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
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
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
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.
Reimagining Assent: When Things Get Lost in Translation in International Pediatric Research
Reimagining Assent: When Things Get Lost in Translation in International Pediatric Research
Original Article
Sarosh Saleem
Asian Bioethics Review, 28 February 2025
Abstract
The necessity of obtaining pediatric assent for research participation is well established within international ethical guidelines. However, the effective implementation of these guidelines poses significant challenges for research ethics committees in numerous developing countries, such as Pakistan, characterized by diverse cultural and socio-economic contexts. This paper critically examines the moral underpinnings of assent, rooted in the principle of respect for persons, which aims to empower, engage, and educate children involved in research processes. Through a case example, this paper reveals the unique obstacles faced by researchers and clinicians in Pakistan, which stem from socio-cultural norms and economic disparities. Such challenges endanger the ethical foundation of assent, creating a disconnect between its philosophical basis and practical execution. Although international guidelines permit contextual adaptation of assent procedures, such flexibility is not adequately articulated within the guidelines, nor is it typically prioritized in practice. This gap undermines the purpose of assent and inadvertently increases the risk of harm to child participants—not from the research itself but rather from a process designed to protect and empower them. This paper emphasizes greater awareness among stakeholders regarding these challenges, urging a reimagined assent process in diverse global contexts. By introducing a clear rationale within research guidelines, the intent is to ensure that researchers and Institutional Review Boards (IRBs) prioritize the contextual understanding of assent, transforming it from a mere procedural formality into a meaningful practice that mitigates potential risks to children and adolescents involved in research.
Editor’s note: We take special note of this article for both its treatment of assent and its application of various guidelines in different cultural contexts.
Complexities of competency and informed consent as applied to individuals with symptoms of Anosognosia
Complexities of competency and informed consent as applied to individuals with symptoms of Anosognosia
Nina M. Labovich
Cambridge University Press, 21 March 2025
Abstract
Anosognosia, commonly understood as a lack of insight, renders individuals with schizophrenia and schizoaffective disorder unable to understand that they are living with a disease, often resulting in a refusal to accept treatment. Typically, to impose involuntary commitment in an effort to obtain treatment, an individual must be a danger to others or themselves. Even if involuntary commitment is imposed, however, an individual may remain competent to refuse medication—despite symptoms of anosognosia and an inability to understand that they are ill. This article examines the existing legal theories of competency and informed consent and proposes a statutory definition of competency that encompasses the specific needs of people with anosognosia, while considering the significant interests at stake when taking away an individual’s right to choose or refuse treatment.
Informed Consent in Mental Healthcare
Informed Consent in Mental Healthcare
Book Chapter
Hanfried Helmchen, Jakov Gather
Ethics in Psychiatry, 20 March 2025 [Springer]
Abstract
The right to self-determination is firmly established in various national and international legal documents, as well as in declarations and codes of medical associations. Medical or research-related interventions can generally only be performed with the informed consent of the person concerned. In this chapter, we, firstly, describe the elements of informed consent and elaborate on the concept of shared decision-making and relevant aspects of the professional-patient relationship in mental healthcare. We then discuss why, what about, how, when and by whom patients with mental disorders should be informed and how decision support can be provided. We conclude by pointing out ethical conflicts which may occur in the context of informed consent, including situations in which patients lack mental capacity and, therefore, cannot give informed consent themselves.
An Assent Framework for People with Intellectual and Developmental Disabilities and Complex Communication Needs
An Assent Framework for People with Intellectual and Developmental Disabilities and Complex Communication Needs
Original Article
Christopher Tullis, Amarie Carnett
Journal of Developmental and Physical Disabilities, 8 March 2025
Abstract
In both research and practice, gaining assent from participants is an ethical imperative in applied behavior analysis. Recent guidance for including assent-based procedures has been provided in the literature (Breaux & Smith, 2023). However, limitations for decision-making when working with individuals who have developmental disabilities and complex communication needs (CCN) may require further guidance given the range of different considerations, such as use and proficiency with an augmentative and alternative communication system (AAC). Thus, this article provides an overview of considerations for individuals with greater support needs, a framework for evaluating assent in clinical practice, suggestions for measurement, and suggestions for future research.
The following article is referenced in the above:
Assent in applied behaviour analysis and positive behaviour support: ethical considerations and practical recommendations
Review
Cassi A Breaux, Kristin Smith
International Journal of Development Disabilities,1 February 2023; 69(1) pp 111-121
Abstract
The term positive behaviour support (PBS) is used to describe the integration of the contemporary ideology of disability service provision with the clinical framework of applied behaviour analysis (ABA). Assent, the participation consent of those not legally able to consent, has gained recent popularity in the fields of ABA and PBS. The goal of assent-based ABA and PBS is a person-centered approach to assessment, intervention, and all other decision-making. In this model, the learner’s assent withdrawal for participation is honored, whether it be a vocal ‘no’ or a non-vocal expression of verbal behaviour. There is currently a limited subset of studies that mention or utilize assent with learners in ABA or PBS. The lack of published research can make assent-based practices seem to be a choice of the practitioner. The authors of this manuscript seek to further define assent, illuminate the necessity of assent-based practices, and offer assent-based procedures in ABA- and PBS-based intervention.
Re-envisioning autonomy: From consent and cognitive capacity to embodied, relational, and authentic selfhood
Re-envisioning autonomy: From consent and cognitive capacity to embodied, relational, and authentic selfhood
Editorial
Jonathan Lewis
Clinical Ethics, 24 February 2025
Excerpt
… In medical ethics, autonomy at its most basic level has tended to be conceptualized in terms of a patient’s ability to understand, deliberate, and decide. Prevailing legal and ethical paradigms have long held that a patient’s expressed preferences—assuming they satisfy the requisite threshold of mental capacity—ought to be respected unequivocally. This model underpins practices such as advance directives, a framework critiqued by Brock for its narrow focus on cognitive capacity. Empirical findings reported by Toomey et al. suggest that lay judgments about decision-making do not align neatly with this capacity-centric model. Their research indicates that when tasked with deciding for another, individuals are inclined to privilege a person’s treatment preference even when the person fails to satisfy the traditional cognitive requirements for capacity so long as the preference reflects the person’s “true self.” According to Strohminger, Knobe, and Newman, the true self consists of those stable, core attributes—values, traits, and dispositions—that consistently define who a person is across time and circumstance. Their research demonstrates that individuals tend to regard actions as more authentic when they are consistent with these enduring, core attributes (rather than reflecting transient states or external pressures). If we, like most theorists of autonomy, consider authenticity to be a key component of the nature of autonomy, then Toomey et al.’s studies could suggest that a decision may not be genuinely autonomous if it does not resonate with these enduring aspects of the self. In other words, and in the context of medical decision-making, a patient’s choice might satisfy the formal criteria for cognitive capacity but still be considered non-autonomous if it deviates from what is widely recognized as the individual’s deep-seated values, interests, and dispositions (see, e.g., Hawkins and Toomey et al.)…
Challenges to gaining informed consent in a low-income urban community in Ghana: a case study of Tetegu, Weija Gbawe
Challenges to gaining informed consent in a low-income urban community in Ghana: a case study of Tetegu, Weija Gbawe
Case Study
Darrold Cordes, Paul Sefah, Dora Marinova
Discover Sustainability, 20 March 2025
Open Access
Abstract
There is a lack of data describing the physical, social, economic, and environmental conditions of low-income communities in Sub-Saharan African cities. Research to obtain this data requires informed consent from business owners and heads of households. This case study focuses on a small enclave of approximately 150 households and associated businesses and community services in Tetegu, Accra, Ghana. Low-altitude aerial and terrestrial surveys were conducted to identify all structures, business types, and occupancy levels of households. A sample of businesses and households were purposively chosen as potential participants in the study. Interviews were conducted and informed consent procedures were followed in accordance with the ethics approval. Data was collected online using a computer tablet and informed consent was recorded electronically. Language and literacy barriers required considerable patience when presenting the scope of the research and participants’ roles and rights. Distrust of researchers, resentment, indifference, and aggressive behavior towards researchers were encountered. Other challenges included health and safety concerns and the quality of telecommunication services. Informed consent was obtained from more than 30% of households and 10% of businesses. The research outcomes may not represent other urban low-income communities in Accra or other cities in Ghana, West Africa, or Sub-Saharan Africa.
Center for Informed Consent Integrity 