English — original text

KAMUZU UNIVERSITY OF HEALTH SCIENCES RESEARCH and ETHICS COMMITTEE (KUREC) CHECKLIST TO ACCOMPANY NEW RESEARCH PROPOSALS SUBMITTED TO THE COMMITTEE When you submit a research proposal for the Committee to approve, first read the document entitled KUREC Elements Of Review attached to this check list. Make sure that your proposal is in the format outlined in the document. Before sending or giving the proposal to the Committee, complete the following check- list by ticking each item you have included. Do not submit the proposal unless you can tick all the boxes, or provide a reason for the absence of any item. Attach the completed check-list to the front of your submission. Provide evidence of payment of US150 processing fee. TITLE OF PROPOSAL: Name of Principal Investigator: Name of Sponsor and amount of sponsorship: Submit all documents in one pdf file of not more than 5MB by email to kurec@kuhes.ac.mw (if the file size is more than 5MB, then please zip the file and submit it as a compressed zipped file). The single pdf file should include the following information in the following order: 01 Completed copy of this checklist as stated above Yes☐or No☐ 02 Covering letter of introduction from Investigator Yes☐or No☐ 03 The study protocol which should include the following:- Study Title Yes☐or No☐ List of Investigators and institution(s) involved Yes☐or No☐ Executive Summary Yes☐or No☐ Background/Introduction Yes☐or No☐ Rational/justification Yes☐or No☐ Objectives of the study: Main objective and Specific Objectives Yes☐or No☐ Methods: Type of study - place of study Yes☐or No☐ Study population Yes☐or No☐ Study period Sample size Yes☐or No☐ Data collection procedures Yes☐or No☐ Data management/analysis Yes☐or No☐ Presentation of results Yes☐or No☐ Dissemination of results Yes☐or No☐ Ethical considerations: including consenting procedures, participant Yes☐or No☐ compensation, participant confidentiality etc. KUREC Checklist to be included in the submission pdf file. Version 1 dated 12 February, 2026 Page 1 of 2

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Possible constraints Yes☐or No☐ Requirements Yes☐or No☐ Training provided for study staff Yes☐or No☐ Budget and Justification of budget Yes☐or No☐ References Yes☐or No☐ 04 Consent forms: include consent forms in both English & Chichewa for adult Yes☐or No☐ participants aged 18 and above, parental consent forms for all minors and assent forms (in addition to the parental consent forms) for all minors between the ages of 7 and 17 years. Any participant payments e.g. compensation, reimbursement etc should be stated by amount in the consent forms. 05 Data collection tools (proformas): those that will involve obtaining information Yes☐or No☐ from research participants should be translated into Chichewa 06 Material transfer agreement forms/documents Yes☐or No☐ 07 Have you applied for a waiver of 10% KUHES overhead fee from the Office of Yes☐or No☐ the Director, Research and Postgraduate Studies? If yes, please attach a waiver letter. 08 Have you submitted this proposal to another Ethics Committee? If yes, please Yes☐or No☐ specify whether approval has been given, and if approval has been awarded, please submit a copy of the approval letter with this submission 09 Letter of support from KUHES Head of the Principal Department hosting the Yes☐or No☐ research 10 Letter(s) of support from Heads of all other Depts. and institutions in which Yes☐or No☐ any research work will be done. 11 Evidence of current active registration with the Medical Council of Malawi for Yes☐or No☐ Principal Investigator and other investigators who are involved in clinical research 12 Brief CV of each investigator Yes☐or No☐ If any item is not ticked, explain why this is not included with the submission. Signed: Name (print): Date: KUREC Checklist to be included in the submission pdf file. Version 1 dated 12 February, 2026 Page 2 of 2

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