Improving oncology first-in-human and window of opportunity informed consent forms through participant feedback
Research
Anna M. Avinger, Hannah Claire Sibold, Gavin Campbell, Eli Abernethy, John Bourgeois, Tekiah McClary, Shannon Blee, Margie Dixon, R. Donald Harvey, Rebecca D. Pentz
BMC Medical Ethics, 19 February 2023; 24(12)
Open Access
Abstract
Background
Although patient advocates have developed templates for standard consent forms, evaluating patient preferences for first in human (FIH) and window of opportunity (Window) trial consent forms is critical due to their unique risks. FIH trials are the initial use of a novel compound in study participants. In contrast, Window trials give an investigational agent over a fixed duration to treatment naïve patients in the time between diagnosis and standard of care (SOC) surgery. Our goal was to determine the patient-preferred presentation of important information in consent forms for these trials.
Methods
The study consisted of two phases: (1) analyses of oncology FIH and Window consents; (2) interviews of trial participants. FIH consent forms were analyzed for the location(s) of information stating that the study drug has not been tested in humans (FIH information); Window consents were analyzed for the location(s) of information stating the trial may delay SOC surgery (delay information). Participants were asked about their preferred placement of the information in their own trial’s consent form. The location of information in the consent forms was compared to the participants’ suggestions for placement.
Results
34 [17 FIH; 17 Window] of 42(81%) cancer patients approached participated. 25 consents [20 FIH; 5 Window] were analyzed. 19/20 FIH consent forms included FIH information, and 4/5 Window consent forms included delay information. 19/20(95%) FIH consent forms contained FIH information in the risks section 12/17(71%) patients preferred the same. Fourteen (82%) patients wanted FIH information in the purpose, but only 5(25%) consents mentioned it there. 9/17(53%) Window patients preferred delay information to be located early in the consent, before the “Risks” section. 3/5(60%) consents did this.
When research becomes practice: the concept of the therapeutic misconception and challenges to consent in clinical trials
When research becomes practice: the concept of the therapeutic misconception and challenges to consent in clinical trials
Sarah Heynemann, Wendy Lipworth, Sue-Anne McLachlan, Jennifer Philip, Tom John, Ian Kerridge
Internal Medicine Journal, 13 December 2022
Open Access
Abstract
Many factors influence patients’ decisions to participate in clinical trials. For many, the primary motivation is the possibility that they might derive some benefit from participation. This is particularly true for patients with limited treatment options, such as patients with advanced cancer. While this is not surprising, it is potentially problematic if patients fail to recognise the distinction between research and clinical care (a phenomenon known as the ‘therapeutic misconception’). This is becoming increasingly problematic as clinical trial designs become more complex, as clinical trials become more embedded in routine clinical care, and as trials are increasingly used by patients and clinicians to access new diagnostic platforms and therapies. We outline some of these recent trends, focusing on the cancer clinical trials landscape as this provides a good case study of the phenomenon. We conclude by making preliminary suggestions that changes to the consent process, perhaps using ‘dynamic consent’ platforms, might help to mitigate the therapeutic misconception and note the need for further research to guide strategies for improving communication and decision-making.
Ethics and the impossibility of the consent form: Ethnography in a Danish nursing home
Ethics and the impossibility of the consent form: Ethnography in a Danish nursing home
Emma Jelstrup Balkin, Mette Geil Kollerup, Ingjerd Gåre Kymre, Bente Martinsen, Mette Grønkjær
Journal of Aging Studies, March 2023
Open Access
Abstract
Based on ethnographic fieldwork in a nursing home in northern Denmark, this article addresses challenges experienced in putting formal ethics requirements into practice. We consider how to unite procedural ethics with actual, lived ethics, when researching with vulnerable participants who live with a cognitively impairing condition. The article centers on the story of one resident, who wanted to share her experiences with what she had perceived as inadequate care, but who baulked once the wordy consent form was produced. The resident panicked that her words could now be used against her, that talking with the researcher would (further) compromise her care. She was caught in a bind, on the one hand she had a deep desire to tell her story, on the other the piece of paper in her hand threatened to trigger her anxiety and depression. In this article we therefore approach the consent form as an agent. By mapping out these unintended consequences of the consent form, we wish to draw attention to the complexities of ethical research conduct in practice, ultimately arguing that the concept of appropriate informed consent should be broadened so that it is sensitive to the lifeworld of participants.
REPRESENT: REPresentativeness of RESearch data obtained through the ‘General Informed ConsENT’
REPRESENT: REPresentativeness of RESearch data obtained through the ‘General Informed ConsENT’
Research
Cristina Bosmani, Sonia Carboni, Caroline Samer, Christian Lovis, Thomas Perneger, Angela Huttner, Bernard Hirschel
BMC Medical Ethics, 13 February 2023; 24(10)
Open Access
Abstract
Background
We assessed potential consent bias in a cohort of > 40,000 adult patients asked by mail after hospitalization to consent to the use of past, present and future clinical and biological data in an ongoing ‘general consent’ program at a large tertiary hospital in Switzerland.
Methods
In this retrospective cohort study, all adult patients hospitalized between April 2019 and March 2020 were invited to participate to the general consent program. Demographic and clinical characteristics were extracted from patients’ electronic health records (EHR). Data of those who provided written consent (signatories) and non-responders were compared and analyzed with R studio.
Results
Of 44,819 patients approached, 10,299 (23%) signed the form. Signatories were older (median age 54 [IQR 38–72] vs. 44 years [IQR 32–60], p < .0001), more comorbid (2614/10,299 [25.4%] vs. 4912/28,676 [17.1%] with Charlson comorbidity index ≤ 4, p < .0001), and more often of Swiss nationality (6592/10,299 [64%] vs. 13,813/28,676 [48.2%], p < .0001).
Conclusions
Our results suggest that actively seeking consent creates a bias and compromises the external validity of data obtained via ‘general consent’ programs. Other options, such as opt-out consent procedures, should be further assessed.
A GDPR-Compliant Dynamic Consent Mobile Application for the Australasian Type-1 Diabetes Data Network
A GDPR-Compliant Dynamic Consent Mobile Application for the Australasian Type-1 Diabetes Data Network
Zhe Wang, Anthony Stell, Richard O. Sinnott
Healthcare, 8 February 2023; 11(4)
Open Access
Abstract
Australia has a high prevalence of diabetes, with approximately 1.2 million Australians diagnosed with the disease. In 2012, the Australasian Diabetes Data Network (ADDN) was established with funding from the Juvenile Diabetes Research Foundation (JDRF). ADDN is a national diabetes registry which captures longitudinal information about patients with type-1 diabetes (T1D). Currently, the ADDN data are directly contributed from 42 paediatric and 17 adult diabetes centres across Australia and New Zealand, i.e., where the data are pre-existing in hospital systems and not manually entered into ADDN. The historical data in ADDN have been de-identified, and patients are initially afforded the opportunity to opt-out of being involved in the registry; however, moving forward, there is an increased demand from the clinical research community to utilise fully identifying data. This raises additional demands on the registry in terms of security, privacy, and the nature of patient consent. General Data Protection Regulation (GDPR) is an increasingly important mechanism allowing individuals to have the right to know about their health data and what those data are being used for. This paper presents a mobile application being designed to support the ADDN data collection and usage processes and aligning them with GDPR. The app utilises Dynamic Consent—an informed specific consent model, which allows participants to view and modify their research-driven consent decisions through an interactive interface. It focuses specifically on supporting dynamic opt-in consent to both the registry and to associated sub-projects requesting access to and use of the patient data for research purposes.
Informed consent in psychotic decompensation
Informed consent in psychotic decompensation
Matea Podgornjak, Lea Hrvat Matić, Anita Stanišić, Ena Gutić, Igor Salopek
European Journal of Bioethics, 20 February 2023
Abstract
The consent of an informed patient is not merely a signature on a legally binding document, but rather a process in which the patient is empowered and becomes an active ally in a treatment. Valid informed consent includes adequate information that is given to the patient in an appropriate manner, the voluntariness of consent, and the patient’s ability to make a decision regarding treatment. Meeting these conditions when treating patients with mental health disorders can be challenging. Mental disorders can compromise a person’s ability to understand relevant information about the nature of their illness as well as their ability to make decisions regarding treatment. However, a psychiatric diagnosis does not imply that a person is unable to make a decision regarding their treatment, nor does it exclude them as an equal partner in the therapeutic process. By reviewing the case of a 39-year-old patient who developed an acute psychotic disorder during the treatment of COVID pneumonia, we dive into the ethical dilemmas that arise when approaching a patient who is experiencing psychotic decompensation.
Prioritizing choice and assent in the assessment and treatment of food selectivity
Prioritizing choice and assent in the assessment and treatment of food selectivity
Holly C. Gover, Gregory P. Hanley, Kelsey W. Ruppel, Robin K. Landa, Juliana Marcus
International Journal of Developmental Disabilities, 1 February 2023; pp 53-65
Abstract
Food selectivity affects up to 72% and 45% of individuals with and without disabilities, respectively, and there is a need for interventions that rely on positive, unrestrictive strategies. We evaluated an assessment and treatment package for food selectivity for young children with developmental disabilities that prioritized caregiver collaboration, client autonomy, and did not rely on restrictive procedures (e.g. escape extinction). The process involved: (a) collaborating with caregivers on the selection of foods and design of the children’s functional analyses; (b) indirectly and directly measuring food preferences prior to treatment; (c) evaluating the sensitivity of mealtime problem behavior to environmental variables through an interview-informed synthesized contingency analysis (IISCA); and (c) incorporating the assessment results into a progressive treatment process consisting of choice-making opportunities and differential reinforcement of successive approximations to consumption. Children also had the ability to opt in and out of treatment sessions. The treatment was effective in increasing consumption of nonpreferred foods and successfully extended to caregivers. Practical implications and directions for future research are discussed.
Adolescent Self-Consent for COVID-19 Vaccination: Views of Healthcare Workers and Their Adolescent Children on Vaccination Autonomy
Adolescent Self-Consent for COVID-19 Vaccination: Views of Healthcare Workers and Their Adolescent Children on Vaccination Autonomy
Original Article
Jeanne R. Delgado, Lisa N. Mansfield, Katia Bruxvoort, Mayra Macias, Joseph Grotts, Bruno Lewin, David Bronstein, Corrine Munoz-Plaza, Peter Szilagyi, John Chang, Kristen Choi
Journal of Adolescent Health, 10 February 2023
Abstract
Purpose
This study explored the perceptions of healthcare worker parents (physicians, nurses, and staff) and their adolescents (aged 12–17 years) on adolescent self-consent to COVID-19 vaccination by applying the concept of positive deviance of those already vaccinated against COVID-19.
Methods
We used a qualitative descriptive design to conduct individual, semi-structured interviews with COVID-19–vaccinated healthcare workers in Southern California and their vaccinated adolescent children. Separate interviews were conducted with parents and adolescents from November to December 2021 using digital phone conferencing software. All interviews were recorded and transcribed. Thematic and constant comparative analysis techniques were used to identify relevant themes and subthemes.
Results
Twenty one healthcare workers (9 nurses, one nurse practitioner, one technologist, and 10 physicians) and their adolescents (N = 17) participated. Three overarching themes were identified to describe participants’ perspectives about adolescent self-consent for COVID-19 vaccination: (1) Family values and practices around adolescent vaccination; (2) Differences in parent and adolescent support for vaccine self-consent laws; and (3) Parent and adolescent uncertainty on readiness for vaccine self-consent laws. Adolescents largely supported self-consent while parents supported the policy if they would be able to have a discussion with their adolescent prior to the decision.
Discussion
Parents and adolescents supported adolescent self-consent for COVID-19 vaccination, with the reservation that adolescents should discuss the decision alongside their parents to exercise their medical autonomy with supportive guidance. Greater adolescent involvement in making decisions and providing self-consent for healthcare, including vaccines, could prepare adolescents to have a greater sense of autonomy over their health and contribute to population health measures.
Consent Rights of Gender Diverse Children in Australia and the United Kingdom: Will the Court’s Involvement End?
Consent Rights of Gender Diverse Children in Australia and the United Kingdom: Will the Court’s Involvement End?
Jacko G
Journal of law and Medicine, 1 December 2022; 29(4) pp 1269-1287
Abstract
Gender diversity allows individuals to express their innate sense of self and has been increasingly recognised over time. Consequently, paediatric gender services have seen exponential increases in referrals internationally. This has resulted in novel issues for courts, such as a child’s “best interests” when accessing puberty-suppressing and gender-affirming medical care. Most recently, in the United Kingdom, the adequacy of information provided to transgender children and their families was also debated. Progression of the common law in Australia has resulted in transgender children consenting to medical treatment once Gillick competent. Yet, Bell v Tavistock [2020] EWHC 3274 temporarily halted the care of the United Kingdom’s transgender children, who were previously afforded consenting rights. On appeal it was determined to be inappropriate for the divisional court to have provided generalised guidance on children’s capacity to consent to medical therapy. Through comparative analysis of case law, the adequacy of these regulations will be assessed.
Children and bioethics: clarifying consent and assent in medical and research settings
Children and bioethics: clarifying consent and assent in medical and research settings
Invited Review
Merle Spriggs
British Medical Bulletin, 8 December 2022
Open Access
Abstract
Introduction
The concept of consent in the pediatric setting is complex and confusing. Clinicians and researchers want to know whose consent they should obtain, when a child can provide independent consent and how that is determined. The aim of this article is to establish what produces the justification to proceed with medical or research interventions involving children and the role of consent in that. I clarify concepts such as consent, assent, capacity and competence.
Source of data
Literature review.
Areas of agreement
Engaging with children and involving them in decisions about matters that affect them is a good thing. Areas of controversy: The role of competence or capacity and the question of when a child can provide sole consent.
Growing points
Flawed assumptions around competence/capacity.
Areas for developing research
An account of children’s well-being that accommodates children’s interests during the transition to adulthood.
Center for Informed Consent Integrity 