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

Abstract

Background Factors 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. Methods This 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. Results Respondents 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. Conclusions Respondents 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.

Caregivers’ perception of the caring challenges in coronavirus crisis (COVID-19): a qualitative study

“…1- Reading and re-reading each transcribed interview, 2- Extracting important terms and phrases from the transcripts, 3- Assigning meaning to the extracted units, 4- Organizing and categorizing similar units, 5- Presenting comprehensive descriptions of the extracted categories, 6- Creating a basic paradigm of the subject under study according to the extracted categories, 7- Confirming the basic paradigm by having the participants verify the themes and categories [ 17 ]. An example of an analysis is outlined in Table 1 .…”

Ethical issues in biomedical research using electronic health records: a systematic review

“…It means that a patient, logging through a patient interface, is able to choose which elements of her records can be accessed by researchers and for how long. Such digital tools are already applied in research and clinical practice (Shelton 2011 , Wallace and Miola 2021 ). This is in congruence with Neal Dickert’s and his colleagues analysis that distinguishes seven different functions of informed consent.…”

Is There a Place for Responsible Artificial Intelligence in Pandemics? A Tale of Two Countries

“…Using AI for augmentation has been a preferred approach to integrating humans and intelligent machines for collective and supporting decision-making capabilities (Davenport & Kirby, 2015 ). Although AI applications in healthcare have accrued excellent resource efficiency and productivity gains (through automation) and improved quality of work and versatility (through augmentation), they also have raised many ethical concerns, including issues of privacy, security, trust, responsibility, and accountability (Murphy et al, 2021 ). Acknowledging the necessary need for the power of AI and the irreversible tide of its use, many organised and scholarly efforts have been advancing frameworks and strategies (Floridi et al, 2018 , Leslie, 2020 , Murphy et al, 2021 ) to mitigate the ethical concerns posed by the applications of AI in healthcare.…”

“…Although AI applications in healthcare have accrued excellent resource efficiency and productivity gains (through automation) and improved quality of work and versatility (through augmentation), they also have raised many ethical concerns, including issues of privacy, security, trust, responsibility, and accountability (Murphy et al, 2021 ). Acknowledging the necessary need for the power of AI and the irreversible tide of its use, many organised and scholarly efforts have been advancing frameworks and strategies (Floridi et al, 2018 , Leslie, 2020 , Murphy et al, 2021 ) to mitigate the ethical concerns posed by the applications of AI in healthcare. Nonetheless, the pandemic has added another complicating factor (urgency) to the discourse on the delicate balance between leveraging AI’s power and mitigating ethical concerns.…”

“…In this regard, when examining the literature on frameworks of models targeting the topic of AI ethics, or responsible AI, the results appear to be modest. Most of these initiatives have often been focused on establishing various groups/organisations and setting out principle documents and reports to provide necessary guidance within this domain (Murphy et al, 2021 ; Floridi, 2018 ). This includes Partnership on AI ( https://www.partnershiponai.org/ ), OpenAI ( https://openai.com ), Foundation for Responsible Robotics ( https://responsiblerobotics.org/ ), Ethics and Governance of Artificial Intelligence Initiative ( https://aiethicsinitiative.org ), Montréal Declaration for Responsible Development of Artificial Intelligence (University of Montreal, 2017 ), Principles for Accountable Algorithms (Jobin et al, 2019 ), the Good AI Society Framework (AI4people) (Floridi et al, 2018 ), and Leslie ( 2019 ) who attempted to provide some guidelines focused towards the explainability of AI systems designs and implementation from a practical perspective.…”