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Consent for trial on record soon
The Government has made a move to ensure that a person’s consent for undergoing a clinical trial is mandatorily audio/video recorded. The measure proposed through amendments in the Schedule Y of the Drugs and Cosmetic Rules intends to address ethical issues such as safety and rights of the patients.
The move comes against the backdrop of an alarmingly high number of deaths during clinical trials and also reports of humans being used as guinea pigs for such tests by drug manufacturers.
The Drug Technical Advisory Board (DTAB), the highest-decision making body of the Health Ministry on technical matters, has recently also decided to make it mandatory for the investigators to adequately inform the volunteers about the therapeutic effects on health in case the treatment fails under the trial, sources said.
Presently, the investigator is required to provide information about the study verbally as well as using a patient information sheet in a language that is not technical and understandable by the study subject.
“Following amendment under sub-para(4) under Schedule Y of the Rules, it will be mandatory for the investigator to make audio/video recording of the procedures of obtaining informed consent of the individual subject and maintain it for record.
“This will authenticate that at the time of enrollment proper care was taken to inform the subject about the pros and cons of the clinical trial and his participation was voluntary,” said sources, pointing out the illegal practices being adopted in many human trials as was in human papilloma virus (HPV) vaccine trials in 2010 which were conducted without proper consent on nearly 23,500 girls in the 10-14 age group in Gujarat and Andhra Pradesh.
It has been felt that it is the duty of the investigator to adequately inform the trial subject about the essential elements of the study and that of the drug to be administered so that the subjects are not treated as guinea pigs.
Also, it is a must that the trial subject is made aware that the drug is a new one and is being administered for the first time. The therapeutic efficacy and serious adverse reactions of a drug too have to be informed to the subject.
More than 1,300 people have died during clinical trials in the country in the last two and half years.
The Government has made a move to ensure that a person’s consent for undergoing a clinical trial is mandatorily audio/video recorded. The measure proposed through amendments in the Schedule Y of the Drugs and Cosmetic Rules intends to address ethical issues such as safety and rights of the patients.
The move comes against the backdrop of an alarmingly high number of deaths during clinical trials and also reports of humans being used as guinea pigs for such tests by drug manufacturers.
The Drug Technical Advisory Board (DTAB), the highest-decision making body of the Health Ministry on technical matters, has recently also decided to make it mandatory for the investigators to adequately inform the volunteers about the therapeutic effects on health in case the treatment fails under the trial, sources said.
Presently, the investigator is required to provide information about the study verbally as well as using a patient information sheet in a language that is not technical and understandable by the study subject.
“Following amendment under sub-para(4) under Schedule Y of the Rules, it will be mandatory for the investigator to make audio/video recording of the procedures of obtaining informed consent of the individual subject and maintain it for record.
“This will authenticate that at the time of enrollment proper care was taken to inform the subject about the pros and cons of the clinical trial and his participation was voluntary,” said sources, pointing out the illegal practices being adopted in many human trials as was in human papilloma virus (HPV) vaccine trials in 2010 which were conducted without proper consent on nearly 23,500 girls in the 10-14 age group in Gujarat and Andhra Pradesh.
It has been felt that it is the duty of the investigator to adequately inform the trial subject about the essential elements of the study and that of the drug to be administered so that the subjects are not treated as guinea pigs.
Also, it is a must that the trial subject is made aware that the drug is a new one and is being administered for the first time. The therapeutic efficacy and serious adverse reactions of a drug too have to be informed to the subject.
More than 1,300 people have died during clinical trials in the country in the last two and half years.
