What motivates British parents to consent for research? A questionnaire study

Academic Division of Child Health, University of Nottingham, The Medical School, Derbyshire Children's Hospital, Uttoxeter Road Derby, DE22 3DT, UK.
BMC Pediatrics (Impact Factor: 1.92). 02/2007; 7:12. DOI: 10.1186/1471-2431-7-12
Source: PubMed

ABSTRACT Informed consent is the backbone of a clinical trial. In children this is given by their parents. There have been many studies in the neonatal population but little is known about the views of the parents of infants and young children from within the United Kingdom. The objectives of this study were to assess what motivates parents to consent to a randomised clinical trial (RCT), their feelings on consent and participation and the factors that would influence their decision to take part in a future study.
The setting was a multi-centre randomised but non-blinded equivalence trial of oral versus intravenous (IV) treatment for community acquired pneumonia in previously well children aged 6 months to 16 years in the UK (PIVOT Study). Parents were sent a postal questionnaire at the end of the study which included open and closed-ended questions. Fishers Exact Test was used to analyse associations in non parametric categorical data.
243 children were recruited into the PIVOT study. Of a possible 235, 136 questionnaires were returned (response rate 59%). Of those questionnaires returned; 98% of parents remembered consenting, 95% felt they were given enough time to make their decision and 96% felt they received enough information. Major reasons for participation were benefit to other children in the future 31%, contribution to science 27%, benefit to their own child 18%. Most parents (85%) did not feel obliged to participate. 62% felt there was an advantage to taking part and 18% felt there was a disadvantage. 91% of parents said they would take part in a similar study in the future, stating influences on their decision being benefit to their own child (91%) and benefit to all children (89%).
The major motivation in parents consenting for their previously well child to participate in an RCT of therapy for an acute medical illness was to increase medical knowledge in the future. Most saw an advantage in taking part in the trial and did not feel obliged to participate.

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    • "The perceived risks, benefits, and importance of the study have been identified as important components of parental decisionmaking [12]. A desire to help their child, to learn more about the disease, and to contribute to medical knowledge have been primary reasons for parental consent [13] [14] [15] [16]. For example, a recent report identified that families of children with sickle cell disease who had favorable opinions of research participation perceived that their child's illness was moderate to severe and that more research is needed in sickle cell disease [17]. "
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    Contemporary clinical trials 11/2010; 31(6):558-63. DOI:10.1016/j.cct.2010.08.007 · 1.99 Impact Factor
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    • "little is known about the ethical issues raised by the inclusion of children in genetic epidemiologic research. A small number of studies have focused on parents' and children's opinions about the consent process [Brody et al., 2003; Broome et al., 2003; Geller et al., 2003; Tait et al., 2004; Stolt et al., 2005; Chappuy et al., 2006; Gattuso et al., 2006; Rodriguez et al., 2006; Eder et al., 2007; Sammons et al., 2007] and general participation [Bernhardt et al., 2003] in studies of genetic susceptibility. Some studies have looked at parents' reasons for participation or refusal, and their considerations of study risks and benefits [Tait et al., 2004; Gattuso et al., 2006; Rodriguez et al., 2006]. "
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    ABSTRACT: The National Institutes of Health and other federal agencies are considering initiating a cohort study of 500,000 people, including 120,000 children, to measure genetic and environmental influences on common diseases. A community engagement pilot study was conducted to identify public attitudes and concerns about the proposed cohort study, including the ethics of involving children. The pilot included 15 focus groups where the inclusion of children in the proposed cohort study was discussed. Focus groups, conducted in six cities, included 141 adults of different ages, incomes, genders, ethnicities, and races. Many of the concerns expressed by participants mirrored those addressed in pediatric research guidelines. These concerns included minimizing children's fear, pain, and burdens; whether to include young children; and how to obtain children's assent. There was little agreement about which children can assent. Some voiced concern about children's privacy, but most expected that parents would have access to children's study results. Some believed children would not benefit from participating, while others identified personal and societal benefits that might accrue. A few people believed that children's participation would not advance the study's goals. To successfully include children, proposed cohort study would need to address children's changing capabilities and rights as they grow and reach the age of consent.
    American Journal of Medical Genetics Part C Seminars in Medical Genetics 02/2008; 148C(1):31-9. DOI:10.1002/ajmg.c.30159 · 3.54 Impact Factor
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    ABSTRACT: 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 chil-dren. A new EU regulation came into effect in 2007 to ensure that medicinal products that are researched, developed and authorised will also meet the thera-peutic 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 re-viewed empirical studies which examined eligible outcomes. The findings of these studies were analyzed in a broad qualitative and descriptive bottom-up proc-ess. Results: We found that the understanding of ad-vanced 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 compre-hension of information given in the consent process should be secured by improving the information ma-terial. The communication process should be more mutual. Children and their families should be em-powered to address their needs in the process of con-sidering participation in a clinical trial.
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