There is concern that the environment in which consent for anesthesia research is sought may be coercive. We therefore designed this study to determine the factors that parents consider in consenting to their child's participation in clinical anesthesia research. The study sample consisted of 246 parents who had been approached for permission to allow their child to participate in a clinical anesthesia study. Parents were asked to complete a questionnaire detailing the reasons for their decision to consent or decline their child's participation. There were no differences in the demographics of the consenters (n = 168) and nonconsenters (n = 78). Perceived risk and the importance of the study were the primary factors in the parents' decisions to consent or decline. Only 2.8% of nonconsenters strongly considered a lack of privacy as a deciding factor; 15.3% stated that they had insufficient time in which to make a decision, and 0% reported having felt pressured. Furthermore, only 3.1% of consenters strongly considered an obligation to consent. Results of this survey highlight factors that influence parents' decisions to consent to their child's participation in clinical anesthesia research. We hope that this information will be important to researchers in providing an appropriate environment for obtaining consent for clinical anesthesia research studies. Implications: Parents who are approached for permission for their child to participate in a research study must be fully informed and under no pressure to consent. This study describes factors that influence parents' decisions to consent to their child's participation in clinical anesthesia research.
"Available evidence on this topic are scanty. Studies carried out in sick children show that the most important reasons influencing parents’ decision are learning more about their child’s illness and altruistic reasons (i.e. to contribute to medical knowledge or to help others)
[2-4]. Other factors highlighted in the scientific literature are the opportunity to have benefits (i.e. "
[Show abstract][Hide abstract] ABSTRACT: Background
Little is known about reasons that influence parents’ decision to participate in studies enrolling healthy children. The aim of this observational study was to verify the reasons that lead pregnant women to give their consent or to refuse participation to a newborn cohort study with a long follow up time.
To prospectively investigate the reasons that lead women to participate, to refuse the participation or to withdraw from a newborn cohort study, three different questionnaires were administered to pregnant women contacted or enrolled in the Phime cohort study, carried out in an Italian Hospital from 2007 to 2010.
Phime study participation was refused by 304 women and 145 withdrew their consent during the follow up. All these women filled in the related questionnaires. Within 632 mothers in follow up at 18 months, 430 filled in the questionnaire on motivation to participate: 97% stated that the main reason was to contribute to research; 96% and 90% stated that they wanted to benefit future babies’ and mothers’ health. Ninety-six percent of women would appreciate to know the results of analysis carried out on biological samples collected and of the overall study results. One third of the mothers (37%) wanted to be involved in the definition of future similar studies, bringing their experience and their views. Within the 304 women who refused participation, 56% stated that the study was too demanding, 26% was not interested in participating and 18% was concerned about the need to collect biological samples and to be submitted to neurocognitive tests. Fifty-two percent of 145 women who withdrew after enrollment stated that the study was too demanding (52%), and 6% was concerned about the biological samples collection.
The altruistic reason appears to be the main reported by women to decide to participate in a newborn cohort study. The fact that the study was too demanding and the need to collect biological samples are important reasons that lead women to refuse participation or to withdraw from the study. An adequate communication on these aspects should minimize difficulties in enrolment and losses to follow up.
"Altruism is frequently cited by researchers and parents as a motivation for consenting to paediatric trials, but the weight of the obligation to protect one's child means it is unlikely that it is an overwhelming consideration when parents are deliberating whether to enter their child in a trial. Regardless of whether they declined or accepted, the primary concern for parents considering an anaesthesiology trial was the child's safety . Similarly, while parents believe that clinical research with children is important, they do not necessarily wish to involve their own children in that research  and their primary objective is to protect their child from harm . "
[Show abstract][Hide abstract] 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
[Show abstract][Hide abstract] ABSTRACT: Background: The standard process of obtaining informed consent sometimes prevents physicians or patients from participating in clinical trials, partly because they are concerned about eventual treatment allocation or the physician is concerned the patient might harbor some uncertainty about the best treatment. Alternative randomization methods have been advocated that may address these and other concerns. Methods: After institutional ethics committee gave its approval, the authors interviewed 770 patients before operation and asked them to consider enrolling in a mock anesthesia trial. Patients were allocated randomly to one of five methods of randomization and consent: one-sided informed consent (the most common approach), prerandomized consent to experimental treatment, prerandomized consent to standard treatment, one-sided physician-modified informed consent, or one-sided patient-modified informed consent. Recruitment rates were compared and sociodemographic and perioperative predictors of recruitment were identified. Results: The randomization method did not result in any significant difference in recruitment rates: one-sided informed consent, 55.6%; prerandomized consent to experimental treatment, 53.3%; prerandomized consent to standard treatment, 53%; one-sided physician-modified informed consent, 60.7%; and one-sided patient-modified informed consent, 56.7% (P = 0.66). Multivariate predictors of recruitment were patient age >45 yr (odds ratio, 1.44; 95% confidence interval [CI], 1.08 to 1.93), English-speaking at home (1.49; 1.0 to 2.21), and male researcher-male patient interaction (1.37; 1.20 to 1.57). Conclusions: No evidence emerged that alternative randomization and consent designs resulted in increased recruitment rates compared with simple one-sided informed consent for a sham anesthesia trial in patients awaiting elective surgery. Older, male patients were more likely to provide consent.
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