Engaging Research Participants with Results: A Rights Informed Approach

Sharing ndings with research participants is gaining attention as an ethical imperative for the research community. However, current discussions on this topic typically take a paternalistic approach to the issue, with the research team having the power to decide whether or not the sharing of results should be carried out and how this is done. In this paper we propose an alternative approach to engaging participants with the ndings from the research to which they have contributed. The ethnographic eldwork for our study was carried out in multiple phases from August 2018 to January 2019 and again from August 2019 to December 2019 among two vulnerable communities in the south Indian state of Kerala. Engagement of research participants with ndings was integrated into the research protocol and various strategies including forming partnerships with participants and identifying appropriate forms of dissemination among the different categories of participants were carried out during eldwork. The format and mode of dissemination varied depending on the participant category and was tailored to ensure that each participant was able to with the ndings as opposed to merely passively receiving the results from our study, Results Previous research studies that had our had not and their Building reciprocal relationships in a way that power disparities and key our Such engagement to our by enabling us to jointly evolve the recommendations from our study. over results highlights paternalistic approach well-being. including and In this we discuss our experience of with the results of our study, the different stages in this process and our learnings from this exercise. We then draw out implications for researchers and suggest a rights informed framework that can promote an active model of sharing research results that acknowledges not only the value that participants bring to the research process but addition is respectful of their own agency. of respect for the agency of participants that had evolved from previous experiences of working with vulnerable communities and engaging research participants with results. This enabled us to identify approaches to discussing this issue with participants during the data collection process, and ensured we planned for adequate time and resources to enable engagement with participants at the end of our study.


Abstract Introduction
Sharing ndings with research participants is gaining attention as an ethical imperative for the research community. However, current discussions on this topic typically take a paternalistic approach to the issue, with the research team having the power to decide whether or not the sharing of results should be carried out and how this is done. In this paper we propose an alternative approach to engaging participants with the ndings from the research to which they have contributed.

Methods
The ethnographic eldwork for our study was carried out in multiple phases from August 2018 to January 2019 and again from August 2019 to December 2019 among two vulnerable communities in the south Indian state of Kerala. Engagement of research participants with ndings was integrated into the research protocol and various strategies including forming partnerships with participants and identifying appropriate forms of dissemination among the different categories of participants were carried out during eldwork. The format and mode of dissemination varied depending on the participant category and was tailored to ensure that each participant was able to engage actively with the ndings as opposed to merely passively receiving the results from our study,

Results
Previous research studies that had been undertaken among our participants had not shared research results with them and were interpreted by the communities that researchers were not interested in making any difference to their situation. Building reciprocal relationships in a way that minimised power disparities and tailoring outputs to forms that promoted active engagement were key factors that helped participants to engage with our results. Such engagement added value to our research by enabling us to jointly evolve the recommendations from our study.
Conclusion Participants contribute to the success of research by providing information that is sought by researchers. Compared to the dominant bio-medical research ethics framework, a rights informed approach to sharing research results with participants acknowledges this and recognises their agency to engage with research ndings. Such an approach is not only socially responsible and ethical, but also improves the impact and legitimacy of research among the participants and the larger population that they represent.

Background
Health research has the capacity to affect the lives of both research participants and the larger communities within which the research is embedded. The knowledge generated by such research can improve how societies organise themselves to improve their health (1). Given this signi cance, historically a lot of attention has been paid to ensuring scienti c rigour and integrity of the research processes especially when it comes to the design, conduct and reporting of research ndings (2). The last fteen years has also seen a growing interest in the sharing of knowledge that is generated by research and making it accessible to both individuals and institutions not involved in the research process(3). This has also been re ected in policies adopted by several funding agencies and institutions which make research available through open access mechanisms (4)(5)(6)(7). Most of these discussions, while acknowledging that the outputs of research should be freely available for all stakeholders in society, limit accessibility primarily for those belonging to academic, policy makers and programme implementers. However, in recent times the sharing of research results with another important research stakeholder -study participants -has started to gain attention (8,9). The Declaration of Helsinki for example states that "all medical research subjects should be given the option of being informed about the general outcome and results of the study".(10) Health research participants often wish to know the results of the research in which they participated. However, most of them do not have access to such results despite increasing numbers of researchers promising to share ndings (11,12). One reason for this may be the fact that while researchers are required to publish their ndings in peer reviewed journals for both professional and organisational reasons, there is no strong motivation driving dissemination to participants or engaging participants further in the research process (12). Also, it is increasingly recognized that sharing ndings with study participants in a meaningful way goes far beyond merely providing them with simpli ed versions of the ndings (13).
Traditionally, research participants are conceptualised as taking a passive role in the research process, having a time-limited function that ends once they provide the information that was sought from them (14). However, there is growing consensus that the active involvement of participants in health research (for example as members of a study advisory committee) improves both the credibility of results and their direct applicability to others (15). This move from participants being a mere data source to active collaborators in research, has also been presented as a consequence of the overall ethical demand for democratisation of research processes (15,16). With this increased recognition of the active role of participants in the design and conduct of research, another area that has begun to merit greater attention is the sharing of research ndings with participants. This has especially been the case for community based participatory research (17,18) and is the focus of this paper.
Most discussions on sharing research ndings with participants have stemmed from a bio-ethical framework (2,8,19). The principles of autonomy, nonmale cence, bene cence and justice have been used to unpack the issues around sharing research ndings with participants in the last few years. Thus, those who advocate the sharing of research ndings with participants have argued that owing from the principle of autonomy, participants have both a right to know about the results of research conducted among them and the ability to take a decision whether they would like to know about the results or not (8,20).
Under this approach researchers routinely offer the option to provide results to the participants who then decide whether they would like to accept it or not. The obligation of researchers to share results with participants has also been recognised as a principle arising out of respect for communities where the research was carried out (8,21,22). Yet another perspective from which sharing results has been encouraged is that of accountability of the researchers(13, 23). Those who take this approach point out that participants make signi cant contributions to research and are no less important than other stakeholders such as funders, researchers etc. Participants provide information that is sought out by the researcher and in return researchers owe them information in the form of results (23). Others however have argued that sharing results is not as straightforward as it seems and any such decisions should involve a careful consideration of the harms and risks versus any bene ts that this might offer to participants (24,25). How best to accomplish this is also not clear and this issue is far more complex than it might at rst appear (19,26).

Conceptual Frameworks To Understand Sharing Of Results
The idea of sharing research ndings with study participants has been around for some time especially in clinical research. In the eld of environmental health research, Morello-Frosch and colleagues discuss three possible frameworks to understand the process of sharing results with participants (27)

2.
A community based participatory framework where there is a strong focus on communicating both aggregate and individual results to participants using protocols that are jointly developed by both the research team and the participants. The decisions rest with both the researchers and the community that was participating in the study (17).
3. Citizen-science 'data-judo' where there is a strong emphasis to report back both aggregate and individual results to participants to promote action at both the individual and community level including advocacy for change. The lead is taken by communities and advocacy groups who have marshalled their own scienti c resources to conduct a study with a view to in uence policy change (29).
While discussing data sharing practices in social sciences, Jeng and colleagues draw out two broad dimensions that affect decisions about whether research ndings and data are shared or not (30). The rst dimension concerns the motivations and characteristics of the individual researchers, whilst the second refers to contextual features of the research such as data characteristics, the research culture of the institutions involved in the research, and the infrastructure required to support data sharing.
These frameworks highlight the importance of sharing results with participants and suggest strategies to achieve this. However, the approach to data sharing highlights the power imbalance that researchers hold about the decision making in this process. By allowing researchers control over the decision whether or not results can be shared, it highlights the ongoing paternalistic approach to decision making and treats the community as a group that does not have its own agency to engage with research results in a way that promotes their overall well-being.
Decisions to share research results are in uenced by a number of considerations including pragmatic and ethical factors. In this paper, we discuss our experience of engaging participants with the results of our study, the different stages in this process and our learnings from this exercise. We then draw out implications for researchers and suggest a rights informed framework that can promote an active model of sharing research results that acknowledges not only the value that participants bring to the research process but in addition is respectful of their own agency.

Study setting and methodology
Our study sought to understand the experience of accessing healthcare services for two diverse marginalised groups in the south Indian state of Kerala. Detailed descriptions of the study setting, and their main ndings have been published previously (31). The ethnographic eldwork for our study was carried out from August 2018 to January 2019 and again from August 2019 to December 2019. Phases included: 1. Building rapport and trust with the participants; 2.
data collection in the form of interviews, focus group discussions and participant observations and concurrent analysis; 3. member checking and sharing results with participants (the focus of this paper). Thus, sharing of research ndings with participants was decided a priori during the study design.
The research participants in this study were either: 1. 1. Community participants-Indigenous communities and widows above the age of sixty and living by themselves (hereafter referred to as widows), 2. 2. Health system participants such as community health workers, nurses and doctors. Having multiple stakeholders required us to discuss and evolve appropriate mechanisms that would promote active engagement and sharing of results with each stakeholder.

Integrating Engagement With Participants Into The Research Protocol
It is important that planning for sharing research results takes place early in the research process, and a clear communication plan should be developed (12,32). In this study, the decision to share results with participants was made during the research design stage. An initial dissemination plan was integrated into the study protocol. Right from the beginning, our approach was that study participants have the right to know about the ndings. This decision was also in uenced by our own positionalities of respect for the agency of participants that had evolved from previous experiences of working with vulnerable communities and engaging research participants with results. This enabled us to identify approaches to discussing this issue with participants during the data collection process, and ensured we planned for adequate time and resources to enable engagement with participants at the end of our study.

Forming Partnerships With Participants
Ethnographic research places a great emphasis on extended contact with participants and building relationships which are reciprocal, as this helps to avoid power disparities and gives greater access to the lived reality of the participants (33). In this study we were particularly conscious of the fact that we were working with vulnerable communities and that building partnerships of mutual respect was key to the success of the research. We did this by spending time with these communities to understand the speci c contexts in which they lived, adopting their customs during interactions both at the times of the initial visits and for data collection, acknowledging their concerns about the research topic and research processes in general. Such extended contact enabled us to understand the existing power differentials and to take steps to build relationships that were reciprocal and respectful.

Results
Impact on community of previous research results not being shared During the initial phase of eldwork among the Indigenous communities, one of the key barriers to building rapport was the negative experience of the community with previous research studies. Several research groups had carried out data collection with the community, but hardly anyone returned to share their ndings with them. The lack of engagement by researchers, post data collection, made community members feel that researchers were far more interested in getting their work done rather than helping the community address their situation. Some even wondered if the researcher accurately reported the information that they had provided.
Health system participants (especially doctors) were also keen to point out the bene ts of disseminating the results and the limitations of not doing so. Many felt that if research aims to impact the local health system where it was carried out, then it is important for researchers to share their ndings with key stakeholders both at the implementation level and at the policy level. This they felt would help to improve their practice by understanding what promotes access to better health and healthcare for the community. According to the health system participants, results published in scienti c journals and other professional avenues were hardly accessible to practitioners in the eld as most of them especially in developing country settings did not have the resources or the time to make regular use of many journals.
The failure of researchers to come back and share ndings gave participants the impression that researchers were only concerned about their professional careers, rather than empowering the community through their research. The community felt that this was unfair as they had spent time and shared information about their lives with researchers. Such experiences also meant that communities were not eager to participate in future research as they considered such exercises futile.
People like you come here for research, but once they nish their work, there is no sign of them. They don't tell us what they have found out and neither do we know what has happened to the report that they wrote. Once they have collected whatever they want no one ever comes back.
Indigenous Community FGD, TI10 I don't think so far anyone has come and spoken about their ndings here. Usually what happens is that people will do some surveys or carry out interviews.
But once that is over, they do not come back. We won't even know where they are or what happened to them after that.
Healthcare provider IDI, MO_4 As part of the initial process of building rapport with both groups of participants, we discussed this issue and entered into mutual agreements with participants that the results of our study would be shared once we had completed analysis of our data. These discussions enabled us to build more equal relationships with participants and to some extent address any power disparities that might have existed between participants and researchers.

Inaccessible research outputs
Peer-reviewed publications, technical reports and policy briefs are some of the traditional avenues through which research results are disseminated. However, for most research participants, especially in the developing world, access to such outputs is highly limited even for medical professionals. Furthermore, most of the traditional avenues established to disseminate research results cater primarily to the research community and other stakeholders such as funders, policy makers and other professionals associated with the subject being researched. etc. Research outputs are therefore tailored to suit such audiences. They are not easily accessible (either physically or intellectually) for other audiences and a different approach is therefore required. For example, marginalised groups have been reported to be eager to hear results, preferring material that is read out to them or uses pictures and other forms of visual or verbal dissemination (34). The community participants in our research were unable to read reports or summary documents which were produced by researchers.
What evolved in our consultations was that a verbal presentation followed by a discussion of the results either in an individual or a group setting would be far more effective for our participants. Merely receiving a copy of a research report was not going to help them engage with the ndings and understand what was being reported.

Engaging communities with results
Once data analysis was completed, the key ndings from our study were presented to all the research participants. As there were multiple categories of participants, we engaged in discussions with each group to identify what would be the best format to share the results of our study. This process enabled us to identify different formats for different categories of participants. For example, the Indigenous communities who participated in this study lived in a closeknit circle and had a community mechanism to discuss issues of common concern. Given our research focus, village chiefs felt the most appropriate forum for sharing the results would be their village meeting. In keeping with this tradition, in each village where data was collected the village chief called for a meeting where everyone from the village was present. Aggregate results were presented one by one and a discussion on each of these results was carried out in the village meeting that was presided over by the village chief.
With the widows, individual meetings were held to talk about the results on a one-to-one basis in their homes. This format suited them the most as each of our participants from this category lived by themselves. Gathering them together would have been counterproductive as it would have disrupted their daily routine and put them in the company of others they did not know well. This would have diminished their ability to engage with the results, ask questions and comment on them freely. With the healthcare providers such as doctors and community health workers, individual meetings were preferred over group settings.
While the aggregate results that we presented were the same for all stakeholders, it was important to ensure that the language and idioms used to describe the results, were accessible for the different participants. For example, given that we were looking at the issue of access to healthcare, it was natural for us to prepare out reports using terms that are readily understood by those with a background in health. However, this would have meant that participants from the community would have found it di cult to engage with our results actively. In order to ensure that this did not happen, discussions were held with some of the Indigenous participants to explore what would be the best form in which to present our results. These discussions helped us to understand that while presenting results it would be useful to use imagery and context that was relevant to the community instead of presenting generic results. For example, having village chiefs convene the village meeting (oor kootam) and preside when results were disseminated drove home the importance of the discussion and improved participant engagement. Secondly while discussing results, imagery and analogies that resonated with their situation and that were drawn from their lives increased the salience of the conversation for participants. For example, while discussing the gradual decline of Indigenous healing traditions and the increasing acceptance of western medicine, parallels were drawn to how the o cial language of the state (Malayalam) had taken over tribal dialects, resulting in tribal terms being replaced with Malayalam words. Thus, the Indigenous word for mother 'avva' was replaced by the Malayalam word 'amma'. Using this imagery resonated with the community and led to discussions about how the neglect of healing traditions should be seen within the overall context of Indigenous ways (including language) not being valued by society. With the community of widows, before presenting results to all participants, feedback was sought from two participants to ensure that the language being used to describe ndings could be understood.
With all participants, the results were used to stimulate discussion around the larger issue of access to healthcare and what it meant for them. This was done to ensure that the process of sharing of results was not monopolised by the researcher, but participants were able to discuss the signi cance of our results to their lives and how they could use it to address some of the gaps in their access to healthcare, the barriers that they face and how they might be addressed.
This form of active engagement enriched the research in two speci c ways. Firstly, it con rmed that our results captured the lived reality of the participants. Secondly, it also enabled us to jointly evolve recommendations to address the issues that had been identi ed.
For example, one of our ndings was about the importance of decentralising the delivery of healthcare services. During our discussions, some of the widows pointed out that there was a speci c aspect of decentralisation that would help them the most. Participants explained that while the neighbourhood clinics had made a difference to their ability to access healthcare services, they still had to travel great distances for diagnostics. This engagement enabled us to evolve a speci c recommendation about decentralisation that was relevant to the community.
Another example was the discussions with medical o cers working among the Indigenous communities. Some of them pointed out how decentralisation had several components and could be operationalised in multiple forms. As they were more aware of the prevailing policy context, they suggested that tailoring the suggestions related to policy and practice to the local policy context would give a greater chance for policy makers to act on them. Thus, among the list of suggestions we had prepared, two of the medical o cers pointed out that appointing young tribal women as community health workers in the villages was not only effective to decentralise healthcare, but also more likely to be acted upon as it was in line with the thinking among policy. Such feedback helped us to tailor some of our recommendations to align with the local policy context when knowledge transfer engagements were undertaken with key policy makers.

Handling multiple viewpoints and unfavourable results
Research results often have ndings that are not favourable to all stakeholders who participated. Furthermore, as research ndings report multiple participant viewpoints, some stakeholders may nd the dominant themes to emerge from a study are not representative of their own views. It is critical that researchers acknowledge this during knowledge transfer and also prepare to engage with participants who might feel that their views have not been adequately represented, or that views contrary to their own have been highlighted. Our study had observations about how healthcare services were planned and delivered which made it di cult for communities to access healthcare. For example, in the case of the Indigenous communities, the centralisation of healthcare was a decision that was taken by o cials in the local health system in order to ensure that most of the services were provided in a secondary care hospital under the supervision of specialist doctors. However, this had the impact of excluding many of the villages who lived far away from this particular hospital. With the widows, the issue of physical infrastructure that was not elderly-friendly was pointed out by some of our participants as being a deterrent to visit the public healthcare facilities even when they required care. We had anticipated that some of the health system participants, particularly those in charge of the local health system might be unhappy with ndings that appeared critical of their service provision. We addressed this by ensuring that the language we used while describing our results did not suggest that any speci c individual or institution was primarily responsible for any negative ndings. For example, while discussing the issue of centralisation we allowed those who disagreed with the nding, particularly from the health service, to present their side of the story. Secondly, we were careful to communicate to all participants that our aggregated ndings were meant to identify systemic issues and did not apply to one particular individual or institution.
The group discussion format that was employed to engage Indigenous participants enabled greater engagement and discussion among all those present. However, it also posed some unique challenges. For example, in one of the early village meetings, a community member objected to some of the ndings that he felt portrayed the local health system in a poor light. We prepared for this by clearly communicating at the beginning of each meeting that it was ne to disagree with the results that were being shared and that everyone present had a right to discuss the results and comment on them.

Discussion And Conclusion
A rights-informed framework to sharing results The last decade has seen a move towards ensuring that the results of scienti c research are freely available for those who are interested to know more about them. However, most discussions focus on enabling the availability of research results for others in the scienti c community to promote further research and knowledge sharing with academic and clinical audiences. Research that reported the sharing of results with participants primarily came from work that used community based participatory designs. But this is changing with calls to share individual results becoming pronounced in health research as well.
Our experience of sharing results with different categories of participants shows that the decision to engage participants with research results has implications across all phases of research. (See Fig. 1). Engaging participants requires researchers to undertake a host of activities from building partnerships with participants, evolving the appropriate form and template for sharing results and nally preparing and engaging participants who hold different views regarding the results as well as varying agency with the outputs of research. This means that research teams need to plan in advance and allocate adequate time and resources for these processes to be carried out. Engaging with participants during the process of sharing results using methods that promote discussion provides opportunities for discussing solutions (27). We found that this helped us to formulate recommendations that were jointly evolved with the different participants, thereby ensuring that our recommendations are grounded in the lived reality of our participants.
Most approaches to sharing research results with participants use the principles of bioethics as the beacon to guide the process. However, these approaches allow researchers the primacy in deciding whether the participants can receive results or not. While the lens of accountability does bring in the aspect of the important contribution of participants, it still focusses on the research processes and the sharing of results as an outcome of accountability to ethical and rigours research processes. Taking a rights-informed approach not only includes in its ambit the ethical and accountability arguments but acknowledges that participants have a right, by virtue of their participation which is key to the conduct of any research, to know the outcomes.
A rights-informed approach considers participants on a level plane with other stakeholders such as the researchers, institutions, funders etc. who are generally understood to have a right to research ndings by virtue of their contributions to the successful conduct of research. Power imbalances in researcherparticipant relations are especially strong in health research where researchers are not only considered to be the 'experts' but also tend to have special relationships with the local health system which further deepens this imbalance. A rights-informed approach addresses some of the inherent power relationships that exist between the researcher and the participants by acknowledging that participants make a signi cant contribution to the success of research and by virtue of this they have the right to receive results. When research participants do not have access to the results, it further adds to the distance between the research community and the participants. Consequently, research remains as something that is distant and disconnected from people's daily lives and its improvement (35). Engaging participants with results is an effective way to address this. It also helps to ensure that research participants appreciate the role and value of research in solving issues pertinent to their lives.
Traditional approaches to sharing results presumes that stakeholders such as policy makers and programme managers are the ones who have the power to act upon research ndings. Dissemination of results therefore prioritises them over participants. As our experience shows, approaches that engender respect for participants and acknowledges their agency shows that even vulnerable communities are able to engage actively with research ndings, add value to it, embed it into their context and add value to the overall research processes.
From our experience we believe that engaging participants with research results cannot be undertaken as an activity that is added at the end of the research cycle. It is important that researchers plan for actively engaging participants with results right from the beginning and identify and evolve the most effective mechanisms of results dissemination during the data collection phase (Refer Fig. 2). This will aid the development of clear communication plans and strategies. It is also important to plan for support options such as counselling services or follow ups with specialists in case adverse results are being communicated, particularly in health-related research.
Institutional ethics committees should engage with this issue and support researchers by drawing up guidelines that promote the active engagement of participants with research results.
Engaging participants with research results takes time and requires resources. In some cases, this includes developing outputs that will aid the process of engaging participants with results such as handouts in local languages, and locally relevant audio-visual material. Funding bodies should actively support this process by highlighting the sharing of results as a participant right; recognising the value of such engagement for the interpretation and application of ndings; and nally, by ensuring that su cient resources are available for researchers to carry out dissemination activities which are appropriate to the participant population. It is imperative for research translation that research results do not only nd their way into peer-reviewed publications, reports and policy briefs. Recognising, respecting, and valuing the rights, agency and ability of study participants to engage in the dissemination process is not optional. It is essential for bringing together the key research processes of investigation, identi cation, and implementation of ideas. It bridges the gap between discovery and delivery of new knowledge. In short, a rights informed approach to engaging participants with study ndings is not only socially responsible and an ethical imperative, it also has implications for the in uence and impact of research where it most counts -the study participants and the larger population they represent.

Consent for publication
Not applicable Availability of data and materials The datasets generated and/or analysed during the current study are not publicly available due to the danger of compromising the con dentiality and anonymity of the participants but are available from the corresponding author on reasonable request.

Competing Interests
The authors declare that they have no competing interests Funding This work was carried as part of the Ph.D. research of the rst author. Field work was supported through a grant available for all Ph.D. candidates towards project expenses at the University of Canberra Authors contributions MSG carried out the data collection and drafted the manuscript with contributions from RG, RD, IM, and PU. MSG and PU were involved in the analysis of the data. All authors were involved in the design of the larger study from which the data for this manuscript emerged. All authors read and approved the nal manuscript.  Phases of research and activities to engage participants with results