Effectiveness of the Informed Consent Process for a Pediatric Resuscitation Trial

Raymond, Tia T.; Carroll, Timothy; Sales, Glenda; Morris, Marilyn C.

doi:10.1542/peds.2009-2427

Cited by 23 publications

(23 citation statements)

References 11 publications

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“…Problems with comprehension and readability [11], a misconception of direct therapeutic benefit [9, 12], and not recognizing the ability to discontinue [9] or opt out of treatment [13] also impede the function of the informed consent process. Importantly, the decision making process involving informed consent may be flawed, especially in high pressure environments [14].…”

Section: Introductionmentioning

confidence: 99%

Decision Making in the PICU: An Examination of Factors Influencing Participation Decisions in Phase III Randomized Clinical Trials

Slosky

Stern

Burke

et al. 2014

International Journal of Pediatrics

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Background. In stressful situations, decision making processes related to informed consent may be compromised. Given the profound levels of distress that surrogates of children in pediatric intensive care units (PICU) experience, it is important to understand what factors may be influencing the decision making process beyond the informed consent. The purpose of this study was to evaluate the role of clinician influence and other factors on decision making regarding participation in a randomized clinical trial (RCT). Method. Participants were 76 children under sedation in a PICU and their surrogate decision makers. Measures included the Post Decision Clinician Survey, observer checklist, and post-decision interview. Results. Age of the pediatric patient was related to participation decisions in the RCT such that older children were more likely to be enrolled. Mentioning the sponsoring institution was associated with declining to participate in the RCT. Type of health care provider and overt recommendations to participate were not related to enrollment. Conclusion. Decisions to participate in research by surrogates of children in the PICU appear to relate to child demographics and subtleties in communication; however, no modifiable characteristics were related to increased participation, indicating that the informed consent process may not be compromised in this population.

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Section: Introductionmentioning

confidence: 99%

Decision Making in the PICU: An Examination of Factors Influencing Participation Decisions in Phase III Randomized Clinical Trials

Slosky

Stern

Burke

et al. 2014

International Journal of Pediatrics

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“…Although parental involvement in PIC trials is similarly limited, with few examples identified, 52,53 parents' experiences and views of NIC trials have been relatively well studied: we have identified 21 papers. 49,51,[54][55][56][57][58][59][60][61][62][63][64][65][66][67][68][69][70][71][72] Many of these papers focus on issues at the 'front end' of trials, such as comprehension, decision-making and views of enrolment in more than one trial.…”

Section: Experiences In Neonatal Intensive Care Units and Paediatric mentioning

confidence: 99%

Death, bereavement and randomised controlled trials (BRACELET): a methodological study of policy and practice in neonatal and paediatric intensive care trials

Snowdon

Brocklehurst

Tasker

et al. 2014

Health Technology Assessment

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“…Understanding and recalling information is difficult for parents in the research context [54] and they also overestimate their understanding [55]. Written information and posters are identified by parents in the PICU as useful information tools in the informed consent process [48,56].…”

Section: Understandingmentioning

confidence: 99%

“…They favor dialogue with the community, which is informed about the project beforehand and its results afterwards [58]. Raymond et al [56] describe an efficient method of in-hospital community consultation for a trial of vasopressin added to adrenaline in cardiac arrest in the PICU. All parents were informed about the trial through posters, written information, a website, and the research team, and were offered the possibility to opt out of the study.…”

Section: Waiver Of Consentmentioning

confidence: 99%

Ethics of Drug Research in the Pediatric Intensive Care Unit

et al. 2014

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Critical illness and treatment modalities change pharmacokinetics and pharmacodynamics of medications used in critically ill children, in addition to age-related changes in drug disposition and effect. Hence, to ensure effective and safe drug therapy, research in this population is urgently needed. However, conducting research in the vulnerable population of the pediatric intensive care unit (PICU) presents with ethical challenges. This article addresses the main ethical issues specific to drug research in these critically ill children and proposes several solutions. The extraordinary environment of the PICU raises specific challenges to the design and conduct of research. The need for proxy consent of parents (or legal guardians) and the stress-inducing physical environment may threaten informed consent. The informed consent process is challenging because emergency research reduces or even eliminates the time to seek consent. Moreover, parental anxiety may impede adequate understanding and generate misconceptions. Alternative forms of consent have been developed taking into account the unpredictable reality of the acute critical care environment. As with any research in children, the burden and risk should be minimized. Recent developments in sample collection and analysis as well as pharmacokinetic analysis should be considered in the design of studies. Despite the difficulties inherent to drug research in critically ill children, methods are available to conduct ethically sound research resulting in relevant and generalizable data. This should motivate the PICU community to commit to drug research to ultimately provide the right drug at the right dose for every individual child.

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Effectiveness of the Informed Consent Process for a Pediatric Resuscitation Trial

Abstract: Parents endorsed resuscitation research with an exception from informed consent. Public disclosure yielded >80% parental awareness. Efforts should be made to ensure awareness of the ability to opt out.

Cited by 23 publications

References 11 publications

Decision Making in the PICU: An Examination of Factors Influencing Participation Decisions in Phase III Randomized Clinical Trials

Decision Making in the PICU: An Examination of Factors Influencing Participation Decisions in Phase III Randomized Clinical Trials

Death, bereavement and randomised controlled trials (BRACELET): a methodological study of policy and practice in neonatal and paediatric intensive care trials

Ethics of Drug Research in the Pediatric Intensive Care Unit

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