Thirty-five-year-old Ritu Bhalla was twice diagnosed with blood cancer, at the ages of four and 11. She developed chronic hepatitis B as a long-term side-effect after cancer treatment.
Three years ago, while waiting for a follow up consultation in a hospital in Delhi, a woman who was not part of the hospital staff approached Bhalla – she asked her to provide a blood sample and sign a consent sheet to take part in a gastrointestinal clinical trial. But she did not explain why.
Bhalla asked for the information sheet or details of the study, but that only annoyed the woman, who she assumed was a trial coordinator, she said. Since no one came forward to explain the study, she refused to participate.
Experts say Bhalla’s experience isn’t a one-off occurrence. This is even as India’s regulatory framework covering clinical trials was significantly strengthened after the Supreme Court’s intervention in 2013, and subsequent amendments were made to the Drugs & Cosmetics Rules.
New rules include provisions for compensation to trial participants, and recording consent on video, especially among vulnerable populations. These, and mandatory registration of ethics committees with the central licensing authority, CDSCO, have improved safeguards for participants, said Poonam Bagai, founder and chairman, CanKids…KidsCan, which also hosts the Pediatric Cancer Research Institute (pCRI),...
Read more
-
Beware! An old pillow used for years becomes a home for the sick; Change on time otherwise health may be affected
-
‘Is Claude Down?’ Anthropic’s AI Faces Global Disruption As Users Flood Downdetector Amid Reports Of Login Errors And Service Glitches
-
Great design and powerful features! Realme’s new smartphone became the topic of discussion, the price was special
-
Where once there was dominance, Tata broke its back, India became the new electronics hub
-
Trail Blazers Rally Past Suns 114-110 in Play-In Thriller
