Documentations to be submitted
- Signed and dated Ethics Review Proposal form
- A statement of agreement to comply with ethical principles set out in relevant guidelines
- All significant previous decision made by other ethical committee*
- Proposal summary not more than two pages
- The protocol of the proposed research together with supporting documents and annexes
- Grant amount with estimated budget breakdown
- Informed consent forms*, Assent forms*, Permission forms*
- Information to be provided to participant concerning research samples*
- Consent/Assent document for taking/keeping biological samples*
- Forms and questionnaires intended for research participants*
- Materials for recruitment of participants*
- Relevant documents and tools/products for the study*
- Material Transfer Agreement*
- Data Transfer Agreement*
- Copy of MOU/LOA*
- Investigators’ curriculum vitae (updated, signed and dated) with recent passport size photo
(* If applicable)
No. 7, 8, 9 and 10 must be submitted in both English and Myanmar language
- All of the above should be submitted in one continuous document with consecutive page numbers and a contents page.
- 18 complete hard copies should be submitted.
- Annex 1 Letterhead
- Annex 2 Agreement to comply
- Annex 3 Waiver for ICF
- Annex 4 Permission Letter
- Annex 5 Checklist
- Annex 6 Summary
- Annex 7 Full Proposal
- Annex 8 Clinical Studies Adults
- Annex 8 Clinical Studies Guardians of Children
- Annex 8 Qualitative Research
- Annex 9 Assent form
- Annex 10 Myanmar (PDF file)
- Annex 10 ICF Myanmar (Word file)
- Annex 11 Information povided before taking biological material
- Annex 12 Consent_keeping Bio logical Material
- Annex 13 English Participant Recruitment Materials
- Annex 13 MM 1.Participant Recruitment Materials (PDF file)
- Annex 13 MM 1.Participant Recruitment Materials (Word file)
- Annex 13MM 2.Participant Refruitment Material
- Annex 14 MTA
- Annex 15 DTA
- Annex 16 Protocol Assessment Form
- Annex 17 Communication to PI
- Annex 18 Site monitoring Form