Informed consent in genetic research and biobanking in India: some common impediments

The principle of informed consent, codified in the Declaration of Helsinki, has been widely seen as fundamental to bio-medical and research ethics. The importance of informed consent is increasing in procedures regulating the acquisition, possession and use of personal information, including genetic and medical information. Informed consent, it is believed, ensures that patients and research subjects can decide autonomously whether to permit or refuse actions that affect them. In response to this assurance, there are numerous guidelines at local, national and international levels that recognise the importance of informed consent, especially in research related to healthcare in developing countries. However, complications arise in applying these guidelines to a particular situation, especially under conditions that are prevalent in developing societies, for instance in India. This article discusses common forms of impediments or hindrances encountered while exercising the principles of informed consent in the context of genetic and genomics related research among the tribal and rural caste communities in India. These hindrances include: illiteracy, poverty, paternalistic attitudes, socio-cultural barriers, ineffective regulatory mechanism and procedural inconsistency among others. The data used in this article is based on an ethnographic study conducted between December 2006 and May 2007 using social-science qualitative research techniques. We observe that three areas require attention: first, the ways in which informed public debate on bioethical issues can be held, and how the application of genetics and genomics in Indian society can be discussed; second, the readiness with which researchers, IRB members and the state appreciate and wish to map the genetic diversity in Indian society; and, third, the risks associated with the application of bioethical principles at a micro-level.