5. Item B5.2 diagram needs to be rewritten: include ethical clearance in the diagram. What are “sending questionnaire” and “reminder phone calls”? Are you performing both a questionnaire and an interview?
6. Item B5.3 Data collection methodology: What is “two group comparison”? Please describe clearly.
7. Please describe the inclusion criteria, exclusion criteria, and withdrawal criteria in item B5.8.1-B5.8.3.
8. Item B5.12 Questionnaire: How long does the interview take?
9. Do you have any permissions from implementing institutions in Somalia? You will be using their information.
10. How will you approach your respondents in Somalia and ask for informed consent? And who will do this? Please describe this clearly in item C4.
11. Please clearly rewrite the information about compensation in item C7.
12. Can your respondents make a call to the number “081-9188688” stated in item C10?
13. With regards to item C12, you will interview your respondent after receiving oral consent. Does this mean you will definitely know who will answer which question?
Participant Information Sheet
14. Please follow the PIS checklist (as attached) and make sure you have the statements covering all necessary items.
Informed Consent Form
15. The interview process may have to write clearly. The respondents may have to read the Informed Consent Form prior to the interview, and then later being interviewed by cell phone. You will do the interview for every respondent or the site staff will do. The Informed Consent Form was written as you will do the interview. You may use the example of Informed Consent Form attached herewith as an example.
Questionnaire
16. Please revise project title. It is different from the title stats in research proposal.
17. Personal information #3. Education level and 5. Job position do not go together.
Other comments
18. Item B4. Expected duration of the study: When the study end?
19. You have 25 references in Appendix A but you cite only #3-6 in the research proposal (FTM ECF-019-04).
20. You don’t have signatures of implementing institutions’ officers in Somalia, nor letters permitting the study in Puntland, Somalia. (Appendix B missed one part).
21. Please insert version date at the footer of every documents.