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

Abstract

BackgroundInformed 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.MethodsThe 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.Results243 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%).ConclusionThe 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.

Factors affecting consent in pediatric critical care research

“…Previous studies on participation in pediatric acute care research for purely altruistic reasons have focused mainly on parental opinion surveys. In these studies parents stated a variable willingness to participate ranging from 30.2% [11] and 31% [23] to 53% [10] and 72% [24]. In 1997, Pierro and Spitz [25] reported an increasing rate of parental refusal for non-therapeutic studies in their surgical unit which they attributed in part to lack of benefit for the individual.…”

Why substitute decision makers provide or decline consent for ICU research studies: a questionnaire study

“…In these patient groups, the next of kin may be more prepared to provide proxy consent. For parents of young children, the primary motives for consenting for research are future benefit for other children and the contribution to clinical science; benefit to their own child appears to be secondary [5,6]. For adult patients with dementia, the hope of benefit to the patient or patient's descendents predominated in drug trials, while more altruistic motives prevailed in studies not evaluating potential treatments [7].…”

Assessing the interest to participate in a dengue vaccine efficacy trial among residents of Puerto Rico

“…This has resulted in cost increases, implementation delays, failure to complete trials, and biased results. [25][26][27][28] Contributing factors to recruitment and retention include lack of trust, inadequate knowledge, fear of side effects and risks, and clinical trial procedures. 25,26,[29][30][31][32][33][34][35][36][37][38][39][40][41][42][43] Although studies have been conducted to understand cultural barriers to participation and retention in clinical trials, none have been conducted in Puerto Rico.…”

“…25,26,[29][30][31][32][33][34][35][36][37][38][39][40][41][42][43] Although studies have been conducted to understand cultural barriers to participation and retention in clinical trials, none have been conducted in Puerto Rico. [25][26][27][28][29][30][31][32][33][34][35][36][37][38][39][40][41][42][43] In addition, formative research regarding factors related to participation in placebo controlled, vaccine trials is lacking. Therefore, we conducted two studies among adults and children in Puerto Rican municipalities with highest dengue incidence from 2000 to 2009 to assess factors influencing participation in dengue vaccine clinical trials in this population.…”

“…While clinical trials, including vaccine trials, have been conducted in Puerto Rico with children, only one was double blinded and placebo controlled. [18][19][20][21][22][23][24] The difficulty in recruiting and retaining participants in clinical trials is well documented, [25][26][27][28] particularly among children. This has resulted in cost increases, implementation delays, failure to complete trials, and biased results.…”