Stakeholders’ perspectives on clinical trial acceptability and approach to consent within a limited timeframe: a mixed methods study
Original Research
Elizabeth Deja, Chloe Donohue, Malcolm G Semple, Kerry Woolfall
BMJ Open, 2 January 2023
Abstract
Objectives
The Bronchiolitis Endotracheal Surfactant Study (BESS) is a randomised controlled trial to determine the efficacy of endo-tracheal surfactant therapy for critically ill infants with bronchiolitis. To explore acceptability of BESS, including approach to consent within a limited time frame, we explored parent and staff experiences of trial involvement in the first two bronchiolitis seasons to inform subsequent trial conduct
Design
A mixed-method embedded study involving a site staff survey, questionnaires and interviews with parents approached about BESS.
Setting
Fourteen UK paediatric intensive care units.
Participants
Of the 179 parents of children approached to take part in BESS, 75 parents (of 69 children) took part in the embedded study. Of these, 55/69 (78%) completed a questionnaire, and 15/69 (21%) were interviewed. Thirty-eight staff completed a questionnaire.
Results
Parents and staff found the trial acceptable. All constructs of the Adapted Theoretical Framework of Acceptability were met. Parents viewed surfactant as being low risk and hoped their child’s participation would help others in the future. Although parents supported research without prior consent in studies of time critical interventions, they believed there was sufficient time to consider this trial. Parents recommended that prospective informed consent should continue to be sought for BESS. Many felt that the time between the consent process and intervention being administered took too long and should be ‘streamlined’ to avoid delays in administration of trial interventions. Staff described how the training and trial processes worked well, yet patients were missed due to lack of staff to deliver the intervention, particularly at weekends.
Conclusion
Parents and staff supported BESS trial and highlighted aspects of the protocol, which should be refined, including a streamlined informed consent process. Findings will be useful to inform proportionate approaches to consent in future paediatric trials where there is a short timeframe for consent discussions.
Year: 2024
Participants’ understanding of informed consent in clinical trials: A systematic review and updated meta-analysis
Participants’ understanding of informed consent in clinical trials: A systematic review and updated meta-analysis
Chengai Wu, Na Wang, Qianqian Wang, Chao Wang, Zhenjie Wei, Zhimin Wu, Shunan Yu, Xieyuan Jiang
PLOS One, 2 January 2024
Open Access
Abstract
Obtaining written informed consent from participants before enrolment in a study is essential. A previous study showed that only 50% of the participants in clinical trials understood the components of informed consent, and the methods of participants’ understanding of informed consent were controversial. This updated meta-analysis aimed to estimate the proportion of participants in clinical trials who understand the different informed consent components. PubMed, EMBASE, the Cochrane Library, and Scopus were searched till April 2023. Therapeutic misconception, ability to name one risk, knowing that treatments were being compared, and understanding the nature of the study, the purpose of the study, the risks and side-effects, the direct benefits, placebo, randomization, voluntariness, freedom to withdraw, the availability of alternative treatment if withdrawn from the trial, confidentiality, compensation, or comprehension were evaluated. This meta-analysis included 117 studies (155 datasets; 22,118 participants). The understanding of the risks and side-effects was investigated in the largest number of studies (n = 100), whereas comprehension was investigated in the smallest number (n = 11). The highest proportions were 97.5%(95% confidence interval (CI): 97.1–97.9) for confidentiality, 95.9% (95% confidence interval (CI): 95.4–96.4) for compensation, 91.4% (95% CI: 90.7–92.1) for the nature of study, 68.1% (95% CI: 51.6–84.6) for knowing that treatments were being compared, and 67.3% (95% CI: 56.6–78) for voluntary nature of participants. The smallest proportions were the concept of placebo (4.8%, 95%CI: 4.4–5.2) and randomization(39.4%, 95%CI: 38.3–40.4). Our findings suggested that most participants understood the fundamental components of informed consent (study confidentiality, nature, compensation, voluntariness, and freedom to withdraw). The understanding of other components, such as placebo and randomization was less satisfactory.
What do educational psychologists consider to be best practice when gaining consent across the 0 to 25 age range?
What do educational psychologists consider to be best practice when gaining consent across the 0 to 25 age range?
Althea Lyons, George Thomas
Educational Psychology In Practice, 8 November 2023
Abstract
Educational psychologists (EPs) have a legal and ethical obligation to gain informed consent prior to any psychological involvement. As EPs work across the 0 to 25 age range, the person giving consent may vary according to the needs of the individual service user and so it is necessary to be aware of relevant legislation and case law. This study explored what might be considered best practice for EPs in gaining consent across the 0 to 25 age range by conducting semi-structured interviews with six professionals as part of an expert reference group. The interviews were thematically analysed using a hybrid inductive-deductive approach. Six main themes were identified: ethical obligations; children’s rights; legal obligations; partnership; informed consent; and, barriers to best practice. There was considerable overlap between some of the main themes, reflecting the complexity of the issue. The findings are discussed in relation to literature in other areas of psychological practice. Implications for practice for individual EPs and EP services are considered, such as the possibility of developing a guidance document for use across the profession, as well as directions for further research.
Agency and power in research: some thoughts about informed consent forms
Agency and power in research: some thoughts about informed consent forms
Claudia Barcellos Rezendea
Saúde e Sociedade, 2023
Open Access
Abstract
This article discusses some premises that constitute informed consent forms, assuming they should not be taken for granted. I argue that the use of informed consent forms should be understood within a research relationship, which is always an intersubjective relation between two or more socially positioned individuals. I develop these reflection based on my recent experiences of anthropological research on pregnancy and birth, during which I used an informed consent form in two stages but not in an intermediary phase, which was dedicated to focus on kinship relations during pregnancy more than the bodily experience itself. Thus, by comparing these three situations, I examine their particularities in obtaining consent, discussing agency, power, and ethics in social research.
Editor’s note: This is a Portuguese language publication. Saúde e Sociedade is a publication of the University of São Paulo.
The Need to Consider Context: A Systematic Review of Factors Involved in the Consent Process for Genetic Tests from the Perspective of Patients
The Need to Consider Context: A Systematic Review of Factors Involved in the Consent Process for Genetic Tests from the Perspective of Patients
Research Article
Frédéric Coulombe, Anne-Marie Laberge
AJOB Empirical Bioethics, 8 January 2024
Abstract
Background
Informed consent for genetic tests is a well-established practice. It should be based on good quality information and in keeping with the patient’s values. Existing informed consent assessment tools assess knowledge and values. Nevertheless, there is no consensus on what specific elements need to be discussed or considered in the consent process for genetic tests.
Methods
We performed a systematic review to identify all factors involved in the decision-making and consent process about genetic testing, from the perspective of patients. Through public databases, we identified studies reporting factors that influence the decision to accept or decline genetic testing. Studies were included if they reported the perspective of patients or at-risk individuals. All articles were thematically coded.
Results
1989 articles were reviewed: 70 met inclusion criteria and 12 additional articles were identified through the references of included studies. Coding of the 82 articles led to the identification of 45 factors involved in decision-making and consent, which were initially divided into three domains: in favor of, against or with an undetermined influence on genetic testing. Each factor was also divided into three subdomains relating to the informed choice concept: knowledge, values or other. The factors in the “other” subdomain were all related to the context of testing (e.g. timing, cost, influence of family members, etc), and were present in all three domains.
Conclusions
We describe the network of factors contributing to decision-making and consent process and identify the context of genetic testing as a third component to influence this process. Future studies should consider the evaluation of contextual factors as an important and relevant component of the consent and decision-making process about genetic tests. Based on these results, we plan to develop and test a more comprehensive tool to assess informed consent for genetic testing.
Patient Perspectives on Data Sharing
Patient Perspectives on Data Sharing
Book Chapter
Louise C. Druedahl, Sofia Kälvemark Sporrong
The Law and Ethics of Data Sharing in Health Sciences, 20 December 2023 [Springer]
Open Access
Abstract
Data sharing is key for artificial intelligence and for future healthcare systems, but the perspectives of patients are seldom included in the larger debates of how, when, and what data to share. This chapter provides an overview of research on patient perspectives on data sharing and associated aspects, including patients’ motivations, concerns, and views on privacy and conditions for sharing. Moreover, these perspectives are put into the evolving context of informed consent and today’s European context of the General Data Protection Regulation (GDPR) and Data Governance Act (DGA). Overall, there seems to be a discrepancy between the patients’ perspective on data sharing and the reality in which their data are to be shared. The current patient views are researched within relatively ‘local’ contexts, where the patient would consent to collecting data for primary use and on patients’ preferences regarding consent and what they see as barriers and motivators for data sharing. However, the reality of data use is moving towards re-use of data for secondary purposes and a context of more altruistic consent such as the DGA. Questions remain regarding how patients perceive sharing and the role of their data in the larger governance of data; seemingly, patient views are lost in the wider debate of innovation and jurisdictional competitiveness. Ensuring that patients’ voices are heard is essential for public acceptance of data sharing, and thus for inclusiveness and equity of results and innovations originating from patients’ shared data.
Informed Consent to Psychedelic-Assisted Psychotherapy: Ethical Considerations
Informed Consent to Psychedelic-Assisted Psychotherapy: Ethical Considerations
Research Article
Andrew Lee, Daniel Rosenbaum, Daniel Z. Buchman
The Canadian Journal of Psychiatry, 17 January 2024
Excerpt
…Given that psychedelics can induce powerful nonordinary states of consciousness and increase suggestibility, challenges surrounding the informed consent process in [Psychedelic-Assisted Psychotherapy] PAP have begun to receive attention. For example, Smith and Sisti suggest that a process of “enhanced consent” be undertaken prior to PAP, characterized by special attention to the shifts in personality and values that can follow a psychedelic experience, the possible mental health side effects of psychedelics, and the possible use of therapeutic touch during treatment. However, Jacobs argues that owing to the particular effects of psychedelics—namely, mystical and ego-dissolution experiences which can occur acutely after administration and longer-term shifts in identity and values—the typical standards for informed consent may not be feasible.
Issues of capacity and consent during the psychedelic experience have received less attention. Individuals using psychedelics often experience profound acute changes to their sensorium along with alterations in mood, detachment from the body, and distortions of their sense of self, time, and reality. Consequently, it may be difficult for patients to appreciate the risks and benefits of terminating the session during the psychedelic experience. It may also be difficult for observers to predict or interpret the internal process and distress of patients during sessions, as their observable behaviour may not be representative of their inner experience…
Informed consent for capacity assessment
Informed consent for capacity assessment
Shaun T. O’Keeffe, Mary Donnelly
International Journal of Law and Psychiatry, January–February 2024
Abstract
In this paper we examine the role of informed consent to capacity assessment, focussing primarily on the two jurisdictions of England and Wales, and Ireland. We argue that in both jurisdictions, a capacity assessment should be regarded as a distinct intervention, separate from the ‘original’ intervention at issue, and that specific informed consent to the assessment should generally be sought in advance. As part of this, we consider what information should be provided so as to ensure informed consent. Having established a baseline requirement for informed consent, we also recognise that informed consent to assessment will not always be possible, either because the person is unable to understand the information about assessment or because the person refuses to be assessed and so, in the final part of the article, we explore how to proceed when informed consent is either not possible or not forthcoming, including an analysis of the implications of the statutory presumption of capacity.
Capacity to consent to treatment in severe eating disorders
Capacity to consent to treatment in severe eating disorders
Research Article
Giovanna Parmigiani, Lorenzo Tarsitani, Fabiano Grassi, Gabriele Mandarelli, Stefano Ferracuti
International Review of Psychiatry, 12 January 2024
Abstract
Eating disorders represent a disabling, deadly and costly condition, whose principal treatment is constituted by weigh restoration and psychotherapy. Partial or total refuse of treatment is very common, leading some authors to question their decision-making capacity (DMC) to consent to treatment. However, very few studies have investigated treatment DMC, leading to contrasting results. Forty-five women were enrolled at the Psychiatric and Eating Disorders Unit of the University Hospital Policlinico Umberto I of Rome. Psychiatric symptoms severity (Brief Psychiatric Rating Scale Expanded, BPRS-E), treatment DMC (MacArthur Competence Assessment Tool for Treatment, MacCAT-T), depressive symptoms (Hamilton Depression Rating Scale, HAM-D), anxiety symptoms (Hamilton Anxiety Rating Scale, HAM-A), symptoms and psychological characteristics of eating disorders (Eating Disorder Inventory, EDI-3) and Metacognitive beliefs (Metacognitions Questionnaire 30, MCQ-30) were assessed. Sixty-seven percent of the total sample showed low treatment DMC; specifically, 70.4% of patients affected by Anorexia Nervosa, 72.7% of patients affected by Bulimia Nervosa, and 42.9% of patients affected by Binge Eating Disorder. Specific psychopathological symptoms enhance or hamper patients’ decisional capacities. Clinicians should be aware of the risk of impaired DMC in this vulnerable group of patients and pay attention at those factors suggesting the need of an in-depth evaluation.
Comparing Anxiety Levels and Pain Scores for Video-assisted and Traditional Informed Consent in Extracorporeal Shockwave Lithotripsy: A Prospective, Randomised, Controlled Study
Comparing Anxiety Levels and Pain Scores for Video-assisted and Traditional Informed Consent in Extracorporeal Shockwave Lithotripsy: A Prospective, Randomised, Controlled Study
Nurul Zubaidah Shahul Hameed, Devindran Manoharan, Lee Say Bob, Susan Woo
Asian Journal of Research and Reports in Urology, 23 January 2024
Abstract
Aims
Traditionally, informed consent involves verbal and/or written material provided to the patient by a treating clinician. Multimedia interventions improve patients’ knowledge and understanding during the informed consent process. This study aimed to compare pre-procedural anxiety levels and pain scores between educational video-assisted informed consent and traditional informed consent for extracorporeal shockwave lithotripsy (ESWL) at our centre.
Study Design
This was a prospective, randomised, controlled study conducted at two centres.
Place and Duration of Study
The study was conducted in two Urology centre Department of Urology, Penang General Hospital and Department of Urology, Hospital Kuala Lumpur between 15th May 2022 and 15th October 2022.
Methodology
The study group consisted of all adult patients undergoing ESWL in both centres. A video presentation explaining the ESWL procedure was developed in two languages, and group allocation was randomised using a computer-based random number generator. Anxiety levels were assessed using the Amsterdam Preoperative Anxiety and Information Scale (APAIS) questionnaire, visual analogue scale, and numerical rating scale used to collect data on pain scores.
Results
A total of 54 respondents, with a predominance of male patients (57.4%) and the majority of patients having completed secondary school education (53.7%). In comparing the two groups, the video-assisted respondents exhibited significantly lower anxiety scores regarding the procedure than those in the traditional group (p< 0.05). However, there were no statistically significant differences between the groups in terms of pain scores, both pre- and post-procedural.
Conclusion
Video-assisted informed consent can reduce procedure-related patient anxiety levels before ESWL; however, there was no difference in pain scores between the two consent methods. patients.
Center for Informed Consent Integrity 