A Pilot Evaluation of an Educational Video to Support Consent to a Pediatric Malignancy Biobank
Research Article
Biopreservation and Biobanking, 27 May 2024
Abstract
Introduction
The collection of biological specimens is necessary to support basic and translational research. However, the complexity of biobanking introduces numerous ethical issues, particularly regarding informed consent.
Objective
To evaluate the acceptability and perceived benefits of an educational video facilitating the consent process for the Children’s Cancer Centre Biobank.
Methods
We invited individuals who had previously consented to be (or their child to be) part of the Biobank, and health professionals who were involved in obtaining consent. Participants watched the video and completed a purpose-designed online survey.
Results
A total of 16 health professionals (invited = 30) and 15 patients/caregivers (invited = 127) participated. Most patients/caregivers felt informed about the Biobank at consent, however, noted how overwhelmed they were at the time and that they did not engage with the written information. Overall, both patients/caregivers and health professionals rated the video favorably regarding the information provided and format. Participants valued that it was simple and clear, with several health professionals noting the need for linguistic translations to better support the families they work with. Most patients/caregivers agreed that the video provided enough information to begin considering participation. This aligned with the health professionals’ feedback that the video was most effective when used as a conversation starter to help formalize the written consent.
Conclusion
Our findings suggest that our video is an acceptable and beneficial tool to assist in the Biobank consenting process, from both the perspective of decision-makers and health professionals obtaining consent. It appears particularly valuable as a precursor to an interactive, formal consent discussion. Further work is required to determine whether our video has a significant impact on outcomes such as decision-making satisfaction and knowledge, and to determine the value to adolescents.
Month: June 2024
Whole genome sequencing in (recurrent) glioblastoma: challenges related to informed consent procedures and data sharing
Whole genome sequencing in (recurrent) glioblastoma: challenges related to informed consent procedures and data sharing
Mira C Hasner, Mark P van Opijnen, Filip Y F de Vos, Edwin Cuppen, Marike L D Broekman
Acta neurochirurgica, 14 June 2024; 166(1)
Abstract
Increased use of whole genome sequencing (WGS) in neuro-oncology for diagnostics and research purposes necessitates a renewed conversation about informed consent procedures and governance structures for sharing personal health data. There is currently no consensus on how to obtain informed consent for WGS in this population. In this narrative review, we analyze the formats and contents of frameworks suggested in literature for WGS in oncology and assess their benefits and limitations. We discuss applicability, specific challenges, and legal context for patients with (recurrent) glioblastoma. This population is characterized by the rarity of the disease, extremely limited prognosis, and the correlation of the stage of the disease with cognitive abilities. Since this has implications for the informed consent procedure for WGS, we suggest that the content of informed consent should be tailor-made for (recurrent) glioblastoma patients.
A contextual integrity approach to genomic information: what bioethics can learn from big data ethics
A contextual integrity approach to genomic information: what bioethics can learn from big data ethics
Scientific Contribution
Medicine, Health Care and Philosophy, 12 June 2024
Nina F. de Groot
Open Access
Abstract
Genomic data is generated, processed and analysed at an increasingly rapid pace. This data is not limited to the medical context, but plays an important role in other contexts in society, such as commercial DNA testing, the forensic setting, archaeological research, and genetic surveillance. Genomic information also crosses the borders of these domains, e.g. forensic use of medical genetic information, insurance use of medical genomic information, or research use of commercial genomic data. This paper (1) argues that an informed consent approach for genomic information has limitations in many societal contexts, and (2) seeks to broaden the bioethical debate on genomic information by suggesting an approach that is applicable across multiple societal contexts. I argue that the contextual integrity framework, a theory rooted in information technology and big data ethics, is an effective tool to explore ethical challenges that arise from genomic information within a variety of different contexts. Rather than focusing on individual control over information, the contextual integrity approach holds that information should be shared and protected according to the norms that govern certain distinct social contexts. Several advantages of this contextual integrity approach will be discussed. The paper concludes that the contextual integrity framework helps to articulate and address a broad spectrum of ethical, social, and political factors in a variety of different societal contexts, while giving consideration to the interests of individuals, groups, and society at large.
Teaching Nurse Practitioner Students Informed Consent Using Audiovisual Peer Feedback
Teaching Nurse Practitioner Students Informed Consent Using Audiovisual Peer Feedback
Sabrina Dollar Kopf, Liang Shan, Somali Nguyen, Tracie White, Rebecca Suttle, Hiboombe Haamankuli
The Journal for Nurse Practitioners, July–August 2024
Abstract
Teaching informed consent is vital to the education of nurse practitioners. However, measures to improve student engagement and content comprehension are lacking. An online course module was created that included a didactic lecture followed by an audiovisual assignment with peer feedback. A pre- and post-survey to assess content comprehension and engagement was conducted. One hundred forty-four students participated in the learning activity. There was a statistical improvement in certain content comprehension-related questions. Audiovisual tools incorporating peer feedback can enhance traditional lecture-based asynchronous graduate nursing education by improving student engagement and comprehension.
Is there an impact of a video-based patient informed consent in elective hand surgery?
Is there an impact of a video-based patient informed consent in elective hand surgery?
Justus Osterloh, Wibke Müller-Seubert, Aijia Cai, Andreas Arkudas, Raymund R. E. Horch
Archives of Orthopaedic and Trauma Surgery, 8 June 2024
Open access
Abstract
Background
Patient informed consent is a crucial subject in preoperative care of patients before elective hand surgery, ensuring that patients have the necessary information and a comprehensive understanding to make autonomous decisions. The use of video-based informed consent systems is an innovative concept to enhance the consent process with multimedia tools. In addition to the conventional process, mostly relying on verbal communication and written documents, the video-based approach aims to present information in a standardized and visually appealing format.
Methods
In this study, 33 patients were asked to watch a video on a tablet about the planned elective hand surgery after a conventional pre-treatment consultation including informed consent throughout verbal explanations and paper forms by an attending physician or resident. All patients were asked to complete a questionnaire after watching the video.
Results
An overwhelming majority of participants, specifically 97.0%, stated that the video improved their understanding of the upcoming surgery. 90.9% of the participant would refer the video to other patients undergoing elective hand surgery, while 72.7% of participants indicated that they would have appreciated the opportunity to view an informational video before undergoing different types of surgeries in the past.
Conclusion
The use of a video-based patient information system in elective hand surgery had a positive impact on patient education and satisfaction with the informed consent process. Therefore, it is a powerful tool in preoperative management to guarantee a standardized and educative informed consent.
Child rights in trans healthcare – a call to action
Child rights in trans healthcare – a call to action
Editorial
Cal Horton, Ruth Pearce, Jaimie Veale, T. C. Oakes-Monger, Ken C. Pang, Annie Pullen Sansfaçon, Sophie Quinney
International Journal of Transgender Health, 12 June 2024
Introduction
Trans healthcare has seen some positive changes over the past two decades, moving from the pathologisation of difference as ‘disorder’, to approaches that recognize and embrace the diversity, dignity and value of trans lives. In a short time, we have also seen a shift from widespread clinical control and gate-keeping to the growing adoption of affirmative approaches to trans healthcare, which are predicated on respecting trans and gender-diverse peoples’ rights to safe and respectful healthcare. Whilst these evolutions are welcome and important, progress is inconsistent and uneven, and subject to legislative and political rollback. Progress is particularly patchy and fragile in healthcare services for trans, gender-diverse, and gender non-conforming children, with children defined here as encompassing all non-adults under the ages of 18 (United Nations, Citation1989). In multiple countries affirmative healthcare is under attack, with children’s trans healthcare services bearing the brunt of attacks on rights-based practice. There are many locations where trans healthcare services for children fail to uphold trans children’s rights, with approaches in children’s services not keeping up with the improvements that are more widely being seen in adult trans healthcare…
Lowering the Age of Consent for Vaccination to Promote Pediatric Vaccination: It’s Worth a Shot
Lowering the Age of Consent for Vaccination to Promote Pediatric Vaccination: It’s Worth a Shot
Margaret Irwin, Derek R. Soled, Christy L. Cummings
Journal of Law, Medicine & Ethics, 31 May 2024
Abstract
This paper challenges historically preconceived notions surrounding a minor’s ability to make medical decisions, arguing that federal health law should be reformed to allow minors with capacity as young as age 12 to consent to their own Centers for Diseases Control and Prevention (CDC)-approved COVID-19 vaccinations. This proposal aligns with and expands upon current exceptions to limitations on adolescent decision-making. This analysis reviews the historic and current anti-vaccination sentiment, examines legal precedence and rationale, outlines supporting ethical arguments regarding adolescent decision-making, and offers rebuttals to anticipated ethical counterarguments.
Consent
Consent
Book Chapter
Prince Raj, Abeer Farhan, Martin T. Corbally
Essential Paediatric Surgery, 2024 [Taylor & Francis]
Abstract
Children have the right to be informed and advised of planned interventions. If the child can be regarded as a moral agent and has the mental capacity to understand their condition and proposed treatment, then they should also be part of the consent process. This may have limited applicability in some jurisdictions, but the surgeon must still be aware of the issues in this age group.
Multimedia consent to improve decisional capacity among youth living with HIV: findings from a randomized controlled pilot trial
Multimedia consent to improve decisional capacity among youth living with HIV: findings from a randomized controlled pilot trial
Research Article
Tiffany Chenneville, Serena Wasilewski, Eric Sumpter, Kaitlyn Ligman, Kemesha Gabbidon, Carina A. Rodriguez
Ethics & Behavior, 31 May 2024
Abstract
This pilot randomized controlled trial explored the feasibility, acceptability, and potential utility of an intervention to improve the decisional capacity (DC) for research consent/assent among youth living with HIV (YLWH). We randomly assigned 30 YLWH aged 13–24 to a control (paper-based) or intervention (multimedia) consent/assent condition. Using a between- and within-subjects design, participants completed a demographic questionnaire and measures of DC, acceptability/feasibility, and voluntary self-consent perceptions after undergoing a hypothetical consent/assent process for a biomedical HIV study. Findings suggest participants found the intervention feasible and acceptable. Participants in the intervention condition scored higher on a DC measure; however, scores did not meet the predetermined cutoff score for adequate DC in either group. The potential implications of these findings for research with youth, including YLWH, are discussed.
Determining capacity of people with dementia to take part in research: an electronic survey study of researcher confidence, competence and training needs
Determining capacity of people with dementia to take part in research: an electronic survey study of researcher confidence, competence and training needs
Research
Sarah Griffiths, Victoria Shepherd, Anna Volkmer
BMC Medical Ethics, 28 May 2024
Open Access
Abstract
Background
Researchers are required to determine whether a person has capacity to consent to a research study before they are able to participate. The Mental Capacity Act and accompanying Code of Practice for England and Wales provide some guidance on this process, but researchers have identified that it can be difficult to determine capacity to consent when a person has complex cognitive or communication needs. This study aimed to understand the experiences and opinions of researchers who recruit people with dementia to research projects, to inform the future development of training resources.
Methods
A mixed method, cross-sectional, electronic survey was circulated via social media and research networks in England and Wales. The survey remained open for ten weeks and included open and closed questions exploring respondents’ confidence in determining capacity in the context of recruiting people with dementia to consent, their views on training and support they have experienced and their suggestions for future training and support needs.
Results
60 respondents completed the survey from across England and Wales. Although 75% of respondents had experience of determining capacity to consent with people with dementia to research, only 13% rated themselves as feeling ‘very confident’ in this. Qualitative content analysis of open responses led to the generation of six themes, explaining researchers’ confidence, competence and future training needs in this area: (1) Researcher uncertainties, (2) Lack of time, (3) Balancing information complexity with accessibility, (4) Gatekeepers, (5) Existing enablers and (6) Envisioning future training.
Conclusions
Researchers would benefit from specific training in undertaking conversations around consent with people with dementia. People with dementia may have fluctuating capacity, and despite support from caregivers, researchers have little practical guidance on methods of determining a person’s ability to understand or appreciate the information they have provided during the consent process. Given the development of large complex trials within dementia research, there is an urgency to develop specific and practical guidance and training for researchers working with people with dementia and their families.
Center for Informed Consent Integrity 