Dynamic Consent for Sensor-Driven Research
Graduate School of Knowledge Service Engineering [Daejeon, South Korea], 2021
Dynamic consent is a term initially emerged in biomedical research that involves a large-scale, long-term participant engagement for continuous data collection (e.g., biosamples, health records). Dynamic consent is a wider concept of informed consent that enables granular consent in dealing with personal data. Dynamic consent is typically incorporated into a personalized digital platform that allows participants to tailor and manage their own consent preferences. This feature leads to improved transparency and proactive privacy management. Due to such benefits, dynamic consent offers potential applications in other domains that collect diverse data that require multiple consents over time. One possible testbed is digital health, where there have been several attempts to track symptoms and diagnose mental illnesses (e.g., depression) with data collected from mobile and wearable devices (i.e., digital phenotyping). As these sensors continuously collect personal data, users may feel uncomfortable in certain private contexts. However, the current status of the studies only provides one-off informed consent without consideration of specific user contexts, which calls for context-aware fine-grained control. Thus, this paper explores the feasibility of dynamic consent in sensor-driven research and suggests a future outlook of dynamic consent usage in mobile and ubiquitous computing.
Using Hyperrealistic Simulations to Improve Digital Informed Consent for Endourological Procedures
Víctor Galve Lahoz, David Corbatón Gomollón, Federico Rodríguez-Rubio Cortadellas, Pedro Gil Martínez, Maria Jesús Gil Sanz, Jorge Rioja Zuazu
BJUI International, 25 December 2021
To show that digital informed consent (DIC) improves the subjective understanding of information and, therefore, informed consent.
Patients and Methods
A nonblinded randomized controlled trial was performed with 84 patients who had undergone a transurethral resection of bladder, transurethral resection of prostate, or ureterorenoscopy between July 2017 to March 2018. The DIC group watched a hyperrealistic simulation on a tablet device before surgery. After surgery and again 30 days later, both groups completed a validated questionnaire that measured subjective understanding, anxiety, and utility of and need for information.
The mean±SD age of participants was 68.7±11.1 years. Nine of 84 patients (10.7%) did not complete the questionnaire. 42 patients were allocated to the DIC group and 42 to the control group. The mean±SD score on immediate subjective understanding in the DIC group was 14.5% higher than in control group (72%±17.5% vs 57.5%±23.5%, respectively; p=0.006). There was no statistical difference among anxiety, utility of and need for information relative to delayed subjective understanding. In subgroup analysis, subjective understanding scores were higher, but not significantly so, among patients with low and higher education levels in the DIC group than in the control group (68%±18.1% vs 54%±22.5%, respectively, p=0.06; and 76%±18.3% vs and 66%±21.9%, respectively, (p=0.89).
Hyperrealistic simulations improved subjective understanding of information and, therefore, informed consent for endourological procedures.
Cognitive Testing of an Electronic Consent Platform: Researcher Perspectives
Daniel Robins, Rachel Brody, Irena Parvanova, Joseph Finkelstein
Studies in Health Technology and Informatics, 15 December 2021; 284 pp 457-462
This study focuses on feedback from domain experts to assess usability and acceptance of the E-Consent electronic consent platform. Quantitative and qualitative data were captured throughout the usability inspection, which was structured around a cognitive walkthrough with heuristics evaluation. Additional surveys measured biobanking knowledge and attitudes and familiarity with informed consent. A semi-structured qualitative interview captured open-ended feedback. 23 researchers of various ages and job titles were included for analysis. The System Usability Scale (SUS) provided a standardized reference for usability and satisfaction, and the mean result of 86.7 corresponds with an ‘above average’ usability rating in the >90th percentile. Overall, participants believe that electronic consenting using this platform will be faster than previous workflows while enhancing patient understanding, and human rapport is still a key component of the consent process. Expert review has provided valuable insight and actionable information that will be used to further enhance this maturing platform.
To draw or not to draw: Informed consent dilemma
Santovito D, Cena G, Tattoli L, Di Vella G, Bosco C
Health and Primary Care, 14 May 2021
Informed consent is a worldwide standard medical practice. The purpose of this study was to determine whether surgical freehand-drawings do facilitate surgeons in the communication process.
Authors carried out a questionnaire survey aimed at exploring physicians’ perceptions of the usefulness of drawings, in terms of level of understanding in consent acquisition procedures. A total of 90 anonymous questionnaires were distributed for doctors to fill in, in surgical and interventional medicine wards of the University Hospital of Turin.
Out of the 90 questionnaires delivered, 37.8% (n=34) were filled out. 93.8% (n=30) of the physicians interviewed consider freehand-drawings a useful tool, 90% (n=27) of the surgeons, who confirmed to routinely use drawing for informed consent acquisition purposes. 96.3% (n=26) of the physicians who draw themselves illustrative images of proposed treatments asserted to perceive a real benefit in patients’ comprehension of the information when visually provided. Many respondent surgeons stated to consider drawing an effective means of information for consent acquisition. Nonetheless, just in 7.4% of the cases, personally drawn explicative images are then added in patients’ medical records, with possible detrimental effects on a medico legal point of view.
Graphical representation is useful for breaking down comprehension barriers resulting not only from the modality in which the information is conveyed but also from patients’ relational, social, and psychological factors, ensuring bi-directionalness of communication and prove in Italy, a Civil Law Country, the communicative effort of physicians in the best interest of the patients.
Capacity to consent to treatment in psychiatry inpatients – a systematic review
Aoife Curley, Carol Watson, Brendan D. Kelly
International Journal of Psychiatry in Clinical Practice, 23 December 2021
Mental capacity for treatment decisions in psychiatry inpatients is an important ethical and legal concern, especially in light of changes in mental capacity legislation in many jurisdictions.
To conduct a systematic review of literature examining the prevalence of mental capacity for treatment decisions among voluntary and involuntary psychiatry inpatients, and to assess any correlations between research tools used to measure mental capacity and binary judgements using criteria such as those in capacity legislation.
We searched PsycINFO, Ovid MEDLINE and EMBASE for studies assessing mental capacity for treatment decisions in people admitted voluntarily and involuntarily to psychiatric hospitals.
Forty-five papers emanating from 33 studies were identified. There was huge variability in study methods and often selective populations, but the prevalence of decision-making capacity varied between 5% and 83.7%. These figures resulted from studies using cut-off scores or categorical criteria only. The prevalence of decision-making capacity among involuntary patients ranged from 7.7% to 42%, and among voluntary patients ranged from 29% to 97.9%. Two papers showed positive correlations between clinicians’ judgement of decision-making capacity and scores on the MacArthur Competence Assessment Tool for Treatment; two papers showed no such correlation.
Not all voluntary psychiatry inpatients possess mental capacity and many involuntary patients do. This paradox needs to be clarified and resolved in mental health legislation; supported decision-making can help with this task.
Doing research with intellectually disabled participants: reflections on the challenges of capacity and consent in socio-legal research
Journal of Law and Society, 16 December 2021
In this article, I reflect on the praxis of doing qualitative interview research involving intellectually disabled people as participants. I explore the ways in which ethical and legal norms work together to shape what is possible in research with intellectually disabled participants. I use stories from the field to explore issues of recruitment and sampling, working with ‘gatekeeper’ organizations, accessible information and informed consent, and data sharing and open access. As these reflections demonstrate, undertaking fieldwork involving intellectually disabled participants presents multiple challenges for socio-legal researchers. They also show that many of the challenges are surmountable, offering concerns, considerations, and solutions that can, and perhaps should, be considered by all socio-legal researchers who wish to ensure that all of the voices of society are included and reflected in their research.
Doctors’ knowledge regarding decision-making capacity: A survey of anesthesiologists|
Alastair Moodley, Ames Dhai
Clinical Ethics, 6 December 2021
Informed consent for anesthesia is an ethical and legal requirement. A patient must have adequate decision-making capacity (DMC) as a prerequisite to informed consent. In determining whether a patient has sufficient DMC, anesthesiologists must draw on their knowledge of DMC. Knowledge gaps regarding DMC may result in incorrect assessments of patients’ capacity. This could translate to an informed consent process that is ethically and legally unsound. This study examined the DMC-related knowledge of anesthesiologists in a group of four university-affiliated hospitals. The findings suggest that anesthesiologists have several areas of knowledge deficiency regarding DMC and DMC assessment. These findings could inform the development of undergraduate and postgraduate curricula.
The introduction of electronic consent for the school aged immunization program
Rebecca Footer, Owen Foster
Public Health Nursing, 8 December 2021
Historically, consent for treatment in the United Kingdom’s National Health Service has been collected using traditional paper forms. For public health services, such as immunizations, this process involved significant time, space, paper, and staff resources. In a bid to provide a more modern, secure, cost-effective and paperless service, an electronic consent (eConsent) form for the routine school aged immunization program was designed and successfully piloted for the HPV 1 vaccine in 25 schools during the summer of 2019, with an average of 80% return rate. This was not only significantly higher than paper consent returns, there was also a significantly quicker return rate. These factors resulted in the clinical record being updated more quickly than ever before which reduced clinical risk. Following the pilot, the program was launched countywide for all school aged immunizations in September 2020. Since its launch some minor issues have been identified but resolved quickly and efficiently. Although still in its early days it is felt that the eConsent system has promoted a more informed and easier collaboration across sectors and has reduced operating costs. Although the use of electronic consent needs to be used more widely, it is felt that this new practice is a success.
The ethical‐legal requirements for adolescent self‐consent to research in sub‐Saharan Africa: A scoping review
Busisiwe Nkosi, Brian Zanoni, Janet Seeley, Ann Strode
Bioethics, 14 October 2021
Support for the enrolment of adolescents in research has been constrained by uncertainties in parental involvement, and the lack of clarity in the ethical and legal frameworks. We conducted a scoping review to examine articles that explored the opinion of scholars on the question of adolescent consent and conditions for parental waivers in research in sub‐Saharan Africa (SSA). Guided by the Preferred Reporting Items for Systematic Reviews and Meta‐Analyses (PRISMA) tool, we searched electronic databases (PubMed, EMBASSE, EBSCOHOST) and also reviewed the references of articles identified for additional relevant literature. We included full text English articles focusing on adolescent consent and parental waivers in SSA that were published between 2004 and 2020. We excluded studies focusing on healthcare, theses, and reviews. We reviewed a total of 21 publications from South Africa (n = 12), Kenya (n = 4) and Botswana, Malawi, Nigeria, Uganda and Zimbabwe (n = 1 each). We identified four broad thematic issues: the current position regarding parental waivers and self‐consent; parental involvement in the consent process; the role of community approval or consent when adolescent self‐consent approaches were used; and complexities and ambiguities in legal requirements and ethical guidelines on adolescent consent. Our findings show inconsistencies and ambiguities in the existing legal and ethical frameworks within and across different countries, and underscore the need for consistent and clearer guidance on parental waivers and adolescent self‐consent. Harmonization of the legal and ethical frameworks taking into account varying contexts is critically important to ensure research on adolescents in SSA meets adolescents’ specific unmet needs.
Bell v Tavistock: Rethinking informed decision-making as the practical device of consent for medical treatment
Abeezar I. Sarela
Clinical Ethics, 27 December 2021
The decision of the High Court in Bell v Tavistock has excited considerable discussion about lawful consent for puberty-blocking drug treatment for children with gender dysphoria. The present paper draws attention to a wider question that surfaces through this case: is informed decision-making an adequate practical tool for seeking and obtaining patients’ consent for medical treatment? Informed decision-making engages the premises of the rational choice theory: that people will have well-crystallised health goals; and, if they are provided with sufficient information about medical treatments, then they will be able to choose the treatment that satisfies their goals. Whilst appealing, the informed decision-making paradigm is assailed by various fallacies, which apply not only to children but also to adults. In Bell v Tavistock, the High Court seems to have recognised such fallacies, and it rejected informed decision-making as an adequate tool for consent from children with gender dysphoria. Similar considerations apply to adults in various situations. Thus, Bell v Tavistock can be seen as an attempt to refine the views on the consent that were expressed by the Supreme Court in Montgomery. It can be inferred that the Supreme Court did recognise the limitations of informed decision-making, but it did not develop this point. Further work is required to formulate an adequate model of decision-making, and Bell v Tavistock serves as a useful reminder to rethink informed decision-making as the device for consent.