We present below, the stakeholders' awareness of debates within academic and regulatory literature relating to benefit sharing, as well as the moral issues that are seen to arise from the conduct of collaborative health related research in resource poor settings. We later examine the extent to which these views have anything in common with those being discussed in the bioethics and regulatory literature about benefit sharing while pointing to some of the implications for this understanding.
Awareness of debates relating to benefit-sharing
In most cases interviews started with questions meant to explore interviewees' awareness of academic and regulatory debate about the fair sharing of benefits in international research undertaken in developing countries. Stakeholders were asked whether they had come across the term benefit sharing in the context of research ethics, primarily, to tease out their familiarity with the debates leading to the emergence of the need to promote the social value and benefit sharing as ethical imperatives. In this particular instance the term 'social value' is used in a broad sense to include all the questions about the value/benefits of the research to communities including its relevance to their health care needs. Seen from this perspective, benefit sharing is one possible way of making research to have social value.
At the research level: Awareness among researchers
"...Benefit sharing? No, I know the English word but I do not know the exact terms... "(Researcher 2).
The quote by Researcher 2 captures a typical response commonly given by researchers involved when asked whether they had come across the concept of benefit sharing.
On several occasions our respondents seemed unaware of the meaning of the term 'benefit sharing' although they insisted that they could infer the meaning from its etymological roots as opposed to its usage in ethics literature. In other cases, some researchers reported that they had not come across the term 'benefit sharing' as illustrated by the following excerpts of the discussion between Researcher 7 and the interviewer.
Interviewer: Have you come across the term benefit sharing before?
Response: Benefit sharing? No.
Interview: What do you think it is?
Response: That's a hard ...., Benefit sharing... I guess it's both the participants benefitting from the study, as the study benefits the clients, and the community, probably... (Researcher 7)
Apart from the outright lack of awareness of the ethical concept, some researchers reported that they never bothered with the finer details over issues relating to benefit sharing but instead, operated on the assumption that their institutions had taken necessary steps to operationalise it. The following quote by Researcher 15, while indirectly illustrating some sense of awareness, portrays a rather distanced engagement with the practical considerations relating to benefit sharing.
...what I know is that at the institute level, they are coming up with the Intellectual Property Rights and Benefit Sharing between the institute and the inventors. This will take care of such issues and we don't have to worry....so the institute will also play its role as a place to which we were affiliated and it will also have its benefits (Researcher- 15).
In yet another instance, a researcher noted that there was some unspoken assumption among researchers that since research protocols are approved by respective institutional review boards including Research Ethics Committees (RECs) the issues concerning benefit sharing had already been addressed, as illustrated by the following quote;
... Ok, since the research that we do, has to be approved by the ethical review committee essentially both the scientific committee and ethical review committee where we usually have to explain the sort of benefits they are likely to get directly in the short term and also you need to explain to them even the long term, how they stand to benefit.... but most of the times we leave it there... (Researcher3).
As expected, there were researchers, although clearly a minority, who reported some awareness of the concept as articulated in the quote by Researcher 13.
"...of course we have considered issues related to what benefits come out of this research because it is an issue that volunteers have been raising. However this has not been explicitly addressed as has been other issues. When we started these vaccine trials here, there was no framework in the country to guide our operations..." (Researcher13).
Research regulatory level: Awareness among members of the IRBs
...the question of benefit sharing particularly in the third world is a very tricky one. From a general point of view the complaint has generally been that in collaborative research in particular, the relationships say between those in the third world and those in the first world has always been tilted in favour of the first world and that therefore works a lot of injustice. ...this makes pursuing benefit sharing quite complex although in most of the International forums where this has been discussed it is clearly there... (Institutional Review Board 1).
Members of the Institutional review boards unlike researchers showed some level of awareness of the concept, although they were perplexed over the practical implications over its consideration in research conducted in Kenya. The above quote was a response to how consideration for benefit sharing was handled within protocols submitted by researchers. Similar challenges relating to lack of clarity over practicalities of engaging with benefit sharing were further articulated by members of different IRBs, who while responding to a similar question observed that;.... It is very tricky. And, I have been engaged in this debate (on benefit sharing) myself and I have said yes, it is good but, let's be practical. Practically the implementation becomes impossible... (Institutional Review Board 2). While these quotes by members of IRBs illustrate concerns over feasibility of engaging with benefit sharing in resource poor settings they nonetheless show some degree of familiarity with the concept. Although this degree of awareness is expected among members of IRBs, their divergence in opinion on the practicality of engaging with benefit sharing in resource poor settings was striking, especially, considering that both IRB 1 and IRB 2 were drawn from the two main bodies with a final mandate for ethical review of research protocols in Kenya.
Awareness at the community level: Awareness among CSOs and other Community Representative Groups
...Benefit sharing is more or less taking ownership of what comes out let's say of an intervention or something like that, like what you are saying like if we have to have collective responsibility towards the fight against HIV and Aids and out of that you find the prevalence rates are going low, infections are quite reduced, there are few infections or there is better life for those who are infected...you see you also benefit, but we are also benefiting as a large collective entity who put in collectively ... (Civil Society Organisation 3).
Awareness of issues relating to benefit sharing at the community level was explored by interviewing respondents drawn from Civil Society Organisations (CSOs)s and other community representative groups including members of Community Advisory Boards (CABs) and the KEMRI Community Representative (KCR) group. The CSOs, CABs and the KCR were expected in theory to champion community interests in research.
Another respondent from a CSO that was involved in championing community interests within research aimed at developing interventions to address malaria, TB and HIV noted that;
....I think benefit sharing refer to a situation where all the parties involved in a given situation feel proud for the success that has been achieved, they feel part and parcel of the mechanism and the system that has brought about that success. So they feel more or less like they have made life or the environment leaving it a better place than it was initially...It is taking ownership of the success. (Civil Society Organisation 5).
As was the case with other stakeholder groups there were limited instances where respondents showed awareness of issues relating to benefit sharing, as illustrated by the quote by Civil Society Organisation 2;
...Of course this is a subject, which has been recognized and debated on the whole issue of benefit sharing, while in the sense of clinical trials or in the sense of other research whether its agricultural research, or biodiversity research where you know at the end of the research there is some kind of commercial product, I think it depends on what is being looked at. In the area of clinical research, the potential benefit from such work, in most cases is pharmaceutical products, this could be a drug, it could be a biological product, and it could even be a medical device that is used in treatment, or could be a vaccine used in prevention, that's the product... (Civil Society Organisation 2).
In theory, this awareness, albeit limited, demonstrate the extent to which some groups are able to discharge their mandate of representing community interests within global research enterprise. Broadly these responses clearly show that there is little formal exposure or joined up thinking with regard to the practical aspects of interpreting abstract ethical guidance on the ground.
Although respondents made only limited use of the concept of benefit sharing as it is emerging in formal ethical discourse, they nevertheless expressed a number of views and concerns about health research that might be considered to point towards the concept. We present exemplars of these views below.
The scope for exploitation
"... There is disease, there is plenty of population, and there is poverty..., there are plenty of poor people who know nothing and who do not know their rights. So that is why it is an easy field to come in and come out. Parachute in, Parachute out...they might be doing something else also without you knowing. If they are drawing blood samples, they're telling you we are doing it for Malaria, but do anybody have control over it, that those blood samples are not going out and they are doing some genetic testing or they are doing something else on it? /.../ that is my fear and concern..." (Institutional Review Board 5).
The quote is an acknowledgement that both individuals and communities participating in research were vulnerable and therefore in need of protection. Such explanations were given as the main reason for considering ethical issues in medical research. "...Ideally there is need to ensure that researchers do not take advantage of the subjects and... (ensure that)... whatever they are doing is acceptable both ethically and scientifically" (Researcher 4).
The potential for exploitation was further articulated by reference to the common features that characterise resource poor settings, including the huge unmet healthcare needs, poverty and lack of a functional research regulatory system, the above quote by Researcher 4 captures some of the concerns among members of the IRBs that health related research might inadvertently promote unfairness among certain classes of people in such settings. The metaphor of a parachute appears to have been used here to illustrate the absence of long-term relationship with the researched community, either in understanding their needs (prior engagement) or any thought about the impacts of research. It is however important to note that there are situations in which long-term relationships between research institutes and communities have been established and this perhaps generates different obligations. The remarks above were made in reference to the concern over vulnerability, and the attendant need for protection against exploitation as previously noted. While these quotes broadly speaks about the need to protect communities from exploitation, it goes beyond the vulnerability produced by conditions of poverty, to also address the potential for local researchers to involve communities in research that is scientifically and ethically sound, but still lacking value to such communities. Where there are conditions of poverty, limited knowledge and the absence of strong mechanisms to govern and regulate research activities, consideration for benefit sharing is seen as being capable of establishing standards to avert crises that are likely to arise from participation in global health research by local communities.
Addressing immediate health care and other societal needs
"...I'd say that the people here come against economic difficulties, that if one involves himself in that research, he expects to be taken care of in terms of access to health/.../for instance, if a child is ill and needs to go to hospital they will get help from the research team..." (Kemri Community Representative 5).
The second concern relates to the need to use resources associated with research in addressing the material conditions of communities that host/participate in research as illustrated by the above quote by a member of a community representative group.
Similar concerns were echoed by some locally based researchers who reported that while the provision of health care services is not the primary goal of research, the dichotomy between research and other social issues should not be stringently applied in poor settings where people have high unmet health care needs.
"...I know it's still like the Governments' thing to do some of those things, but...you should not say I think this is for research, when another person is dying and you have the medicines, I think it's not fair. Even if you have the equipment for research, it can be used for diagnostics if it's so needed." (Researcher 2).
From this appeal to expectations which are brought into the research process by research participants and the call to disregard the dichotomy between research and health care provision, it appears that some of these stakeholders expect the resources associated with research, to be used for responding to the needs of the community, including those related to health care.
Future needs: the importance of access to future interventions and treatments
"... we are learning and we have learnt something from previous research, we have to act now by looking ahead of the vaccine trials as opposed to waiting until the end of the trials and ask ourselves, what will happen in future and start asking those questions ourselves; how will Kenya benefit? How will those individuals benefit? If we can answer those questions now it will be so nice and save us a lot of problems" (Civil Society Organisation 1).
Apart from responding to immediate health care needs, some respondents saw opportunities from participation in health research as potentially securing future access to proven interventions once research was complete. The emphasis on learning and the time dimension for planning were made in reference to HIV/AIDs vaccine trials that were previously undertaken in Kenya but later culminated in disputes over ownership of the results and the expected products pitting the collaborating institutions on one hand, and the research participants on the other.
"... It was not an easy fight to get the pharmaceutical companies to see this point of view to recognize the global corporate social responsibility, to sensitize them to the need and of course there are a lot of people who are suffering from these diseases in the developing world, who are unable to access these drugs because they cannot afford it..." (Civil Society Organisation 2).
The importance of forward thinking as a way of promoting future access of research benefits was equally underscored by reflecting on previous struggles between civil society organisations and the pharmaceutical industries. By making reference to previous drug trials conducted in resource poor settings, which led to the development of effective antiretroviral therapies (ARTs), the quote by Civil Society Organisation 2 demonstrates the potential of benefit sharing to address future community needs relating to proven interventions.
Research and sharing profits
"...I think its business, in my view. Lately I've come to understand that research especially big time research out there is a huge industry. And people will put money on what they see as potentially giving back to them in the future..." (Institutional Review Board 3).
Other respondents regarded consideration for benefit sharing as a tool to foster recognition of the huge opportunities for investment presented by research and the need to enjoin all stakeholders in reaping the benefits. The quote by Institutional Review Board 3 above for instance, represents a concern expressed by local level stakeholders (including members of community advisory boards, community representative groups, researchers and the IRBs) to liken health related research to a business venture whose goal is the pursuit of profit.
The stakeholder accounts presented above therefore underscore the importance of fairness especially in the context of recognising contribution made by research participants and their communities, by participating in the development of medical and public health tools through research.
Developing community support
"... What is the benefit of this for us? You will realise that for the last almost 12 years and especially in the previous decade (the industry) was seen to just purely profit from human suffering and people had a very negative view of the Pharmaceutical Industry. And in the last 10 years, we are sort of re-modelling our self and trying to make sure we project our self in a very responsible manner..." (Pharmaceutical company1)
On the other hand, some stakeholders especially those associated with the funding of health research appealed to the importance of cultivating community support and goodwill by responding to the previous negative press that characterised the conduct of collaborative research in resource poor settings as aptly summarised by the above quote by Pharmaceutical company1.
Resource and risk pooling
"... So our R&D people are coming from the Industry, so we understand it. The multinational big Pharmaceuticals, if they want to do something there because they see the need, they also see the urge from the Global Community, they want to limit their financial exposure in the R&D at least part of the cost are borne by someone else, by the Public Community and also far as the risk, if one Project fails then maybe there will be other Projects coming afterwards" (Public Private Partnership 2).
A related benefit for considering benefit sharing was the need to develop a collective approach to enlisting community support by pooling together resources that can be invested in the development of medical and public health research whose return on investment (ROI) was not guaranteed as summarised by Public Private Partnership 2 above. This particular quote a voice of a stakeholder from a public private partnership, commenting on how appeals to collective resource pooling between the public and private enterprises had successfully been used to address challenges associated with the funding of research into "neglected diseases". Prior to the establishment of partnerships between the public and private ventures, pharmaceutical industries mainly relied on a pure business logic/model in making decisions to invest in the development of health interventions. Such investment decisions were the subject of debate and criticisms, following the publication of the 10/90 report (the statistical finding by the Global Forum for Health Research, that only ten per cent of the world expenditure on health research and development was devoted to the health problems that primarily affect the poorest 90 per cent of the world's population) on Health Research by the Global Forum for Health Research. In response, the pharmaceutical industry teamed with other players to develop alternative funding mechanisms to facilitate research into diseases of public health importance to resource poor settings.
Making actors accountable/socially responsible
In addition, there were concerns touching on accountability among actors involved in research as illustrated by the quote by Institutional Review Board 5.
"... I think you should be realistic, that nobody is going to come back and you may not be there to enforce that somebody should give back to the community...and once they find what they are looking for, they may just take off..." (Institutional Review Board 5).
The concern over whether research sponsors are likely to be accountable to the host community especially in the absence of strong governance and regulatory mechanisms was a key consideration among IRBs and other local level stakeholders. More importantly, the quote underscores the underlying fear that some actors might take advantage of weaknesses within these regulatory mechanisms, and exploit local communities by failing to make research benefits available.