Children's perspectives on the benefits and burdens of research participation

Barned, Claudia; Dobson, Jennifer; Stintzi, Alain; Mack, David R.; O’Doherty, Kieran C.

doi:10.1080/23294515.2018.1430709

Cited by 20 publications

(20 citation statements)

References 24 publications

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“…All but one child had been infected through mother‐to‐child transmission and 49% were maternal orphans (Table ). Only 37% had known their HIV status, for a median duration of 11 months . Some groups included both HIV‐disclosed and undisclosed children, and all precautions were taken at every step of the IICP to minimise the risk of accidental disclosure of HIV status to an undisclosed child.…”

Section: Resultsmentioning

confidence: 99%

“…The process of informed consent requires that researchers obtain the agreement of the child or adolescent's legal representative, to whom the information is commonly directed, and the consent of the school‐age minor, who should express their willingness to participate in the research . Over the past 20 years, considerable attention has been paid to children's perspectives on research , to their capacities to provide informed consent and to the rights and status of vulnerable children .…”

Section: Introductionmentioning

confidence: 99%

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Improving the informed consent process among HIV‐infected undisclosed minors participating in a biomedical research: insights from the multicentre nutritional SNACS study in Senegal

Hejoaka

Varloteaux

Desclaux‐sall

et al. 2019

Tropical Med Int Health

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Objectives Providing research information in a manner accessible to minors participating in biomedical research is a major challenge. Guidance is dramatically lacking regarding best practices for seeking informed consent among undisclosed minors enrolled in HIV‐related research. We implemented an improved informed consent process (IICP) and identified factors associated with understanding of the information presented to HIV‐infected minors prior to their enrolment in a study. Methods We enrolled study participants attending 12 paediatric HIV clinics in Senegal. Children ≥7 years were provided with standardised research information using the IICP, which involves viewing a video and taking part in extended group discussions. Understanding was assessed by seven basic questions scored 1 or 2 points, with a maximum score of 11 points. A score of 9 or more points was defined as satisfactory understanding. Factors associated with understanding were identified using a stepwise logistic regression model. Results Overall, 112 children, with a median age of 12.9 years (IQR: 10.2–15.0), participated in the IICP, of whom 37% were HIV disclosed. 71% achieved a satisfactory understanding score and all gave consent to participate in the research. HIV‐disclosed children were more likely to demonstrate satisfactory understanding than undisclosed children (aOR = 3.2, 95% CI: 1.1–9.6). Age, study setting and education level were not associated with satisfactory understanding. Conclusion These findings provide practical guidance for the development of improved and friendly informed consent processes in research involving minors. The implementation of the paediatric HIV research agenda will require a standardised and operational definition of informed consent, integrating the issue of HIV disclosure.

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Section: Resultsmentioning

confidence: 99%

Section: Introductionmentioning

confidence: 99%

Improving the informed consent process among HIV‐infected undisclosed minors participating in a biomedical research: insights from the multicentre nutritional SNACS study in Senegal

Hejoaka

Varloteaux

Desclaux‐sall

et al. 2019

Tropical Med Int Health

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“…The clinical research nurse introduced the participants to Barned on the day of their interview. Barned described the purpose of the study, explaining that participants were to be interviewed about their experiences living with IBD as part of a larger study exploring youth's involvement in biomedical research (see Barned et al, 2016Barned et al, , 2018. Consent/assent forms were read aloud and signed.…”

Section: Procedures and Materialsmentioning

confidence: 99%

“The Rest of my Childhood was Lost”: Canadian Children and Adolescents’ Experiences Navigating Inflammatory Bowel Disease

et al. 2021

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Children and adolescents with Inflammatory Bowel Disease (IBD) face significant and unique challenges related to their condition. The aim of this study was to better understand some of these challenges, and to explore how Canadian youth respond to them. We interviewed 25 pediatric patients with IBD, ranging in age from 10–17, to find out about their illness experiences. Using a thematic analysis, we discerned three themes: challenges related to diagnosis, making sense of change, and navigating sociability. Taken together, they paint a picture of young people facing great uncertainty prior to diagnosis, pronounced changes to selfhood as they make lifestyle adjustments, and facing difficulties with the implications of reduced sociability because of their disease. We conclude by providing recommendations for the development of resources aimed at helping newly diagnosed pediatric patients navigate these issues.

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“…Children and youth who have been diagnosed with IBD, and their caregivers, are often highly motivated to make the necessary changes to their routine to accommodate dietary and treatment needs [ 12 ]. However, they may experience challenges to completing activities that are viewed as part of research in addition to their usual medical care [ 15 ]. For example, pediatric IBD patients and their caregivers have reported many barriers to medication adherence in medical care settings, including forgetting, being away from home, difficulty swallowing, pain with injectable treatments, interference with other activities, side effects, lack of time, lack of motivation to continue long-term treatments when symptoms improve, inadequate planning, anxiety and depressive symptoms, embarrassment, regiment complexity, and not understanding the reason for taking supplements [ 16 – 25 ].…”

Section: Introductionmentioning

confidence: 99%

Factors contributing to fidelity in a pilot trial of individualized resistant starches for pediatric inflammatory bowel disease: a fidelity study protocol

Castillo

Mack

Lalu

et al. 2021

Pilot Feasibility Stud

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Background The consumption of resistant starches is a promising adjuvant therapy for patients with inflammatory bowel disease. Rigorous evaluation of resistant starches in this setting depends on the intervention being delivered, received, and enacted as intended, that is, with fidelity. As part of a planned pilot trial, participants will be randomized to ingest resistant starches or a placebo. They will also be asked to collect stool samples and keep symptom and dose diaries to inform trial outcomes. We aim to identify potential factors impacting fidelity to the receipt and enactment of trial intervention and data collection activities from the perspective of patients and caregivers in the trial. Identifying fidelity barriers and enablers at the pilot trial phase of a clinical intervention may help to determine optimization processes when expanding to multiple sites in future trials. Methods We will conduct 15-30 semi-structured interviews with pilot trial participants (aged 8-17) and their caregivers. Trial participants will be approached for interviews approximately 6 months after the start of their trial participation. Personal projects analysis, a tool for understanding how individuals manage competing demands in their daily lives, will guide an in-depth exploration of how trial participants engage in activities related to intervention and data collection fidelity (ingesting resistant starches or placebo, collecting stool samples, keeping a symptom and dose diary) amidst the complexities of daily living. Discussion The present study will seek to explore and demonstrate how theory-informed fidelity assessments can be conducted alongside pilot trials to inform future multisite trials. Study results will clarify what factors may affect fidelity to trial intervention and data collection activities. Results may suggest what to modify to optimize the design and conduct, and ensure the integrity, of future multisite trials. Conducting process evaluations alongside clinical trials has the potential to improve our understanding of trial participant experiences. Results will provide a better understanding of how trial participants manage to engage in necessary trial activities along with other priorities.

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Children's perspectives on the benefits and burdens of research participation

Cited by 20 publications

References 24 publications

Improving the informed consent process among HIV‐infected undisclosed minors participating in a biomedical research: insights from the multicentre nutritional SNACS study in Senegal

Improving the informed consent process among HIV‐infected undisclosed minors participating in a biomedical research: insights from the multicentre nutritional SNACS study in Senegal

“The Rest of my Childhood was Lost”: Canadian Children and Adolescents’ Experiences Navigating Inflammatory Bowel Disease

Factors contributing to fidelity in a pilot trial of individualized resistant starches for pediatric inflammatory bowel disease: a fidelity study protocol

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