Mandatory adherence to national ethical guidelines to help ‘improve accountability in CTs, ensure safety of participants’
The Central government’s decision to make adherence to the national ethical guidelines for biomedical research mandatory for the first time would bring about the much-needed transparency and accountability in this field, healthcare experts say. Compliance with the guidance document will be compulsory as per the New Drugs and Clinical Trials Rules 2019 released recently by health ministry. The guidance document, prepared by the Indian Council of Medical Research (ICMR), is aimed at improving the overall quality of research outcomes while ensuring protection of research participants and responsiveness to the health needs of Indians. The details are included under clauses 15, 16, 17, 18 of Chapter IV of the clinical trial rules. The decision to make the guidelines legally binding is welcomed by researchers. “This is a good step. Finally we have a legal mandate for the implementation of the ICMR guidelines,” Anant Bhan, a well-known researcher in bioethics and global health, s...