Month: December 2023

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Informed Consent: A Monthly Review
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January 2024 :: Issue 61

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:

Editor
Paige Fitzsimmons, MA
Associate Director, Center for Informed Consent Integrity
GE2P2 Global Foundation
paige.fitzsimmons@ge2p2global.org

PDF Version: Center for Informed Consent Integrity – A Monthly Review_January 2024

Spotlight Articles

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This month our spotlight section focuses on the practical development of approaches to obtain assent from persons who may not be able to provide full informed consent. Assent is of particular interest to the GE2P2 Global Foundation and we welcome any thoughts or engagement our readers may want to share.

In the Psychology in the Schools research article Review of participatory research assent procedures in school psychology, Flowers et al. point out that ‘[t]ransparency in research is vital for advancing science and safeguarding research participants’ and provide the following recommendations for practitioners:

  • Given the findings that only a small percentage of reviewed articles provided a detailed account of how assent was obtained from children and adolescent participants, it is crucial for practitioners in school psychology research to prioritize and transparently document their assent procedures.
  • While the current review did not identify novel methods for obtaining assent in school psychology research, practitioners should consider looking to related fields for potentially innovative approaches. Engaging participants in a way that enhances their understanding and buy‐in can lead to more accurate and valid research outcomes.
  • Researchers and practitioners in school psychology should advocate for clear reporting standards regarding assent procedures in publications. Providing detailed information about the assent process should be seen as essential to ethical research, and authors and journal editors should consider the value of including this information in their manuscripts.

In Maureen Dykinga’s University of Arizona PhD Dissertation Promoting Health Literacy by Operationalizing a Developmental Approach to Assent, the author finds that in the University of Arizona context, there is a ‘need for operationalized resources that already contain simplified language for PIs to use when assenting youth’. Dykinga notes this research is important for ‘deepening our understanding of the effect age has on interventions and the course of diseases [as this] is dependent upon youth-specific data’.

Review of participatory research assent procedures in school psychology
Research Article
Jaime Flowers, Daniel McCleary, Jillian Dawes, Hunter Marzolf
Psychology in the Schools, 5 December 2023
Abstract
In the realm of psychology and related fields, like school psychology, obtaining informed consent from clients or participants who are 18 years old or older is mandatory for researchers. However, if the individuals are below 18 years old or under a conservatorship, their assent is crucial even if their parent or legal guardian has provided formal consent. Despite the widespread recognition of the importance of assent during research, there is a lack of research and guidelines on how to obtain it effectively. To bridge this gap, we conducted a review and created a summary of research published in school psychology journals on gaining assent during research studies. The articles were categorized based on the experimental design, population, and level of assent described. Our findings offer a comprehensive overview of the current state of research on gaining assent in school psychology, which will enhance transparency in research methods.

Promoting Health Literacy by Operationalizing a Developmental Approach to Assent
PhD Dissertation
Maureen Dykinga
PhD Thesis, 2023 [University of Arizona]
Open Access
Abstract
Background
Since 1991, The Common Rule has provided regulation to protect humans participating in biomedical or social research. Despite clear protocols to obtain informed consent from adults, there is limited information on how to incorporate developmental factors such as simplified language, formative assessment, and feedback into youth assent practices. Adolescence, an important period for developing behaviors that impact health throughout the lifespan, is also a time when developmental capabilities vary greatly among peers of the same chronological age. Meaningfully engaging youth in research begins with an assent that integrates developmental factors and promotes the health literacy of youth. Operationalizing this approach narrows the gap between regulation and research practices.
Methods
To quantify the language complexity of two assent templates, 3 trained speech-language pathologists used Language Sample Analysis; the results were compared. To assess the usefulness of incorporating development into assent, a developmental approach to assent was designed. This approach was implemented with a randomized sample of 50 youth participating in the Children And Teens Study (CATS). A data capture system was utilized to present simplified assent language in segments and ask 6 questions assessing comprehension. For individuals with incorrect answers, feedback was provided, and the same question was presented a second time. To incorporate youth priorities, values, and strengths into assent resources, demographics, educational experiences, exposure to racism, and resiliency data were analyzed. To evaluate the feasibility of shifting institutional assent practices, semi-structured interviews were conducted, assessing the importance of assent, understanding of a developmental approach, its acceptability, the practicality of requiring it, and the resources needed for Principal Investigators (PIs), to be successful. To design a toolkit of operational resources, the knowledge from implementing a developmental approach, analyzing youth data, and conducting the feasibility study was applied.
Results
The simplified assent conveyed the same number of key study details as the more complex assent. 100% of the 6 questions were answered accurately by participants. The cross-section of the youth represented a diverse mix of demographics with 72% reporting comorbidities that impact language, learning, mental, and chronic health. Ninety-eight percent indicated an awareness of racism while 16% had encountered it directly. Youth valued education/knowledge and prioritized flexibility, agency, and autonomy. They demonstrated strengths such as cooperation, connection, and belonging. PIs indicated that assent was important and incorporating a developmental approach was acceptable. They did not believe it would be practical to require this approach. Key barriers were identified as securing buy-in from researchers, addressing time constraints, and gaining institutional support. Resources that strengthen capacity, provide examples, and allow for flexibility, were identified as a need by researchers. A toolkit of resources that reflected youth awareness, priorities, values, and strengths while meeting researcher requests was developed and made available in the resources section of the University of Arizona (UArizona) Institutional Review Board (IRB) website.
Conclusion
The results suggest that integrating a developmental approach was useful in communicating key study elements and reinforced the necessity for inclusive assent practices that align with youth awareness. Incorporating developmental factors into assent empowers youth to exercise health literacy. Providing operational assent resources that reflect the values of diverse youth communities and strengthen the capacity of PIs is the first of many strategies to meaningfully engage youth in research.

Testing and Practical Implementation of a User-Friendly Personalized and Long-Term Electronic Informed Consent Prototype in Clinical Research: Mixed Methods Study

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Testing and Practical Implementation of a User-Friendly Personalized and Long-Term Electronic Informed Consent Prototype in Clinical Research: Mixed Methods Study
Evelien De Sutter, David Geerts, Koen Yskout, Stef Verreydt, Pascal Borry, Liese Barbier, Isabelle Huys
Journal of Medical Internet Research, 19 December 2023
Abstract
Background
Over the years, there has been increasing interest in electronic informed consent (eIC) in clinical research. The user-friendliness of an eIC application and its acceptance by stakeholders plays a central role in achieving successful implementation.
Objective
This study aims to identify insights for the design and implementation of a user-friendly, personalized, and long-term eIC application based on a usability study with (potential) research participants and semistructured interviews with stakeholders on the practical integration of such an application into their daily practice.
Methods
An eIC prototype was evaluated and refined through usability testing among Belgian citizens and iterative redesign. On the basis of a digital literacy questionnaire, a heterogeneous sample of participants was established. Participants needed to complete a series of usability tasks related to personalization and long-term interaction with the research team while using the “think aloud” technique. In addition, usability tests involved completing the System Usability Scale questionnaire and taking part in a semistructured feedback interview. Furthermore, semistructured interviews were conducted with ethics committee members, health care professionals, and pharmaceutical industry representatives active in Belgium and involved in clinical research. Thematic analysis was undertaken using the NVivo software (Lumivero).
Results
In total, 3 iterations of usability tests were conducted with 10 participants each. Each cycle involved some participants who reported having low digital skills. The System Usability Scale scores related to the tasks on personalization and long-term interaction increased after each iteration and reached 69.5 (SD 8.35) and 71.3 (SD 16.1) out of 100, respectively, which represents above-average usability. Semistructured interviews conducted with health care professionals (n=4), ethics committee members (n=8), and pharmaceutical industry representatives (n=5) identified the need for an eIC system that can be easily set up. For example, a library could be established enabling stakeholders to easily provide background information about a clinical study, presented in the second layer of the interface. In contrast, some functionalities, such as informing participants about new studies through an eIC system, were not considered useful by stakeholders.
Conclusions
This study provides insights for the implementation of a user-friendly personalized and long-term eIC application. The study findings showed that usability testing is key to assessing and increasing the user-friendliness of an eIC application. Although this eIC system has the potential to be usable by a wide audience, participants with low digital literacy may not be able to use it successfully, highlighting the need for additional support for participants or other alternatives to an eIC system. In addition, key lessons emerging from the interviews included ensuring that the application is easy to implement in practice and is interoperable with other established systems.

Opportunities to Advance Equity Through Informed Consent Discussions

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Opportunities to Advance Equity Through Informed Consent Discussions
Invited Commentary
Puja J. Umaretiya, Emily E. Johnston
JAMA Network Open, 11 December 2023; 6(12)
Excerpt
As pediatric oncologists, we often ask parents to do the unthinkable: grapple with a child’s new cancer diagnosis and participate in a clinical trial informed consent discussion within hours to days of each other. Informed consent is essential to our practice because access to clinical trials is the standard of care in pediatric oncology. These discussions are both emotionally charged and medically complex, adding challenges to effective communication. Nearly 2 decades ago, Kodish and colleagues first examined this process in a cohort of parents consenting to therapeutic trials for children with newly diagnosed acute leukemia and found that only one-third of parents understood the concept of randomization and that non–English-speaking families were less likely than English-speaking families to understand key aspects of informed consent. Since then, our trials and informed consent discussions have become more complex. Aristizabal et al found that these gaps in our informed consent process persist, particularly for historically marginalized groups exposed to adverse social determinants of health…

Editor’s Note: The text of the commentary does not reference assent or the involvement of pediatric patient in consent processes.

Challenges regarding informed consent in recruitment to clinical research: a qualitative study of clinical research nurses’ experiences

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Challenges regarding informed consent in recruitment to clinical research: a qualitative study of clinical research nurses’ experiences
Research
Trails, 11 December 2023; 24(801)
Tove Godskesen, Joar Björk, Niklas Juth
Open Access
Abstract
Background
Clinical research nurses (CRNs) have first-hand experience with ethical challenges and play a crucial role in upholding ethical conduct and adherence to the principles of informed consent in clinical research. This study explores the ethical challenges encountered by CRNs in the process of obtaining informed consent for clinical research.
Methods
A qualitative exploratory design. Semistructured interviews (n = 14) were conducted with diverse CRNs in Sweden. These CRNs covered a wide range of research fields, including pharmaceutical and academic studies, interventions, and observational research, spanning different trial phases, patient categories, and medical conditions. The interviews were analysed using inductive qualitative content analysis.
Results
The analysis identified three main categories: (i) threats to voluntariness, (ii) measures to safeguard voluntariness, and (iii) questionable exclusion of certain groups. CRNs face challenges due to time constraints, rushed decisions, information overload, and excessive reliance on physicians’ recommendations. Overestimating therapeutic benefits in stages of advanced illness emerged as a risk to voluntariness. CRNs outlined proactive solutions, such as allowing ample decision-making time and offering support, especially for terminally ill patients. Concerns were also voiced about excluding certain demographics, such as those with language barriers or cognitive impairments.
Conclusions
In conclusion, upholding ethical research standards requires recognising various factors affecting patient voluntariness. Researchers and CRNs should prioritise refining the informed consent process, overcoming participation challenges, and aligning scientific rigour with personalised care. Additionally, a concerted effort is vital to meet the diverse needs of patient populations, including equitable inclusion of individuals with language barriers or cognitive limitations in clinical studies. These findings have significant implications for enhancing the ethics of clinical research and advancing person-centred care.

Parental Perceptions of Informed Consent in a Study of Tracheal Intubations in Neonatal Intensive Care

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Parental Perceptions of Informed Consent in a Study of Tracheal Intubations in Neonatal Intensive Care
Original Research Article
Susanne Tippmann, Janine Schaefer, Christine Arnold, Julia Winter, Norbert W. Paul, Eva Mildenberger, André Kidszun
Frontiers in Pediatrics, 2023
Abstract
Obtaining informed consent in neonatal emergency research is challenging. The aim of this study was to assess parental perceptions of informed consent following participation in a clinical trial in neonatal emergency care. This was a supplementary analysis of a randomised controlled trial comparing video and direct laryngoscopy for neonatal endotracheal intubation in the delivery room and neonatal intensive care unit. After obtaining informed consent for the clinical trial, parents were asked to answer a series of self-administered questions about their perceptions of clinical trial participation and the consent process. Informed consent had been given either before birth, after birth but before inclusion in the trial, or after inclusion in the trial. We received responses from 33 mothers and 27 fathers (n = 60) of the 63 preterm and term infants who participated in the study. Fifty-three (89.8%, n = 59) parents agreed that infants should participate in clinical trials, and 51 (85%, n = 60) parents agreed that parents should be asked for informed consent. Fifty-three (89.8%, n = 59) parents felt that their infant’s participation in this particular trial would be beneficial. Fifty-two (86.7%, n = 60) parents felt that the informed consent process was satisfactory. One parent (100%, n=1) approached before birth, 23 parents (82.1%, n=28) approached after birth but before enrolment and 26 (83.9%, n=31) parents approached after enrolment were satisfied with the timing of the consent process. Eight (13.3%, n = 60) parents felt.

Comparative analysis of multiple models of electronic informed consent in clinical research

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Comparative analysis of multiple models of electronic informed consent in clinical research
Xu Zuo, Yue Li, Yingshuo Huang
Chinese Journal of Medical Science Research Management, 2023; (4) pp 194-199
Objective
To provide decision-making support for electronic informed consent selection and promotion in clinical research, and lay a possible theoretical foundation for better protection of subjects′ rights and interests, as well as promotion of clinical research quality and efficiency.
Methods
This paper summarized the relevant laws and regulations of electronic informed consent, analyzed the advantages and challenges of the application of electronic informed consent in clinical research, sorted out several common electronic informed consent modes in domestic clinical research, explored their operational processes and applications, and discussed their advantages and limitations.
Results
At present, three electronic informed consent modes were mainly used in domestic clinical studies. Each had their own advantages and limitations in terms of convenience of operation, data security, privacy protection of subjects, cost input, popularization degree and so on.
Conclusions
Electronic informed consent needs continuing improvement of relevant laws and regulations and the joint efforts of all stakeholders engaged in clinical research. The sponsor and the researcher should take full consideration of the cost, safety, security, feasibility, and ofters, and make the selection according to the actual needs of the research.

Social Determinants of Health and Informed Consent Comprehension for Pediatric Cancer Clinical Trials

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Social Determinants of Health and Informed Consent Comprehension for Pediatric Cancer Clinical Trials
Original Investigation
Paula Aristizabal, Shilpa Nataraj, Arissa K. Ma, Nikhil V. Kumar, Bianca P. Perdomo, Maria Elena Martinez, Jesse Nodora, Lin Liu, Euyhyun Lee, Courtney D. Thornburg
JAMA Network Open, 11 December 2023; 6(12)
Abstract
Importance
Ensuring valid informed consent (IC) prior to enrollment in clinical trials is a fundamental ethical right.
Objective
To assess whether social determinants of health (SDOH) and related sociocontextual factors are associated with parental IC comprehension in therapeutic childhood cancer clinical trials.
Design, Setting, and Participants
This cross-sectional study prospectively enrolled 223 parents of children with newly diagnosed cancer at Rady Children’s Hospital San Diego, a large quaternary academic center in California, from October 1, 2014, to March 31, 2021. Linear mixed effects models were used to assess whether IC comprehension overall and by domain (purpose, procedures, and randomization; risks and benefits; alternatives; and voluntariness) were associated with SDOH and sociocontextual factors. Data were analyzed from January 1, 2022, to July 31, 2023.
Exposures
Informed consent for a therapeutic childhood cancer clinical trial.
Main Outcomes and Measures
The primary outcome of interest was IC comprehension and its associations with SDOH (marital status, language, educational attainment, employment, insurance type, socioeconomic status, and health literacy) and sociocontextual factors (ethnicity, satisfaction with informed consent, and cancer type).
Results
Of 223 parents, 172 (77.1%) were aged 18 to 44 years, 111 (49.8%) were Hispanic, 152 (68.2%) were women, and 163 (73.1%) were married. In terms of race, 2 (0.9%) were American Indian or Alaska Native, 22 (9.9%) were Asian or Pacific Islander, 8 (3.6%) were Black, 149 (66.8%) were White, and 42 (18.8%) were more than 1 race. In multivariable linear mixed-effects analyses, limited vs adequate health literacy was associated with lower comprehension of informed consent overall (mean [SD], 68.28 [11.81] vs 79.24 [11.77]; β estimate, −9.02 [95% CI, −12.0 to −6.07]; P < .001) and with lower comprehension of the purpose, procedures, and randomization (mean [SD], 65.00 [12.64] vs 76.14 [11.53]; β estimate, −7.87 [95% CI, −10.9 to −4.85]; P < .001); risks and benefits (mean [SD], 62.84 [20.24] vs 73.14 [20.86]; β estimate, −10.1 [95% CI, −15.6 to −4.59]; P < .001); alternatives (mean [SD], 54.27 [43.18] vs 82.98 [34.24]; β estimate, −14.3 [95% CI, −26.1 to −2.62]; P  .02); and voluntariness (mean [SD], 76.52 [24.33] vs 95.39 [13.89]; β estimate, −9.14 [95% CI, −14.9 to −3.44]; P = .002) domains. Use of Spanish vs English language for medical communication was associated with lower comprehension overall (mean [SD], 66.45 [12.32] vs 77.25 [12.18]; β estimate, −5.30 [95% CI, −9.27 to −1.34]; P = .01) and with lower comprehension of the purpose, procedures, and randomization (mean [SD], 63.33 [11.98] vs 74.07 [12.52]; β estimate, −4.33 [95% CI, −8.43 to −0.23]; P = .04) and voluntariness (mean [SD], 70.83 [24.02] vs 92.54 [17.27]; β estimate, −9.69 [95% CI, −16.8 to −2.56]; P = .009) domains.
Conclusions and Relevance
In this cross-sectional study including parents of children with newly diagnosed cancer who provided IC for their child’s participation in a therapeutic clinical trial, limited health literacy and use of Spanish language for medical communication were associated with lower comprehension of IC. These findings suggest that, in this setting, parents with limited health literacy or those who use Spanish language for medical communication may not fully comprehend IC and therefore may not make truly informed decisions. These findings support the investigation of interventions, across pediatric disciplines, tailored to the participant’s language and health literacy level to improve IC comprehension, particularly in racial and ethnic minority populations.

Editor’s Note: The text of the article does not reference assent or the involvement of pediatric patient in consent processes.

Boundaries of Parental Consent: The Example of Hypospadias Surgery

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Boundaries of Parental Consent: The Example of Hypospadias Surgery
Katrina Roen, Rogena Sterling
Social Sciences, 8 December 2023; 12(12)
Abstract
Human rights organisations raise concerns about medical interventions on children with intersex variations, particularly when these interventions impinge on the child’s bodily autonomy and are without a sound biomedical basis. Psychosocial literature and legal literature have made very different contributions to thinking about the healthcare of people with intersex variations, but both literatures pay attention to the process of informing patients about elective interventions and the workings of consent. The present paper addresses the absence of dialogue across medical, legal, and psychosocial literatures on the surgical treatment of children with intersex variations. The analysis presented in this paper focusses on the assumptions underpinning the practice of allowing parents to consent on behalf of their children to elective surgery in the instance of hypospadias. In this paper, we (i) introduce consent from a medico-legal perspective, (ii) analyse selected documents (including medical, psychosocial, and human rights documents) in relation to the concept of parental consent on behalf of a child, and (iii) reconsider the current practice of inviting parents to give consent for elective genital surgery on infants. What emerges from our analysis is a picture of long-term relationships and interactions over time within which the consent process is located. The focus is not whether consent is granted, but whether free and informed consent is granted. This picture allows us to expand the understanding of “informed consent,” highlighting the importance of producing ethical interactions between health professionals and patients with the view that these relationships last for years. Understanding consent as a process, considering information as dynamic, partial, and negotiated, and understanding the doctor–patient interaction as relational might enable us to imagine the kind of informed consent process that genuinely works for everyone concerned. Our examination of selected legal, medical, and psychosocial texts raises doubt about whether current hospital practice meets the requirement of informed parental consent on behalf of children undergoing hypospadias surgery.

Editor’s Note: The text of the article does not reference assent or the involvement of pediatric patient in consent processes.

Informed Consent In Genetic Research

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Informed Consent In Genetic Reasearch
Ljupco Chakar, Aleksandar Stankov, Goran Pavlovski, Natasha Bitoljanu, Viktorija Belakaposka Srpanova, Ana Ivcheva, Rosica Siamkouri, Zlatko Jakjovski
Journal of Morphological Sciences, 27 December 2023
Abstract
Recognizing the ethical, legal, and social implications (ELSI) of genetic testing becomes crucial for physicians in the face of complex medical issues, as they are increasingly expected to counsel their patients regarding the medical, psychological, and social responses arising from genetic information. Genetic medicine, with its extreme complexity and the potential repercussions on an individual’s life, raises important questions in the ethical, deontological, and legal realms of medicine, playing a primary role in personalized medicine. The aim of this paper is to underscore the significance of informed consent and to provide insights into the ethical procedures associated with genetic testing.

Editor’s note: The Journal of Morphological Sciences is a publication of the Brazilian Society of Anatomy and the Panamerican Association of Anatomists.