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, 2025
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.

Measuring the efficacy of community consultation in a pediatric exception from informed consent trial
Original Article
Ann R. Johnson, Naomi O. Riches, John M. VanBuren, Ana E. Corona, Kammy Jacobsen, Shu Yang, Manish I. Shah
Academic Emergency Medicine, 29 December 2024
Open Access
Abstract
Background
Community consultation activities are required by the Food and Drug Administration prior to conducting research using exception from informed consent (EFIC) for emergency research and aim to provide additional participant protections. However, it is difficult for institutional review boards (IRBs) to assess the efficacy of such activities. In this study, our primary aim was to evaluate the efficacy of the PediDOSE trial’s consultation activities by answering key questions about whether consultation efforts reached a relevant community and if the perspectives of the consulted community coincided with those of parents actually enrolled in the study.
Methods
Qualitative findings of semistructured interview data collected during community consultation efforts were compared with interview responses from parents of children enrolled in the PediDOSE trial to identify common themes.
Results
Most themes were identified in both groups, but additional themes emerged with parents of enrolled participants that may be important for future study teams and IRBs to consider. Even with an overrepresentation of White and non-Hispanic/Latino participants in the community consultations compared to those who were enrolled in the EFIC study there was common overlap of themes.
Conclusions
Parent interviews added to our understanding beyond the themes identified in the consultation interviews. The theme of therapeutic misconception was not found in the consultation interviews, possibly due to the child’s emergency medical care being theoretical. With modest accommodations, collection of additional demographic and follow-up interview data can successfully assess key elements of community consultation efficacy for EFIC trials.

Strengthening Informed Consent for Federal Research through Person-Centered Development and Administration
Research Report
Lauren Farrell, Mikaela Tajo, Elsa Falkenburger, Soumita Bose
Urban Institute, 26 December 2024
Summary
    In September 2021, the Office of Planning, Research, and Evaluation (OPRE) within the Administration for Children and Families (ACF) contracted with the Urban Institute to conduct the Advancing Contextual Analysis and Methods of Participant Engagement (CAMPE) project. The goal of the CAMPE project was to aid OPRE in better understanding, incorporating, and advancing equitable research practices in OPRE projects. To achieve this goal, the project was designed to support OPRE’s efforts to develop tools and guidance for applying an equity lens to research and evaluation projects in the federal context. A core focus of the project was on ways to better engage people who have lived experience with ACF programs as collaborators and partners in research and evaluation.

One key aspect of this work included developing and engaging a community advisory board (CAB) of individuals who have lived experience with ACF programs (Temporary Assistance for Needy Families, the Child Care and Development Fund, refugee resettlement, child welfare and foster care, and others) to get feedback and input on several OPRE documents and materials related to research processes. Urban recruited, onboarded, trained, and supported a 13-member CAB to review and comment on these materials. The CAMPE CAB reviewed multiple documents and processes within OPRE to advance the aim of more equitable research practices in OPRE projects. One OPRE process that the CAB reviewed was for informed consent.

The CAMPE CAB reviewed a sample OPRE study informed consent form, which includes the steps researchers take and the language they use to inform people of their rights, risks, and benefits when choosing whether to participate in a research study. This report contains the CAB’s recommendations on developing and implementing person-centered informed consent processes. A person-centered approach reflects an understanding of the perspective, position, and experience of the intended participant.

Women’s Experience of the Consent Process to Planned Caesarean Section and Its Surgical Risk: A Qualitative Study
Research Article
Malathy Nithiyananthan, Jacqueline Nicholls, Melissa Whitten, Katherine Maslowski, Anne Lanceley
British Journal of Obstetrics & Gynaecology, 25 December 2024
Open Access
Abstract
Objective
To explore how women appreciated the risks discussed within the consent process for planned caesarean section (CS).
Design
Exploratory qualitative interview study.
Setting
NHS Teaching Hospital in Central London.
Population
Women over the age of 18, English speaking, scheduled for a planned CS.
Methods
Semi-structured interviews were conducted before and after a woman’s CS. Eighteen women were recruited and interviewed prior to undergoing CS and 12 of these were interviewed following CS. Interviews were audio-recorded, transcribed and thematically analysed.
Main Outcome Measures
Themes generated from analysis of interviews exploring the experiences of women consenting to CS and specifically their awareness of postpartum haemorrhage (PPH), hysterectomy, organ damage and risk of placental abnormalities in future pregnancies.
Results
Two broad themes and four subthemes were identified (1) Untimely provision of risk information: (a) superficial risk discussions during the antenatal period and full risk disclosure on the day of surgery and (b) incompleteness absent or sparse risk disclosure prior to making the decision to undergo the CS, where women were unaware of specific risks and (2) Emotional overload: (a) fear of risks and (b) fear that a CS will be denied to them—women’s cognitive response and notably their emotional response to their situation limited their understanding of risks disclosed.
Conclusion
The consent process for planned CS was found to lack appropriate and full risk disclosure. Risk disclosure was ill-timed or deficient in facilitating women’s understanding of risks reflecting a consent process which does not meet legal and professional standards of informed consent.