 Good afternoon everybody and I'm sorry not to be with you live in this presentation. We've had a recent bereavement in the family and so I'm preferring to record this. And so I'm going to talk about strengthening ethical practice at the frontline of global health research. And I'm going to be drawing heavily on experience from research I've conducted. As part of the work that I did based at the Kenry Welcome Trust Research Centre in Kenya. And I lived there for and worked there for 27 years until I returned to UK last year. And so there are many factors about conducting research in resource pool settings that not only promote the need to actually do the research in the first place. But also lead to some potential for exploitation in research practice. And some of these factors are very high morbidity and mortality rates in many low and middle income settings. The public health facilities that are available being very constrained in terms of resources. Different levels between research staff and local populations and potential participants in terms of norms, values, access to technological information, etc. And differences in terms of resources and power often. So these types of contexts where research is much needed, but there's also potential for exploitation really raise a range of different ethical challenges and highlight the importance of taking context into account when thinking about those ethics issues and challenges. So there are many different ways to think about research ethics. You can think from the ground up almost about what are the ethical issues that you're experiencing when you're actually conducting research in the field are their questions where you're and situations where you're thinking am I doing the right thing here is this morally acceptable. And here we might look to guidelines to think about how we might handle these dilemmas and ethically challenging moments. Or there might be a slightly more top down I guess way of applying guidelines. I'm thinking about how different ethics guidelines might apply in practice for the kind of research that I'm doing in these contexts. So looking at the issues and the realities on the ground in relation to different concepts and requirements in guidance and thinking what does that mean about how I should do my study or respond to a particular situation. And I've put these two as separate but of course they overlap with each other and might feed into one another. Ethics guidelines are really important but where on earth do we begin? There are so many different guidances out there to support research ethics practice. So one document that I and many colleagues have found really useful has been this one by Emmanuel Atau which outlines some of the ethics principles and benchmarks for health related, especially clinical research and developing countries. And what they did was they worked with all of the existing guidance that they could find that was relevant and organized it into a series of these different principles here and for each principle they gave a set of ideas or benchmarks. They called them of how you might meet those particular principles in practice. And if anybody's interested in this area I really recommend this document and we use it a lot because it's familiar to many of the committees who review a lot of our work. It's got many relevant ideas that are not only relevant to clinical research in developing countries as initially intended but also for social science research, health systems research. But of course it's still extremely challenging because although there are those different benchmarks it's still difficult to know how do I actually apply each of those different benchmarks in practice. And in many cases when you're doing research and there are challenges between how you balance across these different principles which might pull you in slightly different directions. And in terms of contextualization what's useful about this document is it really highlights and adds in and gives emphasis to those two principles that are in red there collaborative partnership and respect for participants and communities. And in terms of the benchmarks of how do you do that and some of the challenges around that an area that has gained a lot of attention and that we've worked in a lot in case. So one element that's hugely promoted now is community and wider stakeholder engagement in research, and it's hugely promoted for a range of different reasons, not only because it's the right thing to do. And that it's, it's just really important that people feel respected and included. So for its intrinsic goals but also because it can achieve something else so engaging with communities and stakeholders can help us learn about what is the right research question to be asking the right type of research designed to be doing in a particular context. And about exactly how studies might be rolled out in different settings to make sure that they're more acceptable and relevant to local communities that in turn can help make sure that there's more interest among potential participants to get involved in research which can have a really positive impact on the quality of research because good science requires good ethics and the two really cannot be seen independently of each other. So although it's widely promoted and really important to do we also have to be aware that it's it's as with all of the other principles complex and highly contested in terms of how you actually go about doing community engagement making sure that it's meaningful. So when you're engaging or planning a study, for example, who are the different types of communities that you might engage with. And who represents those communities you can't talk to thousands of different people but if you select representatives are you selecting the right representatives do they know and understand the issues and do those communities want those people and believe they should represent them. Are they speaking on behalf of those communities or are they just typical members of those communities giving their views as those members. Another area that can be really complex is is how much power you actually handing over to other stakeholders and community members as part of your engagement process. What's the depth of the engagement. Are you just primarily information sharing or are you really trying to consult in order to change how you're organizing your search and how you're thinking as an institution or as an individual. And if you're doing small scale interactions where and studies where there really can be perhaps much more flexibility around research planning. How do you scale up some of the learning and the thinking to these huge international research programs and maintain an ability to hold that being research question and study and the learning study across multiple sites. And a real issue that's often underestimated about community engagement. It tends to be thought of as a good, but it's possible that there can be perverse or unintended outcomes. So, you know, when you're engaging communities, it takes people's time, it takes people's energy resources and you're engaging with inevitably some parts of communities or stakeholders. So we have to be really careful not to inappropriately use people's time and we need to make sure that power relations in our interactions between researchers and communities and not inadvertently reinforce and we need to be careful not to accidentally feed into local politics issues in the process of engaging communities. And the whole reason to engage with communities can really be unclear often with community engagements kind of consider to be always just the thing that you should do. So the goals can be unclear and sometimes it's a series of different goals which once you put them against each other, you can see that they're in tension and they pull you in slightly different directions, which can make the community engagement a little bit of a mess in terms of what people are seeking to achieve and what's what's being achieved in practice. So I think community engagement, hopefully I'm showing you that community and state broader stakeholder engagement is really important. Indeed, it's part of the basic principles really of doing good quality and research that's responsive to local priorities and concerns and that's ethically responsible. It's not a mechanistic set of activities and we have to be really careful not only about just reducing it to tick box exercises that are not helpful for the science or the ethics and that we're not actually causing harm unintentionally. So the messages are that guidelines are important, that good science is good ethics that implementing guidance, even with some of the most useful guidance available can be challenging, weighing between different principles, responding to contextual issues and differences, and that community engagement has its own dilemmas and challenges. A really important thing about ethics issues at the front line is that even when you've got a really well developed proposal with community and stakeholder engagement in advance it's approved by research ethics committees. Many ethical dilemmas emerge in the conduct of doing research and they're experienced by people at the front line of conducting research who are often called field workers or research assistants or clinical frontline staff. And so I'm just going to go on to talk a little bit more about that now. So we've actually looked as part of an international research program at the in five different settings research environments at the kind of dilemmas that researchers face after approval of studies. And to try and learn about how we might better respond in order to support ethical practice at the front line of research. So across these different settings which include Royal and Urban Kenya, different sites in Thailand and in South Africa. What we heard from frontline staff and and many of us have been and play roles as frontline staff ourselves is that these staff face many different kinds of diverse and important roles. And they interact with stakeholders and participants who are often facing layered vulnerabilities related to their social economic status, their health, their wellbeing, their support processes and access to health care, etc. And their agency or ability to act and make decisions is sometimes constrained by these contexts in which they live. In doing these roles in these contexts of layered vulnerability and often constrained agency frontline staff face numerous ethical dilemmas and often inadequate support in dealing with these dilemmas by the research hierarchies and teams that they're part of. They just often try to deal with things the best that they can in their daily lives. And so we argued that it's really important research in vulnerable populations like the ones we were involved in continues because there's often not enough research in these vulnerable communities, which is tailored and relevant for those settings and environments. But at the same time, it's really important that there's much greater recognition of the kind of ethics dilemmas and and issues that these frontline staff face and that they need support with that and that this is really an essential justice concern in the conduct of research in low income populations. So just so that you can hear this, some of the issues and dilemmas from people at the frontline themselves, I'd just like you to watch this video which was produced drawing on the research that we conducted as part of this international consortium. We are the frontline research staff. We are the people who gather data, take samples, speak with participants and their families, carry research messages through public engagement events. Some of us are senior in our research institution. Some are not so senior. But what makes us similar is that we visit people's homes and sometimes we even land up sharing meals with them. Often we are working in our own neighborhoods, in our own communities. We listen to people's stories and struggles with interest, concerns and sometimes sadness because these are stories that we know very well. We often land up being the first of research in communities and a bridge between researchers and communities. We have a lot of knowledge to share and face many challenges. Many of the challenges we face are to do with what should we do, what are our responsibilities in the community. These are really often difficult, ethical or moral problems for us. Research is often done in places with a high burden of disease but also where there are many other health, social, political or environmental challenges. There may be a drought happening, water shortages, protests around a political election or staff strikes. In Kenya, communities are facing many of these challenges during our research including a huge national nurses strike. Here in Mesot, along the time Myanmar border, migrants who join research on malaria and pregnancy are also sometimes living in fear of being discovered if they do not have documents. The roads and bridges may be blocked or become unavailable because of flooding, making it difficult for people to get to a research site, which is also where they come to the clinic for care. We also see so many difficult journeys. Frontline staff also often have to cross the river in high waters during rainy season. So the biggest ethical challenges facing the frontline staff are around wanting to help people directly. When research results may not happen quickly and benefits may not come for many years. Sometimes I wonder why we are gathering data when what I want to do is to help people directly by providing care or medicine, something that is needed today. I realize it is important to develop better health interventions but then I wish we could do more now. We need more support in responding to ethical challenges in our day-to-day research in our context. Something that often struck me in my interactions with families in a very low-income area of Nairobi was how much young mothers went through to try to get their babies treated or to keep them well and restore their health. So they would try to access money, which was often not easy. They would seek advice from various networks on what to do and this included their in-laws, parents, their neighbors, friends, sometimes negotiating with their own spouses. And all of this was happening in what were very often difficult living environments. Here in South Africa, HIV has been a serious health burden and so it remains a major research focus. But there are so many other health and social problems that we see people struggling with. Despite the challenges communities face, they show strength and are resilient. It is important not to label people as vulnerable or use stereotypes because this can mask their unique needs and inadvertently exclude them from research that could benefit them. For example, labeling adolescents as vulnerable to HIV may stigmatize them and hinder participation in HIV research. We also see examples of young people's agency. For instance, they portray themselves as proactive and being agents of changing the community whilst managing the HIV disease. So their inclusion in research is important to inform context-relevant research and interventions which support their agency. It is incredible to see how families and women will work so hard to provide for their family and make difficult journeys to seek care and to participate in research. People sometimes think that young people or women do not have power to make choices in their lives, but they do. There was a young girl, she was 16, and she joined a study because she said she wanted to gain more knowledge, she wanted to learn more. So our question is, how can we work together with communities to make sure research priorities align with what matters most to the community? As frontline researchers, we offer a valuable perspective and bridge to understanding people's needs within research and beyond in their day-to-day struggles. But we also struggle in knowing how best to respond to the many dilemmas of care that we encounter in our work and we need more support. We hope that by raising our voices, research leaders, institutions and funders will hear us and we can work together to ensure that research remains a tool for improving lives for everyone. One of the studies that we were conducting as part of this consortium in Kenya was linked to a multidisciplinary observation study which was trying to work out what's contributing to high mortality among young children post discharge from hospital. And the researchers who were conducting this research highlighted a whole range of different ethical challenges. Looking at the bubbles in relation to challenges faced in hospitals on the left, in the middle, related to the child and family and in the right in relation to the community included, for example, what to do when you know that the referral that you've given as a clinician somewhere else, for example, for chronic heart disease might well not be affordable to a family. What do you do when you ask a family about a situation at home and they're so hungry that they cry? What do you do when you can see that a mother, for example, of a sick young child is clinically ill herself, possibly depressed? And what do you do with wider challenges that you are aware of in communities? For example, that local services have run out of really key food supplements that are essential for families to continue to be making a recovery post hospital discharge. So with all of these types of situations and there are so many examples, not only in this type of research, but more widely, these are incredibly emotionally difficult for those people who are confronting them. They ask themselves, what should I do? Where does my responsibility as a clinical researcher begin? Where does it end? When I make a decision, what's the impact on other people in terms of fairness around me? What about the research team? Am I introducing new problems and issues for the research team? And what about other studies? If I'm introducing some kind of support process, will that have an impact on what other studies have to do? Is that something good, useful, positive or challenging for other studies and reinforcing inequities and challenges between participants and communities that will actually cause unintended harm? Rather than be helpful. So something that we initiated within this study and that we've published about if you're interested in reading about this was that we started establishing regular ethics reflection discussions where we deliberately brought people together, including frontline staff, but also more senior staff as a safe space to really talk through what kinds of challenges they've been facing, not to keep it to themselves, but what kind of dilemmas have been faced, how that's been handled and to support one another and share ideas about appropriate responses. And so in doing that, what we were hoping to be able to do is to basically bring people's different types of knowledge together, to be able to think about responsibilities, actions and why we have those responsibilities or aren't able to act on those responsibilities or be the best people to act on that in that particular situation. And we developed a tool based on the ethics literature to help us think through some of these issues, and I won't go through this slide in detail. But basically what this tool helped us work out is whether nothing really can be done but helped us just be at greater peace with that situation in that context. So that's A in that in that hexagon box there, or whether we needed to actually immediately change what everybody was doing. B, C, it might be that we needed to change something about how the design of the study was being run, types of benefits that were being given to participants, how consent was being run. That's C, or going up to D, we might also then require to shift, for example, institutional policy around how what benefits are acceptable should be given. And it might even be that we have to advocate for change in terms of national ethics guidance and what's acceptable or not acceptable. And so we would take each scenario down at the bottom and blue, think about how urgent or serious is the issue for that person at that time. How related to the research is it, is it caused by the research or revealed by it, or just a background situation such as high levels of poverty that is going to be hugely widely experienced. Think about how much capacity is there for the person to be helped, and should the research team member or others be the best people to act on that, or should it be referred to others and what are the anticipated impacts of the activity. And so the hexagons would help us think through in relation to that issue, what then needs to be done. And we found that this really was useful in terms of giving us all and especially frontline staff psychological relief. It really helped us share the kind of ideas thinking and issues that aren't often shared. There often isn't time with busy research teams, but it made sure that these issues were heard up health research hierarchies. It really brought to life some of the policies and plans that are in place for research teams. But it wasn't easy. And, you know, perhaps most importantly on the right hand column there at the bottom is that many emotional issues were unsolvable, at least in the short term. In other situations where going back to my first slide, there is really very difficult contextual issues that are brought about by global and national and local structural injustices. As an individual research group, it can be really difficult to take on all of the responsibilities for responding. So I think it's important to include guidelines are really important for ethics practice and good ethics is at the heart of doing and inseparable from doing good science and implementing guidance can be really challenging, including guidance around and the community engagement is essentially around building relations between different communities and stakeholders. And there is some guidance available which I'll show you in a reference shortly which might be really helpful in working through that process. Many ethical dilemmas in conducting research arise post approval of a research protocol and are faced by frontline staff. And I feel strongly that post approval ethics support processes must be built into all research activities and how research is conducted over the course of implementation. And just leaving you with two particular references that I think might be useful if anybody's interested in following on this in any more detail. Thank you.