INSTITUTIONAL REVIEW BOARD (1)
MINISTRY OF HEALTH AND SPORTS
CERTIFICATE OF APPROVAL
Full title of the study:
Protocol ID:
Principal investigators:
Review date:
Expiration date:
This is to certify that the above study on ".." was considered by the Institutional Review
Board (1), the Ministry of Health and Sports on 26-Jun-2014, meets the requirements of
……..and was APPROVED on 5-Aug-2014
The Principal Investigator is responsible for
1. Ensuring that all researchers associated with this study are aware of the conditions
of approval and which documents have been approved.
2. Complying all the policies and procedures, as well as with all applicable laws in
Myanmar regarding the protection of human subjects in research, including, but not
limited to, the following:
o
Ensuring that personnel performing the study are qualified, appropriately
trained, and will adhere to the provision of the approved protocol,
o
Implementing no changes in the approved protocol or consent process or
documents without prior IRB (1) approval (except in an emergency, if necessary
to safeguard the well-being of human subjects and then notifying the IRB as
soon as possible afterwards),
1
o
Obtaining the legally effective informed consent from human subjects or their
legally responsible representatives, and using only the currently approved
consent process and stamped consent documents, as appropriate, with human
subjects,
o
Assure that adequate resources to protect the research participants (i.e.
personnel, funding, time, equipment and space) are in place before
implementing research study, and that the research will stop if adequate
resources become unavailable.
3. Notifying the Secretary of the Institutional Review Board (1), via amendment or
progress report, of
o
Serious or unexpected adverse events as well as protocol violations or other
incidents related to the protocol to the IRB in writing within 10 working days.
o
Any significant change to the project and the reason for that change, including
an indication of ethical implications (if any);
o
Serious adverse effects on participants and the action taken to address those
effects;
o
Any other unforeseen events or unexpected developments that merit
notification;
o
The inability of the Principal Researcher to continue in that role, or any other
change in research personnel involved in the study;
o
Any expiry of the insurance coverage provided with respect to sponsored
clinical trials and proof of re-insurance;
o
A delay of more than 12 months in the commencement of the study; and,
o
Termination or closure of the study.
Additionally, the Principal Investigator is required to submit
2

A Progress Report on the anniversary of approval and on completion of the study;
The Institutional Review Board (1) may conduct an audit at any time.
SPECIAL CONDITIONS
.
SIGNED:
Dr. Toe Thiri Aung
Secretary, IRB-1
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