Biomedical and Health Experimentation in South Asia: Critical Perspectives on collaboration, governance and competition

Lead Research Organisation: University of Edinburgh
Department Name: Sch of Social and Political Science


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Description There are huge expectations regarding the growth of clinical trials in South Asia, and particularly in India, but the number of clinical trials predicted is not being realised. Having committed to the project of growth, Governments in the regions are struggling to ensure that the ethical and technical infrastructure to support trials is up to international standards, and this is resulting in a variety of tensions concerning governance, resourcing, distribution of benefit which were played out during our research and which are evident from the sample findings below.1. Institutional Ethics Committees [ECs] are heavily dependent on institutions and sponsors for their very existence. They are mainly ad hoc bodies set up to fulfill a statutory requirement. Independent ECs have emerged as a mirror of the processes of outsourcing and subcontracting, which are an integral part of the clinical research industry. Just as various functions of the research process are outsourced to specialized firms, ethics review has been outsourced to independent ECs to facilitate the clinical trials process. Overt conflicts of interests in ECs are common, such as directors of institutions or key functionaries of the sponsors sitting on EC. Members are also compromised because they share financial interests or professional or personal relationships with the other stakeholders in the research. However, there are also covert conflicts of interest. When the existence of the EC is itself so dependent on the development of the clinical research industry and their role is so deeply embedded in the logic of market capitalism, there is an intrinsic interest in facilitating commercially funded research, which poses limits to the extent that the EC can exercise its independence. The particular problem of the ECs in India (and elsewhere in South Asia) may, therefore, not be resolved by measures currently being considered in the region. It is necessary to create a structural framework that protects the independence of the ECs and enables them to function in accordance to the existing or envisaged guidelines. A rationalization of the numbers of ECs, laws and rules that regulate EC 'shopping', an independent funding mechanism and an effective mechanism for audit are required. These cannot be achieved without replacing the current market-based logic of development of ECs with one that stems from public interest. The objective of the ECs must not be to promote research, but to promote ethics. This goal cannot be achieved without the state assuming the central role in the process.2. In clinical trials, the research capacity of the Principal Investigators [PIs] remains very limited. Although PIs acquire and (some) hope to utilise skills in their own research, these skills are usually limited to good protocol adherence and data collection. The most important elements of a research project, such as protocol writing, sample selection and statistical analysis of data are all done elsewhere. Hence, in reality, the PIs are mostly acting as data collectors and the data are immediately handed over to the sponsoring drug company. PIs have no authorship or publication rights. Accountability in these trials is distributed and hidden. As the trial is structured with many compartments and players coming in only for a particular role without engaging with the trial completely, tracing one individual or entity for an error or harm is difficult. While data safety and monitoring boards exist, and ECs mandate that all Severe Adverse Events (SAE s) should be reported, the practical reality of this is very complicated. The PI delegates tasks to an array of staff, such as Co investigators, Clinical Research Co-ordinators, and Clinical Research Assistants. Also, monitors from the CRO visit the site regularly. Most of the paper work and coordination, including interacting with patients and ethics committees, is carried out by young life science graduates. They have not had standardized training courses, and they turn over regularly. In these circumstances, many of the ethical issues are handled poorly or not at all.3. In public health interventions, the biomedical RCT model for evidence generation has become dominant. The understanding of public health ethics is very problematic, as most field workers who collect data have no formal training and learn 'on the job'. Most experiments are usually some interventions which are useful services, as opposed to limited or no services at all. Hence the concept of free, voluntary informed consent is complicated, as are issues of post-trial benefits. The interventions we studied aimed to be scaled up and become public policy. Our study suggests that such up-scaling often bears only a very limited relationship to the findings of the intervention, since the up-scaling takes place before the study has been completed, or policy changes much more extensively than the study results warrant.
Exploitation Route Through research on other kinds of research in South Asia and elsewhere
Sectors Communities and Social Services/Policy,Education,Environment,Healthcare,Government, Democracy and Justice,Security and Diplomacy

Description Findings contributed to policy discussions in India regarding the regulation of clinical trials.
First Year Of Impact 2012
Sector Healthcare
Impact Types Policy & public services

Description Situating Evidence in Public Health Interventions: Experiences from India, Nepal and Sri Lanka 
Form Of Engagement Activity Participation in an activity, workshop or similar
Part Of Official Scheme? No
Geographic Reach National
Primary Audience Policymakers/politicians
Results and Impact Paper given in panel 'Anthropologies in and of public health in the 21st century'
Year(s) Of Engagement Activity 2012