Ananthakrishnan N, Shanthi A K
Mahatma Gandhi Medical College and Research Institute, Pondicherry, India.
Indian J Med Ethics. 2012 Jul-Sep;9(3):207-9. doi: 10.20529/IJME.2012.067.
The "Ethical guidelines for biomedical research on human participants" prepared by the Indian Council of Medical Research in 2006 came as a welcome step in the process of regulation of research on human subjects, since clear cut Indian guidelines were absent earlier. The guidelines have been accepted as the standard operating manual by Institutional Ethics Committees (IEC) in India. However, over a period of time, it has become obvious that the guidelines lack clarity in certain areas and require to be revised in the light of experiences of members in the IECs. Some of these problems with the ICMR guidelines have been highlighted in this paper to press for revision of the manual in the light of these experiences.
印度医学研究理事会于2006年制定的《人体生物医学研究伦理准则》，是人类受试者研究监管进程中一项值得欢迎的举措，因为此前印度缺乏明确的准则。该准则已被印度的机构伦理委员会（IEC）接受为标准操作手册。然而，随着时间的推移，很明显这些准则在某些领域缺乏清晰度，需要根据IEC成员的经验进行修订。本文强调了ICMR准则存在的一些问题，以期根据这些经验推动对手册进行修订。
