Informed Consent: A Monthly Review
March 2023 :: Issue 51
This digest aggregates and distills key content addressing informed consent from a broad spectrum of peer-reviewed journals and grey literature, and from various practice domains and organization types including international agencies, INGOs, governments, academic and research institutions, consortiums and collaborations, foundations, and commercial organizations. We acknowledge that this scope yields an indicative and not an exhaustive digest product.
Informed Consent: A Monthly Review is a service of the Center for Informed Consent Integrity, a program of the GE2P2 Global Foundation. The Foundation is solely responsible for its content. Comments and suggestions should be directed to:
Paige Fitzsimmons, MA
Associate Director, Center for Informed Consent Integrity
GE2P2 Global Foundation
PDF Version: GE2P2 Global_Informed Consent – A Monthly Review_March 2023
Patients acceptance and comprehension to written and verbal consent (PAC–VC)
Robert C. Welsh, Shane Kimber, Justin Ezekowitz, Rabia Kashur
BMC Medical Ethics, 23 February 2023; 24(14)
Acute myocardial infarction (AMI) research is challenging as it requires enrollment of acutely ill patients. Patients are generally in a suboptimal state for providing informed consent. Patients’ understanding to verbal assents have not been previously examined in AMI research. Patients’ Acceptance and Comprehension to Written and Verbal Consent (PAC–VC) compared patients’ understanding and attitudes to verbal and written consents in AMI RCTs.
PAC–VC recruited patients from 3 AMI trials using both verbal N = 12 and written N = 6 consents. We compared patients’ understanding using two survey questionnaires. The first questionnaire used open-ended questions with multiple choice answers. The second questionnaire used a 5-point Likert scale to measure patients understanding and attitudes to the consent process. Overall answers average scores were categorized into three groups: Adequate understanding (71–100) %, Partial understanding (41–70)% and Inadequate understanding (0–40)%.
Responses showed patients with verbal assent had adequate understanding to most components of informed consent, close to those of written consent. Most patients did not read written information entirely and believed that it is not important to make a final decision. Patients favoured to have written information be part of the consent but not necessarily presented during the initial consent process. Patients felt less pressured in the verbal assent arm than those of written consent.
Patients had adequate understanding to most components of verbal assent and comparable to those of written consent. Utilizing verbal assents in the acute care setting should be further assessed in larger trials.
Electronic informed consent: effects on enrolment, practical and economic benefits, challenges, and drawbacks—a systematic review of studies within randomized controlled trials
Ana Teresita Mazzochi, Martin Dennis, Ho-Yan Yvonne Chun
Trials, 21 February 2023; 24(127)
Enrolment is one of the most challenging aspects of conducting clinical trials, preceded by the process of informed consent (IC). Different strategies to improve recruitment in clinical trials have been used, including electronic IC. During COVID-19 pandemic, barriers to enrolment have been evident. Although digital technologies were acknowledged as the future of clinical research and potential advantages were shown for recruitment, electronic informed consent (e-IC) has not yet been globally adopted. The purpose of this review is to investigate the effect of using e-IC on enrolment, practical and economic benefits, challenges, and drawbacks when compared to traditional informed consent, through a systematic review.
Embase, Global Health Library, Medline, and The Cochrane Library databases were searched. No limit was set for publication date, age, sex, or study design. We included all studies within a randomized controlled trial (RCT), published in English, Chinese or Spanish, evaluating the electronic consent process used in the parent RCT. Studies were included if any of the three components ((i) information provision, (ii) participant’s comprehension, (iii) signature) of the IC process was designed as electronic, whether administered remotely or face-to-face. The primary outcome was the rate of enrolment to the parent trial. Secondary outcomes were summarized according to the various findings reported on the use of electronic consent.
From a total of 9069 titles, 12 studies were included in the final analysis with a total of 8864 participants. Five studies of high heterogeneity and risk of bias showed mixed results on the efficacy of e-IC on enrolment. Data of included studies suggested e-IC could improve comprehension and recall of study-related information. Meta-analysis could not be conducted due to different study designs and outcome measures and the predominantly qualitative findings.
Few published studies have investigated the impact of e-IC on enrolment and findings were mixed. e-IC may improve participant’s comprehension and recall of information. High-quality studies are needed to evaluate the potential benefit of e-IC to increase clinical trial enrolment.
Improving oncology first-in-human and window of opportunity informed consent forms through participant feedback
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)
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.
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.
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
Sarah Heynemann, Wendy Lipworth, Sue-Anne McLachlan, Jennifer Philip, Tom John, Ian Kerridge
Internal Medicine Journal, 13 December 2022
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
Emma Jelstrup Balkin, Mette Geil Kollerup, Ingjerd Gåre Kymre, Bente Martinsen, Mette Grønkjær
Journal of Aging Studies, March 2023
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’
Cristina Bosmani, Sonia Carboni, Caroline Samer, Christian Lovis, Thomas Perneger, Angela Huttner, Bernard Hirschel
BMC Medical Ethics, 13 February 2023; 24(10)
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.
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.
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).
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
Zhe Wang, Anthony Stell, Richard O. Sinnott
Healthcare, 8 February 2023; 11(4)
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
Matea Podgornjak, Lea Hrvat Matić, Anita Stanišić, Ena Gutić, Igor Salopek
European Journal of Bioethics, 20 February 2023
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
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
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.