Perceptions of motivation and willingness to participate in randomized clinical trials in emergency obstetric and newborn care among survivors of severe obstetric complications

Previous studies have shown that participants in emergency research may not understand the research and therefore may not make informed decisions to participate. Little is documented about motivation for research participation in randomized clinical trials in emergency obstetric and newborn care. Conducted among survivors of severe obstetric complications, this study sought to assess beliefs, perceptions and values as well as motivation and willingness for participation in research. This was a qualitative study conducted among 18 survivors of severe obstetric complications who were attending the post-natal clinic of Kawempe National Referral Hospital, Uganda. The participants were contacted 6–8 weeks after surviving severe obstetric complications during pregnancy or childbirth. Eighteen in-depth interviews were conducted from June 1 to July 6, 2019. The issues explored included interviewees’ perceptions and beliefs regarding 1) what constitutes clinical trial research in emergence obstetric and newborn care, 2) the purpose and necessity to conduct such research, 3) how emergency research-related information should be delivered to potential participants and their caregivers, 4) why women would be willing and motivated to participate in this type of research, and 5) the potential benets and risks to research participants. Data were analyzed according to themes using the constant comparative method.


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Background In pregnancy and perinatal emergency contexts, obtaining informed consent for randomized clinical trials (RCTs) may be complicated by challenges related to information disclosure, comprehension and competence for voluntary authorization to participate. In the current best practice, written trial information often describes, among other things, the purpose, risks, potential bene ts, and what will happen during the study; however, participants may not comprehend the information [1][2][3]. It may also not be clear to participants why they are expected to conduct themselves in a certain manner, or why they have to accept certain procedures to be performed in a stipulated manner [2,3]. What motivates prospective participants to consent for research in low-and middle-income countries (LMICs) may be related to how they understand the disclosed information. Informed consent to participate in research involves understanding of the purpose, bene ts, risks and alternatives to participation, with clear differentiation between medical care and research, much as clinical research may entail involvement in clinical care-related activities [4,5].
Several publications [1,3,4,6,[7][8][9] show that many participants may not understand research and therefore may not make informed decisions to participate. For instance, a study that assessed participant understanding of clinical trial information (three months after clinical trial enrollment) found that only 23% knew that treatment was randomly allocated, only 57% knew they might receive a placebo, and only 42% knew that adverse effects could occur [6]. Yet this study was conducted among participants who were not in a critical care context at the time of enrollment. Obtaining informed consent in emergency contexts is beset with several potential challenges related to failure to disclose information or failure to understand disclosed information about the research. Challenges include potential inability to communicate with (and obtain informed consent from) very sick, anxious, unconscious or sedated patients [7][8][9]. Also, critically ill patients' cognition may be compromised by the illness or the ongoing emergency treatment [7][8][9]. Such individuals are even less likely to comprehend or remember salient factors related to the research in which they participate and may lack the decisional capacity to give voluntary consent [1,4,6,[7][8][9].
The factors that in uence willingness to participate in research in emergency obstetric and newborn care may include altruism and pre-formed decisions made prior to invitation to participate [10][11][12][13][14][15][16]. For instance, in a clinical trial in pediatric care, some participants went through the process of informed consent when they had already made up their minds to accept research participation [10], indicating that the disclosure of clinical trial information may have had little in uence on their decisions or willingness to participate. This may be for altruistic reasons, therapeutic optimism or therapeutic misconception [11]. A systematic review of participation in a clinical trial by pregnant women [12] found that aspirational, collateral and direct bene ts, third party in uence, and absence of inconvenience were factors that facilitated decision`s to participate. In this study [12], barriers to participation included inconveniences, (perceived) potential risks, and lack of trust in the research enterprise. Altruistic reasons, therapeutic optimism and a desire to get information about their children's health are important factors that in uence willingness and decisions by mothers (for their newborns) to participate in research [13]. For instance, in a newborn cohort study that investigated the theoretical acceptability and willingness of mothers to involve their newborns in clinical research [ [13], altruistic reasons were the main driver given for the mothers' consent to research participation. The possibility that the mother would consent was higher if the child was healthy, if the clinical research was intended to solve a child's speci c problem, and if the perceived study risks were low [13]. Also, the most important reasons for parents' acceptance of their children's participation in clinical investigations, in addition to altruism, was a need to learn more about their children's illness [14][15][16].
Theories that describe motivation include the incentive theory, humanistic theory, drive theory and expectancy theory [17]. The incentive theory suggests motivation depends on external rewards, and individuals intentionally pursue certain actions so as to gain rewards. The humanistic theory posits that individuals have strong cognitive reasons to perform various actions, according to the hierarchy of needs, which represents different motivations at different levels of need. In line with the drive theory of motivation, individuals are motivated to take certain actions so as to reduce internal tension from uncertainty caused by unmet needs (such as illness, fear of pregnancy complications or worries about making the correct decision regarding participation). The expectancy theory posits that when individuals think about the future, they formulate different expectations such that they actively pursue actions that enable them to achieve positive outcomes. In this study, in line with the above theories, motivation was de ned as the compelling reason(s) an individual has for acting or behaving in a particular way in given circumstances, arising from within the individual (intrinsic motivation), or inspired by other people or events (extrinsic motivation). The theoretical framework for this study was the socio-ecological framework, which is suitable for analyzing motivation. An individual's motivation for enactment of a behavior may be in uenced by intrinsic factors or extrinsic factors. Intrinsic factors are factors within the individual (such as personal need for healthcare or urge and desire to help others). The extrinsic factors also include interpersonal interactions with the healthcare system (in case of any health needs for self or for others), and interactions with immediate family contexts, community or society. This socio-ecological framework was used to assess personal factors (health status, knowledge, attitudes, perceptions, beliefs and misconceptions), interpersonal factors (in uence of family and peers), community-level factors (institutional policies, practices and traditions) and society-level factors (such as legislation and healthcare policies).
The socioecological framework recognizes that whereas individuals are responsible for enacting own behaviors, individual behavior is in uenced by factors at different levels. The objective of this study was to gain a deeper understanding of factors that potentially motivate participation in obstetric and newborn clinical trials among survivors of obstetric complications in Uganda. This population theoretically could have been potential participants in emergency obstetric research if an opportunity to participate were available. We explored perceptions of survivors of obstetric complication on potential motivation and willingness to participate in randomized clinical trials in emergency obstetric and newborn care.

Study setting and participants
This phenomenological study was conducted in the postnatal clinic of Kawempe National Referral Hospital, a 450-bed specialized obstetrics and gynecology referral hospital in Kampala, Uganda, which serves as one of the public referral obstetric hospitals for Uganda. The hospital is also a research setting for several local and international clinical research projects, including clinical trials-conducted by graduate students and other researchers in Uganda. Consequently, many mothers are usually involved as participants in clinical research projects, though most of these are observation studies, as for ethical constraints, clinical trials in this populations are few. The study participants in this study were survivors of severe obstetric complications-where the mothers and newborns were at risk of morbidity or mortalityincluding severe preeclampsia/eclampsia, antepartum hemorrhage and obstructed labor. These women, who were attending the postnatal clinic at this hospital, were contacted 6-8 weeks after the obstetric events.
Data collection procedure Data collection occurred from June 1 to July 6, 2019 and involved in-depth interviews with 18 survivors of severe obstetric complications (see Table 1) during their postnatal visit (at least 6 weeks after suffering severe obstetric complications during pregnancy or childbirth). The inclusion criteria were women aged 18 years or older, with history of severe obstetric complications, and providing informed consent for participation. Participants were purposefully selected on their routine appointments to the postnatal clinic. They were identi ed by both the research assistants and the investigator (DKK), after which they were given information about the study by the research assistants and invited to participate. To verify eligibility, the investigator assessed the patients' medical records to con rm that they had suffered a severe obstetric complication (severe preeclampsia, eclampsia, obstructed labor or obstetric hemorrhage during immediate prior pregnancy or childbirth). Potential participants provided written signed informed consent after being provided with detailed information about the study, which was reviewed verbally with each individual. Prospective participants were given assurance that they were free to decline, and that even if they declined, their decision would not affect the care that they were entitled to from the postnatal clinic. They were also assured that their information would be kept con dentially and no identi able information would be revealed. A copy of the signed consent form was also provided to each participant. While all respondents understood both languages, the interviews were conducted in English for 12 participants, in Luganda only for 3 participants and both English and Luganda (3 interviews). With permission from study participants, the interviews were audio recorded and eld notes were taken to provide an opportunity to document impressions, contexts, behaviors and nonverbal communications, which could be relevant to how participants understood research and what meanings they would attach to an invitation to take part in research during emergency obstetric and newborn care. For instance, from their voice tone, emotions and eagerness to respond, particularly on recalling the experiences at time of complications, one could surmise degree of willingness to participate if they had been invited to participate.
Issues explored, through semi-structured interviews included: 1) what constitutes clinical trial research in emergence obstetric and newborn care, 2) opinions and perceptions regarding the purpose and necessity to conduct such research, 3) perceptions on disclosure of trial information (how and when should participants be invited and how information about research participation should be given to potential participants), 4) what factors may affect comprehension of disclosed information (such as severity of disease, language use, decision aids, ways in which the information is presented, ease of reading the consent document, contextual factors such as research environment, privacy, con dentiality), 5) why women would be willing and motivated to participate in this type of research, and 6) the potential bene ts and risks to research participants.

Data analysis
During data analysis, eld notes provided important context to the interpretation of audio recordings of interviews from the non-verbalized communications, responses and behaviors. All audio recordings were transcribed verbatim and compared with eld notes to add to the meanings stated in the responses. Once transcription was complete, transcripts were read carefully while listening to the audio recording so as to correct any areas that needed clari cation. Other eld information, such as pauses, laughter, looks of discomfort, as well any other contextual information that might have affected the participant were inserted into the transcripts, using periods such as punctuation, commas or full stops. The information in the transcripts was anonymized by deleting reference to names, places or signi cant events that could enable identi cation of the individual participants.
The codes were aggregated into themes (groups of word patterns or phrases with similar meaning) to provide a description of the experience of the phenomenon (motivation and willingness to participate in randomized clinical trials during emergency obstetric care). Representative quotes from participants derived from the individual transcripts were included to illustrate the source of interpretations of information.

Ethical considerations
This research was reviewed and approved by the Makerere University School of Medicine Research and Ethics Committee (SOMREC) and Mulago Hospital Research and Ethics Committee. The Institutional Review Board of Johns Hopkins University School of Public Health relied on SOMREC as the IRB of record. Permission to conduct the study was also obtained from the Department of Obstetrics and Gynecology, Makerere University. As noted above, the study posed potential risk of psychological distress if individuals were reminded of unpleasant past experiences during their prior hospitalization with acute illness. Any information shared about unpleasant experiences from previous obstetric complications was received in an empathetic manner. Participants who seemed emotionally affected by recall of unpleasant experiences during pregnancy or childbirth were counseled.

Motivation to participate in research
All the women who were invited agreed to participate in the study. Table 1 shows the socio-demographic and clinical pro les of respondents. All these had severe obstetric complications that constituted the severe morbidity, which included severe obstructed labor, eclampsia and obstetric hemorrhage. All except two had completed at least primary level of education, three had participated prior in clinical trials for prevention of Mother-to-Child HIV transmission, and only 2 were primipara, indicating that they had prior experiences with the healthcare system before the index pregnancy or delivery where they developed obstetric complications.
Many survivors of pregnancy complications had the view that research about the cause of illness was necessary to obtain answers to many questions about pregnancy-related complications so as to develop new medications, to improve on existing medications, to examine the causes of illnesses or to identify how to improve the health of women during pregnancy, as exempli ed by two respondents: Respondent 7: "There is always a lot that is not known about illness in pregnancy. And sometimes emergencies occur suddenly. On one day you are ne, the next day you are very sick. Even doctors cannot explain why the diseases occur. It is necessary to nd answers to those questions." Respondent 2: "Finding out better ways of treating disease is good. Investigations provide answers to many questions about the disease. They are therefore necessary even when you know that gathering the evidence requires many pregnant women to be involved, even if it may lead to some dangers to pregnant women, with all the risks that (it) entails." Some respondents, especially when asked about whether it is acceptable for them to be involved in those investigations, were of the view that in such emergency situations, investigations were not the priority.
Rather, it was providing the necessary emergency care that was a priority, but acceptance would depend on how the information was communicated and on whether the mothers understood, as exempli ed by two of the respondents. Preferences regarding consent process Regarding how invitation to participate should be communicated, most respondents were of the view that this should be when they or the unborn babies were out of danger, and therefore when they could understand without what was referred to as "pressure", "stress" or "anxiety. " The respondents preferred that the information would need to be simpli ed and brief, if they were to consider participating, as exempli ed by two respondents: Other respondents were of the view that the information about the research should be given privately or individually, rather than to everyone present, and participation should be con dential. Privacy and con dentiality were highly valued, as exempli ed by one respondent: Respondent 5: "They need to come to you and then ask, are you going to take part. That should concern only me. I may not want other people, even my relatives to know that I am involved." Interviews explored whether randomization to different study groups, may in uence trial acceptability. Most participants did not understand the reason or bene t of randomization. While seemingly in con ict with the concept of randomization, most respondents were of the view that the investigators would decide what was best for them, and therefore they would not mind the randomization procedures. Thus, to most participants, it was okay for the investigators to decide for them, and they trusted them to make the correct decisions for them. This misunderstanding signals trust in clinical researchers to do what is best for individual clinical trial participants regardless of methodological constraints such as the need for randomization, and is exempli ed by two respondents: Solidarity and communal consent The community played an integral role in the uptake and acceptability of clinical trials amongst respondents. Patient decision-making was intimately tied to the relationship with others in their local community, whose advice was considered important for the decision whether or not to participate. This is exempli ed by three respondents: Respondent 1: "I have ever looked after a mother who was involved in something like that (participated in an HIV drugs trial during pregnancy). Before joining, we discussed the ideas and thought it would be a good thing. Most respondents considered the advice of family members and friends as very crucial in decisionmaking, especially in emergency situations. A number of participants reported that the bene ts of the trial should be available to everyone involved, including other patients and community members, so because of that, their advice regarding participation was necessary. This would place the need for high standard of health care to be extended towards the patients in the investigation and that other community members would guarantee that the correct things are done. Members in the community, not only those involved in the study, would share the blame rather than the individual alone if something went wrong, as exempli ed by one respondent.
Respondent 3: "If the purpose if generating information to help science, then it should not be a personal responsibility but a responsibility of everybody. This means that even the community members, the health facility managers and local political leaders should have a say about which investigations are acceptable… If they gave a green light prior, then that makes it easy for me to accept invitation to participate. Because then I know the major concerns that I may also have would have been addressed." The local political leaders and other trusted members in the community were thought to have a signi cant in uence on clinical trial acceptability. When the local leader or in uential person (such as a nurse or doctor) is trusted by the community members and this individual approves the trial, the potential study participants will be much more comfortable with the invitation and (making own) decision to participate in the clinical trial. The prior acceptance by the community, especially the in uential members, that such investigations should be conducted is a guarantee for easier acceptance and motivation to participate in the clinical trial. Similarly, this prior acceptance reduces the likelihood of declining further participation or default by participants (such as loss to follow up) from the clinical trial requirements as exempli ed by other respondents:

Bene ts, risks and compensation for research-related harms
Most participants were of the view that participation should involve possibility of personal bene t for them, their unborn baby or the newborn at birth. Regarding potential bene ts, the respondents suggested that they expect individualized care, better care or some medications if they agreed to participate, as exempli ed by two respondents: Respondent 1: "They have to convince me that it is a good idea. They need to talk to me in a language I understand best, not English. I expect that they would provide me with better care. For instance, get me the drugs I need, or give me better attention." Respondent 7: "At least they should contribute to some of my expenses like on drugs or food. They have to assure me that there is something to gain for me or my baby…I need to later be able to say, yes, taking part was a good idea. I want a higher standard of care if I participate. This can only be if I am better off than those who do not take part." For many respondents, hope for bene t was a signi cant motivation for clinical trial participation. This is exempli ed by the following respondents: Respondent 1: "I had to buy most of the drugs. If you are very sick, they (doctors and nurses) tell you buy this and that medicine, that it will make you get better. Before the research study, when you visit the government hospital, you pay for the tests, you buy the medicines and sometimes you do not have the money. If they can provide the drugs I need, then I would take part. That may save me some of the expenses." While most participants could be motivated by the need to help other mothers (without possibility of personal bene t), they were not willing to accept the invitation unless their newborns were to bene t, that is, they were unwilling to participate in research for the sake of generating information to help other newborns. This is demonstrated by the respondents below: Respondent 6: "Maybe for myself I can accept participation even if I may not bene t, as long as my participation could bene t other women so that they do not suffer like me. However, where my baby is involved, I cannot do anything like that. I can't participate for the sake of helping others." Respondent 14: "Sometimes you hear rumors that those involved in research are given free drugs and they pay for the laboratory tests and other investigations. If they invited me and I knew they offered these, then I would not hesitate to join." Respondent 11: "I would not have a problem making the decision (to participate in research). But many times, you take part but you never know what has come out of the blood and other samples they take. If I were to know the results, then I would take part…Even if I may not personally bene t, I would need to know the results…If it is for my baby to take part, I would not accept, unless my child is to bene t." Other respondents suggested that participation would depend on how they were approached and how the invitation to participate was presented. A prior positive relationship cultivated with them by health workers would make it easier for them to make the decision to participate. This is exempli ed by two respondents below: Regarding potential burdens or risks, respondents suggested that participation may lead to spending a longer period of time in the health facility as researchers complete the study, or due to some unexpected harm. Where there may be a possibility of signi cant harm, most respondents would either hesitate to participate, or would decline the invitation to continue participation, as exempli ed by two respondents: Respondent 8: "You never know what happens. If they give you medication that is not fully tested, the baby may be affected. Even me I may get complications. In that case I will have to decline or may leave their study." Respondent 6: "They may keep you longer in hospital because they still want you to do this or that procedure, taking off more blood, doing more checks on you. If what they tell me involves any of that, then I would not join. I would not want unnecessary delays." Respondents were highly in uenced whether or not to participate by whether there would be risks for their baby. Risks to the mother herself were secondary, in comparison. The main reason for giving the baby priority was that the baby needs to be able to grow optimally and survive the pregnancy. Most respondents reported that they would tolerate more risk than they would tolerate for the baby, as exempli ed by several respondents: For research that involved invasive research procedures, women were willing to accept procedures that included blood draws or caesarean section among the study procedures, provided they were assured of safety for them or their unborn baby. However, they needed guarantees that these procedures have a clear medical indication and would be similar to procedures that are undertaken in case of obstetric emergencies. This is exempli ed by three respondents: Respondent 1: "I am sure many women suffer the same problem I had. If (taking part in research) can put my baby in danger, I cannot accept. I would not accept anything that they are just trying out…May be some risk for me is acceptable, but for my baby, the danger should be zero if I am to accept for the sake of bene tting others. ..I cannot accept treatment chosen by chance or lottery. It should be medicine that works…I think many would also do the same (accept to take part in research) to help other women".
Respondent 6: "When I remember what I went through, I think it is important to help others in that critical period to also have this joy, to be able to appreciate my happiness that I went through this period well… There may be some danger. But if there is hope, then I would accept and go through it... May be this is God's way of using me to help others… But I would leave immediately if I suspect some serious danger to my baby," Respondent 3: "I had to buy most of the medications. Even many investigations (like the ultrasound scan) were not free. If the participation may provide you a chance to have someone else meet these costs, then I would willingly participate." On the issue of whether there should be compensation for adverse events or harms that may arise during the research, most respondents were of the view that it is the responsibility of investigators to plan and provide compensation, regardless of whether harms that eventuate were foreseeable. Participants were more concerned about harms or injuries that may cause death or disability (either serious or permanent). Respondents perceived that the responsibility of compensation should be guaranteed by the community or health facilities and should be enforceable. Monetary compensation, provision of treatment for the adverse event, or both, were thought necessary and the type of response was thought to depend on the circumstances and nature of the complication. In the absence of an appropriate response, respondents believe that researchers should be held responsible and could even be sued to obtain the compensation. This is exempli ed by two respondents: Respondent 1: "If the investigators suspect that my life may be put in danger, they should be ready for compensation by treating me or my baby, and even pay me some money for the trouble caused to me. … The society should guarantee that this happens and should put the investigators to task if they fail." Discussion This study found that perceived level of risk to the unborn baby or newborn, in comparison to perceived potential risk to the mother, had more in uence on motivation and willingness to participate in clinical trials in the emergence obstetric and newborn care setting. Secondly, hope of some bene t, either therapeutic or material, heavily in uences decisions for clinical trial participation. Thirdly, community solidarity and community decision-making in uence individual decisions. Depending on the context, the degree of in uence may be persuasive enough to affect independent process of the decision to participate, thereby affecting voluntariness for trial participation. Lastly, contextual factors, particularly poor access to needed health services and trust in the healthcare system in uence motivation and willingness for clinical trial participation.
The ndings are in agreement with ndings of a systematic review on facilitators and barriers for pregnant women's participation in research [12], which found that (aspirational, direct and collateral) bene ts, third-party in uence and absence of inconvenience were facilitators, while lack of trust in research, perceived risks and third-party in uence were barriers. Similarly, a study that investigated reasons why women may consent to have their newborns participate in pediatric research [13] found three main predictors: perceived importance of the study, perceived bene ts and low perceived risk (if risk to the fetus is minimal, participation may be acceptable). Likewise, from the socio-ecological framework, diverse factors acting at different levels in uence decisions for clinical trial acceptability or continuing trial participation [11,12,13,28,29].
The perceived in uence of the community in motivation for clinical trial participation The perceived in uence of the community in motivation for clinical trial participation suggests that the community level is a major potential locus of decision-making for research participation in emergency obstetric and newborn care. This locus operates through in uence on clinical trial acceptability in general and in uence on willingness or motivation for individual trial participation. The nature of in uence may be such that it affects an individual's ability to process the information in line with their own preferences and values. In that way, the in uence poses a potential threat to voluntariness for research participation. The in uence may affect appreciation (recognition of the nature, meaning and signi cance of the decision to participate); reasoning (the ability to process the information and derive conclusions, including ability to weigh risks, bene ts and evaluate potential consequences) and values (or ability to recognize and express consistent and stable set of ideals that guide reasoning on the process of making choices). The effect on voluntariness does not mean that potential participants should neither seek or value what others think about the participation decision nor count that in uence as essential towards their motivation to participate. However, the in uence becomes critical if (in a situation where one knows what others think about their decision), individuals cannot make an independent decision or do not feel that they own the decision afterwards. In this perspective, individuals may nd themselves compelled by circumstances or external pressure to make decisions which may be contrary to their ideals, values and preferences, much as the decision is independent (that is, the ultimate decision to make the choice was theirs).
In addition, the perception of clinical trial participation as 'bene t-sharing' may impede individual choice with regard to balancing risks and bene ts prior to decisions for enrolment. Individuals may nd themselves compelled by the need for some material or therapeutic bene ts, though the ultimate decision remains in their power. A community or health facility's failure to balance the provision of care with opportunities for clinical trial participation to the patients (or their caregivers) could lead to an 'empty choice' (where clinical trial participation is practically only one viable option) [28]. This situation could occur where structural factors related to challenges in healthcare (such as absence of basic medications) impede balanced decision making [28,30,31].
The emergency obstetric care research context apparently has potential to affect both voluntariness, particularly in emergency situation where life is usually at stake and decisions may need to be urgently made regarding clinical trial participation. Any in uence on understanding ultimately affects decisionmaking, even if it may not affect autonomy, competence or voluntariness. Such in uence includes basic understanding (comprehension of the facts involved in that decision); appreciation (insight' into the circumstances of a given decision, that is, recognition of the nature, meaning and signi cance of the decision); reasoning (the ability to process the information and derive conclusions including ability to weigh risks, bene ts and evaluate potential consequences); choice (availability of choices and ability to express or communicate the intended decision or choice); or values (ability to recognize and express minimally consistent and stable set of values to guide reasoning on the process of making choices). The in uence, if inappropriate may be potentially manipulative or persuasive for mothers in emergency contexts, and thus may negatively or positively in uence participation in clinical trials, and potentially in uence discontinuation. The ethical guidelines [4,6,7] require that a decision to participate should not be unduly in uenced by other factors, and that clinical trial-related information should be disclosed, there should be comprehension, and potential participants should use this information to process risks, bene ts and alternatives, and that individuals should make an independent decision in line with their preferences and values. The study ndings that many potential participants either do not understand randomization or don't care about its implications are an apparent contradiction to the requirements of regulations and guidelines which require understanding of the process of randomization in clinical trials.
The expectations of the community and study context to in uence clinical trial participation has been reported in prior studies [10][11][12][13]. For instance, in a mixed methods study nested in a malaria vaccine trial [10], over 60% of mothers accepted because of free medication where the initial sources of information were neighbors or friends for over 60% of respondents. Similarly, over 95% of 342 respondents had already made a decision to participate by the time they were interviewed, and over 85% indicated intentions to participate if asked [10]. The study ndings suggest that while employing culturally appropriate means of engaging potential research participants prior to or during may be challenging, it may be more appropriate and acceptable for research in emergency obstetric care contexts [29]. This may involve community engagement, harnessing communitarian consent and nurturing solidarity.
Communal decision-making goes beyond traditional philosophical and ethical notions of autonomy and informed consent, to acknowledge in uence of signi cant "others" in the decision-making for clinical trial participation in certain contexts [29,36,37]. This recognition acknowledges that respondents are embedded in communal lives, where other members of the community contribute to the health and welfare of others, and therefore could contribute to decision-making about healthcare seeking [36], and thus, to clinical trial participation. Communal decision-making acknowledges that individuals are also social persons who reside within a particular socio-cultural context, which in uences those individuals' viewpoints as well as their normative set of values and ideals, including those values regarding decisions for and the informed consent process for research participation [36]. This is not ethically problematic (does not compromise voluntariness for research participation) as long as individuals remain with the option to make the nal decisions regarding research participation.
An individual-based informed consent model may be problematic in settings and contexts where norms of decision-making emphasize communal decisions and solidarity rather than individual autonomy [29,36,37]. Each individual may have their own understanding of who they are, what they value, how they and others should be treated as people, and what important relationships need to be honored [36]. Similarly, each individual may have his/her speci c views about disease and illness, with related fears, concerns and unanswered questions [36]. While individuals may have different ways of interpreting consent, disease and illness, communal views, values and questions regarding illness, ill-health and research may in uence research participation [37].

Solidarity and motivation for research participation in emergency obstetric care
Much as solidarity is not well utilized in bioethics [38], it may be an important consideration, as much as altruism, for research participation in emergency obstetric and newborn care [39]. Ter Meulem [40] presents solidarity as the degree of social cohesion in a group or society whereby individuals, because of various motivations, are willing to serve and promote the collective interest of the group or of society. The possibility of willingness to participate in research without possibility of potential bene t, yet with conviction that others may be helped, and expectation of others to do the same at a time of need, represents more of solidarity rather than social capital, altruism or mere reciprocity. Willingness to support the greater good (as part of solidarity) does not impose on individuals a moral imperative to do so [40] and neither does it impose an imperative to accept the in uence of others. There are reports that informed consent for community research in many areas of sub-Saharan Africa is communal [41] and a manifestation of solidarity. Solidarity refers to the shared vulnerabilities of where community members engender initiatives for helping them to address unmet needs, including bearing costs of assisting others regarded as similar [42]. It represents disposition to call for-and expect-assistance when in need [42] when faced by shared risks, vulnerabilities and opportunities [43. In this study, much as women would participate in research (to generate information that might help others, even where they themselves would not bene t), they had concerns about the health of their children during research participation, and expressed no interest in joining simply for the sake of helping others especially if participation could put the baby at risk. This solidarity may motivate individuals to decline enrolment or ongoing participation, in cases of mistrust or miscommunication about trials [32,[44][45][46]. Solidarity a rms that individuals have agency and power [47,48] to accept or refuse the in uence of others in line with their preferences and values.

Conclusion
Many women who suffered pregnancy complications were potentially willing to participate in research during emergency obstetric care. Motivations for participations include possibility of bene t for others or baby, but for altruism and solidarity only if the mother were to participate with assurances of no potential harm to the pregnancy or newborn. Trust in the investigators was a strong perceived predictor of willingness to participate in research. Thus, investigators should be mindful of this and consider whether research poses any additional risk (beyond the risk of usual obstetrical complexity to the pregnancy or newborns) when they discuss research with potential participants in the emergency obstetric and newborn care context. Irrespective of whether the research addresses maternal, fetal or newborn problems, researchers should employ measures that reduce potential risks (as well as maximize potential bene ts) of participation to women, the unborn babies or the newborns. Secondly, investigators ought to employ strategies to foster, employ or strengthen culturally appropriate means of engaging potential research participants prior to or during enrollment, including solidarity and community consent. Thirdly, investigators should prioritize building trust in the healthcare system (and in research itself), by addressing research problems that address perceived community needs and through maintaining professional credibility.

Declarations
Ethics approval and consent to participate This research was approved by the Research and Ethics Committee of Makerere University School of Medicine, and Mulago Hospital Research and Ethics Committee as well as permission from the Department of Obstetrics and Gynecology, Makerere University. Participation in this research was voluntary and respondents provided informed consent. Prospective participants were given assurance that they were free participate and that even if they declined, their decision would not affect the due care that they were entitled to. They were also assured that the information collected from them would be kept con dentially and no identi er information would be revealed. Permission was obtained from the participants to have the interview proceedings audio recorded, with assurance that the recordings were only for research purposes and were to be kept con dentially. The study posed potential risk of psychological harm if potential participants or participants were reminded of unpleasant past experiences during their prior hospitalization with acute illness. All the communication with potential participants was done in a respectful and professional manner, and any information about the unpleasant experiences of obstetric complication was made in an empathetic manner.

Consent for publication
Not applicable Availability of data and material The data is available on request from the corresponding author

Competing interests
The authors declare that they have competing interests Authors' contributions DKK conceptualized the study, conducted the literature review, did the data collection and drafted the manuscript. JA, NEK, NKS and AAH were mentors on the project and contributed to the study design, advised on data collection and analysis, and reviewed manuscript drafts. GC provided advice on the research design and development of data collection instruments. All authors reviewed all versions including the nal manuscript draft.