India draws up new guidelines for medical research

doi:10.1136/bmj.321.7268.1042/c

BMJ 2000;321:1042 ( 28 October )

News extra

India draws up new guidelines for medical research

Ganapati Mudur New Delhi

The Indian government has finalised a set of ethical guidelines for biomedical research in humans, but policymakers say that they will need to be backed by legislation "for real impact."

The guidelines, released by the Indian Council of Medical Research this week, cover wide ranging issues including informed consent, procedures for new drug trials, fetal research, transplantation, and human genetics.

All institutions engaged in biomedical research have been asked to set up institutional ethics committees to approve research projects involving humans through "formal meetings."

Fetal research, gene therapy, and all international research collaborations will, however, require approval from national level ethics committees. The guidelines say that somatic gene therapy may be used only to tackle life threatening or seriously disabling illnesses.

They impose an indefinite ban on human cloning, germline therapy, and on any "gene therapy to enhance or change normal human traits." . . . [Full text of this article]

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