The Indian Council of Medical Research (ICMR) is planning to come out with an ethical guideline for bio-banking in the country. The attempt is to caution against the possible misuse of the harvested biological materials for commercial purposes. The bio-genetic material is known to be of tremendous interest to the diagnostic industry due to its critical use in identifying new tools for early detection of diseases. The guideline would supplement the proposed "national guideline on stem cell research", which is to provide technical guidelines for the conduct of stem cell research and stem cell harvesting and banking.
The inclusion of the ethical guideline is to be the major addition in the revised version of the 'Ethical Guidelines for Biomedical Research on Human Subjects' that is being finalized by ICMR and Department of Biotechnology (DBT).
ICMR sources informed that all chapters in the existing guideline for biomedical research on humans are being thoroughly updated in the revised version. "Stem cell research and bio-banking are to be included as separate chapters in the revised guideline," sources said. The guideline is ready and would soon be circulated for expert comments, they added.
As reported earlier, the revised version would specify the norms and conditions that need to be satisfied before one can go for international collaborations in biomedical research. The move is in view of the increasing interest shown by foreign companies to outsource their clinical trials from India. ICMR - DBT want to ensure that no international collaboration is taking place purely on the basis of commercial interests. The guideline would talk about universal ethical requirement, community agreement and community consultation as part of introducing greater transparency in clinical trials.
The ICMR Ethical Guidelines for Biomedical Research on Human Subjects, first brought out in 2000, is an attempt to protect the vulnerable population from being subjected to unethical clinical trials.