Trudy Goodenough

Children's consent to research participation: social context and personal experience invalidate fixed cutoff rules.

David Wendler and Seema Shah (2003) offer an interesting proposal concerning children’s assent to participation in nontherapeutic biomedical research. They argue that children should be considered competent to consent to such participation provided they have attained a level of cognitive and prosocial development such that they are able to understand the nature and point of altruistic decisions and actions. On the basis of psychological evidence they argue that this develops between the ages of 10 and 14. They argue on practical and moral grounds for an agebased cutoff for assent to research participation at 14 years old. Other commentators on Wendler and Shah’s paper draw attention to a number of moral and practical challenges to this proposal. We would like to draw attention to what we regard as weaknesses in the scientiac basis of the paper. It is important to note that Wendler and Shah start with U.S. federal guidelines, move on to identify the underlying moral principles (drawing heavily on the standard “Four Principles” approach), and only then seek to identify a psychological foundation for the means to apply these principles in practice. Their argument turns on a psychological account of the development of the capacity for altruism as the basis for capacity to assent to participation in nontherapeutic biomedical research. Although there is some analytical interest in the proposition that capacity for altruism is a necessary condition for capacity to assent to participation in nontherapeutic research, had they approached the issue of children’s capacity to consent or assent more directly, they might well have obtained a different result. Most work on research ethics commences, as do Wendler and Shah, with a theoretical and legal analysis of the requirements for ethical research. Occasionally, empirical work is conducted to determine the acceptability of guidelines or policy in the aeld of research ethics. Yet we have found almost no research that seeks to analyze in any detail research participants’ reasoning and values concerning the ethical issues in research, or to understand how far the ethical issues identiaed by research participants are consistent with the issues raised by ethicists or ethical

Parental perceptions of barriers and facilitators to preventing child unintentional injuries within the home: a qualitative study

BackgroundChildhood unintentional injury represents an important global health problem. Most of these injuries occur at home, and many are preventable. The main aim of this study was to identify key facilitators and barriers for parents in keeping their children safe from unintentional injury within their homes. A further aim was to develop an understanding of parents’ perceptions of what might help them to implement injury prevention activities.MethodsSemi-structured interviews were conducted with sixty-four parents with a child aged less than five years at parent’s homes. Interview data was transcribed verbatim, and thematic analysis was undertaken. This was a Multi-centre qualitative study conducted in four study centres in England (Nottingham, Bristol, Norwich and Newcastle).ResultsBarriers to injury prevention included parents’ not anticipating injury risks nor the consequences of some risk-taking behaviours, a perception that some injuries were an inevitable part of child development, interrupted supervision due to distractions, maternal fatigue and the presence of older siblings, difficulties in adapting homes, unreliability and cost of safety equipment and provision of safety information later than needed in relation to child age and development. Facilitators for injury prevention included parental supervision and teaching children about injury risks. This included parents’ allowing children to learn about injury risks through controlled risk taking, using “safety rules” and supervising children to ensure that safety rules were adhered to. Adapting the home by installing safety equipment or removing hazards were also key facilitators. Some parents felt that learning about injury events through other parents’ experiences may help parents anticipate injury risks.ConclusionsThere are a range of barriers to, and facilitators for parents undertaking injury prevention that would be addressable during the design of home safety interventions. Addressing these in future studies may increase the effectiveness of interventions.

Social Science Gets the Ethics Treatment: Research Governance and Ethical Review

The paper examines the current provision for ethical review within the social sciences and considers how existent structures could be improved to protect human research subjects in accordance with international guidelines and regulation. This paper examines the current regulation of social science in the form of professional guidelines, peer review, funding application procedures and steering/advisory groups, and compares these processes with the independent ethical review currently required for health research. This paper also addresses the concepts of ‘risk’ and regulation by comparing the provision of review processes for health and non-health based research. The authors question the distinctions made between different types of medical research which represent epidemiological research, for example, as non-intrusive thus creating a hierarchy of research which results in social science researchers slipping through the ethical review net.

Home-Based Care for Special Healthcare Needs: Community Children’s Nursing Services

Background:Community children’s nursing services (CCNS) provides nursing and supportive care, ranging from relatively simple to highly technological interventions, to children and young people (0–18 years) within the family home. Objectives:The aim of this study was to elicit the perspectives on and experiences about CCNS in England in relation to things that are working well or that could be improved and the vision for services. Methods:Using a qualitative approach, underpinned by an Appreciative Inquiry philosophy, researchers worked closely with advisory groups (six children and young people, four parents, and five professionals) to design and implement the study. Arts-based participatory appreciative workshops were held in nine regional locations in England; shared activities were undertaken to elicit participants’ experiences. Participants unable to attend the workshops were able to contribute via semistructured interview (face to face or by telephone) or by a dedicated blog or e-mail. Results:Thematic analysis was used, and 214 people participated: families (n = 82), children (n = 27), and professionals or stakeholders (n = 105). Things that were working well were effective communication, robust leadership, actively enabling the child’s care to be sustained at home, and partnerships based on mutual trust. Problems relating to feelings of marginalization, ineffective commissioning, under provision of services and hours of service availability, lack of equipmentor resources, and poor communication between services and settings were areas of concern. The vision for CCNS was for a flexible, equitable, and accessible service that supported children’s and families’ needs and choices and which enabled parents to be parents first rather than caregivers. Discussion:Care at home reduces the disruption to children’s and families’ lives and can empower them to make decisions and control routines and practices. Having CCNS situated within larger teams with strong interdisciplinary and transdisciplinary practices seems to offer the best benefits for children and families. Findings from this study have directly influenced government policy and practice. Further research is needed to determine efficacy of particular models and practices.

Contemporary hazards in the home: keeping children safe from thermal injuries

Objective To explore the knowledge and reported thermal injury prevention practices among parents of children aged 0–4 years in disadvantaged areas. Methods Parents of pre-school children in Childrens Centres in four study areas in England (Nottingham, Newcastle, Norwich and Bristol) were interviewed using a structured schedule. Interviews covered smoke alarms, bedtime routines, fire escape plans, other thermal prevention practices and parental knowledge of first aid. Results Of the 200 respondents, most reported ownership of at least one smoke alarm (n=191, 96%), of which 95% were working. Half reported a fire prevention bedtime routine (n=105, 53%) or fire escape plan (n=81, 42%). Most parents had matches or lighters in the home (n=159, 80%), some stored where children under 5 years of age could reach them (n=30, 19%). There was a high prevalence of irons (n=188, 94%) and hair straighteners (n=140, 70%). A third of both devices were used daily. Just 17 (12%) parents reported leaving hair straighteners, when hot but not in use, in a heatproof bag. Knowledge of correct initial first aid for a small burn was good (n=165, 83%), but parents reported other potentially harmful actions, for example, applying ointment (n=44, 22%). Conclusions Most families report at least one working smoke alarm, but many do not have fire escape plans or fire prevention bedtime routines. A number of reported practices could compromise child safety, such as storage of matches or lighters and leaving hair straighteners to cool unprotected. Reappraisal of health promotion messages, in light of new household consumables, is necessary.

Poison prevention practices and medically attended poisoning in young children: multicentre case–control study

Introduction Childhood poisonings are common, placing a substantial burden on health services. Case–control studies have found inconsistent evidence about modifiable risk factors for poisonings among children aged 0–4 years. This study quantifies associations between poison prevention practices and medically attended poisonings in children aged 0–4 years. Methods Multicentre case–control study conducted at hospitals, minor injury units and family practices from four study centres in England between 2010 and 2013. Participants comprised 567 children presenting with unintentional poisoning occurring at home and 2320 community control participants matched on age, sex, date of event and study centre. Parents/caregivers provided data on safety practices, safety equipment use, home hazards and potential confounders by means of self-completion questionnaires. Data were analysed using conditional logistic regression. Results Compared with community controls, parents of poisoned children were significantly more likely not to store medicines out of reach (adjusted OR (AOR) 1.59; 95% CI 1.21 to 2.09; population attributable fraction (PAF) 15%), not to store medicines safely (locked or out of reach (AOR 1.83; 95% CI 1.38 to 2.42; PAF 16%) and not to have put all medicines (AOR 2.11; 95% CI 1.54 to 2.90; PAF 20%) or household products (AOR 1.79, 95% CI 1.29 to 2.48; PAF 11%) away immediately after use. Conclusions Not storing medicines out of reach or locked away and not putting medicines and household products away immediately after use increased the odds of secondary care attended poisonings in children aged 0–4 years. If associations are causal, implementing these poison prevention practices could each prevent between 11% and 20% of poisonings.

Risk and protective factors for falls on one level in young children: multicentre case–control study

Background Childhood falls are an important global public health problem, but there is lack of evidence about their prevention. Falls on one level result in considerable morbidity and they are costly to health services. Objective To estimate ORs for falls on one level in children aged 0–4 years for a range of safety behaviours, safety equipment use and home hazards. Design, setting and participants Multicentre case–control study at hospitals, minor injury units and general practices in and around four UK study centres. Participants included 582 children less than 5 years of age with a medically attended fall injury occurring at home and 2460 controls matched on age, sex, calendar time and study centre. Main outcome measure Fall on one level. Results Cases’ most common injuries were bangs on the head (52%), cuts or grazes not needing stitches (29%) or cuts or grazes needing stitches (17%). Comparing cases to community controls in the adjusted analyses, significant findings were observed for only two exposures. Injured children were significantly less likely to live in a household without furniture corner covers (adjusted OR (AOR) 0.72, 95% CI 0.55 to 0.95), or without rugs and carpets firmly fixed to the floor (AOR 0.76, 95% CI 0.59 to 0.98). Conclusions We did not find any safety practices, use of safety equipment or home hazards associated with a reduced risk of fall on one level. Our findings do not provide evidence to support changes to current injury prevention practice.

Evaluating implementation of a fire-prevention Injury Prevention Briefing in children’s centres: cluster randomised controlled trial

Background Many developed countries have high mortality rates for fire-related deaths in children aged 0–14 years with steep social gradients. Evidence-based interventions to promote fire safety practices exist, but the impact of implementing a range of these interventions in children’s services has not been assessed. We developed an Injury Prevention Briefing (IPB), which brought together evidence about effective fire safety interventions and good practice in delivering interventions; plus training and facilitation to support its use and evaluated its implementation. Methods We conducted a cluster randomised controlled trial, with integrated qualitative and cost-effectiveness nested studies, across four study sites in England involving children’s centres in disadvantaged areas; participants were staff and families attending those centres. Centres were stratified by study site and randomised within strata to one of three arms: IPB plus facilitation (IPB+), IPB only, usual care. IPB+ centres received initial training and facilitation at months 1, 3, and 8. Baseline data from children’s centres were collected between August 2011 and January 2012 and follow-up data were collected between June 2012 and June 2013. Parent baseline data were collected between January 2012 and May 2012 and follow-up data between May 2013 and September 2013. Data comprised baseline and 12 month parent- and staff-completed questionnaires, facilitation contact data, activity logs and staff interviews. The primary outcome was whether families had a plan for escaping from a house fire. Treatment arms were compared using multilevel models to account for clustering by children’s centre. Results 1112 parents at 36 children’s centres participated. There was no significant effect of the intervention on families’ possession of plans for escaping from a house fire (adjusted odds ratio (AOR) IPB only vs. usual care: 0.93, 95%CI 0.58, 1.49; AOR IPB+ vs. usual care 1.41, 95%CI 0.91, 2.20). However, significantly more families in the intervention arms reported more behaviours for escaping from house fires (AOR IPB only vs. usual care: 2.56, 95%CI 01.38, 4.76; AOR IPB+ vs. usual care 1.78, 95%CI 1.01, 3.15). Conclusion Our study demonstrated that children’s centres can deliver an injury prevention intervention to families in disadvantaged communities and achieve changes in home safety behaviours.

106 Researching children’s experience of traumatic events; exploring child behaviour in dwelling fires

Background Understanding child behaviour during injury-risk events supports development of injury prevention education and interventions, but asking children to recall events may cause distress. We found an absence of published evidence on child-reported behaviour in accidental dwelling fires. Therefore we aimed to develop methods to; identify and recruit families who had an accidental fire at home; enable families to tell their stories with minimal distress, and test the feasibility of such methods for a future study. Methods Consultation with frontline, educational and strategic staff in the Devon and Somerset Fire and Rescue Service (DSFRS), parents, young people, the mother of a burned child and working with a clinical psychologist and ethics committee Chair informed the development of methods for family identification, recruitment and participation. The DSFRS identified dwelling fires in the previous 12 months and sent study information inviting families to contact the research team. Results Leaflets sent to 218 households resulted in 8 enquiries (3.7% response) and 3 families recruited (1.4% participation). Families were more likely to engage if contacted 3–6 months after the fire than if >6 months. Five parents and 6 children took part. Face-to-face interviews included a meeting with the parents alone to learn about the fire and negotiate arrangements for the children’s interview, conducted later that day, led by a psychology researcher. Art materials enabled children’s storytelling and strategies provided to stop the interview if children became distressed. Support for families and researchers after the interviews was required. Conclusions Engaging families in qualitative studies of potentially distressing injury-risk events requires extensive preparation, flexibility and negotiation. Examples of materials and learning from this study will be presented and may be applicable to other injury research studies where hearing the voice of the child is paramount.

119 Cluster-randomised controlled trial of a fire safety injury prevention briefing in children’s centres

Background The UK has high mortality rates for fire-related deaths in children aged 0–14 years with steep social gradients. Interventions to promote fire safety practices can be effective in reducing the risk of fire-related injury. We therefore developed an evidence-based fire safety intervention comprising an Injury Prevention Briefing (IPB), training and facilitation for use in children’s centres. Methods A cluster randomised controlled trial, with integrated qualitative study, was conducted across four study sites in England involving children’s centres in disadvantaged areas; participants were staff and families attending those centres. Centres were stratified by study site and randomised within strata to one of three arms: IPB plus facilitation (IPB+), IPB only, usual care. IPB+ centres received initial training and facilitation at months 1, 3, and 8. Data collected comprised baseline and 12 months parent- and staff-completed questionnaires, home safety activity logs and staff interviews. The primary outcome was the proportion of families with a home fire-escape plan. Treatment arms were compared by using multilevel models to account for clustering by centre. Results 1112 parents at 36 CCs participated. There was no significant effect of the intervention on family possession of fire-escape plans (AOR IPB only vs. usual care: 0.93, 95% CI: 0.58, 1.49; AOR IPB+ vs. usual care 1.41, 95% CI: 0.91, 2.20). However, significantly more families in the intervention arms achieved more fire-escape planning behaviours (AOR IPB only vs. usual care: 2.56, 95% CI: 01.38, 4.76; AOR IPB+ vs. usual care 1.78, 95% CI: 1.01, 3.15). Conclusions Our study demonstrated that children’s centres can deliver an injury prevention intervention to families in disadvantaged communities and achieve changes in home safety behaviours.