Review Decision:
The investigators are qualified
the requirement by IRB;
Research protocol and consent
forms basically meet the requirement of IRB;
Please provide the following
additional documents to the IRB for documentation:
Approval from Chinese DNA
export office for shipment of bio-specimen
SOP of bio-specimen shipment
The IRB agrees
to conduct the clinical study after the submission of the above
complementary documents
Review result: Agree
Agree after revised
Review after revised
Disagree Terminated
or paused
Please conduct the study and protect
the health and rights of the respondents in accordance with
Chinese laws, regulations, and agreements: SFDA “Good
clinical practice” (2003), “Provisions for clinical
trials of medical devices” (2004), WMA “Declaration of
Helsinki”, and CIOMS “International ethical guidelines
for biomedical research involving human subjects”, MOH
“Ethical review of biomedical research involving human
subjects”, approved protocol and consent forms by IRB.
In the progress of the study, any
changes of the main investigators, protocol, and consent forms
need to be submitted to IRB for reviewing the amendment.
If any serious adverse events
happened, the applicants need to submit a report to the IRB; After
the urgent event, provide detailed follow up report on the adverse
event as soon as possible.
Annual and regular reports need to
be submitted to the IRB. A written report need to be submitted to
the IRB in case of any possible situation which may have
significant impact on the progress of the study or increase the
risk to the respondents.
A violation report should be
submitted to the IRB in the events that the clinical trial (or
study) enrolled subjects who are not qualify, remained subjects
who should be quit due to meet the criteria of termination,
provided wrong treatment or dosage, provided combined medicine
which the protocol forbids to do so; and the possibility of having
impact on subjects’ health/rights, and any situation of
impacting the science of the study and violating the ethnic
principal or regulations.
If the
applicants pause or terminate the clinical trial (or study),
please provide a report to the IRB. When the clinical trial (or
study) is completed, a completion report should be submitted by
the applicant to the IRB.
Institute (Seal of
Sichuan University West China Hospital)
Chairman of the IRB:
Dec. 9, 2011
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