Who is liable to pay compensation in case of ADR in investigator initiated clinical trial( IIT) , the investigator who is also a sponsor in IIT or the institution to which investigator belongs?
you need to carefully conclude the contract. They should be written, who and what pays
Rimple, look at these articles https://www.jstage.jst.go.jp/article/jscpt/47/6/47_219/_pdf
https://pdfs.semanticscholar.org/5e21/10a60476a1bcf59942bbb67aefd586cc0a3a.pdf
Depends somewhat on the legislative framework of the country in which the ADR occurs. In general the trial sponsor (usually the employer of the trial PI) has overall legal responsibility for the trial and would be liable for trial-specific adverse events but not clinical negligence. Trial sponsors often have insurance to cover such events. If the trial involves an unlicensed IMP there may be a contract between the manufacturer & sponsor to manage ADR compensation.
Dear Rimple,
I can see that you are associated with AIIMS, Jodhpur.
You have mentioned that the investigator is also the sponsor at IIT. The sponsor will ahve to ultimately pay for medical management/compensation related to ADR.
In an Investigator initiated trial, the investigator also plays the role of a sponsor. The investigator is liable to pay for medical management in case of an ADR. A provision for compensation is to be made in the study budget. Those funds will be utilized to reimburse the patient when an ADR occurs.
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