Indian Regulator Issues Ethics Guidelines on Biomedical Research Involving Children
The Indian Council of Medical Research has issued national ethics guidelines on biomedical research involving children. The 23-page document notes the special challenges for research in developing countries where parents are often illiterate and may confuse research with treatment. It also cites susceptibility to financial inducements to participate in clinical trials.
The broad recommendations include keeping treatment and testing in children to a minimum, ensuring therapy is age-appropriate and that studies are conducted in as familiar settings for children as possible. Investigational drugs should be tested first on adults, sometimes to Phase 3. Risk assessments should be done for any therapies that would be above the normal standard of care. Informed consent and patient and parent understanding are also discussed.
Comments on the guideline — which applies to researchers, sponsors and ethics committees — are due Nov. 15. Read it at www.fdanews.com/Indian-Biomedical-Guidelines-Children.pdf.
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