to participate (odds ratio (OR0 0.14; 95% CI 0.02 to 0.98); parents who expressed the neutral reason were not significantly less likely to have declined (OR 0.32; 95% CI 0.03 to 3.29). DISCUSSION The 34 parents who during qualitative interviews spontaneously commented on research participation cited a variety of reasons to decide whether their neonate should participate in research studies. From their perspective, these parents felt that they are able to make informed decisions by using Table 1 Participation in interviews stratified by other concurrent study participation Concurrent studies Current interview study Participated Declined Total Genetic aetiology of CHD 25 2 27 EEG/long term development 28 2 30 New anaesthetic 11 5 16 Anti-hypertensive 1 2 3 Phosphodiesterase inhibitor 3 0 3 Total 68 11 79 CHD, Congenital heart disease; EEG, electroencephalogram. Table 2 Unsolicited reasons from parents for opinions about research participation Reasons Parents (n = 34) Number Percentage Societal benefit 18 53 Personal benefit 16 47 Perception of risk 10 29 No harm 9 26 Anti-experimentation 4 12 F268 Hoehn, Wernovsky, Rychik, et al www.archdischild.com Downloaded from http://fn.bmj.com/ on August 25, 2015 - Published by group.bmj.com specific reasons of societal benefit, personal benefit, risk perception, perceived lack of harm, and anti-experimentation beliefs. They did not report feeling undue pressure given the critically ill state of their newborn child. In agreement with other investigations of parental permission, we found that parents who perceived benefit, either personal or societal, were more likely to participate than if they perceived risk.11 Rarely, though, have these investigations studied parents who had recently made decisions about research participation for sick neonates. One study, which administered a questionnaire to parents within ‘‘a few days’’ after considering research participation for their infant, reported that research participation correlated with a composite ‘‘risk, benefit, and attitudes’’ factor.12 This factor included the probability and magnitude of risk and benefit, altruism, general attitude to research, perceived complexity of decisions, freedom to make decisions, and concerns about reprisal.12 Our study also collected data within 72 hours of research participation decision, and in contrast with the close ended questionnaire study, analysed unsolicited comments from parents who spontaneously offered as reasons for research participation perceptions of societal and personal benefit, in addition to perceiving risk or lack of harm. Societal benefit is an often cited reason for neonatal research participation.2 13 In our study, societal benefit was cited by more than 50% of the parents as a reason for their neonate to participate in a clinical trial. In the large Euricon study on the informed consent process for neonatal randomised trials, 49% of the parents chose to participate to benefit future infants.2 An altruistic perspective of parents of critically ill neonates to help future babies is positively associated with research participation, in both our study and the literature.13 Personal benefit was the next most common reason for parents to choose research participation. Parents perceived the extra monitoring of an EEG portion as a clear and immediate benefit to their neonate. In other studies involving neonatal research, personal benefit was the primary reason to choose research participation.2 It has been reported that sick newborn infants may benefit from participation in a randomised controlled trial, as the placebo group had a better outcome than the eligible but non-randomised group.14 There is no clear explanation for this so called ‘‘inclusion benefit’’ phenomenon.13 Our study, with its small sample of parents, has both strengths and weaknesses. The data were collected by interview near to the time when parents had decided whether to participate in research studies, with the mean interview day only three days after their neonate had cardiothoracic surgery. This proximity of decision to data collection minimises potential recall bias, which hampers the interpretation of other retrospective studies of parental permission.15 16 Because of the spontaneous nature of parental comments about research participation, our study was not designed to link parental comments to specific research studies, and could thus do so only when parents mentioned a specific identifying feature of a study, such as the EEG leads. We used no means of objectively testing parental understanding of the specific elements of parental permission, nor did we guide them through a structured interview with regard to risks, benefits, and reasons for participation. The spontaneity of the parental comments, though, can also be viewed as an important strength of our study, as the parents were not prompted nor led to mention societal or personal benefit. Our findings suggest that systematic, prospective exploration of the reasons parents of critically ill neonates use to make decisions both for and against research participation is warranted. Furthermore, objective testing of the different elements of the parental permission process would enable comparisons between parents’ perception of risks and benefits and the actual probability and magnitude of risks and benefits. The parents’ perspective should be incorporated into the ongoing discussion of the optimal way to obtain parental permission for neonatal research participation. Authors’ affiliations S Hoehn, R M Nelson, Department of Anesthesiology and Critical Care Medicine, The Children’s Hospital of Philadelphia and the University of Pennsylvania School of Medicine, Philadelphia, PA, USA G Wernovsky, J Rychik, C Feudtner, R M Nelson, Department of Pediatrics, The Children’s Hospital of Philadelphia and the University of Pennsylvania School of Medicine G Wernovsky, J Rychik, J W Gaynor, T L Spray, Cardiac Center at The Children’s Hospital of Philadelphia J W Gaynor, T L Spray, Department of Surgery, The Children’s Hospital of Philadelphia and the University of Pennsylvania School of Medicine and Division of