taped, transcribed, and analysed using N-Vivo qualitative software.10 Three independent reviewers of the transcripts identified parental reasons in the interviews. Through dialogue, a consensus set of reasons was defined—that is, societal benefit, personal benefit for their neonate, perception of risk, perception of no harmful consequences, and anti-experimentation. The transcripts were then reanalysed in the light of the reasons. To gain further insight into the experience and self report of this sample, we conducted a limited statistical exploratory data analysis. The existence of significant bivariate associations was determined using the x2 test. The binomial distribution was used to estimate confidence intervals for proportions. The association between the expression of certain reasons for research participation and declining to participate in research was estimated using the cross table odds ratio. These analyses were conducted using Stata 8.2 (Stata Statistical Software 8.2, College Station, Texas, USA). RESULTS Thirty four parents of 24 neonates spontaneously offered their reasons for or against research participation. Of these F267 www.archdischild.com Downloaded from http://fn.bmj.com/ on August 25, 2015 - Published by group.bmj.com parents, 29 were white, four were African American, and one was Hispanic. Fourteen were fathers. Eighteen received a prenatal diagnosis of congenital heart disease, and 16 had neonates who were diagnosed postnatally. The diagnoses of the neonates included hypoplastic left heart syndrome (13), transposition of the great arteries (4), total anomalous pulmonary venous return (3), coarctation of the aorta (3), and tetralogy of Fallot with absent pulmonary valve (1). Parents cited five types of reason for or against research participation during the interviews (table 2) Societal benefit Benefit to the general population was the most prevalent theme mentioned by parents as a reason to participate in a research study (18/34). ‘‘I want other families to benefit from this stuff, too’’ reported one parent. ‘‘I thought we could help other people’’ reported another parent describing why she chose to participate in the genetics study. Personal benefit The second most commonly cited reason (16/34) concerned possible benefit to their neonate, especially with the study that involved postoperative electroencephalogram (EEG) monitoring.8 ‘‘EEG provides vehicle for feedback’’ was mentioned by one father. When one parent was asked how they selected studies in which to participate, the answer was ‘‘just the ones that are beneficial to the baby.’’ Risk A third of parents (10/34) cited the risk of harm as a consideration when deciding whether to have their neonate participate in research studies. Parents distinguished between risks perceived when considering participation from risks appreciated while participating in a study. ‘‘After I saw everything they fixed to her head … I was worried that chunks of hair and skin would be missing off her head’’ expressed one parent after watching EEG leads being placed on her neonate. For parents who declined research participation because of risk, they often mentioned wanting ‘‘standard, normal care.’’ For the antihypertensive study after repair of aortic coarctation, one father reported that he declined participation because he worried that the baby might suffer harm during the five minute waiting period that the study protocol specified before the dose of medication could be changed. ‘‘I didn’t want my baby’s blood pressure to be like borderline stroke or seize and them be doing, ‘30 more seconds’.’’ No harm Nearly a third of parents (9/34) chose to participate in a research study because they perceived no risk of harm associated with participation. ‘‘I just think it was a neutral decision and it wasn’t going to hurt her in any way.’’ Others had specific examples of no harm, such as ‘‘no pricks, no needles, no chemicals.’’ One mother reported her perception of no harm as it related to the institution, ‘‘it’s top notch. You’re not going to do something that’s going to put them at risk.’’ Anti-experimentation Several parents (4/34) expressed anti-experimental beliefs. ‘‘It’s like taking your car in for an experiment basically.’’ Four parents used metaphors comparing neonates participating in research studies to both guinea pigs and frogs. One parent who gave permission for her neonate to participate in two studies and declined one study reported that she declined because ‘‘it’s more like research, just felt like he was more or less a guinea pig.’’ Time and pressure None of the parents interviewed reported having felt any pressure to participate in the research studies. One parent, however, commented that a ‘‘half hour before surgery is not the time to ask about a research study.’’ Conversely, other parents described having sufficient ‘‘time to ponder.’’ One parent advocated a prenatal approach for parental permission, ‘‘that way you’d have a couple of months to come up with questions instead of a couple of hours.’’ Timing of diagnosis, research participation, and reasons We categorised the reasons of societal and personal benefit as ‘‘pro’’ reasons, the perception of risk and anti-experimental beliefs as ‘‘con’’ reasons, and the perception of no harm associated with research participation as a ‘‘neutral’’ reason in parental research participation decision making. Five parents expressed neither pro nor con reasons; 18 expressed only pro reasons; five expressed only con reasons; and six expressed both pro and con reasons. Using these aggregated categories of reasons, we found that there was no association between when the neonate’s congenital heart malformation had been diagnosed (prenatally or postnatally) and declining to participate in any research study (p = 0.8) or in the parents’ expression of either pro (p = 0.8) or con (p = 0.5) reasons. All parents who declined to participate in a research study cited a con reason (8/8; one tailed 97.5% confidence interval (CI) 63% to 100%); conversely, among parents who cited a con reason, 73% declined to participate in a study (8/11; 95% CI 39% to 94%). Parents who expressed a pro reason were less likely to have declined