Accessing records obtained via an RTI query, the paper states that the ICMR’s nod to the clinic to conduct the procedure violates key ethical and procedural requirements
According to a paper published in the Indian Journal of Medical Ethics there are “yawning regulatory gaps” in the uterus transplant procedures being planned in India.
In May, a Pune hospital attempted India’s first uterus transplant, where a 46-year-old donated her uterus to her 26-year-old daughter. Permissions to conduct the procedure were granted by the state health authorities in Maharashtra. Lead author of the paper, journalist Sandhya Srinivansan writes that the approvals obtained were “inadequate and flawed.”
The transplant was done by an onco-surgeon assisted by a cardiac transplant surgeon, but did not include a surgeon as specified in the Human Organ and Transplants Act, the author says. The Act mandates presence of a surgeon with one year training in the respective organ transplantation as an active member of team.
The paper also points out flaws in the way Indian Council of Medical Research (ICMR) gave its nod to a Bengaluru clinic for conducting uterus transplant trials.
Accessing records obtained via an RTI (Right To Information) query, the paper states that the ICMR’s nod to the clinic to conduct the procedure violates key ethical and procedural requirements.
ICMR’s ethical guidelines say that transplant research may be conducted to help save human life. Permission was granted even though it is not a national health priority, a requirement for such research work. Also, a central ethics committee of the government was never consulted before issuing the go ahead.
Srinivansan writes that India has “phantom regulators”, and that the ICMR should have formulated guidelines before the first transplant occurred.
“In addition to the risks, there are other questions, including how it would be used in a society where women face pressure to give birth. It is unfortunate that such research is currently free from most regulation. As the apex body governing health research, the ICMR could at least have brought together civil society organisations to develop research guidelines before the first transplant in India.”
HIGH-RISK OP
Uterus transplant is still in experiment stage with only 25 women globally having undergone the procedure:
- Harvesting of the uterus for transplantation from a live donor is a complex, high-risk procedure
- To ensure adequate blood supply, a large section of blood vessels is taken with the uterus
- Swedish surgeons, leading the research, agree that it subjects the donor to “substantial surgical risk”
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