Parental opinion of consent in neonatal research

Abstract

BackgroundNeonatal research, particularly neonatal emergency research is a challenging area, notably in relation to obtaining valid prospective informed consent. The aim of this study is to determine parental perceptions of the consent process involved in performing research in newborn care, to explore methods used to obtain consent and their acceptability to parents.MethodsA parental questionnaire was developed that examined attitudes towards research and hypothetical research studies, in which the acceptability of various methods of consent was examined (informed, waived, deferred). These research scenarios were of varying time sensitivity and perceived risk level. The study setting was an Irish maternity hospital.ResultsThere were 600 responses to the questionnaire. In 93% of cases, parents felt that their involvement in the consent process was essential. In emergency situations, 52% felt full prospective informed consent was necessary; however, almost 28% of parents would feel pressure to consent. Most (75%) parents would prefer to be approached to discuss neonatal research studies antenatally, irrespective of study type and 40% of parents felt that neonates involved in research studies received overall better care. Acceptability of deferred consent was greater than waived, and was highest for the more emergency-based scenarios presented.DiscussionParents feel that they should play a central role in research involving their children. There were differences in the acceptability of various consent methods with strongest agreement for informed consent and lowest agreement for waived consent. Parents were more willing to accede to deferred consent in the cardiopulmonary resuscitation scenario study. These findings provide useful insights to consent strategies in future newborn research studies.

Parental perspectives long term after neonatal clinical trial participation: a survey

“…Recently, professional stakeholders and parent representatives made recommendations to ensure effective communication in consent procedures in this setting [ 31 ]. Alternatively, other types of consent procedures avoiding recruitment during a stressful period (such as antenatal consent or deferred consent) could be explored [ 4 , 32 ].…”

Deferred consent for the enrolment of neonates in delivery room studies: strengthening the approach

“…Recently, McCarthy et al examined parental attitudes towards the appropriateness of different consent approaches for hypothetical studies with neonates. In this study, most parents preferred a prospective consent approach 31. Rich and Katheria, however, suggested that deferring consent for DR studies is acceptable for parents 32.…”

Informed consent for neonatal trials: practical points to consider and a check list

“…27 32 Informed consent setting Routine antenatal visits are a unique opportunity to provide general information to all future parents about neonatal research currently being conducted at the hospital. 33 For certain neonatal and maternal conditions, these visits can also be an opportunity to provide more specific information and discuss with parents the potential inclusion of their child into a study. 34 This may provide parents with more time to discuss compared with providing this information only at the time of inclusion.…”