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To link to full-text access for this article, visit this link: http://dx.doi.org/10.1016/j.socscimed.2005.10.008 Byline: Claire Snowdon, Diana Elbourne, Jo Garcia Keywords: Random controlled trials; Decision-making; Perinatal trials; Parents; United Kingdom Abstract: For some perinatal trials, parents can be asked to make important decisions about trial participation within limited timeframes in highly stressful circumstances. This qualitative study explores the pace of decision-making for 78 parents associated with one or more of four such trials in the UK. The themes associated with rapid decisions were concern for their baby, reactions to staff, and perceptions of the benefits and risks associated with the trial. Those who took longer to decide whether or not to participate often described similar emotions to those who made rapid decisions, but their slower decisions were because more time was available, they wanted further discussion or they found the decision particularly difficult. The majority of those who made rapid decisions felt that there were no risks associated with the trial in question, in contrast to the majority of those who made slower decisions who felt there were risks. The parents did not appear to view rapid decisions as problematic. Although there was evidence of parental vulnerability in each trial context, they largely felt that they acted swiftly and responsibly in the best interests of their child in accordance with the timeframes that were set for them. Author Affiliation: London School of Hygiene and Tropical Medicine, London, UK

Randomized controlled trials (RCTs) are widely accepted by the scientific community as the most rigorous way of evaluating interventions in health care. Although their central feature, random allocation of treatment, is generally seen as methodologically appropriate, its application has caused much debate amongst health professionals and ethicists. This paper describes the views of parents who consented that their critically ill newborn baby should be enrolled in a neonatal trial. In-depth interviews were used to determine their responses to the trial and randomization. The nature of the trial was often poorly understood. The random basis of the allocation of treatment and the rationale behind this approach were also problematic issues. Some parents did not perceive a random element in the process at all. These findings advance understanding of the perceptions of trial participants and raise important issues for those concerned with RCTs. Greater understanding of participants' views provides the potential to improve the management of future trials and so the experience of those agreeing to take part. Key words - randomization, clinical trial participation, attitudes, ECMO