Guidelines for the ethical conduct of medical research involving children

McIntosh, Neil; Bates, Peter; Brykczynska, Gosia; Dunstan, G. R.; Goldman, Allan L.; Harvey, Dan; Larcher,; McCrae, D; McKinnon, Anna; Patton, Mary Anne; Saunders, John; Shelley, Pauline

doi:10.1136/adc.82.2.177

Cited by 219 publications

(29 citation statements)

References 3 publications

(1 reference statement)

Supporting

Mentioning

Contrasting

Order By: Relevance

“…Ethical guidelines require that children's assent is sought for medical research if they are competent to do so. 40 41 Owing to the emergency situation, the CATCH protocol stated that assent was to be sought from children “as soon as their condition allows.” 39 Of the 1485 children participating in CATCH, 274 (18.5%) were of an age (>5 years) typically considered suitable to allow meaningful engagement in assent discussions (95 of whom were in the elective arm), although only three forms documenting children's assent were received across both the elective and emergency arms of the trial. When we explored this during the practitioners focus group discussions, they pointed to the young age profile of CATCH participants and the condition of children who may have been ventilated or were “a bit drowsy” (P11, female doctor, focus group 4) as explanations.…”

Section: Resultsmentioning

confidence: 99%

How parents and practitioners experience research without prior consent (deferred consent) for emergency research involving children with life threatening conditions: a mixed method study

et al. 2015

View full text Add to dashboard Cite

ObjectiveAlternatives to prospective informed consent to enable children with life-threatening conditions to be entered into trials of emergency treatments are needed. Across Europe, a process called deferred consent has been developed as an alternative. Little is known about the views and experiences of those with first-hand experience of this controversial consent process. To inform how consent is sought for future paediatric critical care trials, we explored the views and experiences of parents and practitioners involved in the CATheter infections in CHildren (CATCH) trial, which allowed for deferred consent in certain circumstances.DesignMixed method survey, interview and focus group study.Participants275 parents completed a questionnaire; 20 families participated in an interview (18 mothers, 5 fathers). 17 CATCH practitioners participated in one of four focus groups (10 nurses, 3 doctors and 4 clinical trial unit staff).Setting12 UK children's hospitals.ResultsSome parents were momentarily shocked or angered to discover that their child had or could have been entered into CATCH without their prior consent. Although these feelings resolved after the reasons why consent needed to be deferred were explained and that the CATCH interventions were already used in clinical care. Prior to seeking deferred consent for the first few times, CATCH practitioners were apprehensive, although their feelings abated with experience of talking to parents about CATCH. Parents reported that their decisions about their child's participation in the trial had been voluntary. However, mistiming the deferred consent discussion had caused distress for some. Practitioners and parents supported the use of deferred consent in CATCH and in future trials of interventions already used in clinical care.ConclusionsOur study provides evidence to support the use of deferred consent in paediatric emergency medicine; it also indicates the crucial importance of practitioner communication and appropriate timing of deferred consent discussions.

show abstract

Section: Resultsmentioning

confidence: 99%

How parents and practitioners experience research without prior consent (deferred consent) for emergency research involving children with life threatening conditions: a mixed method study

et al. 2015

View full text Add to dashboard Cite

show abstract

“…Secondly, the consent must be given willingly and researchers are advised [2] to exert no pressure on families, to give them as much time as possible to consider whether they want to participate, to emphasize that parents or children have a right to refuse to participate or withdraw their children’s participation at any point in time, and to encourage families to discuss the project and ask questions.…”

Section: Introductionmentioning

confidence: 99%

“…Firstly, in relation to the provision of information, the Child Health Ethics Advisory Committee of the Royal College of Paediatrics [2] states that, for consent to medical research to be informed, researchers must discuss several subjects with families. These include the purpose of the research, whether there are direct benefits for the child (and if so the difference between research and treatment), the meaning of relevant research terms (e.g.…”

Section: Introductionmentioning

confidence: 99%

Opinions of Children about Participation in Medical Genetic Research

Pal

Sozanska²,

Madden

et al. 2010

Public Health Genomics

View full text Add to dashboard Cite

Aims: The objective was to evaluate children’s opinions about their participation in a large research project. Methods: Polish children between 6 and 14 years of age completed a questionnaire about their participation in the Polish Gabriel study (which aims to identify genetic and environmental causes of asthma). In total 706 questionnaires were collected. Results: Children’s main motivation for participation was wanting to know whether they were healthy or not. Most children could think of no reasons to reconsider participation. Children aged 6–10 years might reconsider participating because they did not know what was going to happen. A third of the children were not informed by anybody about the study. Especially the youngest children indicated a need for a tailored letter (42%). The youngest children were less often asked for their opinion about participation. All children preferred that both parents and children are asked for consent or assent. Children who were not informed or not asked for their opinion seemed less emotionally involved in the study. Conclusion: While researchers and parents tend to focus their information provision to older children and include them in decision-making, especially the younger children expressed a need for more tailored information and involvement in their participation in research.

show abstract

“…There are several opinions on the rule of seven and minor children; several guidelines state that assent should be obtained where children have sufficient understanding and intelligence to understand what is proposed, and that this ability could be determined taking into consideration the child’s age, maturity, and psychological state. 8 , 12 , 13…”

Section: Discussionmentioning

confidence: 99%

“…It has been recommended that a flexible approach should be adopted, and that there may be exceptions to the rule of seven. 8 , 9 All children, even those not judged as competent to make decisions for themselves, have a right to receive information given to them in a way that they can understand and could give their assent or dissent. 10 , 11 In addition, the importance of protecting children from harm suggests that the sustained dissent of all children, including those who are unable to provide assent, should be respected.…”

Section: Introductionmentioning

confidence: 99%

Perception of assent in biomedical research among medical specialists and trainees in Abakaliki, Nigeria

Onoh

Umeora

Ezeonu

et al. 2014

AHMT

View full text Add to dashboard Cite

BackgroundAssent is the child’s affirmative agreement to participate in research. Consent from parents and assent from children are required in research involving children.ObjectiveTo determine the knowledge, perception, and level of practice of assent in children among medical specialists and trainees in research work as well as the level of ethical norms observed during research.MethodsA semistructural questionnaire was designed for a cross-sectional survey of medical specialists and trainees at the Federal Teaching Hospital Abakaliki at their different departments in the months of January and February 2013. The questionnaires were completed and analyzed.ResultsA total of 113 questionnaires were distributed, correctly completed, and analyzed. The mean age of the respondents was 36.2±5.9 years, with a range of 25–55 years. The mean duration of practice was 6.3±3.9 years, with a range of 3–20 years. The majority of respondents were trainees (106, 93.8%). There was no significant association between sociodemographic variables of the respondents and the practice of obtaining assent in research involving children (P>0.05). Ethical clearance was obtained by all medical specialists during their research, but none of those whose research involved children got assent from the children. The majority of medical specialists (80%) and trainees (65.1%) support the practice of assent as a mandatory prerequisite in ethical study. Most of the medical specialists (83.3%) and trainees (65.1%) agree that parents could be influenced by other considerations and benefits in enrolling their children in research. Assent after consent in research involving children in African setting was acknowledged as a necessity by 66.7% of medical specialists and 75.2% of trainees.ConclusionAssent was observed as a necessary ethical issue in research involving children in this study; however, it is often not sought in our setting.

show abstract

Guidelines for the ethical conduct of medical research involving children

Cited by 219 publications

References 3 publications

How parents and practitioners experience research without prior consent (deferred consent) for emergency research involving children with life threatening conditions: a mixed method study

How parents and practitioners experience research without prior consent (deferred consent) for emergency research involving children with life threatening conditions: a mixed method study

Opinions of Children about Participation in Medical Genetic Research

Perception of assent in biomedical research among medical specialists and trainees in Abakaliki, Nigeria

Contact Info

Product

Resources

About