Data Privacy and E-Consent in the Public Sector
Book Chapter
Abhay Bhatia, Anil Kumar, Pankhuri Bhatia
The Ethical Frontier of AI and Data Analysis, 2024 [IGI Global]
Abstract
In the era of the internet, all face administrative and legal responsibilities obtaining informed consent and safeguarding personal information, with the public growing mistrust to data collection. Moral consent management takes place in account of person’s views, subjective norms, and sense of control. When obtaining consent, this chapter aims to combat this cynicism. It accomplishes this by creating a novel conceptual model of online informed consent that combines the TPB with the autonomous authorisation model of informed consent. It is argued logically and is bolstered. As a result, it develops a model for online informed consent that is based on the ethic of autonomy and makes use of theory based on behaviour to enable a method of eliciting agreement that can put interest of users first and then promotes moral the information management and the marketing techniques. This approach also presents an innovative idea, the informed attitude for the validity of informed consent. It also indicates that informed permission may be given against.
Optimizing the consent process for emergent laparoscopic cholecystectomy using an interactive digital education platform: a randomized control trial
Optimizing the consent process for emergent laparoscopic cholecystectomy using an interactive digital education platform: a randomized control trial
Anood Alqaydi, Erin Williams, Sulaiman Nanji, Boris Zevin
Surgical Endoscopy, 18 March 2024
Abstract
Background
Informed consent is essential for any surgery. The use of digital education platforms (DEPs) can enhance patient understanding of the consent discussion and is a method to standardize the consent process in elective, ambulatory settings. The use of DEP as an adjunct to standard verbal consent (SVC) has not been studied in an acute care setting.
Methods
We conducted a prospective randomized control trial with patients presenting to the emergency department of a tertiary care hospital with acute biliary pathology requiring a laparoscopic cholecystectomy (LC) between August 2021 and April 2023. Participants were randomized 1:1 to receive either a DEP module with SVC or SVC alone. Baseline procedure-specific knowledge and self-reported understanding of risks and benefits of LC were collected using a questionnaire. Primary outcome was immediate post-intervention knowledge assessed using a 21-question multiple choice questionnaire. Secondary outcomes were delayed procedure-specific knowledge and participants’ satisfaction with the consent discussion.
Results
We recruited 79 participants and randomized them 1:1 into the intervention group (DEP + SVC, n = 40) and the control group (SVC, n = 39). Baseline demographics and baseline procedure-specific knowledge were similar between groups. The immediate post-intervention knowledge was significantly higher for participants in the intervention versus the control group with a Cohen’s d effect size of 0.68 (85.2(10.6)% vs. 78.2(9.9)%; p = 0.004). Similarly, self-reported understanding of risks and benefits of LC was significantly greater for participants in the intervention versus the control group with a Cohen’s effect size of 0.76 (68.5(16.4)% vs. 55.1(18.8)%; p = 0.001). For participants who completed the delayed post-intervention assessment (n = 29), there continued to be significantly higher retention of acquired knowledge in the intervention group with a Cohen’s effect size of 0.61 (86.5(8.5)% vs. 79.8 (13.1)%; p = 0.024). There was no difference in participants’ self-reported satisfaction with the consent discussion between groups (69.5(6.7)% vs. 67.2(7.7)%; p = 0.149).
Conclusion
The addition of digital education platform to standard verbal consent significantly improves patient’s early and delayed understanding of risks and benefits of LC in an acute care setting.
Assessing the impact of mixed reality-assisted informed consent: A study protocol
Assessing the impact of mixed reality-assisted informed consent: A study protocol
Gianluca Scalia, Stefano Maria Priola, Sruthi Ranganathan, Tejas Venkataram, Valeria Orestano, Salvatore Marrone, Bipin Chaurasia, Rosario Maugeri, Domenico Gerardo Iacopino, Lidia Strigari, Maurizio Salvati, Giuseppe Emmanuele Umana
Surgical Neurology International, March 2024
Abstract
Background Informed consent is a crucial aspect of modern medicine, but it can be challenging due to the complexity of the information involved. Mixed reality (MR) has emerged as a promising technology to improve communication. However, there is a lack of comprehensive research on the impact of MR on medical informed consent. The proposed research protocol provides a solid foundation for conducting future investigations and developing MR-based protocols that can enhance patients’ understanding and engagement in the decision-making process.
Methods
This study will employ a randomized controlled trial design. Two arms will be defined: MR-assisted informed consent (MRaIC) as the experimental arm and conventional informed consent (CIC) as the control arm consent, with 52 patients in each group. The protocol includes the use of questionnaires to analyze the anxiety levels and the awareness of the procedure that the patient is going to perform to study the impact of MRaIC versus CIC before medical procedures.
Results
The study will evaluate the impact of MR on patients’ information comprehension, engagement during the process of obtaining informed consent, emotional reactions, and consent decisions. Ethical concerns will be addressed.
Conclusion
This study protocol provides a comprehensive approach to investigate the impact of MR on medical informed consent. The findings may contribute to a better understanding of the effects of MR on information comprehension, engagement during the process of obtaining informed consent, psychological experience, consent decisions, and ethical considerations. The integration of MR technology has the potential to enhance surgical communication practices and improve the informed consent process.
Trust-Building: Why Virtual Formats Threaten the Moral Ends of Surgical Informed Consent
Trust-Building: Why Virtual Formats Threaten the Moral Ends of Surgical Informed Consent
John H. Lee, Katherine E. Neff, Christian J. Vercler
Annals of Surgery, Surgical Perspectives, 26 February 2024
Abstract
The COVID-19 pandemic forced a wide range of medical practices to virtual formats, including the preoperative informed consent practice. However, virtual informed consent persists despite the pandemic largely considered resolved. The continued use of virtual formats relies on a problematic “information-transfer” model of informed consent. We suggest that a “trust-building” model of consent as a better conceptualization of what is occurring during the consent process. Highlighting how virtual formats might fail to fulfill this fuller understanding of consent on both interpersonal and systemic levels, we offer up an ethical structure for physicians to navigate this novel virtual space.
Gillick competence: an inadequate guide to the ethics of involving adolescents in decision-making
Gillick competence: an inadequate guide to the ethics of involving adolescents in decision-making
Clinical ethics
Avraham Bart, Georgina Antonia Hall, Lynn Gillam
Journal of Medical Ethics, 20 February 2024
Abstract
Developmentally, adolescence sits in transition between childhood and adulthood. Involving adolescents in their medical decision-making prompts important and complex ethical questions. Originating in the UK, the concept of Gillick competence is a dominant framework for navigating adolescent medical decision-making from legal, ethical and clinical perspectives and is commonly treated as comprehensive. In this paper, we argue that its utility is far more limited, and hence over-reliance on Gillick risks undermining rather than promoting ethically appropriate adolescent involvement. We demonstrate that Gillick only provides guidance in the limited range of cases where legal decisional authority needs to be clarified. The range of cases where use of Gillick actually promotes adolescent involvement is narrower still, because several features must be present for Gillick to be enacted. Each of these features can, and do, act as barriers to adolescent involvement. Within these limited situations, we argue that Gillick is not specific or strong enough and is reliant on ethically contestable principles. Moreover, in most situations in adolescent healthcare, Gillick is silent on the ethical questions around involving adolescents. This is because it focuses on decisional authority—having the final say in decision-making—which is one small subset of the many ways adolescents could be involved in decision-making. The implication of our analysis is that use of Gillick competence tends to limit or undermine adolescent involvement opportunities. We propose that those working with adolescents should be judicious in seeking Gillick’s guidance, instead drawing on and developing alternative frameworks that provide a comprehensive model for adolescent involvement.
Evaluating the Decisional Capacity for Informed Consent of Transition age Children to Adolescents in Human Subject Research
Evaluating the Decisional Capacity for Informed Consent of Transition age Children to Adolescents in Human Subject Research
Research Article
Kamran Salayev, Ulviyya Aslanova, Kerim Munir
Journal of Empirical Research on Human Research Ethics, 10 December 2023
Abstract
This study aimed to evaluate children’s capacity for informed consent. We translated into Azerbaijani language and adapted the University of California, San Diego Brief Assessment of Capacity to Consent (UBACC). We enrolled four healthy groups: children aged 11, 12, and 13 years and adults. We provided the participants with information about the simulated research proposal and a related informed consent form. Subsequently, they were administered the UBACC. The mean total UBACC scores were 11.9 (11-year-olds), 12.7 (12-year-olds), 14.0 (13-year-olds), and 16.0 (adults). The gradual increase in the mean UBACC scores with age suggests the continuous maturation of the capacity to comprehend the informed consent process. There was no specific cutoff age to decide whether the children were competent enough to provide informed consent.
Lack of assent to dental examination in children with intellectual disabilities: Dentists’ practices in Europe and ethical issues
Lack of assent to dental examination in children with intellectual disabilities: Dentists’ practices in Europe and ethical issues
Original Article
Ariane Camoin, Isabelle Blanchet, Lionel Dany, Pierr Le Coz, Bérengère Saliba-Serre, Corinne Tardieu
Special Care in Dentistry, 19 March 2024
Abstract
Aim
(1) To determine the repartition of criteria which can be considered as marks of lack of assent by the child with
intellectual disabilities from the dentist’s point of view and whether that influences the decision to examine the patient or not. (2) To explain the decision of practitioners and determine the ethical implications of these practices.
Methods
An anonymous and structured questionnaire was distributed online using the scenario of a 9-year-old child with moderate cognitive impairment with eight different oppositional behaviours. The practitioners were asked about their perception of the patient’s lack of assent and about their decision to perform the dental examination or not.
Results
The proportion of them who performed a dental examination despite the patient’s refusal represented between 13% and 28.8% of the population of respondents.
Conclusion
There was an ambivalence among the practitioners who carried out a dental consultation when children were uncooperative. They adopted a teleological point of view. It calls for us to reflect on the ethical principles of autonomy and beneficence.
Reliability of clinical judgment for evaluation of informed consent in mental health settings and the validation of the Evaluation of Informed Consent to Treatment (EICT) scale
Reliability of clinical judgment for evaluation of informed consent in mental health settings and the validation of the Evaluation of Informed Consent to Treatment (EICT) scale
Original Research
Nicola Di Fazio, Donato Morena, Federica Piras, Fabrizio Piras, Nerisa Banaj, Giuseppe Delogu, Felice Damato, Paola Frati, Vittorio Fineschi, Stefano Ferracuti, Gabriele Sani, Claudia Dacquino
Frontiers of Psychology – Quantitative Psychology and Measurement, 26 February 2024
Excerpt
The competence assessment to give informed consent in the legal and healthcare settings is often performed merely through clinical judgment. In the present pilot study, we evaluated the reliability of clinical judgment in the mental health field, with a focus on assessing the general competence of outpatients with schizophrenia. Moreover, we tested a new scale (“Evaluation of Informed Consent to Treatment” -“EICT” Scale) suitable as a standardized assessment tool. The scale assesses four dimensions of competence, Understanding, Evaluating. Reasoning and Expressing a choice. Thirty-four outpatients with schizophrenia were evaluated for their competence to consent by five referring clinicians with different backgrounds (psychiatrist, forensic psychiatrist, geriatrician, anesthetist, and medico-legal doctor). Correlation analyses were conducted between the scores obtained by the clinicians on a modified version of the Global Assessment of Functioning scale (GAF) designed specifically to subjectively assess functioning in each of the four competence dimensions. Moreover, two validated competence scales (Mac-CAT-T, SICIATRI-R), and a neuropsychological battery were administered along with scales for evaluating neuropsychiatric symptoms severity and side effects of medication…
Comprehension of informed consent and voluntary participation in registration cohorts for phase IIb HIV vaccine trial in Dar Es Salaam, Tanzania: a qualitative descriptive study
Comprehension of informed consent and voluntary participation in registration cohorts for phase IIb HIV vaccine trial in Dar Es Salaam, Tanzania: a qualitative descriptive study
Research
Masunga K. Iseselo, Edith A. M. Tarimo
BMC Medical Ethics, 13 March 2024; 25(29)
Open Access
Abstract
Background
Informed consent as stipulated in regulatory human research guidelines requires volunteers to be well-informed about what will happen to them in a trial. However, researchers may be faced with the challenge of how to ensure that a volunteer agreeing to take part in a clinical trial is truly informed. This study aimed to find out volunteers’ comprehension of informed consent and voluntary participation in Human Immunodeficiency Virus (HIV) clinical trials during the registration cohort.
Methods
We conducted a qualitative study among volunteers who were enrolled in the registration cohort of HIV clinical trials in Dar es Salaam, Tanzania. A purposive sampling strategy was used to obtain twenty study participants. The data were collected between June and September 2020 using a semi-structured interview guide. In-depth interviews were used to collect the data to obtain deep insights of the individual study participants on the comprehension of informed consent and participation in the clinical trial. A thematic analysis approach was used to analyze the data. Themes and subthemes were supported by the quotes from the participants.
Results
Volunteers described comprehension of informed consent from different perspectives. They reported that various components of the informed consent such as study procedure, confidentiality, risk and benefits were grasped during engagement meetings. Furthermore, the volunteers’ decision to participate in the registration cohort was voluntary. However, trial aspects such as health insurance, free condoms, and medical checkups could have indirectly influenced their reluctance to withdraw from the study.
Conclusion
Engagement meetings may increase the comprehension of informed consent among potential participants for HIV clinical trials. However, trial incentives may influence participation, and thus future research should focus on the challenges of giving incentives in the study. This will ensure comprehension and voluntary participation in the context of HIV clinical trials.
The informed consent process: An evaluation of the challenges and adherence of Ghanaian researchers
The informed consent process: An evaluation of the challenges and adherence of Ghanaian researchers
Paa-Kwesi Blankson, Florence Akumiah, Amos Laar, Lisa Kearns, Samuel Asiedu Owusu
Developing World Bioethics, 13 March 2024
Abstract
This study assessed challenges faced by researchers with the informed consent process (ICP). In-depth interviews were used to explore challenges encountered by Investigators, Research assistants, Institutional Review Board members and other stakeholders. An electronic questionnaire was also distributed, consisting of Likert-scale responses to questions on adherence to the ICP, which were derived from the Helsinki Declaration and an informed consent checklist of the US Department of Health and Human Research (HSS). Responses were weighted numerically and scores calculated for each participant. The median score of the level of adherence to the informed consent process was 93%. Most of the respondents (60%) cited the lack of time for the ICP to be a challenge, with 65% indicating a lengthy consent document to be the main challenge with the informed consent document. Challenges with language and communication were the dominant theme among informants. Despite the high adherence of Ghanaian researchers and research assistants to the ICP, challenges are still prevalent, requiring diligent and continuous efforts in research implementation.
Center for Informed Consent Integrity 