Sunday, 2 December 2012

With India emerging as the major hub for global clinical trials, the Indian Council of Medical Research (ICMR) has proposed compensation for volunteers in case of injury during research

By Syed Akbar
Hyderabad: With India emerging as the major hub for global
clinical trials, the Indian Council of Medical Research (ICMR) has
proposed compensation for volunteers in case of injury during research.

The ICMR in its XII Plan Document announced that it would prepare new
revised guidelines and policy documents on stem cell research and
therapy, besides ethical guidelines for biomedical research involving
human subjects. They call for compensation to participants in case of
research-related injury. There will be guidelines ob bio banking which
includes cord blood banks.

At present, there is no provision for financial and medical
compensation to volunteers involved in clinical and medical research.
There have been several cases of severe side reactions including
death. In addition, there are no proper ethical guidelines on
recruitment of volunteers. It will also push forward for early
enactment of the Bill on “Biomedical and Health Research involving
Human Participants (Regulation of Ethical, Legal and social issues)”.

The country’s premier medical research body will for the first time
focus on mentally ill and cognitively impaired patients. It will come
out with ethical guidelines for conducting research on such people.

Apart from ethical guidelines on research involving human beings, the
ICMR will take up new research on cardiovascular diseases to determine
the role of various macro and micro nutrients in hypertension (high
blood pressure). In diabetes, the focus will be on use of animal
models to test the efficacy of anti-diabetic and anti-obesity drugs.
It will also conduct research to find out if asthma has anything to do
with obesity.

There will be national electronic disease surveillance system policies
for control progrmmes on cancer, diabetes, cardio vascular diseases
and stroke, and stem cell therapy.

“Studies in diabetes would be intensified with new genetic approaches
to the understanding and management of type 2 diabetes including
transplantation of pancreas.
New areas of research on malaria include genome sequencing of vectors
and parasites to study insecticide susceptibility, drug resistance,
rapid molecular diagnostics for Plasmodium, new therapeutic targets
for malaria, HIV/malaria co-infection and impact of climate change,”
the ICMR document pointed out.

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