Ethical challenges in biobanking: moving the agenda forward in India.

There is no agreement on the typology and definition of biobanks.The present regulations across countries, including India, focus ongenomic and genetic databases and DNA and cell line biobanking.It is unclear how the range of the holdings of biological samples in diagnostic and research laboratories fall under these regulatory frameworks. Biobank-related research has become very attractive because of advances in sample storage and data processing, a better understanding of the human genome, and high throughput laboratory assays. There is extensive literature and much debate on the subject, especially on the ethical and regulatory dilemmas, in the developed countries, but this is hardly the casein developing countries. This paper is based on a review of the published documents and data, and aims at evaluating the ethical frameworks for biobanking in the Indian context. The issues of"'broad consent; commercialisation of samples, and extended sample use are discussed. The governance of biobanks emerges as an integral part of the ethical responsibilities of institutions. It also makes the implementation of national guidelines possible, and helps to enhance the trust and confidence of local contributors in biobank research.