Motivation to participate and experiences of the informed consent process for randomized clinical trials in emergency obstetric care in Uganda

Dan Kabonge Kaye

doi:10.1186/s12910-021-00672-w

Abstract

BackgroundInformed consent, whose goal is to assure that participants enter research voluntarily after disclosure of potential risks and benefits, may be impossible or impractical in emergency research. In low resource settings, there is limited information on the experiences of the informed consent process for randomized clinical trials in the emergency care context. The objective of this study was to explore the experiences of the informed consent process and factors that motivated participation in two obstetrics and newborn care randomized clinical trials (RCTs).MethodsThis was a qualitative study conducted among former participants of RCTs in the emergency obstetric care context, conducted at Kawempe National Referral Hospital, Uganda. It employed 30 in-depth interviews conducted from June 1, 2019 to August 30, 2019. Issues explored included attitudes about research, the purpose of the research in which they participated, motivations to take part in the study, factors that influenced enrolment decisions, and experiences of the informed consent process.ResultsRespondents felt that research was necessary to investigate the cause, prevention or complications of illness. The decisions to participate were influenced by hope for material or therapeutic benefit, trust in the healthcare system and influence of friends and family members. Many were satisfied with the informed consent process, though they did not understand some aspects of the research.ConclusionRespondents valued participation in RCTs in emergency obstetric and newborn care. Hope for benefit, altruism, desire to further scientific knowledge and trust in the investigators featured prominently in the motivation to participate. Both intrinsic and extrinsic factors were motivators for RCT participation.

Highlights

Informed consent, whose goal is to assure that participants enter research voluntarily after disclosure of potential risks and benefits, may be impossible or impractical in emergency research
Data collection occurred from June 1 to August 30, 2019 and involved in-depth interviews with 30 former research participants of two randomized clinical trials in emergency obstetric care
Personal and intrinsic factors in relation to motivation to participate in Randomized Clinical trial (RCT) Many participants believed that their participation in research was a good decision taken, giving several reasons why they found enrollment in research acceptable

Summary

Introduction

Informed consent, whose goal is to assure that participants enter research voluntarily after disclosure of potential risks and benefits, may be impossible or impractical in emergency research. Pregnancy and perinatal emergency care contexts pose numerous practical and ethical challenges related to disclosure, comprehension and decisional capacity and for voluntary authorization to participate) [1,2,3,4,5,6,7]. 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 recruitment. The emergency care context adds a stressful component to both patients and caregivers

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