Exception From Informed Consent for Pediatric Resuscitation Research: Community Consultation for a Trial of Brain Cooling After In-Hospital Cardiac Arrest

Morris, Marilyn C.; Nadkarni, Vinay; Ward, Frances Rieth; Nelson, Robert M.

doi:10.1542/peds.2004-0482

Cited by 80 publications

(86 citation statements)

References 18 publications

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“…Some have argued that a minimum of 30 minutes is needed to seek meaningful informed consent. 24 Due to placental disruption a 32-yearold woman has delivered her premature infant by emergency cesarian delivery. Immediately after birth her infant develops severe respiratory failure and needs ventilatory support.…”

Section: Ii1 Trials That Have Time Limitations For Seeking Consentmentioning

confidence: 99%

“…Especially for those with chronic illness or for pregnant women at risk for complications, there may be opportunities to explain relevant research studies in advance. 12,23,24 For example, (future) parents with an imminent premature birth could be informed about possible research before the urgent situation arises. However, this needs to be balanced against the potential to cause unnecessary anxiety in those who, although at risk, do not go on to have the complications that make them eligible for a trial.…”

Section: Ii2 Potential Solutionsmentioning

confidence: 99%

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Clinical Trial Decisions in Difficult Circumstances: Parental Consent Under Time Pressure

et al. 2015

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Treatments and interventions used to care for children in emergencies should be based on strong evidence. Well-designed clinical trials investigating these interventions for children are therefore indispensable. Parental informed consent is a key ethical requirement for the enrollment of children in such studies. However, if time is limited because of an urgent need for intervention, there are additional ethical challenges to adequately support the informed consent process. The acute situation and associated psychological impact may compromise the ability of parents to give informed consent. Little evidence exists to guide the process of consent seeking for a child’s research participation when time is limited. It is also unclear in what circumstances alternatives to prospective informed consent could be applied. This article describes possible options to manage the informed consent process in an appropriate, practical, and, we believe, ethical way when time is limited.

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Section: Ii1 Trials That Have Time Limitations For Seeking Consentmentioning

confidence: 99%

Section: Ii2 Potential Solutionsmentioning

confidence: 99%

Clinical Trial Decisions in Difficult Circumstances: Parental Consent Under Time Pressure

et al. 2015

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“…A life-threatening situation substantially limits parents' perception of the optional nature of enrolling their child into a RCT [38,57,58].…”

Section: Emotional State and Willingness To Volunteermentioning

confidence: 99%

“…In such a stressful situation, a notable group of parents state that they feel obliged to take part in the study or that they feel to have no choice in the interest of their child's health [59][60][61]. In contrast, in emergency situations parents fear that doing research would cause a delay starting the proper treatment [15,57].…”

Section: Emotional State and Willingness To Volunteermentioning

confidence: 99%

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Determinants of decision-making and patient participation in paediatric clinical trials: A literature review

Wulf¹,

Krasuska²,

Bullinger³

2012

OJPed

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Background: Studies have shown that many drugs used in children may not have been authorised for use in this age group. This poses significant risks on children. A new EU regulation came into effect in 2007 to ensure that medicinal products that are researched, developed and authorised will also meet the therapeutic needs of children. This will mean an increased demand for children to participate in clinical trials. Objectives: To identify the needs and motivations of children and their families who have participated, might participate or declined to participate in clinical trials. Methods: We did a literature search and reviewed empirical studies which examined eligible outcomes. The findings of these studies were analyzed in a broad qualitative and descriptive bottom-up process. Results: We found that the understanding of advanced concepts of research such as randomisation is often insufficient. The needs of families affected by a serious disease are not addressed explicitly. Personal benefit and altruistic motives were two important reasons for participation. Conclusions: The comprehension of information given in the consent process should be secured by improving the information material. The communication process should be more mutual. Children and their families should be empowered to address their needs in the process of considering participation in a clinical trial.

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Emergency Clinical Trials

Borrás-Blasco

Navarro-Ruiz

Borrás

2010

Pharmaceutical Sciences Encyclopedia

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Emergency clinical trials involve the administration of the study drug to healthy human volunteers or to patients under the supervision of a qualified investigator, usually a physician, pursuant to a reviewed protocol. Research in this field continues to grow because this department is often considered as a desirable place to conduct clinical research due to the broad and undifferentiated spectrum of acute conditions encountered. There are some specific aspects when studying emergency medicine that have to be taken into account. One of them is the emphasis on ultrarapid diagnosis and treatment to save the critically ill emergency patient.

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Exception From Informed Consent for Pediatric Resuscitation Research: Community Consultation for a Trial of Brain Cooling After In-Hospital Cardiac Arrest

Cited by 80 publications

References 18 publications

Clinical Trial Decisions in Difficult Circumstances: Parental Consent Under Time Pressure

Clinical Trial Decisions in Difficult Circumstances: Parental Consent Under Time Pressure

Determinants of decision-making and patient participation in paediatric clinical trials: A literature review

Emergency Clinical Trials

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