Abstract
BackgroundConducting clinical trials with pre-term or sick infants is important if care for this population is to be underpinned by sound evidence. Yet, approaching the parents of these infants at such a difficult time raises challenges to obtaining valid informed consent for such research. In this study, we asked, What light does the analytical literature cast on an ethically defensible approach to obtaining informed consent in perinatal clinical trials?MethodsIn a systematic search, we identified 30 studies. We began our analysis by applying philosophical frameworks, which were then refined as concepts emerged from the analytical studies, to present a coherent picture of a broad literature.ResultsBetween them, the studies addressed four themes. The first three were the ethical basis for parental informed consent for neonatal and/or perinatal research, the validity of parental consent in this context, and the range of possible options in methods for gaining consent. The last was the issue of risk and the possibility of a double-standard or asymmetry in the current approaches to the requirement for consent for research and consent for clinical treatment.ConclusionsIn addressing these issues, the analysed studies showed that, whilst there are a variety of possible defences for seeking parental ‘consent’ to neonatal and/or perinatal clinical trials, these are all consistent with the strongly and widely held view that it is important that parents do give (or decline) consent for such research. So far as the method of obtaining consent is concerned, none of the existing consent processes reviewed by the research is satisfactory, and there are philosophical reasons for supposing that at least some parents will fail to give valid consent in a neonatal context. Furthermore, in giving parental ‘consent’ in a perinatal context, parents are authorising infant participation, not giving ‘proxy consent’. Finally, there are reasons for giving weight to both parental ‘consent’ and the infant’s best interests in both research and clinical treatment. However, there are also reasons to treat these factors differently in the two contexts, and this may be partly due to the differing relevance of risk in each case. A significant gap is the lack of any detailed discussion of a process of emergency and/or urgent ‘assent’, in which parents assent or refuse their baby’s participation as best they can during the emergency and later give full consent to continuing participation and follow-up.Electronic supplementary materialThe online version of this article (doi:10.1186/s13063-016-1562-3) contains supplementary material, which is available to authorized users.
Highlights
Conducting clinical trials with pre-term or sick infants is important if care for this population is to be underpinned by sound evidence
What light, does the analytical literature cast on an ethically defensible approach to obtaining informed consent in perinatal clinical trials? We suggest that these results reveal five key points about the consent process and highlight one important gap in the research
There are a variety of possible defences for seeking parental ‘consent’ to neonatal and/or perinatal clinical trials, and these are consistent with the strongly and widely held view that it is important that parents do give consent for such research, as found in the empirical literature [1]
Summary
Conducting clinical trials with pre-term or sick infants is important if care for this population is to be underpinned by sound evidence. Approaching the parents of these infants at such a difficult time raises challenges to obtaining valid informed consent for such research. The recruitment of pre-term or sick infants to trials requires approaching parents at a difficult time, often within a tight time frame for making a decision. This raises challenges for the obtaining of valid informed consent to such research. We undertook two systematic reviews of the research addressing these ethical challenges within the context of a larger project focused on improving care for the pre-term infant. The aim of the review of the empirical research was to synthesise observational and qualitative studies that explored the process of recruitment and consent, and parents’ and clinicians’ views and experiences of that process [1]
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