The Prof Ranjit Roy Chaudhury expert committee has summarily rejected the academic institutions' plea for a separate compensation package for clinical trial related deaths in investigator-initiated clinical trials in academic & research centres.
“Injury or death needs to be compensated, irrespective of whether the volunteer is participating in a pharmaceutical drug clinical trial or an academic research trial. The same yardstick applies to volunteers of both types of trials and the same procedures will have to be followed,” the expert committee in its recommendation to the government said.
The committee, constituted by the union health ministry in February this year to formulate policy, guidelines and SOPs for approval of new drugs including biologicals, clinical trials and banning of drugs, further recommended that in order to encourage academic and clinical research (non pharmaceutical-company related) in academic institutions, the government of India and state governments should create a fund by imposing a cess. The fund so created should be made available to the academic institution for paying compensation.
It further recommended that academic research may be approved by the institutional ethics committee (IEC) and needs to go for approval to the DCGI only if a new drug is being evaluated or a new use for an existing drug is being tried out.
Earlier, the committee had received representations from academic institutions in which it was pleaded that medical colleges and research institutes would not be able to pay the compensation which may have been recommended in favour of patients and volunteers in non-pharmaceutical clinical trials. It was further argued that most of these studies are part of the theses of postgraduate students, and academic research will suffer if the same yardstick is applied to the academics in these studies as for pharmaceutical companies. The representation further suggested that these studies could be approved by the IECs and need not be approved by the DCGl, except in cases of trials for new indications of already-approved drugs.