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Centre
to restructer consent form to facilitate embryonic research
Jayashree
Padmini - New Delhi
IDENTIFYING
the potential of stem cell research in the country and to open the
doors for full utilization of available embryos the Centre is incorporating
the required stipulations in the consent form.
Dr
Vinayak, advisor, Department of Biotechnology, told Express Pharma
Pulse, that the department is working out the nitty-gritties of
the consent form for getting informed consent from the couple so
that infertility clinics can go ahead with research work on embryos.
The existing consent form was quite sketchy and considering the
emerging scenario of increased use of embryos for research purposes
the government has decided to design a most appropriate consent
form.
 A
subcommittee has been formed that is now busy framing the particulars
to be incorporated in the consent form so as to prevent any malpractice
by researchers as well as to ensure that the couple could not have
a claim on the research done. ‘‘The consent form will
be finalized in a week’s time and we will put up in the website,’’
said Dr Vinayak. Each programme on stem cell has to be cleared by
the bioethics committee and frozen embryos should not be more than
14 days old, he added.
Talking
on recombinant-DNA products, Dr Vinayak said that the department
has constituted a Recombinant Committee in order to address all
issues related to recombinant products. ‘‘We have put
forward the issue to the Ministry of Health and the committee that
would act as a single window has already been constituted,’’
he said. The idea is to bring in speedier implementation, usher
in higher degree of transparency, and to address the safety and
efficacy issues in a comprehensive manner. The new committee’s
role is to act as advisory committee that will look into phase III
studies and recommend to GEAC (Genetic Engineering Approval Committee)
for environmental clearance.
Earlier
the Review Committee on Genetic Manipulation was the advisory body,
that will now look into only the pre-clinical and phase I &
II studies. The decision on recombinant products came under the
purview of three ministries where the products had to pass individually
through the three bodies under these ministries. Drug Controller
General of India, under the Ministry of Health is the body responsible
for giving the final market authorization based on the clinical
data generated.
RCGM
is under DBT, Ministry of Science & Technology whereas the Genetic
Engineering Approval Committee (GEAC), is under the Ministry of
Environment.
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