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: 1.93). 02/2007; 7(1):12. DOI: 10.1186/1471-2431-7-12
Source: PubMed


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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    • "A way of coping with parents’ disappointment when their child is randomized to the control group is to emphasize the important role of their child as a control and appeal to the parents’ altruistic motives for participation. Even though the benefits to the child seem to be of utmost importance to parents, it has previously been shown that parents also give altruism as a major motive for participation [29-31]. It is therefore important to make it clear to the parents that the control group is precisely as important for the trial as the intervention group. "
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    ABSTRACT: When a child participates in a clinical trial, informed consent has to be given by the parents. Parental motives for participation are complex, but the hope of getting a new and better treatment for the child is important. We wondered how parents react when their child is allocated to the control group of a randomized controlled trial, and how it will affect their future engagement in the trial. We included parents of newborns randomized to the control arm in the Danish Calmette study at Rigshospitalet in Copenhagen. The Calmette study is a randomized clinical trial investigating the non-specific effects of early BCG-vaccine to healthy neonates. Randomization is performed immediately after birth and parents are not blinded to the allocation. We set up a semi-structured focus group with six parents from four families. Afterwards we telephone-interviewed another 19 mothers to achieve saturation. Thematic analysis was used to identify themes across the data sets. The parents reported good understanding of the randomization process. Their most common reaction to allocation was disappointment, though relief was also seen. A model of reactions to being allocated to the control group was developed based on the participants' different positions along two continuities from 'Our participation in trial is not important' to 'Our participation in trial is important', and 'Vaccine not important to us' to 'Vaccine important to us'. Four very disappointed families had thought of getting the vaccine elsewhere, and one had actually had their child vaccinated. All parents involved in the focus group and the telephone interviews wanted to participate in the follow-ups planned for the Calmette study. This study identified an almost universal experience of disappointment among parents of newborns who were randomized to the control group, but also a broad expression of understanding and accepting the idea of randomization. The trial staff might use the model of reactions in understanding the parents' disappointment and in this way support their motives for participation. A generalized version might be applicable across randomized controlled trials at large.Trial registration: The Calmette study is registered in EudraCT ( with trial number 2010-021979-85 (
    Trials 04/2014; 15(1):126. DOI:10.1186/1745-6215-15-126 · 1.73 Impact Factor
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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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    ABSTRACT: Protocol-eligible subjects may not be candidates for research participation or may decline. To determine factors that affected accrual, we evaluated enrollment in BABY HUG, a multi-center, randomized, placebo-controlled Phase III trial of hydroxyurea (HU) in infants with sickle cell anemia. An anonymized registry of potential subjects served as the primary source of data. Study coordinators considered all infants less than age 18 months with a hemoglobin FS diagnosis on newborn screening. Data included the number of potentially eligible subjects, whether parents were approached, and reasons for participating or declining. Of 1106 potential participants, 28% were not approached for reasons such as prior poor adherence to clinical care. Interested families expressed willingness to contribute to medical knowledge (51%), hope of being randomized to receive hydroxyurea (51%), and desire for closer clinical care (51%) as reasons for participating. Disease severity or the perception that their child was ill had less impact on willingness to participate (16%). Parents who declined cited fear of research (19%), transportation problems (14%), and the demanding nature of the study (25%). Ultimately, 234 (21%) gave informed consent, with little variability of acceptance rates among sites. Importantly, the number of subjects enrolled correlated with the number of families that were approached. Sites that excluded patients based on clinical/psychosocial biases were not more successful in recruiting than those who approached all eligible subjects. Large, demanding clinical trials require an adequate pool of potential participants. Approaching all potentially eligible patients without predetermined biases enhances success in recruitment.
    Contemporary clinical trials 11/2010; 31(6):558-63. DOI:10.1016/j.cct.2010.08.007 · 1.94 Impact Factor
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    • "Nevertheless, around two thirds of discussions between parents and practitioners about childhood cancer trials contained some mention of altruism, though it was usually raised by clinicians rather than families [90]. There was no evidence that the mention of altruism affected trial recruitment rates suggesting that it was not coercive, but a number of other studies report altruism to be a motivating factor for parents considering trial entry [28,91,92]. In some cases this could be an artefact of the study design: where people are asked retrospectively to indicate a rationale for their actions they can endorse motivations which construct these in a socially desirable light whilst free of other demands. "
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    ABSTRACT: As the number of randomised controlled trials of medicines for children increases, it becomes progressively more important to understand the experiences of parents who are asked to enroll their child in a trial. This paper presents a narrative review of research evidence on parents' experiences of trial recruitment focussing on qualitative research, which allows them to articulate their views in their own words. Parents want to do their best for their children, and socially and legally their role is to care for and protect them yet the complexities of the medical and research context can challenge their fulfillment of this role. Parents are simultaneously responsible for their child and cherish this role yet they are dependent on others when their child becomes sick. They are keen to exercise responsibility for deciding to enter a child in a trial yet can be fearful of making the 'wrong' decision. They make judgements about the threat of the child's condition as well as the risks of the trial yet their interpretations often differ from those of medical and research experts. Individual parents will experience these and other complexities to a greater or lesser degree depending on their personal experiences and values, the medical situation of their child and the nature of the trial. Interactions at the time of trial recruitment offer scope for negotiating these complexities if practitioners have the flexibility to tailor discussions to the needs and situation of individual parents. In this way, parents may be helped to retain a sense that they have acted as good parents to their child whatever decision they make. Discussing randomised controlled trials and gaining and providing informed consent is challenging. The unique position of parents in giving proxy consent for their child adds to this challenge. Recognition of the complexities parents face in making decisions about trials suggests lines for future research on the conduct of trials, and ultimately, may help improve the experience of trial recruitment for all parties.
    BMC Medical Ethics 03/2009; 10(1):1. DOI:10.1186/1472-6939-10-1 · 1.50 Impact Factor
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