11 Other ethics YES NO N/A committees’ involvement specified 12 If YES to above - YES NO N/A Have approval letters been submitted? 13 Is applicant affiliated YES NO N/A to BREC e.g. BREC – member? If yes, please specify 14 Clinical protocol YES NO N/A submitted 15 BREC details on YES NO N/A Information Sheet updated/checked 16 Statistics addressed YES NO N/A 17 Information to YES NO N/A participants submitted 18 Informed consent YES NO N/A documents submitted 19 Signature of PI YES NO N/A 20 Signature of HOD YES NO N/A 21 Signatures of YES NO N/A 22 Questionnaires YES NO N/A submitted 23 Translation of YES NO N/A documents certified 24 Materials Transfer YES NO N/A Agreement (MTA) 25 Will genetic studies be YES NO N/A performed? If yes, provide consent form 26 Export certificate for YES NO N/A tissue storage/transportation 27 Permission from YES NO N/A Department of Health/Province 28 One copy of grant YES NO N/A funding proposal if funded by any US DHHS source, e.g., NIH, CDC, DAIDS 29 Proof of payment of YES NO N/A BREC review fee if externally funded 30 Copy of MCC approval YES NO N/A or application
11 Other ethics committees’ involvement specified YES NO N/A 12 If YES to above - Have approval letters been submitted? YES NO N/A 13 Is applicant affiliated to BREC – e.g. BREC member? If yes, please specify YES NO N/A 14 Clinical protocol submitted YES NO N/A 15 BREC details on Information Sheet updated/checked YES NO N/A 16 Statistics addressed YES NO N/A 17 Information to participants submitted YES NO N/A 18 Informed consent documents submitted YES NO N/A 19 Signature of PI YES NO N/A 20 Signature of HOD YES NO N/A 21 Signatures of YES NO N/A 22 Questionnaires submitted YES NO N/A 23 Translation of documents certified YES NO N/A 24 Materials Transfer Agreement (MTA) YES NO N/A 25 Will genetic studies be performed? If yes, provide consent form YES NO N/A 26 Export certificate for tissue storage/transportation YES NO N/A 27 Permission from Department of Health/Province YES NO N/A 28 One copy of grant funding proposal if funded by any US DHHS source, e.g., NIH, CDC, DAIDS YES NO N/A 29 Proof of payment of BREC review fee if externally funded YES NO N/A 30 Copy of MCC approval or application YES NO N/A