Compensation guidelines for research related injury in India

recommend that research participants who suffer physical injury as a result of their participation are entitled to financial or other assistance to compensate them equitably for any temporary or permanent impairment or disability. In case of death, their dependents are entitled to material compensation. The Drug Controller General of India (DCGI) 4 now mandates that all ICFs incorporate a clause stating that that in case of study related injury or death, the sponsor will provide complete medical care as well as compensation. The Central Drugs Standards Control Organization (CDSCO) of the Directorate General of Health Services (DGHS) of the Ministry of Health and Family Welfare (MHFW) as well as the Indian Council of Medical research (ICMr) have issued draft guidelines 4,5 for compensation of research related injury on its website requesting feedback from all interested parties. These Guidelines apply to all clinical research, whether sponsored by the Pharmaceutical or Medical Device Industry, Government or Academia or individual investigators. As an Academic Institute committed to highest clinical, ethical and moral standards and practices in research, we too agree with the principle that patients who suffer injury due to their participation in a clinical trial must be provided with free treatment. We also agree that compensation over and above free treatment and rehabilitation costs may be payable to the patient, and in case of death the next of kin should receive compensation. However, we have serious concerns over some of the provisions, and believe that they may be detrimental to investigator initiated research. The net effect of the proposals, taken in their entirety will in fact only serve to make clinical research a monopoly of large pharma while suffocating academic initiative and research in areas with no perceived marketability or economic gain. In addition, there is a lack of clarity on several points regarding the practical implementation of these principles. 1. Mandatory compensation for the following is not rational: a. failure of an investigational product to provide intended therapeutic effect b. administration of placebo providing no therapeutic benefits c. adverse effects due to concomitant medications The above clauses are included in the CDSCO draft guidelines as being grounds for compensating research participants. The basis for performing clinical trials and any form of research is because there is equipoise or lack of knowledge about the efficacy of new treatments. Therefore, compensating patients being treated with new investigational products because the product did not have its intended therapeutic effect does not make sense. In fact, lack of knowledge about this very fact is what mandates the research to be done in the first place. Similarly, placebos are frequently used in clinical research where no effective alternative treatment exists primarily to avoid bias in interpreting the effects of the investigational drug. The placebo is not expected to provide therapeutic benefit though on occasion it has shown to do so. Compensation being provided for patients because the placebo does not have a therapeutic effect again does not make sense. Patients with disease are frequently prescribed multiple drugs and treatment, most of which are standard or routine treatment which they would take regardless of whether they are research participants or not. In addition, patients take the investigational drug as part of the research protocol. Adverse events occurring due to the other concomitant medications are common and are in no way related to the research itself. Having to compensate for injury resulting from these concomitant medications is again illogical. Comparing the CDSCO draft guidelines with the ICM r draft guidelines shows this glaring contradiction wherein the above three points are specifically mentioned in the ICMr guidelines as not being entitled to compensation while the CDSCO guidelines mandate it. While we hope that these clauses crept in inadvertently into the draft CDSCO guidelines (possibly a typographic error), we would like to make our opinion about these clauses clear.