NEW DELHI: India will finalize guidelines on compensation for research-related injury soon.
As per the Indian Council of Medical Research's Ethical Guidelines for Biomedical Research on Human Participants (2006), 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."
Now, trial subjects end up as guinea pigs and don't get any compensation if they get hurt.
The Indian Society for Clinical Research (ISCR) and Forum for Ethics Committees in India (FERCI) have prepared draft guidelines addressing issues related to compensation for research-related injury.
ICMR has invited comments on these guidelines by December 31, and then it will finalize the norms.
Under the new guidelines, mothers undergoing clinical trials which harm their unborn child will be able to demand compensation from researchers conducting the trial.
"Compensation will have to be paid to a child injured in-utero through the participation of the parent in clinical research," the guidelines say.
The Indian law for clinical trials - the amended Schedule Y of the Indian Guidelines for Clinical Trials and the ICMR Ethical Guidelines for Biomedical Research on Human participants, 2006, - have specified the need for provision of compensation of participants for research-related injuries.
The guidelines apply to all clinical research, whether sponsored by the pharmaceutical or medical device industry, government or academia or individual investigators.
The compensation, it says, could be in the form of payment for immediate medical/ surgical management of research-related injuries or for permanent disabilities. It says the Informed Consent Document (ICD) should state that the research participant has a right to claim compensation in case of research-related injuries and whom to contact for their rights as research participants.
The draft says compensation has to be paid, irrespective of whether injury was foreseeable/predictable and that the research participant had given h/his consent in writing about participating in the research study.
"The payment will be the responsibility of the investigator/institution," the draft says. Fear of unethical trials, being conducted by multinational drug companies on naive Indian villagers, has been a serious concern over many years.
Claims made by the research participant should be settled within a reasonable timeframe not exceeding 90 days. Any disputes will have to be settled within a reasonable timeframe preferably within 90 days. The guideline adds, "Compensation will not be paid to research participants receiving placebo in consideration of its failure to provide a therapeutic benefit or for natural progression of an underlying disease."
As per the Indian Council of Medical Research's Ethical Guidelines for Biomedical Research on Human Participants (2006), 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."
Now, trial subjects end up as guinea pigs and don't get any compensation if they get hurt.
The Indian Society for Clinical Research (ISCR) and Forum for Ethics Committees in India (FERCI) have prepared draft guidelines addressing issues related to compensation for research-related injury.
ICMR has invited comments on these guidelines by December 31, and then it will finalize the norms.
Under the new guidelines, mothers undergoing clinical trials which harm their unborn child will be able to demand compensation from researchers conducting the trial.
"Compensation will have to be paid to a child injured in-utero through the participation of the parent in clinical research," the guidelines say.
The Indian law for clinical trials - the amended Schedule Y of the Indian Guidelines for Clinical Trials and the ICMR Ethical Guidelines for Biomedical Research on Human participants, 2006, - have specified the need for provision of compensation of participants for research-related injuries.
The guidelines apply to all clinical research, whether sponsored by the pharmaceutical or medical device industry, government or academia or individual investigators.
The compensation, it says, could be in the form of payment for immediate medical/ surgical management of research-related injuries or for permanent disabilities. It says the Informed Consent Document (ICD) should state that the research participant has a right to claim compensation in case of research-related injuries and whom to contact for their rights as research participants.
The draft says compensation has to be paid, irrespective of whether injury was foreseeable/predictable and that the research participant had given h/his consent in writing about participating in the research study.
"The payment will be the responsibility of the investigator/institution," the draft says. Fear of unethical trials, being conducted by multinational drug companies on naive Indian villagers, has been a serious concern over many years.
Claims made by the research participant should be settled within a reasonable timeframe not exceeding 90 days. Any disputes will have to be settled within a reasonable timeframe preferably within 90 days. The guideline adds, "Compensation will not be paid to research participants receiving placebo in consideration of its failure to provide a therapeutic benefit or for natural progression of an underlying disease."
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