Lay persons\u2019 perception of the requirements for research in emergency obstetric and newborn care

Dan Kabonge Kaye

doi:10.1186/s12910-020-00568-1

Abstract

BackgroundFactors that could potentially act as facilitators and barriers to successful recruitment strategies in perinatal clinical trials are not well documented. The objective was to assess lay persons’ understanding of the informed consent for randomized clinical trial in emergency obstetric and newborn care.MethodsThis was a qualitative study conducted among survivors of severe obstetric complications who were attending the post-natal clinic of Kawempe National Referral Hospital, Uganda, 6–8 weeks after surviving severe obstetric complications during pregnancy or childbirth. The study that involved 18 in-depth interviews was conducted from June 1, 2019 to July 6, 2019. The issues explored included perceptions of the purpose and necessity to conduct such research how research-related information would be disclosed, and what could be the potential benefits and risks of participation. The data was analyzed by thematic analysis.ResultsRespondents felt that research was necessary to investigate the cause, prevention or complications of an illness, especially as much was known about some pregnancy and newborn complications. Most believed that the emergency contexts affects whether and what prospective participants may understand if information about research was disclosed. Whereas they did not see the value of procedures like randomization, they felt that if these and any other procedures necessary should be done transparently and fairly. The decisions to participate would significantly be influenced by possibility of risk to the unborn baby or the newborn. Solidarity was an important influence on decision-making.ConclusionsRespondents valued participation in RCTs in emergency obstetric and newborn care. However, they expressed concerns and valued openness, transparency and accountability with regard to how clinical trials information is disclosed and the decision-making process for clinical trial participation. While autonomy and solidarity are contradictory values, they complement each other during decision-making for informed consent.

Highlights

Factors that could potentially act as facilitators and barriers to successful recruitment strategies in perinatal clinical trials are not well documented
Acceptability of research in emergency obstetric and newborn care Many survivors of pregnancy complications had the view that investigations about the cause of illness was necessary, reasons given being that this was the way to develop new medications, to improve on existing medications, or to identify how to make better women who develop illness during pregnancy
The view that there was something new that needed to be understood was the major reason survivors found research in emergency obstetric and newborn care acceptable and relevant, as exemplified by two respondents: Respondent 7: “There is always a lot that is not known about illness in pregnancy

Summary

Introduction

Factors that could potentially act as facilitators and barriers to successful recruitment strategies in perinatal clinical trials are not well documented. Kaye BMC Med Ethics (2021) 22:1 emergency contexts, obtaining informed consent for randomized clinical trials (RCTs) has potential practical and ethical challenges related to disclosure, comprehension and capacity (or competence) for voluntary authorization to participate) [2,3,4,5,6,7]. These challenges include inability to communicate to (and get consent from) very sick, anxious, unconscious or sedated patients, depending on how severe the patient’s condition and what medication they are taking or have already received at the time of the informed consent process. Potential participants may have incorrect interpretations of the requirements for informed consent [5, 6, 8]

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Conclusion