3 research outputs found
Ethical review and children’s research in Ireland.
A substantial increase in research into the lives of children has been experienced over the last 20 years in many countries, including Ireland. This increase is not only in the amount of research undertaken, but also in the multidisciplinary range of such research. Research with children involves working with potentially vulnerable participants, who not only require specific protection but also have the capacity for independent agency that necessitates respect from researchers. With the increase in research, there has been a related increase in awareness by the research community of the need to ensure that all research with children is carried out to the highest ethical standards. Until recently, ethical review of research was left to the discretion of the researchers, who were generally considered sufficiently trustworthy to safeguard their participants’ rights and well-being by virtue of their education and professional standing. Over the last two decades, however, it has become more common to convene Research Ethics Committees to review research proposals with the goal of ensuring that ethical requirements are fulfilled and to provide ethical oversight to researchers. This has resulted in an increase in the number of Research Ethics Committees operating worldwide, including in Ireland.
In relation to children’s research, ethical review attempts to ensure that research projects have provisions in place that will enable researchers to do justice to the duties of both protection and respect of child participants. However, a variety of problematic issues have been highlighted. Research with children into the ethics of children’s research has identified tensions between balancing risk and benefit, on the one hand, and autonomy, competence and parental authority, on the other. The reliability and validity of review by Research Ethics Committee has also been brought into question: not only are requirements vastly different between countries (Hearnshaw, 2004), but there is ample evidence to show that decision-making by different Research Ethics Committees In the same country can differ significantly (Garfield, 1995), even when they are governed by the same authority (Angell et al, 2006). In order to counter this variability, it has been argued that increased regulation needs to be put in place and this has happened in some countries
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Evaluation of a group based cognitive behavioural therapy programme for menstrual pain management in young women with intellectual disabilities: protocol for a mixed methods controlled clinical trial
BACKGROUND: Menstrual pain which is severe enough to impact on daily activities is very common amongst menstruating females. Research suggests that menstrual pain which impacts on daily functioning may be even more prevalent amongst those with intellectual disabilities. Despite this, little research attention has focused on pain management programmes for those with intellectual disabilities. The aims of this pilot study were to develop and evaluate a theory-based cognitive behavioural therapy (CBT) programme for menstrual pain management in young women with intellectual disabilities.
METHODS/DESIGN: The study utilised a mixed methods controlled clinical trial to evaluate elements from a CBT programme called Feeling Better (McGuire & McManus, 2010). The Feeling Better programme is a modular, manualised intervention designed for people with an intellectual disability and their carers. The programme was delivered to 36 young women aged 12 – 30 years who have a Mild - Moderate Intellectual Disability, split between two conditions. The treatment group received the Feeling Better intervention and the control group received treatment as usual. To evaluate the effectiveness of the programme, measures were taken of key pain variables including impact, knowledge, self-efficacy and coping. Process evaluation was conducted to examine which elements of the programme were most successful in promoting change.
DISCUSSION: Participants in the intervention group were expected to report the use of a greater number of coping strategies and have greater knowledge of pain management strategies following participation in the intervention and at three month follow-up, when compared to control group participants. A significant advantage of the study was the use of mixed methods and inclusion of process evaluation to determine which elements of a cognitive behavioural therapy programme work best for individuals with intellectual disabilities.
TRIAL REGISTRATION: Current Controlled Trials ISRCTN7556775