Before embarking on any research, the international health researcher and sponsors should take great care in assuring that the community/participants are not left ‘worse off’ than they already were before beginning the trial [1
]. It is noteworthy that most clinical trials are conducted on chronic diseases. If a trial shows that a new treatment for a chronic disease like diabetes, hypertension or HIV is substantially more effective than the existing standard of care, it is an ethical obligation of the sponsors to provide that drug to the trial participants for as long as they require it [1
Many public health professionals from developing countries have suggested that post-trial responsibilities be conceived of, more broadly to encompass strengthening of manpower through education and/or ‘health systems reinforcement’ rather than simply be confined to vague terms such as ‘reasonable’ and ‘affordable availability’ of drugs developed by the research. In a resource-poor country like Pakistan, post-research responsibilities may extend to ensuring provision of additional skilled staff or equipment to a hospital or to enhance delivery services such as those required for vaccination. The sponsors and funding agencies should focus on capacity building and strengthening health delivery systems. They should also train personnel specifically to transfer the skills so as to empower them to take charge after the research team has left.
Justice as reciprocity:
The participants have contributed to the society and the sponsors and researchers owe them post-trial access to any beneficial drug or intervention developed as a result of their participation and by virtue of reciprocity. Their contribution does not end when the trial ends [3
]. Follow-up of such participants after the trial is over, enables assessment of long term health impacts of an intervention and is imperative to scientific knowledge about that intervention, but more importantly, it is an obligation to ensure safety of research participants in the intervention group. Interruption of provision of high quality medicines to the participants is unfair and exploitative. The community where research has taken place should be the direct beneficiaries of the research.
Justice as fairness:
It is also seen that most international health research conducted in developing countries exposing the participants to unknown risks, actually develops medicines for use in the industrialized nations [3
]. The for-profit sponsors make a lot of money from results of successful research. This increases several folds, the responsibility of the sponsors and the investigators toward the participants. Just how far these post-trial benefits may extend remains a contentious issue in research ethics. But it is very clear that these points be discussed at the level of proposal development and in consultation with the local Ministry of health. This will guide researchers as to what exactly is the current need for that particular community and the expectations of the participants regarding post-trial provision.
Needless to say, the credibility of the entire research is dubious if there is no social value for the community being researched by the researchers. The research should address the health needs and problems of the community being researched.
In other words, the fair distribution of benefits and burdens of research to maintain equity in research ethics [1
]. Studies which are conducted on participants of one community, for the benefits to be solely enjoyed by another community rightly draw criticism.
An important addendum here is that in most cases, recruitment process of participants in developing countries is significantly undermined by a poorly communicated and hence poorly understood informed consent. The post-trial provisions and responsibilities should be clearly laid out and negotiated with, as a matter of priority not only with the participants, but with the sponsors, funding agency the local community and the ministry of health in the form of a “pre-trial agreement”. This will ensure avoidance of any future exploitation. It will also address, respect for persons (autonomy) of the individual participants, because they will know exactly what to expect after the trial is over and they will have a clearer picture of what they are getting into.
For instance, if a research is being conducted by a medical device manufacturer and during the study it is discovered that this new device is successful in detecting blood sugar levels more accurately as compared to all the existing devices in the market. Then the post-research responsibility for the researchers and sponsors is to provide that device, ideally free of cost to all participants and controls. Not only that, the laboratory testing and monitoring of various other indicators of adequate sugar control, annual physical examinations although not required for the study, should also be catered for. Another manner in which sponsors and funding agencies can deliver their responsibilities after the research is to devise strategies to ensure the manufacture of generic copies of patented drugs for poor countries [4
]. Randomized controlled trials of artemisinin (a Chinese herb) combination therapy for malaria were largely undertaken in Africa and Asia. As a result of the researchers’ post-trial efforts price-drops have been achieved and easier-to use formulations have become available to the participants and the community.
If nothing else, then the sponsors should seek joint initiatives of international agencies and through private-public partnerships to produce affordable drugs [4
]. One way is to collaborate with the Ministry of Health which agrees to pay a proportion of the cost of the drug/intervention. This will also indicate a political will and commitment of the local authorities and the trial sponsors will be under increased pressure to contribute to the costs. There are many private organizations like GAVI (Global Alliance for Vaccination and Immunization) or Global fund for HIV, Malaria and Tuberculosis [1
] that can cover costs based on humanitarian grounds, if they are involved at the research proposal stage. A concern is that post-trial responsibilities may discourage international research, but that should not be the case. There are many ways that sponsors can circumvent problems of financial constraints and it has been done before and these problems are not unsolvable. Medecins Sans Frontieres (MSF) is conducting a study of the effectiveness of a nutritional intervention in catch-up growth of children after an acute episode of malaria in Africa [5
]. The supplement is expensive and to make the supply of this supplement sustainable beyond the study, MSF is currently working on price reductions of this supplement as well as making efforts to increase its supply through local production. They have also made a commitment to stay in the community for at least 2 years after the end of the study.
If a social sciences research is being conducted to determine whether the basic risk factor of glue-sniffing and begging in street children is poverty or lack of primary education, then the sponsor may fulfill their post research responsibility by setting up the infrastructure of a school for the study participants where they can get quality education and a certain fixed stipend as an incentive to go to school. This will have a dual purpose, firstly, the children will be off the streets at least during the day and secondly they will get a purpose in life, with education. They will also be able to get financial aid as a result and it is highly likely that they may be able to support themselves if not their families also in a dignified manner. The sponsor and investigators will be ‘giving back’ to the entire community by uplifting them. This is a social responsibility of researchers. Such social service goes a long way in expressing some gratitude to the community which has contributed so significantly to the researchers’ study objectives. Direct feedback from participants has revealed that even digging a few boreholes in an area where water shortage is a problem, or providing adequate supply of chlorine tablets for water purification, or setting up a water filtration plant in the locality helps. Such measures create a bond amongst researcher and participant, the benefits of which are reaped for a long time even after the study has ended.
Finally, a very important responsibility of the research enterprise is the Dissemination of results of the study to the participants and to the entire community. The results of the study should be discussed in detail with the participants and the community leaders. This can be achieved by conducting “dissemination workshops” [6
]. Not only that, access to these results is to be ensured in order to maintain transparency.
According to the latest guidelines released by WMA, “Negative and inconclusive as well as positive results must be published or otherwise made publicly available. Sources of funding, institutional affiliations and conflicts of interest must be declared in the publication” [2
]. Furthermore, every research study involving human subjects must be registered in a publicly accessible database before recruitment of the first subject [2
]. In developing countries, more than anywhere else, community engagement throughout the research is to be encouraged.
Involvement of the participants and the community gives them a true sense of partnership with the researcher which further strengthens the activities related to the project.