Evaluation of Ethical Conflicts Associated With Randomized Controlled Trials in Critically Ill Children

Morris, Amelia; Zaritsky, Arno; Fever, Gretchen Le; Saha, Somnath

doi:10.1097/00003246-199801001-00173

Cited by 5 publications

(8 citation statements)

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“…The concept of equipoise has dominated the discourse of research ethics for several decades despite mounting empirical evidence that clinicians and patients appear generally not to be in equipoise and find randomization difficult 2,3,5,6,8,11 . Rather than entering the recruitment pathway as tabula rasa, clinicians and patients have experiences, stories, ideas and emotions – or preferences – about the interventions being tested.…”

Section: Introductionmentioning

confidence: 99%

Patient advocacy and patient centredness in participant recruitment to randomized‐controlled trials: implications for informed consent

Tomlin

deSalis

Toerien

et al. 2012

Health Expectations

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Context With the routinization of evidence-based medicine and of the randomized-controlled trial (RCT), more patients are becoming Ôsites of evidence productionÕ yet, little is known about how they are recruited as participants; there is some evidence that Ôsubstantively valid consentÕ is difficult to achieve.Objective To explore the views and experiences of nurses recruiting patients to randomized-controlled trials and to examine the extent to which their recruitment practices were patient-centred and patient empowering.Design Semi-structured in-depth interviews; audio recording of recruitment appointments; thematic interactional analysis (drawing on discourse and conversation analysis).Setting and participants Nurses recruiting patients to five publicly funded RCTs and patients consenting to the recording of their recruitment sessions.Main outcome measures The views of recruiting nurses about their recruitment role; the extent to which nurse-patient interactions were patient-centred; the nature of the nursesÕ interactional strategies and the nature and extent of patient participation in the discussion.Results The nurses had a keen sense of themselves as clinicians and patient advocates and their perceptions of the trial and its interventions were inextricably linked to those of the patients. However, many of their recruitment practices made it difficult for patients to play an active and informed part in the discussion about trial participation, raising questions over the quality of consent decisions.Conclusion Nurses working in patient recruitment to RCTs need to reconcile two different worlds with different demands and ethics.

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Section: Introductionmentioning

confidence: 99%

Patient advocacy and patient centredness in participant recruitment to randomized‐controlled trials: implications for informed consent

Tomlin

deSalis

Toerien

et al. 2012

Health Expectations

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“…In the survey of Morris et al [30], discussed in Sect. 1.3, a large majority of physicians admitted that they may be biased toward the study arm on the basis of published data from uncontrolled studies.…”

Section: Protocol Adherencementioning

confidence: 99%

“…These challenges may be specific to the culture and legislation of each individual country; this article focuses mainly on research in high-income countries. The ethical dilemma of conducting research in the PICU is recognized by pediatric intensivists themselves; in a survey of 415 pediatric intensivists, over 95 % found randomized controlled trials (RCTs) on potentially lifesaving therapies ethically acceptable, but at the same time almost all were in ethical conflict with these studies [30]. The specific challenges faced by researchers in the PICU are, first, the extraordinary physical environment of the PICU that presents challenges to the design and conduct of research and its ability to generate useful results.…”

Section: Challenges Of Drug Research In the Picumentioning

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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“…Results have been published in reports and in international papers and covers, both sexual child abuse in general (5), abuse within the family (6) and physical violence against children in the family (7).…”

Section: Previous Nordic Surveys On Child Abuse Finlandmentioning

confidence: 99%

Framework for Nordic youth surveys on child sexual abuse and exposure to violence outside and in the family.

Helweg‐Larsen¹

2009

TemaNord

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Framework for Nordic youth surveys on child sexual abuse and exposure to violence outside and in the family. Nordic co-operationNordic cooperation is one of the world's most extensive forms of regional collaboration, involving Denmark, Finland, Iceland, Norway, Sweden, and three autonomous areas: the Faroe Islands, Greenland, and Åland.Nordic cooperation has firm traditions in politics, the economy, and culture. It plays an important role in European and international collaboration, and aims at creating a strong Nordic community in a strong Europe.Nordic cooperation seeks to safeguard Nordic and regional interests and principles in the global community. The working group comprised of broad professional qualifications including pediatric, gynecology, child and adolescence psychiatry and psychology, sociology, criminology, public health and forensic sciences. The group's clinical and research experiences laid the basic for the recommendations in order to find a common Nordic framework for youth surveys on child abuse. These are presented in the present report.During two group meetings in June and August 2008, methods for data collection, key topics to be included in youth surveys and ethical issues related to including minors in a survey on sensitive topics were discussed. Based on experiences of the previous Nordic school and youth surveys, the research network in this report presents recommendations on the survey method and the key questions, which may describe the prevalence, character and consequences of sexual abuse and physical violence against children in the best way and, thus, ensure that comparable data on this issue is available in the Nordic countries. In October 2008 at a research network meeting, we represented our first results of 9th grade surveys conducted during 2008 in Finland and Denmark. Experiences on various practical issues concerning the implementation of Internet and lap-top based surveys were also discussed.By establishing a research network for a youth survey in different aspects of child violence in the Nordic countries, the aim was to encourage a joint Nordic framework. This aim has been met. At a dialogue meeting the Nordic researchers have agreed upon a survey model that may describe the current prevalence and character of child abuse and have tried to ensure future joint research projects on risk factors of child violence and abuse in the different Nordic countries based on comparable data. The project period according to the final plan consists of four subprojects: Karin Helweg-Larsen1. Statistics on violence 2. Youth surveys, the feasibility of a joint Nordic framework (the present project) 3. Evaluation of Rrestraining orders in the Nordic countries (besöksförbud) 4. Ethnic minority women and their exposure to violence The present report describes the planning of a framework for youth surveys, project number 2 which aims to ensure comparable data on sexual abuse and physical violence against children and adolescents in and outside the family. In the report is documented the ba...

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Evaluation of Ethical Conflicts Associated With Randomized Controlled Trials in Critically Ill Children

Cited by 5 publications

References 0 publications

Patient advocacy and patient centredness in participant recruitment to randomized‐controlled trials: implications for informed consent

Patient advocacy and patient centredness in participant recruitment to randomized‐controlled trials: implications for informed consent

Ethics of Drug Research in the Pediatric Intensive Care Unit

Framework for Nordic youth surveys on child sexual abuse and exposure to violence outside and in the family.

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