design space, including social media, interactive quizzes, chat-bots, annotation tools, and virtual learning sessions. To explore both the user experience and how futuristic consent processes might be facilitated, the workshops involved people eligible to participate in digital health research (N=21) and service providers (N=20), including researchers and IRB members. Our findings offer five principles to improve digital informed consent processes: be concise, promote transparency, value time and effort, cultivate trust, and navigate platform risks.
デジタルヘルス研究におけるインフォームド・コンセントの設計に関する考察：参加者の視点 Considerations for the Design of Informed Consent in Digital Health Research: Participant Perspectives
Brian J. McInnis, Ramona Pindus, […], and Camille Nebeker
Journal of Empirical Research on Human Research Ethics Published:October 14, 2024
DOI:https://doi.org/10.1177/15562646241290078
Abstract
The research team, prospective participants, and written materials all influence the success of the informed consent process. As digital health research becomes more prevalent, new challenges for successful informed consent are introduced. This exploratory research utilized a human centered design process in which 19 people were enrolled to participate in one of four online focus-groups. Participants discussed their experiences with informed consent, preferences for receiving study information and ideas about alternative consent approaches. Data were analyzed using qualitative methods. Six major themes and sixteen sub-themes were identified that included study information that prospective participants would like to receive, preferences for accessing information and a desire to connect with research team members. Specific to digital health, participants expressed a need to understand how the technologies worked and how the volume of granular personal information would be collected, stored, and shared.
デジタルヘルスチェックリストと読みやすさツールを適用して、デジタルヘルス研究におけるインフォームドコンセントを改善する Applying a Digital Health Checklist and Readability Tools to Improve Informed Consent for Digital Health Research
Camille NebekerMaryam Gholami,Daniah Kareem,Emily Kim
Frontiers in Digital Health Published:15 July 2021
DOI:https://doi.org/10.3389/fdgth.2021.690901
Abstract
Background: As research involving human participants increasingly occurs with the aid of digital tools (e.g., mobile apps, wearable and remote pervasive sensors), the consent content and delivery process is changing. Informed consent documents to participate in research are lengthy and difficult for prospective participants to read and understand. As the consent communication will need to include concepts and procedures unique to digital health research, making that information accessible and meaningful to the prospective participant is critical for consent to be informed. This paper describes a methodology that researchers can apply when developing a consent communication for digital health research.
Methods: A consent document approved by a US institutional review board was deconstructed into segments that aligned with federal requirements for informed consent. Three researchers independently revised each segment of text with a goal of achieving a readability score between a 6–8th grade level. The team then consulted with an external readability expert well-versed in revising informed consent documents into “plain language.” The resulting text was evaluated using Microsoft Word and Online-Utility accessibility software. The final step involved adding visual images and graphics to complement the text. The Digital Health Checklist consent prototype builder was then used to identify areas where the consent content could be expanded to address four key domains of Access and Usability, Privacy, Risks and Benefits, and Data Management.
Results: The approved consent was evaluated at a 12.6 grade reading level, whereas the revised language by our study team received 12.4, 12, and 12.58, respectively. The final consent document synthesized the most readable of the three revised versions and was further revised to include language recommended by the software tool for improving readability, which resulted in a final revised consent readability score of a 9.2 grade level. Moreover, word count was reduced from 6,424 in the original consent to 679 in the rewritten consent form.
Conclusion: Utilizing an iterative process to design an accessible informed consent document is a first step in achieving meaningful consent to participate in digital health research. This paper describes how a consent form approved by an institutional review board can be made more accessible to a prospective research participant by improving the document readability score, reducing the word count and assessing alignment with the Digital Health Checklist.
