A Randomized Controlled Trial of Video-Assisted Electronic Consent vs. Standard Consent for Percutaneous Kidney Biopsy (eConsent Bx)
Pedro Henrique Franca Gois, Vera Y. Miao, Rebecca Saunderson, Marina Wainstein, Kylie-Ann Mallitt, Shaun Patrick Chandler, Belinda Elford, Rebecca Hudson, Julia Jefferis, Helen Healy, Ann Bonner,
Journal of the American Society of Nephrology, October 2024
Abstract
Background
Video-assisted electronic consent (eConsent) enhances understanding, reduces anxiety, and boosts satisfaction in medical procedures. Yet, its impact on percutaneous kidney biopsies (PKB) remains unexplored. We aimed to assess patient-reported benefits of eConsent versus conventional consent for PKB.
Methods
In a single-center, open-label, RCT, consecutive patients undergoing PKB were randomized (1:1) to either video-assisted eConsent (intervention) or conventional consent (control). The intervention group accessed an online platform featuring an 8-minute explanatory animation before providing eConsent, while the control group was consented by clinicians and signed a paper form. The primary outcome was questionnaire-based patient comprehension, with secondary outcomes including patient-reported experience (KidneyPREM), anxiety, and satisfaction with consent.
Results
Median participant age was 52 years (IQR [34-65]), 30.7% had ≤ year 12 education and 69.3% post-secondary qualifications. Baseline characteristics were similar between groups. PKB comprehension was significantly higher in the intervention group compared to control (3 more questions correct/9; p<0.001), regardless of education level. Moreover, the intervention group demonstrated better understanding of critical information related to pre- and post-PKB care and when to seek medical attention for complications. There were no statistically significant differences in KidneyPREM, anxiety, or satisfaction between groups.
Conclusion
Video-assisted eConsent enhances PKB comprehension without affecting KidneyPREM, anxiety or satisfaction. These benefits extend to patients with lower education levels. Its implementation could standardize and streamline consent processes in PKB, with potential application in other nephrology domains.
Patient and practice characteristics related to patient’s consent for health data exchange
Patient and practice characteristics related to patient’s consent for health data exchange
J J Keuper, K Hek, LHD van Tuyl, R S Batenburg, R A Verheij
European Journal of Public Health, 28 October 2024
Abstract
Background
Sharing patient health data electronically between healthcare providers can prevent medical errors and improve patient safety. In the Netherlands, exchange of health information is facilitated on a national level and is only allowed with patient consent. Consequently, it is important to know which factors are related to this patient consent.
Methods
Routine electronic health records data from up to 10% of Dutch general practices (sourced from the Nivel Primary Care Database) were utilized, covering the period from 2016 to 2020. We examined whether patient consent for health data exchange varied depending on patient and practice characteristics, which are expected to have a relationship with granting consent for health data exchange. Therefore, multilevel analysis was performed.
Results
The percentage of patients granting consent ranged between 40%-50% in the period 2016 to 2019, while this was 97% in 2020, due to the governmental corona opt-in regulation. Significant disparities were observed across several of the included patient and practice characteristics in relation to patient consent for all the years examined. In most years, patient consent provision varied by gender, age, socioeconomic position, location, and healthcare use. Practice characteristics showed notable differences in patient consent across information systems, patient volumes, and practice types over all years examined.
Conclusions
We observed significant variations in patient consent for health data exchange, both among the included patient (need) and practice characteristics. These differences may stem from unequal exposure to opportunities to grant consent, differences in risk of inadequate communication between healthcare providers, levels of health literacy, and practice resources. These factors should be taken into account by policymakers when further implementing and upscaling the national health data exchange system.
Parental Confirmation of a Child’s Consent to Data Processing
Parental Confirmation of a Child’s Consent to Data Processing
Paulina Klisowska
Adam Mickiewicz University Law Journal, 2024; pp 49–59
Open Access
Abstract
This article attempts to define the conditions for consenting to the processing of children’s personal data under the GDPR. The article focuses on analysing the data protection law, regarding to the most important problem, that at present, consent to data processing involves at most a few clicks or nudges, making it difficult to speak of any real control of data controllers over whether consent to the processing of a child’s personal data has been lawfully given or confirmed by an authorized person. It’s not hard to see that the young age of users, along with limited awareness of data protection and the risks associated with its use, makes this topic extremely relevant and worth addressing.
Editor’s note: Adam Mickiewicz University is based in Poznań, Poland.
Enabling Demonstrated Consent for Biobanking with Blockchain and Generative AI
Enabling Demonstrated Consent for Biobanking with Blockchain and Generative AI
Caspar Barnes, Mateo Riobo Aboy, Timo Minssen, Jemima Winifred Allen, Brian D. Earp, Julian Savulescu
The American Journal of Bioethics, 5 November 2024
Abstract
Participation in research is supposed to be voluntary and informed. Yet it is difficult to ensure people are adequately informed about the potential uses of their biological materials when they donate samples for future research. We propose a novel consent framework which we call “demonstrated consent” that leverages blockchain technology and generative AI to address this problem. In a demonstrated consent model, each donated sample is associated with a unique non-fungible token (NFT) on a blockchain, which records in its metadata information about the planned and past uses of the sample in research, and is updated with each use of the sample. This information is accessible to a large language model (LLM) customized to present this information in an understandable and interactive manner. Thus, our model uses blockchain and generative AI technologies to track, make available, and explain information regarding planned and past uses of donated samples.
Precision medicine and Friedreich ataxia: promoting equity, beneficence, and informed consent for novel gene therapies
Precision medicine and Friedreich ataxia: promoting equity, beneficence, and informed consent for novel gene therapies
International Journal for Equity in Health, 8 November 2024
Faith A. A. Kwa, Evie Kendal
Open Access
Abstract
Friedreich Ataxia (FA) is an incurable neurodegenerative disease with systemic consequences affecting vital organs including those of the central and peripheral nervous systems. This article will use FA as an example to explore some of the practical and ethical issues emerging in precision medicine for rare diseases. It will first describe the existing management strategies available for FA patients, before considering the potential impact of gene therapy trials on the prevention and treatment of disease symptoms. Finally, ethical considerations will be discussed, including equity of access and managing resource allocation dilemmas; balancing benefits, burdens and harms; and gaining informed consent for novel treatments.
Ethical issues in vaccine trial participation by adolescents: qualitative insights on family decision making from a human papillomavirus vaccine trial in Tanzania
Ethical issues in vaccine trial participation by adolescents: qualitative insights on family decision making from a human papillomavirus vaccine trial in Tanzania
Lucy Frost, Ms Tusajigwe Erio, Hilary Whitworth, Ms Graca Marwerwe, Richard Hayes, Kathy Baisley, Silvia de SanJosé, Deborah Watson-Jones, Kirstin Mitchell
BMC Medical Ethics, 20 November 2024
Open access
Abstract
Background
Research in children is essential for them to benefit from the outcomes of research but involvement must be weighed against potential harms. In many countries and circumstances, medical research legally requires parental consent until the age of 18 years, with poorly defined recommendations for assent prior to this. However, there is little research exploring how these decisions are made by families and the ethical implications of this.
Aim
To explore key ethical debates in decision-making for participation of children and adolescents in a human papillomavirus (HPV) vaccine trial.
Methods
Semi-structured interviews were undertaken with Tanzanian girls (aged 9–16 years) who had participated in an HPV vaccine trial (n = 13), their parents or guardians (n = 12), and girls together with their parents (in paired parent-child interviews) (n = 6). The interviews were analysed using thematic analysis. Interview data came from a qualitative acceptability study undertaken as part of the Dose Reduction Immunobridging and Safety Study of Two Human Papillomavirus (HPV) Vaccines in Tanzanian Girls (DoRIS) trial.
Results
Girls and parents desired collaborative decision-making, with parents ultimately making the decision to consent. However, girls wanted a larger part in decision-making. Decisions to consent involved many people, including extended social networks, the trial team, media outlets and healthcare professionals and this resulted in conflicts to be negotiated. Deciding where to place trust was central in participants and parents considering decisions to consent and overcoming rumours about trial involvement.
Conclusions
Existing models of decision-making help to understand dynamics between parents, adolescents and researchers but neglect the important wider social impacts and the fundamental nature of trust. Children’s roles in discussions can be evaluated using the principles of consent: autonomy, freedom and information. Concepts such as relational autonomy help to explain mechanisms families use to negotiate complex consent decisions. Whilst interviewees supported the maintenance of legal parental consent, researchers must design consent processes centring the child to ensure that whole family decision-making processes are supported.
Tools for effective patient education to manage outcome expectations in paediatric facial reanimation: a systematic review
Tools for effective patient education to manage outcome expectations in paediatric facial reanimation: a systematic review
Systematic Review
Dimitris Reissis, Cédric Zubler, Edel de Buitleir, Sam Brown, Jonathan Leckenby, Adriaan Grobbelaar
Plastic and Aesthetic Research, 30 October 2024
Open Access
Abstract
Aim
Informed consent for paediatric facial reanimation requires effective patient/parent education and involvement in a shared decision-making (SDM) process to help set their expectations and understanding from the outset. No article in the current literature has systematically reviewed the available tools for facilitating effective patient/parent education and the validity of informed consent in the context of paediatric facial reanimation.
Methods
A systematic literature review was undertaken, following the Preferred Reporting Items of Systematic Reviews and Meta-analyses (PRISMA) 2020 guidelines. MEDLINE via PubMed, Embase and Cochrane Library were searched and the results screened and reviewed in accordance with pre-defined inclusion and exclusion criteria.
Results
The initial search yielded 478 articles, of which only 4 fulfilled the study’s inclusion criteria. One cohort study evaluated qualitative feedback from patients and their relatives participating in a family education and support day for paediatric facial palsy, while another article from the same group reviewed the readability of online education resources. The remaining two articles represented educational reviews focusing on treatment and patient education based on expert opinion without providing original outcome data.
Conclusion
There is a paucity of evidence regarding patient/parent education to support the informed consent process for children undergoing paediatric facial reanimation. There remains a need for further resources and platforms to be developed that may support children and their parents in engaging in a SDM process, setting appropriate expectations, and providing valid informed consent for their surgery.
Prescribing contraceptives to minors without parental knowledge and consent
Prescribing contraceptives to minors without parental knowledge and consent
M Peled-Raz, O Goldstick
European Journal of Public Health, 28 October 2024
Abstract
Background
Sexually active adolescents may seek oral contraceptives without parental consent, posing challenges due to minors’ confidentiality and consent regulations. This is especially the case under the un-nuanced Israeli legal scheme regarding adolescents’ care.
Methods
Israeli OBGYNs were contacted through mailing lists and social media groups and asked to fill an online questionnaire regarding their experience and protocols concerning prescription of contraceptives to minors. They were also asked about their comprehension of the relevant legal obligations, the importance they ascribe to different ethical interests and considerations, as well as their training.
Results
Of the 177 responding gynecologists, 75% consulted minors about contraceptives during the past year, most of them without any training on providing care to adolescents. More than a third of respondents believed that parental involvement wasn’t legally required, while only 8% thought it mandatory for all minors under the age of 18. Most (75%) would ‘almost always’ prescribe contraceptives without parental knowledge upon request, while 20% never would. No correlation was found between respondents’ practices and their perception of the legal obligations. Participants agreed that the risk to the health of the minor due to having sex without contraceptives is of utmost importance. Those willing to prescribe gave greater weight to minor’s autonomy consideration, while those who do not prescribe were more concerned with the acts legal ramifications. The majority set the age of 15 as the threshold for consistently prescribing contraceptives to minors without parental involvement.
Conclusions
Access to contraceptives for mature minors without parental involvement is vital. There is great need for education and training for healthcare providers on providing medical treatment to adolescents, as well as for the development of policies and guidelines, addressing adolescents’ health disparities.
The ethical inadequacy of uninformed surrogate consent: advancing respect for persons in clinical research
The ethical inadequacy of uninformed surrogate consent: advancing respect for persons in clinical research
Robert R. Harrison
Theoretical Medicine and Bioethics, 10 November 2024
Abstract
In clinical research, decision-making capacity is often equated with unspecified conceptions of autonomy, and autonomy is often equated with personhood. On this view, the loss of decision-making capacity is seen as a loss of autonomy, and the loss of autonomy subsumes a loss of personhood. An ethical concern arises at the intersection of those philosophical considerations with the legal considerations in informed consent. Because persons with inadequate decision-making capacity cannot provide legally effective consent, enrollment in research can occur only if a surrogate gives permission on the person’s behalf. Federal regulations and resulting institutional policies allow permission from surrogates empowered under state law to consent to medical treatment procedures, typically in a hierarchy of legislatively prioritized relationships lacking regard for what the surrogate actually knows about the current research-related values and preferences of the potential subject. As a result, the research enterprise often countenances reliance on surrogates who have no relational or informational basis for an enrollment decision that aligns with the values and preferences of the subject. Arguing from the perspective that losing decision-making capacity does not alter the moral status of persons, and that respect for persons rather than respect for autonomy is the central ethical obligation, I assess the ethical implications of allowing persons with no knowledge of the values and preferences of the potential subject to make enrollment decisions, concluding that reliance on uninformed surrogates is not an ethically defensible approach to enrolling subjects in clinical research.
Electroconvulsive therapy and informed consent: navigating clinical efficacy and patient rights
Electroconvulsive therapy and informed consent: navigating clinical efficacy and patient rights
Conference Presentation
Anghel Claudia
Beyond borders: united for mental health 2024; Chişinău, Moldova, 10-13 October 2024
Abstract
Electroconvulsive Therapy (ECT) remains a highly effective treatment for severe mental health disorders, such as treatment-resistant schizophrenia and major depressive disorder. However, its use raises important ethical and legal concerns, particularly regarding informed consent. Balancing the clinical efficacy of ECT with patients’ rights to make informed decisions about their treatment is a complex challenge for mental health professionals. Informed consent is crucial, requiring that patients fully understand the potential benefits, risks, and side effects of ECT before agreeing to the procedure. Mental health care providers must ensure that patients are not only informed about the short- and long-term effects of ECT but also supported in their decisionmaking process. This includes addressing any cognitive impairments or mental health symptoms that may impact their capacity to give informed consent. Additionally, legal guardians or family members may be involved in the consent process, especially when patients are unable to provide it themselves. Ultimately, navigating the delicate balance between ensuring the clinical success of ECT and respecting patient autonomy is essential for ethical practice. Continued research into improving patient education and consent processes can help to understand the efficacy of ECT and the rights of them receiving this treatment.
Center for Informed Consent Integrity 