Accelerating implementation of visual key information to improve informed consent in research: a single-institution feasibility study and implementation testing
Angela Hill, Ashley J Housten, Krista Cooksey, Eliana Goldstein, Jessica Mozersky, Mary C Politi
BMJ Open, 18 March 2025
Abstract
Objective
Current consent processes often fail to communicate study information effectively and may lead to disparities in study participation. The 2018 Common Rule introduced a mandatory key information (KI) section as a means of improving consents; however, it frequently remains lengthy and prohibitively complex. We conducted a feasibility study of an accessible visual KI template for use in routine studies.
Design
Parallel feasibility study and implementation testing.
Setting
Single Midwestern US academic centre, between July 2023 and July 2024.
Participants
To develop and implement the visual KI template, we used rapid implementation science methods and recruited decision-making and clinical experts, patients and community partners to iteratively adapt the KI template. To assess its efficacy, we surveyed patient participants eligible to enrol in one of four clinical trials that used the visual KI template as part of informed consent.
Primary and secondary outcome measures
The primary outcome was participant knowledge about clinical trial details. Secondary outcomes included decisional conflict about joining the trial (validated SURE measure), KI template acceptability (validated Acceptability of Intervention Measure) and perceived self-efficacy communicating about trial details with researchers/clinicians (items adapted from the Perceived Efficacy in Patient/Physician Interaction measure). Feasibility was evaluated based on reach, number of modifications needed to tailor the intervention to each pilot trial, and time required for ethics reviews.
Results
Of 85 study participants across the four clinical trials using the visual KI page, the weighted mean knowledge score about trial details was 87.4% correct (range 77.8%-88.9%). Few (n=9; 10.6%) reported decisional conflict about whether to participate. Almost all (n=82; 96.5%) participants stated they approve using the visual KI template. 79 (92.9%) participants reported feeling confident asking clinicians or researchers questions about the trial.
Conclusions
Visual KI templates can improve potential participant comprehension and in doing so, may reduce barriers to participation in research. Parallel feasibility studies and implementation science methods can facilitate the rapid development and evaluation of evidence-based interventions, such as improved informed consent templates.

The Effects of Written Versus Video Aids on Informed Consent Across Different Types of Surgeries: A Randomized Controlled Study
Ziyao Liu, Li Yuan, Wei Rong, Pei Wang
Current Problems in Surgery, 17 March 2025
Open Access
Abstract
Background
Previous studies have demonstrated the effectiveness of written and video aids in improving surgical informed consent; however, the relative effectiveness of these two aid formats remains unclear.
Objective
To compare the effects of written and video aids on informed consent across different types of surgeries.
Methods
270 participants (193 inpatients and 77 college students) were randomly allocated to a hypothetical informed consent procedure of hemorrhoidectomy, laparoscopic cholecystectomy, or arthroscopic knee meniscus repair. Within each informed consent procedure, participants randomly received either traditional verbal informed consent, verbal informed consent plus written aids, or verbal informed consent plus video aids. Participants’ understanding of their disease and surgery, satisfaction with the consent process, and anxiety levels were assessed.
Results
Providing written aids, but not video aids, in addition to conventional verbal consent significantly improved patient understanding compared to verbal consent alone (P = 0.037). Neither aid affected patient satisfaction or anxiety (P > 0.05). No significant differences emerged in understanding, satisfaction, or anxiety scores between written and video aid groups across surgery types (P > 0.05).
Conclusions
Providing written aids can improve patient understanding but have no effect on satisfaction or anxiety during surgical informed consent process. There are no differences in the effects of written and video aids on informed consent across different surgery types. Their relative effectiveness needs to be further determined.

Improving Comprehension of Consent Forms in Online Research: An Empirical Test of Four Interventions
Research Article
Naomi K. Grant, Leah K. Hamilton, Jenalyn M. Ormita
Journal of Empirical Research on Human Research Ethics, 14 March 2025
Open Access
Abstract
Informed consent is a guiding ethical principle when conducting research involving human participants. Yet, consent forms are often skimmed or ignored, jeopardizing informed consent. In two experiments, we test four interventions designed to encourage participants to read online consent forms more carefully. Experiment 1 employed a 2 (length: short or long) by 2 (timing: fixed or free) by 2 (quiz: present or absent) between-participants design. We measured instruction-following and comprehension of the consent form. Results showed that fixed timing and a quiz led to greater instruction-following, but consent form length had no effect. Experiment 2 employed a 2 (length: short or long) by 3 (delivery format: live, audiovisual, standard written) between-participants design. Once again, length had no effect, but both live and audiovisual formats increased instruction-following and comprehension. We recommend that researchers consider using fixed timing, adding a quiz, and/or using alternative delivery formats to help participants make an informed decision.

Pictorial Art for gaining Informed Consent in low-literacy settings
Swapnil.G. Ghotane, Clarice. Holt, Stephen.J. Challacombe, Patric. Don-Davis, David. Kamara, Jennifer.E. Gallagher
Patient Education and Counseling, 12 March 2025
Open Access
Abstract
Objective
Gaining informed consent for research in low-literacy setting is challenging. This study explores the creation and use of pictorial art in information and consent form in Sierra Leone (SL).
Methods
A pictorial ‘information and consent’ (PIC) sheet was developed with an illustrator (co-author) and local colleagues for a national oral health survey involving school children in SL. Evaluation included 500 participants (children and parents) who received a feedback form to assess their satisfaction with pictures and also their effectiveness in aiding understanding of the research process, using a visual five-point Likert scale. Data were descriptively analysed using STATA v.18.
Results
Feedback was received from 360 children (aged 12 and 15 years) and 14 parents of 6-year-olds. The average rating, out of five, for the question about liking pictures on the PIC sheet was 4.83 (S.D. = 0.62), while rating for how well pictures helped them understand the survey was 4.87 (S.D. = 0.54). Although most feedback was positive, a small minority expressed negative views.
Conclusion
Overall, participants appreciated that the pictorial aids had helped in understanding the research process.
Practical Implications
Pictorial aids show potential to improve comprehension and informed consent in low-literacy settings, indicating a promising approach for future research in similar contexts.

Supplementing Consent for a Prospective Longitudinal Cohort Study of Infants With Antenatal Opioid Exposure: Development and Assessment of a Digital Tool
Jamie E Newman, Leslie Clarke, Pranav Athimuthu, Megan Dhawan, Sharon Owen, Traci Beiersdorfer, Lindsay M Parlberg, Ananta Bangdiwala, Taya McMillan, Sara B DeMauro, Scott Lorch, Myriam Peralta-Carcelen, Deanne Wilson-Costello, Namasivayam Ambalavanan,   Stephanie L Merhar, Brenda Poindexter, Catherine Limperopoulos, Jonathan M Davis, Michele Walsh, Carla M Bann
JMIR Formative Research, 4 March 2025
Abstract
Background
The Outcomes of Babies With Opioid Exposure (OBOE) study is an observational cohort study examining the impact of antenatal opioid exposure on outcomes from birth to 2 years of age. COVID-19 social distancing measures presented challenges to research coordinators discussing the study at length with potential participants during the birth hospitalization, which impacted recruitment, particularly among caregivers of unexposed (control) infants. In response, the OBOE study developed a digital tool (consenter video) to supplement the informed consent process, make it more engaging, and foster greater identification with the research procedures among potential participants.
Objective
We aim to examine knowledge of the study, experiences with the consent process, and perceptions of the consenter video among potential participants of the OBOE study.
Methods
Analyses included 129 caregivers who were given the option to view the consenter video as a supplement to the consent process. Participants selected from 3 racially and ethnically diverse avatars to guide them through the 11-minute video with recorded voice-overs. After viewing the consenter video, participants completed a short survey to assess their knowledge of the study, experiences with the consent process, and perceptions of the tool, regardless of their decision to enroll in the main study. Chi-square tests were used to assess differences between caregivers of opioid-exposed and unexposed infants in survey responses and whether caregivers who selected avatars consistent with their racial or ethnic background were more likely to enroll in the study than those who selected avatars that were not consistent with their background.
Results
Participants demonstrated good understanding of the information presented, with 95% (n=123) correctly identifying the study purpose and 88% (n=112) correctly indicating that their infant would not be exposed to radiation during the magnetic resonance imaging. Nearly all indicated they were provided “just the right amount of information” (n=123, 98%) and that they understood the consent information well enough to decide whether to enroll (n=125, 97%). Survey responses were similar between caregivers of opioid-exposed infants and unexposed infants on all items except the decision to enroll. Those in the opioid-exposed group were more likely to enroll in the main study compared to the unexposed group (n=49, 89% vs n=38, 51%; P<.001). Of 81 caregivers with known race or ethnicity, 35 (43%) chose avatars to guide them through the video that matched their background. Caregivers selecting avatars consistent with their racial or ethnic background were more likely to enroll in the main study (n=29, 83% vs n=43, 57%; P=.01).
Conclusions
This interactive digital tool was helpful in informing prospective participants about the study. The consenter tool enhanced the informed consent process, reinforced why caregivers of unexposed infants were being approached, and was particularly helpful as a resource for families to understand magnetic resonance imaging procedures.