Compensation in case of
injury or death during clinical trial
(1)
In
the case of an injury occurring to the clinical trial subject, he or she shall
be given free medical management as long as
required.
(2)
In case the injury occurring to the trial subject is
related to the clinical trial, such subject shall also be entitled for
financial compensation as per order of the Licensing Authority defined under clause (b) of rule 21, and the
financial compensation will be over and above any expenses incurred on the medical management
of the subject.
(3)
In the case of clinical trial related death of the
subject, his/her nominee(s) would be entitled for financial compensation, as
per the order of the Licensing Authority defined under clause (b) of rule 21, and the financial
compensation will be over and above any expenses incurred on the medical management of the subject.
(4)
The financial compensation for clinical trial related
injury or death could be in the form of:-
(a)
payment for medical management;
(b)
financial compensation for trial related injury;
(c)financial compensation to
nominee(s) of the trial subject in case of death;
(d)
financial compensation for the child injured in-utero because of the
participation of parent
in clinical trial.
(5) The Sponsor or his representative, whosoever
had obtained permission from the Licensing Authority for conduct of the clinical trial,
shall provide financial compensation, if the injury or death has occurred
because of any of the following reasons, namely:-
(a)
adverse effect of investigational product(s);
(b)
any clinical trial procedures involved in the study;
(c)violation of the approved
protocol, scientific misconduct or negligence by the Sponsor or his
representative or the Investigator;
(d)
failure of investigational product to provide intended therapeutic
effect;
(e)
use of placebo in a placebo-controlled trial;
(f)
adverse effects due to concomitant medication excluding standard care,
necessitated as part
of approved protocol;
(g)
injury to the child in-utero because of the participation of parent in
clinical trial.
(6) Procedure for payment
of financial compensation
(a)
The Investigator shall report all serious and unexpected adverse events
to the Licensing Authority
as defined under clause (b) of rule 21, the Sponsor or his representative whosoever had obtained
permission from the Licensing Authority for conduct of the clinical trial and
the Ethics Committer that accorded approval to the study protocol, within
twenty four hours of their
occurrence as per Appendix XI.
(b)
(i) The cases of serious adverse events of death shall be examined as
under:
(A)
An independent Expert Committee shall be constituted by the licensing Authority as defined under rule 21(b) to examine
the cases and recommend to the Licensing Authority for the purpose of arriving
at the cause of death and quantum of
compensation in case of clinical trial related death.
(B)
The Sponsor or his representative, whosoever had obtained permission from the Licensing Authority
for conducting the clinical trial, and the Investigator shall forward
their reports on serious adverse event of death after due analysis to Chairman of the Ethics
Committee and Chairman of the Expert
Committee with a copy of the report to the Licensing Authority as defined under rule 21(b) and the head of the
Institution where the trial has been
conducted, within ten calendar days of occurrence of the serious adverse event of death.
(C)
The Ethics Committee shall forward its report on serious adverse event
of death after due analysis
along with its opinion on the financial compensation, if any, to be paid by the Sponsor or his
representative, whosoever had obtained permission from the Licensing Authority as defined under rule
21(b) for conducting the clinical
trial, to the Chairman of the Expert Committee with a copy of the report to the Licensing Authority
within twenty one calendar days of the occurrence of the serious adverse event of death.
(D)
The Expert Committee shall examine the report of serious adverse event of death and give its recommendations to the
Licensing Authority for the purpose of
arriving at the cause of the adverse event within thirty days of receiving the
report from the Ethics Committee, and the Expert Committee while examining the event, may take into consideration,
the reports of the Investigator,
Sponsor or his representative whosoever had obtained permission from the
Licensing Authority for conducting the clinical trial and the Ethics Committee.
(E)
In the case of clinical trial related death, the Expert Committee shall
also recommend the quantum of
compensation to be paid by the Sponsor or his representative, whosoever had obtained permission
from the Licensing Authority
as defined under rule 21(b) for conducting the clinical trial.
(F)
The Licensing Authority shall consider the recommendations of the
Expert Committee and shall
determine the cause of death and pass orders as deemed necessary.
(G)
In case of clinical trial related death, the Licensing Authority, after considering the
recommendations of the Expert Committee, shall decide the quantum of compensation to
be paid by the Sponsor or his representative, whosoever had obtained permission from the
Licensing Authority for conducting the clinical trial and shall pass orders as deemed necessary
within three months of receiving
the report of the serious adverse event.
(ii) Cases of serious adverse events, other than deaths, shall be
examined as under:
(A)
The Sponsor or his representative, whosoever had obtained permission from the Licensing Authority
for conducting the clinical trial, and the Investigator shall forward their reports on
serious adverse event, after due analysis, to
the Licensing Authority as defined under rule 21(b), Chairman of the Ethics Committee and the head of the
Institution where the trial has been conducted
within ten calendar days of occurrence of the serious adverse event.
(B)
The Ethics Committee shall forward its report on the serious adverse event, after due analysis,
along with its opinion regarding the financial compensation, if any, to be paid by the Sponsor
or his representative, whosoever had obtained permission from the Licensing Authority as
defined under rule 21(b) for conducting the clinical
trial, to the Licensing Authority within
twenty one calendar days of occurrence of the serious adverse event.
(C)
The Licensing Authority shall determine the cause of injury and pass
order as deemed necessary. The
Licensing Authority shall have the option to constitute an independent Expert Committee,
wherever considered necessary, to examine such serious adverse events of injury, which will recommend
to the Licensing Authority for arriving at the cause
of the injury and also the quantum of compensation in case of clinical trial
related injury, to be paid by the Sponsor or
his representative whosoever had obtained permission from the Licensing Authority as defined under rule
21(b) for conducting the clinical trial.
(D)
In case of clinical trial related injury, the Licensing Authority, shall
decide the quantum of compensation
to be paid by the Sponsor or his representative whosoever had obtained permission from the
Licensing Authority for conducting the clinical trial, and shall pass orders as deemed
necessary within three
months of receiving the report of the serious adverse event.
(c) The Sponsor or his
representative, whosoever had obtained permission from the Licensing Authority for
conducting the clinical trial, shall pay the compensation in case of clinical trial related injury or death as per the
order of the Licensing Authority as defined under
rule 21 (b) within thirty days of the receipt of such order.
