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AF01-06 (EN)

MEMORANDUM

Office: ……………………………… Tel.:……………………..


Reference number ………………………………… Date: ………………………
Issue: Submission of thesis proposal for research ethics review

Attention: Chairman of The Research Ethics Review Committee for


Research Involving Human Research Participants, Group I,
Chulalongkorn University
Attachment: 1. Memorandum and application form, 8 copies each.
2. Research proposal and relevant documents and materials,
8 copies each.

My name is …………………………...………………………… (Graduate


student/Lecturer/Researcher) Faculty/Institution …………….
………………….. , would like to submit a research proposal on the
topic of ........................................................................................................
…………………………………………………………… for research ethics review.
This research proposal has already been approved for relevant and
scientific merit by the committee involved.

………………………………..…………
……………………………………………

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(………………..………………………..) (………….
……………….…………….)
Principal advisor
student/researcher
Date ………/…………./………… Date
………/…………./…………

Certified for the application.

……………………..………………………
(………….……………………………….)
Dean/Director
Date …….……/……….…./……..…….

Form of
Application Form for Research Ethics Review

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1. Project name in Thai (if required) .


………………………………………………………..………………………...……
Project name in English …………………………………………………..
…………………………………………………....
2. Name of principal investigator …………………………………………..
………………………………………………….
Position: ……………………………………………………………………..…….
…………………………………………………….
Institution ……………………………………………….
…………………………………………………………………….……..….
Telephone …………………. Cellphone……………………E-mail Address:
…………………
3. Declaration of conflict of interest  No  Yes,
specify………………….……..
4. Other ongoing research projects  No  Yes, specify
number…………..….
5. Population/Participant:
5.1 Vulnerable
( ) psychosis ( ) prisoner/under
captivation
( ) younger than 18 years old ( )
pregnancy
( ) senile dementia ( ) dementia
( ) disabled ( )
minority/different religion
( ) mental retarded ( ) refugee

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( ) lover of same sex ( ) migrant


laborer
( ) drug addict ( )
draftee/conscript
( ) having disease (specified) ……….. ( )
sex worker
( ) Other
………………………………………………………………………………….………
5.2 Non-vulnerable (specified)
……………....................................................................
6. Number of places to collect data ………………. specified
……………………………………………..
Which site has Ethical Review Board (specified)
…………………………..……………..……………...
………………………………………………………………………………………………………
………………………………….
7. Funding Agency
………………………………………………………………………………………….
…………………..
 granted  in the review process
Amount of fund …………………………………..
8. Thesis proposal has been approved by
…………………………………………………………..………...
..
………………………………………………………………………………………………………
………..……………………..

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Date ……………………………………………………………………………………….
………………………………………
9. Name of other institutions (multi-center study)
……………………………………………………..….

10. Attached documents

Ye N Official
s o used
  
10.1 Memorandum and Application
Form
(AF 01-06 research proposal/thesis)
  
10.2 Participant Information Sheet and
Consent Form   
Note: local language version need to be
submitted for review
10.3 Memorandum for waiver of
Participant information sheet
and consent form (if applicable)
  
10.4 Work plan of every activity
including period of research
ethics review
10.5 Qualification of principal
  
investigator
10.6 Research Proposal with details,
including
10.6.1 Project Name.   
  
10.6.2 Rationales/Background of
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problem
10.6.3 Review literature   
10.6.4 Objectives of research   
10.6.5 Conceptual framework   
10.6.6 Research methodology   
10.6.7 Population/Participants   
10.6.8 Benefits and risks to
  
participant/to public
10.6.9 How to approach potential
participant/access to medical   
record etc.
  
10.6.10 How to protect welfare and
safety of participants
including risk management
10.6.11 Limitation of research   
  
10.6.12 References
  
10.6.13 Budget
10.6.14 Experts approved of research
tool/intervention
program/guideline
Specified 1.   
…………………………………………
2. …………………………………………
3. …………………………………………
  
10.6.15 Other documents e.g.:
Advertising leaflet for

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potential participants etc.


Specified …………………………………………

11. CD/Thumb drive/Flash drive: details of 10.1 to 10.6

12. I am willing to comply with the followings:


12.1 Fully understand that it is unethical to collect studied
data before the project has been approved by the
Research Ethics Review Committee for Research Involving
Human Research Participants, Group I, Chulalongkorn
University (RECCU).
12.2 Research project activities must be ended not later
than the approval expired date. If extension of approval
required, application should be done along with research
progress report not less than one month prior to expired
date.

12.3 Strictly conduct the research project activities as


mentioned in the proposal.
12.4 Use only forms bearing the RECCU’s seal of approval:
(Participant Information Sheet and consent form, research
tools/intervention program/guideline, and advertising
leaflet (If any).
12.5 Report to RECCU for any serious adverse events within
5 working days
12.6 Report to RECCU for any change of the research
project activities prior to conducting the activities.
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12.7 In case of discontinuing of research project before due


date, report to RECCU within 2 weeks with explanation.
12.8 Send final report (AF 01-15) and abstract for a one
year (or less) research project within 30 days after the
completion of the research project. For thesis, send
abstract within 30 days after the completion of the
research project. If no abstract sent, it is assumed that the
project is finished.
12.9 For research project which conducting has many phases,
the committee will approve phase by phase. When
request approval of the next phase, the researcher must
send progress report of the previous phase along with full
research project of that phase.

…………………………………………………… ……..……….
……………………………
(……………………….……………………….) (………..…….
………………………….)
Principal advisor Principal
investigator
Date………/…………./…………
Date ………/…………./…………

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