Toward a further understanding of assent
Discussion
Cody Morris, Jacob P. Oliveira, Jesse Perrin, Caitlyn A. Federico, Paula J. Martasian
Journal of Applied Behaviour Analysis, 15 February 2024
Abstract
Arranging assent opportunities is an increasingly common strategy for involving clients in therapeutic decisions within behavior analysis. Recent behavior-analytic articles have helped create a basic behavioral definition and conceptualization of assent, but much more guidance is needed for practitioners and researchers interested in embedding assent into their practices. The purpose of this article is to advance the conceptualization and understanding of assent and assent practices by refining previous definitions and conceptualizations of assent and providing six essential considerations for embedding assent into practice. The six considerations consist of determining the applicability and feasibility of assent, assessing assent-related skills, arranging assent procedures and teaching assent-related skills, arranging fair choices, selecting opportunities to assess assent, and informally assessing assent. Following the discussion of the considerations for assent practices, we issue a call for specific topics of research on assent.
Month: March 2024
Impact of a Clinical Decision Support Alert on Informed Consent Documentation in the Neonatal Intensive Care Unit
Impact of a Clinical Decision Support Alert on Informed Consent Documentation in the Neonatal Intensive Care Unit
Emily Sangillo, Neena Jube-Desai, Dina El-Metwally, Colleen Hughes Driscoll
Pediatric Quality and Safety, January-February 2024; 9(1)
Abstract
Background
Informed consent is necessary to preserve patient autonomy and shared decision-making, yet compliant consent documentation is suboptimal in the intensive care unit (ICU). We aimed to increase compliance with bundled consent documentation, which provides consent for a predefined set of common procedures in the neonatal ICU from 0% to 50% over 1 year.
Methods
We used the Plan-Do-Study-Act model for quality improvement. Interventions included education and performance awareness, delineation of the preferred consenting process, consent form revision, overlay tool creation, and clinical decision support (CDS) alert use within the electronic health record. Monthly audits categorized consent forms as missing, present but noncompliant, or compliant. We analyzed consent compliance on a run chart using standard run chart interpretation rules and obtained feedback on the CDS as a countermeasure.
Results
We conducted 564 audits over 37 months. Overall, median consent compliance increased from 0% to 86.6%. Upon initiating the CDS alert, we observed the highest monthly compliance of 93.3%, followed by a decrease to 33.3% with an inadvertent discontinuation of the CDS. Compliance subsequently increased to 73.3% after the restoration of the alert. We created a consultant opt-out selection to address negative feedback associated with CDS. There were no missing consent forms within the last 7 months of monitoring.
Conclusions
A multi-faceted approach led to sustained improvement in bundled consent documentation compliance in our neonatal intensive care unit, with the direct contribution of the CDS observed. A CDS intervention directed at the informed consenting process may similarly benefit other ICUs.
Assessment of the current status of real-world pharmacogenomic testing: informed consent, patient education, and related practices
Assessment of the current status of real-world pharmacogenomic testing: informed consent, patient education, and related practices
Original Research
Lucas Pereira, Cyrine-Eliana Haidar, Susanne B. Haga, Anna G. Cisler, April Hall, Sanjay K. Shukla, Scott J. Hebbring,
Emili J. W. Leary
Frontiers in Pharmacology, 8 February 2024
Abstract
Introduction
The practice of informed consent (IC) for pharmacogenomic testing in clinical settings varies, and there is currently no consensus on which elements of IC to provide to patients. This study aims to assess current IC practices for pharmacogenomic testing.
Methods
An online survey was developed and sent to health providers at institutions that offer clinical germline pharmacogenomic testing to assess current IC practices.
Results
Forty-six completed surveys representing 43 clinical institutions offering pharmacogenomic testing were received. Thirty-two (74%) respondents obtain IC from patients with variability in elements incorporated. Results revealed that twenty-nine (67%) institutions discuss the benefits, description, and purpose of pharmacogenomic testing with patients. Less commonly discussed elements included methodology and accuracy of testing, and laboratory storage of samples.
Discussion
IC practices varied widely among survey respondents. Most respondents desire the establishment of consensus IC recommendations from a trusted pharmacogenomics organization to help address these disparities.
The Effects of Placement and Order on Consent to Data Linkage in a Web survey
The Effects of Placement and Order on Consent to Data Linkage in a Web survey
Jonathan Burton, Mick P Couper, Annette Jäckle
Journal of Survey Statistics and Methodology, 24 February 2024
Abstract
We report on an experiment in a supplemental web survey as part of a longitudinal study in the United Kingdom where we ask survey respondents to consent to two forms of data linkage to health records and to consent to be mailed a serology kit. We varied the placement (early, early in context, or late in the survey) and order (linkage first or serology first) of the consent requests. We also examine reasons for consent or non-consent. We find that order of the requests does not make much difference, but making the requests early in the survey significantly increases consent rates over asking them after a series of content-related questions (by 3.4 percentage points) or later in the survey (by 7.2 percentage points). This is consistent with previous research showing that early requests for consent in a survey have a positive effect. The main reason chosen for not consenting related to the personal nature of the information requested.
Consent Management System on Patient-Generated Health Data
Consent Management System on Patient-Generated Health Data
Randine P, Salant E, Muzny M, Pape-Haugaard L
Studies in Health Technology and Informatics, 1 January 2024
Abstract
We consent to many things in life, but sometimes we do not know what we consent to. When discussing data protection in Europe, consent has been associated with permission under the GDPR, and health data are highly sensitive. Patients cannot make an informed decision without being provided with the information they need upfront: no informed decision, no informed consent. This paper presents a consent management system for patient-generated health data stored with HL7 FHIR specification, tested on Type 1 diabetes synthetic data. This architecture, based on using FHIR as an unequivocal data exchange format, can lead to individuals (patients) taking control of their data, enabling potential data exchange and reuse of health data across countries and organisations, in line with the European Commission proposal of a European Health Data Space.
Translating the consent form is the tip of the iceberg: using cognitive interviews to assess the barriers to informed consent in South African health facilities
Translating the consent form is the tip of the iceberg: using cognitive interviews to assess the barriers to informed consent in South African health facilities
Pillay N, Ncube N, Moopelo K, Mothoagae G, Welte O, Shogole M, Gwiji N, Scott L, Moshani N, Tiffin N, Boulle A, Griffiths F, Fairlie L, Mehta U, LeFevre A, Scott K
Sexual and Reproductive Health Matters, 1 December 2023
Abstract
The increasing digitisation of personal health data has led to an increase in the demand for onward health data. This study sought to develop local language scripts for use in public sector maternity clinics to capture informed consent for onward health data use. The script considered five possible health data uses: 1. Sending of general health information content via mobile phones; 2. Delivery of personalised health information via mobile phones; 3. Use of women’s anonymised health data; 4. Use of child’s anonymised health data; and 5. Use of data for recontact. Qualitative interviews (n = 54) were conducted among women attending maternity services in three public health facilities in Gauteng and Western Cape, South Africa. Using cognitive interviewing techniques, interviews sought to:(1) explore understanding of the consent script in five South African languages, (2) assess women’s understanding of what they were consenting to, and (3) improve the consent script. Multiple rounds of interviews were conducted, each followed by revisions to the consent script, until saturation was reached, and no additional cognitive failures identified. Cognitive failures were a result of: (1) words and phrases that did not translate easily in some languages, (2) cognitive mismatches that arose as a result of different world views and contexts, (3) linguistic gaps, and (4) asymmetrical power relations that influence how consent is understood and interpreted. Study activities resulted in the development of an informed consent script for onward health data use in five South African languages for use in maternity clinics.
Assessment of Consent Comprehension Among Kenyan Adolescents, Young Adults, and Parents: Comparison of Enhanced and Standard Consenting Procedures
Assessment of Consent Comprehension Among Kenyan Adolescents, Young Adults, and Parents: Comparison of Enhanced and Standard Consenting Procedures
Original Article
Winnie Kavulani Luseno, Bonita J. Iritani, Shane Hartman, Fredrick S. Odongo, Florence Anyango Otieno, Barrack Otieno Ongili, Stuart Rennie
Journal of Adolescent Health, March 2024
Abstract
Purpose
Youth aged 15–19 years and parents of minors aged 15–17 years in sub-Saharan Africa are under-represented in empirical consent research. Thus, knowledge is limited concerning the adequacy of consent procedures and need for strategies to improve consent comprehension among these groups. We assessed comprehension following standard consent procedures and evaluated an enhanced procedure among Kenyan youth and parents.
Methods
Participants were adolescents aged 15–17 years (n = 273), their parents (n = 196), and young adults aged 18–19 years (n = 196). We used a quasi-experimental cohort design to implement standard and enhanced (single condition: extended discussion, test/feedback) consent procedures. Participants completed a 21-item informed consent comprehension assessment instrument.
Results
After standard consent procedures, mean comprehension scores were 11.36, 13.64, and 13.43 (score range: 0–21) among adolescents, young adults, and parents, respectively. About 6.2% of adolescents, 19.6% of young adults, and 21.4% of parents answered ≥ 80% of the questions correctly. After the enhanced procedures, comprehension scores (15.87 adolescents, 17.81 young adults, and 16.77 parents) and proportions answering ≥ 80% of the questions correctly (44.9% adolescents, 76.8% young adults, and 64.3% parents) increased significantly. Regression analysis indicated statistically significant differences (p < .001) in comprehension scores between the enhanced and standard groups (β = 3.87 adolescents, β = 4.03 young adults, and β = 3.60 parents) after controlling for sociodemographic factors.
Discussion
Enhancing consent procedures with extended discussions, quizzes, and additional explanation where understanding is inadequate is a promising approach for improving comprehension. However, poorer comprehension among adolescents compared to young adults and parents underscores the need for research to identify additional approaches to improve understanding.
Incorporating parental values in complex paediatric and perinatal decisions
Incorporating parental values in complex paediatric and perinatal decisions
Rosa Geurtzen, Dominic J C Wilkinson
The Lancet – Child & Adolescent Health, 11 January 2024
Summary
Incorporating parental values in complex medical decisions for young children is important but challenging. In this Review, we explore what it means to incorporate parental values in complex paediatric and perinatal decisions. We provide a narrative overview of the paediatric, ethics, and medical decision-making literature, focusing on value-based and ethically complex decisions for children who are too young to express their own preferences. We explain key concepts and definitions, discuss paediatric-specific features, reflect on challenges in learning and expressing values for both parents and health-care providers, and provide recommendations for clinical practice. Decisional values are informed by global and external values and could relate to the child, the parents, and the whole family. These values should inform preferences and assure value-congruent choices. Additionally, parents might hold various meta values on the process of decision making itself. Complex decisions for young children are emotionally taxing, ethically difficult, and often surrounded by uncertainty. These contextual factors make it more likely that values and preferences are initially absent or unstable and need to be constructed or stabilised. Health-care professionals and parents should work together to construct and clarify values and incorporate them into personalised decisions for the child. An open communication style, with unbiased and tailored information in a supportive environment, is helpful. Dedicated training in communication and shared decision making could help to improve the incorporation of parental values in complex decisions for young children.
Adolescent assent in research: a relational ethics approach
Adolescent assent in research: a relational ethics approach
Case Study
Happy Indri Hapsari, Mei-Chih Huang
Indian Journal of Medical Ethics, October-December 2023
Open Access
Abstract
Researchers often neglect adolescents’ willingness to participate in research. The granting of permission by parents is sometimes not in accordance with the unwillingness of adolescents. Relational ethics is the right approach to overcome inconsistencies between legal and ethical agreements in granting parental permission and adolescent’s assent. This is because relational ethics is based on building relationships among many parties. The focus of this case study is to improve understanding of the assent of adolescents through intensive study of research conflict, reinforced using existing research and to understand how relational ethics can be used as an approach in decision making, especially in conflicts between parental permission and assent from adolescents.
Are Psychedelic Experiences Transformative? Can We Consent to Them?
Are Psychedelic Experiences Transformative? Can We Consent to Them
Brent M. Kious, Andrew Peterson, Amy L. McGuire
Perspectives in Biology and Medicine, 20 February 2024; pp 143-154
Abstract
Psychedelic substances have great promise for the treatment of many conditions, and they are the subject of intensive research. As with other medical treatments, both research and clinical use of psychedelics depend on our ability to ensure informed consent by patients and research participants. However, some have argued that informed consent for psychedelic use may be impossible, because psychedelic experiences can be transformative in the sense articulated by L. A. Paul (2014). For Paul, transformative experiences involve either the acquisition of knowledge that cannot be obtained in any other way or changes in the self. Either of these characteristics may appear to undermine informed consent. This article argues, however, that there is limited evidence that psychedelic experiences are transformative in Paul’s sense, and that they may not differ in their transformative features from other common medical experiences for which informed consent is clearly possible. Further, even if psychedelic experiences can be transformative, informed consent is still possible. Because psychedelic experiences are importantly different in several respects from other medical experiences, this article closes with recommendations for how these differences should be reflected in informed consent processes.
Center for Informed Consent Integrity 