Why ‘understanding’ of research may not be necessary for ethical emergency research

Abstract

Background: Randomized controlled trials (RCTs) are central to generating knowledge about effectiveness of interventions as well as risk, protective and prognostic factors related to diseases in emergency newborn care. Whether prospective participants understand the purpose of research, and what they perceive as the influence of the context on their understanding of the informed consent process for RCTs in emergency obstetric and newborn care are not well documented. Methods: Conceptual review. Discussion: Research is necessary to identify how the illnesses may be prevented, to explore the causes, and to investigate what medications could be used to manage such illness. Voluntary informed consent requires that prospective participants understand the disclose information about the research, and use this to make autonomous informed decision about participation, in line with their preferences and values. Yet the emergency context affects how information may be disclosed to prospective research participants, how much participants may comprehend, and how participants may express their voluntary decision to participate, all of which pose a threat to the validity of the informed consent. I challenge the claim that the 'understanding' of research is always necessary for ethical informed consent for research during emergency care. I argue for reconceptualization of the value of understanding, through recognition of other values that may be equally important. I then present a reflective perspective that frames moral reflection about autonomy, beneficence and justice in research in emergency research. Conclusion: While participant 'understanding' of research is important, it is neither necessary nor sufficient for a valid informed consent, and may compete with other values with which it needs to be considered.

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

“…Considering that some participants were eager to participate even before invitation, it is unclear whether the participation decision was influenced by the disclosed information. Therefore, it is unclear whether decision making for research participation should depend primarily on the disclosed information rather than participants' views and values [31,32]. Normative principles relating to how consent ought to be obtained in emergency care research contexts raise important and difficult ethical questions [28][29][30][31][32][33][34]: For instance, how should the information be disclosed to prospective participants (some of whom may be unable to comprehend the information)?…”

“…Therefore, it is unclear whether decision making for research participation should depend primarily on the disclosed information rather than participants' views and values [31,32]. Normative principles relating to how consent ought to be obtained in emergency care research contexts raise important and difficult ethical questions [28][29][30][31][32][33][34]: For instance, how should the information be disclosed to prospective participants (some of whom may be unable to comprehend the information)? Is comprehension of the disclosed information) necessary (especially if participants can demonstrate adequate knowledge before or participants do not use this information for decision-making) ?…”

A Study of a Culturally and Contextually Situated Multimedia Approach to Recruit a Hard-to-Reach Spanish-Speaking Population for a Randomized Control Trial (RCT)

“…Since then, the issue of participant understanding in relation to upholding proper ethical standards for consent has received attention. There are divergent opinions (e.g., Kaye, 2020;Wendler, 2011), but the consensus is that extra measures are required to help potential research participants better understand what they are signing-up for (Boutin-Foster et al, 2013;Wade et al, 2009). The study of strategies for communicating information about a research study to potential participants and ensuring sufficient communication required for informed consent is a relatively new area of investigation.…”

“…While a number of strategies have been identified for increasing participation among these populations, recruiting for randomized control trials (RCTs) can be particularly challenging (Bonevski et al, 2014; Shedlin et al, 2011; Stoecklin-Marois et al, 2011; Viruell-Fuentes, 2007; Winter et al, 2018). Research concepts and study designs involving randomization are complex and difficult to communicate.…”

“…FMIs are considered an underrepresented, hard-to-reach population for participation in health research. They are often extremely difficult to recruit for any study and they demonstrate a high level of attrition because of mistrust related to a negative political climate surrounding immigrants and immigration, experiences of social and historical trauma, social isolation, lack of Spanish-speaking research teams with the social and contextual skill to recruit and educate potential participants (Bonevski et al, 2014; Shedlin et al, 2011; Stoecklin-Marois et al, 2011; Viruell-Fuentes, 2007), and quotidian life factors (such as working two jobs and having to juggle children and work). Recruiting FMIs for a RCT is even more challenging because of the complexity of the research concepts involved.…”