Informed Consent, Therapeutic Misconception, and Unrealistic Optimism
Lynn A. Jansen
Perspectives in Biology and Medicine, Spring 2020; 63 (2) pp 359-373
Abstract
The Belmont Report attested to the cardinal importance of informed consent for ethical research on human subjects. Important challenges to securing informed consent have emerged since its publication more than 40 years ago. Among some of the most significant of these challenges are those that highlight social psychological factors that have the potential to impair the appreciation of relevant information disclosed in the informed consent process. Responding to these challenges requires us to think harder about the content of the principle of informed consent and the demands that it imposes on investigators. This article focuses on two challenges in particular, that presented by the so-called therapeutic misconception, and that presented by the psychological bias of unrealistic optimism. After outlining an account of the principle of informed consent as it applies to the research context, the article briefly reviews the empirical literature on the therapeutic misconception and the bias of unrealistic optimism. It then relates these phenomena to the principle of informed consent, paying special attention to the ethical demands they impose on investigators. The article concludes by considering how recent trends to integrate research and clinical care affect the main points it has advanced.
Year: 2020
Evaluating survey consent to social media linkage in three international health surveys
Evaluating survey consent to social media linkage in three international health surveys
Zeina N. Mneimneh, Ronny Bruffarets, Yasmin A. Altwaijri, Colleen McClain
Research in Social and Administrative Pharmacy, 10 August 2020
Abstract
Background
The use of Twitter data for health-related research has been increasing over time. While the organic nature of the data offer new opportunities, the limited understanding of how and by whom the data are generated poses a challenge for advancing health-related research. Individual-level data linkage could shed light into the data generation mechanism.
Objectives
This paper investigates whether consent to link survey data with Twitter public data is associated with socio-demographic and Twitter use pattern factors and whether consenters and non-consenters differ on health-related outcomes.
Methods
Data from three health related surveys that use probability samples of the target population were used: 1) A college population web survey in KU Leuven University, 2) An adult population web survey of the US population, and 3) A population face-to-face survey in the Kingdom of Saudi Arabia (KSA). In all surveys, respondents reported whether they have a Twitter account, and Twitter users were asked to provide consent for linking their survey responses to their public Twitter data.
Results
Consent rate estimates from the two web surveys in Belgium and the US were 24% and 27% respectively. The face-to-face survey in KSA yielded a higher consent rate of 45%. In general, respondent’s sociodemographic characteristics were not significantly associated with consent to link. However, more use of social media and reporting sensitive information in the survey were found to be significantly correlated with higher consent. Consenters and non-consenter were not found to be statistically different on any of the health related measures.
Conclusions
Very few differences were found between those who consented to link their survey data with their Twitter public data and those who did not. Modifiable design variables need to be investigated to maximize consent while maintaining balance between consenters and non-consenters.
A Novel Framework Using Remote Telesimulation With Standardized Parents to Improve Research Staff Preparedness for Informed Consent in Pediatric Critical Care Research
A Novel Framework Using Remote Telesimulation With Standardized Parents to Improve Research Staff Preparedness for Informed Consent in Pediatric Critical Care Research
Denise LaMarra, Jaclyn French, Christine Bailey, Martha T. Sisko, Kerry Coughlin-Wells, Michael S. Agus, Vijay Srinivasan, Vinay M. Nadkarni
Pediatric Critical Care Medicine, 28 July 2020
Open Access
Abstract
Objectives
The Heart And Lung Failure—Pediatric INsulin Titration study was experiencing poor subject enrollment due to low rates of informed consent. Heart And Lung Failure—Pediatric INsulin Titration investigators collaborated with the Perelman School of Medicine Standardized Patient Program to explore the novel use of telesimulation with standardized parents to train research staff to approach parents of critically ill children for informed consent. We describe the feasibility, learner acceptance, and financial costs of this novel intervention and performed a post hoc analysis to determine if this intervention improved study consent rates.
Design
Observational, comparative effectiveness study.
Setting
Heart And Lung Failure—Pediatric INsulin Titration study enrolling sites.
Subjects
Research staff (at the remote site).
Interventions
Individual 90-minute Skype telesimulation sessions with standardized parent and simulation facilitator (at the training site).
Measurements and Main Results
Forty telesimulation sessions with 79 Heart And Lung Failure—Pediatric INsulin Titration research staff (participants) at 24 remote sites were conducted. Despite some technical delays, 40 out of 40 simulations (100%) were completed. Based on feedback surveys, 100% of respondents agreed (81% strongly agreed) that telesimulation sessions achieved intended learning objectives to prepare research staff to approach parents of eligible critically ill children to obtain informed consent. Additionally, 100% of respondents agreed (74% strongly agreed) that they would use lessons from the telesimulation when approaching parents to obtain informed consent for research. Telesimulation with standardized parents achieved lower financial costs (approximately $85 per session) compared with traditional in-person site visits for training research staff. There was no significant improvement in study consent rates with the intervention (pre: 46% vs post: 48%; p = 0.78).
Conclusions
Remote telesimulation with standardized parents is feasible, acceptable, and associated with lower financial costs to prepare research staff to obtain informed consent from parents of critically ill children eligible for clinical research trials. Despite this novel approach, Heart And Lung Failure—Pediatric INsulin Titration study consent rates did not improve, suggesting that other factors influence parental consent and decision making in complex multicenter clinical research trials.
The language and communication attributes of graphic symbol communication aids – a systematic review and narrative synthesis
The language and communication attributes of graphic symbol communication aids – a systematic review and narrative synthesis
Review Article
Simon Judge, Nicola Randall, Juliet Goldbart, Yvonne Lynch, Liz Moulam, Stuart Meredith, Janice Murray
Disability and Rehabilitation: Assistive Technology, 23 April 2019; pp 652-662
Abstract
Background
Symbol communication aids are used by children with little or no intelligible speech as an Augmentative and Alternative Communication strategy. Graphic symbols are used to help support understanding of language and used in symbol communication aids to support expressive communication. The decision making related to the selection of a symbol communication aid for a child is poorly understood and little is known about what language and communication attributes are considered in this selection.
Aim
To identify from the literature the language or communication attributes of graphic symbol communication aids that currently influence AAC practice.
Method and Procedure
A search strategy was developed and searches were performed on a range of electronic databases for papers published since 1970. Quality appraisal was carried out using the CCAT tool and papers rated as weak were not included in the review.
Results
Eleven studies were included in the review reporting data from 66 participants. Weaknesses were identified in most studies that would limit the validity of the results for application to practice. Included studies investigated aspects of vocabulary organization and design, the process of vocabulary selection, and the choice of the symbol system and encoding method. Two studies also evaluated innovative communication aid attributes.
Conclusions
Information from studies reported in the research literature provides a sparse source of information about symbol communication aids from which clinicians, children or family members may make informed decisions.
Who Has the Ability to Consent?
Who Has the Ability to Consent?
La Vonne Ann Downey, Les Zun
Primary Care Companion for Central Nervous System Disorders, 20 August 2020; 22(4)
Abstract
Objective
Previous studies have shown no consistent examinations for testing the ability of patients to consent in hospital emergency departments (EDs). The primary objective of this study was to compare providers’ opinions with 3 capacity assessment tools to determine the ability of medical and psychiatric patients to consent in the ED.
Method
The study was conducted at a level 1 inner-city general hospital ED from June 2016 to October 2017. The study participants comprised a random sample of English-speaking patients aged ≥ 18 years who presented with any medical or psychiatric complaint. Each patient was administered 3 tools: the standard ED consent form, the Aid to Capacity Evaluation (ACE), and the Mini-Mental State Examination. The results of these assessments were then compared to the provider’s opinion of the patient’s ability to provide consent.
Results
A total of 283 patients participated in the study, and 84.4% were able to consent according to providers. There was a high level of consistency with the provider’s assessment and the other assessment tools on the patient’s ability to consent. Most patients, both medical and psychiatric, showed the ability to consent. However, this was less true for psychiatric patients with schizophrenia, as 32.6% (n = 14) were unable to consent.
Conclusions
The study revealed that the ACE capacity assessment was highly consistent with the providers’ assessment for medical (88.3%) and psychiatric patients (80.3%), but not for psychiatric patients with schizophrenia. Using the ACE, patients with schizophrenia presenting to the ED were significantly less able to understand their illnesses (0.01) and treatments (0.04) and thus were less able to give consent.
The capacity to consent to treatment in amyotrophic lateral sclerosis: a preliminary report
The capacity to consent to treatment in amyotrophic lateral sclerosis: a preliminary report
Original Communication
Rossella Spataro, Vincenzo La Bella
Journal of Neurology, 6 August 2020
Abstract
Background
Facing the relentless worsening of their condition, ALS patients are required to make decisions on treatments and end-of-life care. A cognitive impairment showed to be a negative prognostic factor in ALS patients, perhaps affecting the ability to make informed decisions. Notwithstanding its crucial role, the capacity to consent to treatment (CCT) has never been evaluated in these patients.
Objectives
To assess the CCT in an ALS cohort in comparison to a control group, and to study the effects of demographic and clinical variables on this high-level cognitive function.
Methods
102 ALS patients and 106 healthy controls (HC) were enrolled. CCT was assessed using the MacArthur Competence Assessment Tool for Treatment (MAC-CAT-T) and the performance was classified into the three CCT outcomes (full credit, partial credit, no credit). Cognitive and psychological variables were assessed by MMSE, phonemic fluencies, Frontal System Behavioural Scale (FrSBe), and ALS Depression Inventory (ADI). Clinical and demographic variables were analyzed as possible predictors of the MAC-CAT-T outcomes. After a 1-year follow-up, CCT and neuropsychological assessments were repeated.
Results
Most ALS patients (i.e., from 75 to 83% according to the different sub-items) retain full CCT. However, a subpopulation of the ALS patients showed a reduced CCT with respect to the HC. Age, education, phonemic fluency, and depression appeared related to the CCT outcomes. After 1 year, only the reasoning items worsened.
Conclusions
This is a preliminary report suggesting that the large majority of ALS patients can retain full ability to choose between treatment options. However, demographic and neuropsychological variables may affect CCT, pointing to the need for special attention to the consent disclosure in this disease.
Advances and challenges in conducting ethical trials involving populations lacking capacity to consent: A decade in review
Advances and challenges in conducting ethical trials involving populations lacking capacity to consent: A decade in review
Victoria Shepherd
Contemporary Clinical Trials, August 2020; 95
Abstract
Informed consent is an essential requirement prior to clinical trial participation, however some ‘vulnerable’ groups, such as people with cognitive impairments and those in medical emergency situations, may lack decisional capacity to consent. This raises ethical and practical challenges when designing and conducting clinical trials involving these populations, who are frequently excluded as a result. Despite recent advances in improving informed consent processes, there has been far less attention paid to the enrolment of adults lacking capacity.
Exclusion criteria are an important determinant of the external validity of clinical trial results. The exclusion of these populations, and consent-based recruitment biases which arise from the challenges of identifying and involving surrogate decision-makers, leads to trials which are not representative of the clinical population.
This article discusses the involvement of adults who lack decisional capacity to consent in clinical trials and presents the advances over the previous decade and the remaining ethical challenges for the inclusion of this under-represented population in research.
Ethical considerations cited in child health research published in leading nursing journals : 2015-2019
Ethical considerations cited in child health research published in leading nursing journals : 2015-2019
Y Wu, ML Howarth, C Zhou, L Yang, X Ye, R Wang, C Li, M Hu, W Cong
International Journal Of Nursing Practice, 24 August 2020
Abstract
Background: Child health research comprises complex ethical considerations. Understanding the extent to which the ethical process is reported in child health research is needed to improve reporting. Aims: To identify reportage of ethical considerations in child health research in leading nursing and paediatric journals. Methods: All child health research published between 2015 and 2019 in ten leading nursing journals and two paediatric journals were retrieved and critically appraised for the reportage of informed consent and ethical approval. Results: Eight hundred and fifty-one child health research papers were included. Whilst 544 (79.9%) of the prospective studies mentioned informed consent, only 300 (55.2%) reported that written informed consent was obtained from the participants. Overall, 748 (87.9%) of child health research papers noted obtaining research ethics committee approval. Articles that mentioned financial support were significantly more likely to report informed consent and ethical approval than unfunded studies (all P<0.001). Prospective studies showed higher rates of reportage of ethical approval compared to retrospective studies (P=0.027). Rates of child consent (assent) obtained in different age groups of children ranged from 29.6% to 66.3%. Conclusion: Despite improvements in the reportage of ethical review and approval processes in child health research, consistent and transparent reports are still lacking.
Opt-out consent in children’s emergency medicine research
Opt-out consent in children’s emergency medicine research
T Long, A Rowland, S Cotterill, SR Woby
Comprehensive Child and Adolescent Nursing, 17 August 2020
Abstract
There is global acceptance that individuals should be allowed to decide whether or not to take part in research studies, and to do so after being informed about the nature of the research and the risk that might attach to participation. The process of providing detailed information before seeking consent (formalised by signatures) in advance of undertaking research procedures may not be possible in some circumstances, and sometimes an amended approach may be adopted. The use of opt-out consent has been recognised as a valid and ethical means of recruiting participants to studies particularly with large samples and where the risk to participants is small. However, it is sometimes misunderstood and can be a problematic factor in being accepted by research ethics committees and governing authorities. This may be due partly to differing expectations of the amount of information and support offered, together with the nature of the process that is adopted to ensure that a decision has been made rather than consent simply being assumed. In accordance with ongoing discussions with young people, and following consultation with parents, an opt-out consent strategy including varied means of providing information was employed in a large study of 44,501 cases of children attending emergency or urgent care departments. The study was conducted over more than 12 months in dissimilar emergency departments and an urgent care unit, and was designed to support better decision-making in paediatric emergency departments about whether children need to be admitted to hospital or can be discharged home safely. Robust analysis of the factors that exerted the greatest impact on predicting the need to admit or the safety of discharging children led to a revised version of a an existing tool. In this article we review approaches to consent in research, the nature and impact of opt-out consent, the factors that made this an effective strategy for this study, but also more recent concerns which may make opt-out consent no longer acceptable.
Informed consent approaches for clinical trial participation of infants with minor parents in sub-Saharan Africa: A systematic review
Informed consent approaches for clinical trial participation of infants with minor parents in sub-Saharan Africa: A systematic review
Research Article
Angela De Pretto-Lazarova, Domnita Oana Brancati-Badarau, Christian Burri
PLOS One, 4 August 2020
Abstract
Background
Regulations are vague regarding the appropriate decision-maker and authority to consent for children of minor parents participating in clinical trials. In countries with high rates of underage mothers, such as in sub-Saharan Africa, this lack of guidance may affect the rights of potential paediatric participants already bearing increased vulnerability. It can also influence the recruitment and generalizability of the research. We provide evidence and discuss informed consent management in such cases to inform best practice.
Materials and methods
We searched PubMed/MEDLINE, Embase, CINAHL, and Google Scholar for articles published up to March 2019. In total, 4382 articles were screened, of which 16 met our inclusion criteria. Studies addressing informed consent in clinical trials involving children with minor parents in sub-Saharan Africa were included. We performed descriptive and qualitative framework analyses. The review was registered in PROSPERO: CRD42018074220.
Results
Various informed consent approaches were reported. Articles supporting individual consent by minor parents based on emancipation or “mature minor” status lacked evidence in the context of research. National laws on medical care guided consent instead. When no laws or guidance existed an interpretation of the local decision-making culture, including community engagement and collaboration with local ethics committees, defined the informed consent approach.
Conclusions
The review emphasises that the implementation of informed consent for children with minor parents may be variable and hampered by absent or ambiguous clinical trial regulations, as well as divergent local realities. It may further be influenced by the research area and study-specific risks. Clear guidance is required to help address these challenges proactively in clinical trial planning. We provided a set of questions to be considered in the development of an ethically acceptable informed consent approach and proposed information that should be integrated into international clinical trial guidelines.
Center for Informed Consent Integrity 