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Parental opinions regarding consent for observational research of no or minimal risk in the pediatric intensive care unit.

ABSTRACT: Background:The aim of the study was to determine opinions and knowledge regarding the process of obtaining informed consent to participate in observational research in pediatric intensive care. Methods:Survey 1 asked decision makers what model(s) of consent was acceptable for each type of observational research both before and after background information. Survey 2 asked decision makers about the experience of being asked for consent to observational research, and knowledge regarding the consent process both before and after background information. Results:Cooperation rate was 100/117 (85%). The proportion in favor of any of the offered alternatives to signed informed consent for observational research, after receiving all the background information, was 74-80%, lowest for observational prospective research with a minimal risk intervention 37/50 (74%; 95% CI 60-84%). The proportion who agreed they felt overwhelmed by being approached for consent to observational research was 26 (52%; 95% CI 39-65%). Most respondents (from 60 to 74%) felt they understood the concepts regarding observational research; however, after reading background information, most (from 60 to 74%) felt their understanding had improved "a great deal". Conclusion:Understanding of risk, practical difficulties, consent bias, and Research Ethics Board safeguards was poor. Future study is needed to confirm our finding that most agreed with alternative methods of consent for observational research.

SUBMITTER: Hodson J

PROVIDER: S-EPMC6916229 | biostudies-literature | 2019

REPOSITORIES: biostudies-literature

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Parental opinions regarding consent for observational research of no or minimal risk in the pediatric intensive care unit.

Hodson Jessica J Garros Christiana C Jensen Jodie J Duff Jonathan P JP Garcia Guerra Gonzalo G Joffe Ari R AR

Journal of intensive care 20191216

<h4>Background</h4>The aim of the study was to determine opinions and knowledge regarding the process of obtaining informed consent to participate in observational research in pediatric intensive care.<h4>Methods</h4>Survey 1 asked decision makers what model(s) of consent was acceptable for each type of observational research both before and after background information. Survey 2 asked decision makers about the experience of being asked for consent to observational research, and knowledge regard ...[more]

PMID: 31890222

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Project description:Parental presence at the bedside (PPB) of critically ill children in the pediatric intensive care unit (PICU) is necessary for operationalizing family-centred care. Previous evidence syntheses emphasize parent-healthcare provider interactions at rounds and resuscitation; our focus is the parent-child dyad. Prior to embarking on further study, we performed a scoping review to determine the breadth and scope of the literature addressing PPB of critically ill children in the PICU. We searched five online databases (MEDLINE, EMBASE, CINAHL, Cochrane Library, and PSYCHINFO) and the grey literature to identify English and French reports from January 1960 to June 2020 addressing physical parental presence with children (birth to 18 years) in intensive care units, without limitation by methodology. Screening, reference selection, and data extraction were performed by two independent reviewers. Data were extracted into a researcher-designed tool. We identified 204 publications (81 quantitative, 68 qualitative, 22 mixed methods, and 9 descriptive case or practice change studies, and a further 24 non-study reports). PPB was directly assessed in 78 (38%) reports, and was the primary objective in 64 (31%). Amount or quality of presence was addressed by 114 reports, barriers and enablers by 152 sources, and impacts and outcomes by 134 sources. While only 6 reports were published in the first two decades of our search (1960-1980), 17 reports were published in 2019 alone. Conclusions: A relatively large body of literature exists addressing PPB of critically ill children. Separate systematic evidence syntheses to assess each element of PPB are warranted. Scoping review protocol registration: Open science framework, protocol nx6v3, registered 9-September-2019. What is Known: • Parental presence at the bedside of critically ill children must be enabled to facilitate family centeredness in care. • Systematic evidence syntheses have focused on parental presence at rounds or resuscitation, rather than with the child throughout the intensive care journey. What is New: • Many reports (n=204) address parental presence at the bedside in the pediatric intensive care unit, though most do as incidental findings • Identifies studies addressing key elements of parental presence in the PICU including barriers and enablers to, amount and quality of, and impact and outcomes of parental presence, and demonstrates trends over time and geography.

Project description:OBJECTIVES:Seeking consent for minimal risk research in the ICU poses challenges, especially when the research is time-sensitive. Our aim was to determine the extent to which ICU patients or surrogates support a deferred consent process for a minimal risk study without the potential for direct benefit. DESIGN:Prospective cohort study. SETTING:Five ICUs within a tertiary care hospital. PATIENTS:Newly admitted ICU patients 18 years old or older. INTERVENTIONS:We administered an eight-item verbal survey to patients or surrogates approached for consent to participate in a minimal risk, ICU-based study. The parent study involved noninvasive collection of biosamples and clinical data at the time of ICU admission and again 3 days later. If patients had capacity at the time of ICU admission, or if a surrogate was readily available, consent was sought prior to initial sample collection; otherwise, a waiver of consent was granted, and deferred consent was sought 3 days later. Quantitative and qualitative data were analyzed. MEASUREMENTS AND MAIN RESULTS:One hundred fifty-seven individuals were approached for consent to participate in the parent study; none objected to the consent process. One hundred thirty-five of 157 (86%) competed the survey, including 94 who consented to the parent study and 41 who declined. Forty-four of 60 individuals (73%) approached for deferred consent responded positively to the question "Did we make the right choice in waiting until now to ask your consent?" three of 60 (5%) responded negatively, and 13 of 60 (22%) made a neutral or unrelated response. The most common reason given for endorsing the deferred consent process was the stress of the early ICU experience 25 of 44 (61%). CONCLUSIONS:Most patients and surrogates accept a deferred consent process for minimal risk research in the ICU. For appropriate ICU-based research, investigators and Institutional Review Boards should consider a deferred consent process if the subject lacks capacity and an appropriate surrogate is not readily available.

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Parental opinions regarding consent for observational research of no or minimal risk in the pediatric intensive care unit.

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Parental opinions regarding consent for observational research of no or minimal risk in the pediatric intensive care unit.

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