Makerere University School of Health Sciences Research and Ethics Committee (MAKSHSREC) is accredited by UNCST under REC No: UG-REC-010. NIH-OHSP accreditation is under IRB No. IRB00008104, IORG No:0006758 .and FWA No. FWA0002891.

MAKSHSREC is committed to upholding integrity, protecting research participants and advancing ethical research in Uganda, and therefore pleased to share with you practical information on the different types of submission, review categories, submission requirements and templates/documents.

Note that review meetings are held twice a month (first & last Tuesdays of every month). All submissions are made online via the NRIMS online portal: https://nrims.uncst.go.ug/   

For further information, contact the Secretariat: Email: healthsciences.irb@gmail.com or Tel: +256 774 313924 /+256 703 313924

Physical location: 2^nd floor, School of Pharmacy building next to the University police - Makerere University main campus, accessible via the Eastern Gate.

 MAKSHSREC functions:

To Provide Research Oversight by:

1. Reviewing research protocols
2. Monitor ongoing approved research studies in order to:

1. Maintain ethical standards of practice in research
2. Protect research participants and researchers from harm or exploitations
3. Preserve the research participants rights and welfare
4. Ensure adherence to ethical conduct of research protocols approved

TYPES OF SUBMISSIONS FOR REVIEW INCLUDE:

1. Initial/new research protocol submission
2. Amendment submission
3. Renewal submission
4. SAE reports
5. Protocol violation and protocol deviation
6. Study close out

REVIEW CATEGORY BY MAKSHSREC

1. Regular review
2. Fast track/speedy review
3. Expedited review
4. Exemption from review

SUBMISSION REQUIREMENTS

1. NEW APPLICATION TO CONDUCT RESEARCH

1. NON CLINICAL TRIAL RESEARCH SUBMISSION REQUIREMENTS

• Submit online via NRIMS portal: https://nrims.uncst.go.ug/
• Complete and signed new application form 101
• A complete Research protocol with version number and date - the foundational blue print with study title, list of investigators, summary/abstract, background to the study, problem statement, significance, justification, objectives, literature review, methodology, workplan, dissemination plan, community engagement plan, data sharing and ownership (where applicable), environmental impact assessment (where applicable), budget, references/bibliography etc.
• A site-specific implementation plan (Applicable for multi-site studies).
•  Signed research protocol by supervisor(s) & student (applicable to Undergraduate, Master & PhD students)
• Proof of research protocol approval from the Principal Investigator’s home institution only if the research protocol originates from outside Uganda because approval from Uganda where data will be collected is final (if applicable)
• International collaborative research study shall have a Uganda- based PI/Co-PI listed on the protocol, who must be employed at and/or affiliated to a recognized local organization that is relevant to the area of the proposed research. He or she must be qualified and competent to actively lead and/ or supervise the research study. A collaborative agreement shall be signed by a legally authorized person at the local institution.
•  Proof of research protocol approval from the Principal Investigator’s department in form of minutes for PhD and Master students: a letter from Supervisor for Undergraduate students (Applicable to PhD, Master and undergraduate students studying within Uganda)
• Plagiarism report (If applicable to your study)
• Proof of training in Human Subject Protection (HSP), and other trainings relevant to your study like Good Clinical Practice (GCP), Good Laboratory Practice (GLP) etc. (If applicable)
• Recruitment informed consent fforms following our format: Must be provided in English and translated into the local languages of the target population.
• Assent form following our assent form format: Must be provided in English and translated into the local languages of the target population. (If applicable to the study)
• Informed consent for sample /specimen storage & future use: Must be provided in English and translated into the local languages of the target population. (If applicable to the study)
•  Study instruments/tools e.g. questionnaires, FGD guide, observation checklist, desktop review checklist, case report forms, videos, flip charts, data abstraction form and other data collection tools/forms:  must be provided in English and translated into the local languages of the target population (if applicable)
• CVs for the study team
• COVID 19 and Ebola risk management plan for studies that will involve interviewing research participants (if applicable)
• Community engagement plan
• Data Sharing and Use Agreement (if applicable)
• Material Transfer Agreement (if applicable)
• Research participant’s time and transport reimbursement payment logs
• Proof of payment of review fees depending on the review category chosen (Contact MAKSHSREC Admin for review fees amount).
• And any other document relevant to the study
• Templates/forms can be downloaded from the website
• Incomplete submission will be rejected until all submission requirements are met.
• Submit two weeks prior to the next REC meeting.
•  Review meetings are held twice a month (first & last Tuesdays of every month)

2. CLINICAL TRIAL SUBMISSION REQUIREMENTS

• Submit online via NRIMS portal: https://nrims.uncst.go.ug/
• Complete and signed new application form 101
• A complete Research protocol with version number and date - the foundational blue print with study title, list of investigators, summary/abstract, background to the study, problem statement, significance, justification, objectives, literature review, eligibility criteria, methodology, workplan, dissemination plan, community engagement plan, data sharing and ownership (where applicable), environmental impact assessment (where applicable), budget, references/bibliography etc.
• A site-specific implementation plan (Applicable for multi-site studies).
• Samples of trial drugs or devices (where applicable).
• Investigators’ Brochure (IB)-A compilation of the clinical and non-clinical data on the investigational product relevant to the study
• Quality & Manufacturing Documents: Certificate of Good Manufacturing Practice (GMP) for the trial medicine
• Insurance & Indemnity: Proof of trial insurance for participants sourced from a local provider or in consultation with the NDA.
• Investigator Details: CVs, training records in research ethics, and a valid license to practice in Uganda for the Principal Investigator (PI)
• Recruitment Informed Consent Forms following our format & Participant Leaflets: Must be provided in English and translated into the local languages of the target population.
• Assent form following our assent form format: Must be provided in English and translated into the local languages of the target population. (only if applicable to the study)
• Informed consent for sample /specimen storage & future use: Must be provided in English and translated into the local languages of the target population. (only if applicable to the study)
• Study instruments/tools e.g. questionnaires, FGD guide, observation checklist, desktop review checklist, case report forms, videos, flip charts, data abstraction form and other data collection tools/forms:  must be provided in English and translated into the local languages of the target population (if applicable)
• Proof of research protocol approval from the Principal Investigator’s home institution only if the research protocol originates from outside Uganda because approval from Uganda where data will be collected is final (if applicable)
• International collaborative research study shall have a Uganda- based PI/Co-PI listed on the protocol, who must be employed at and/or affiliated to a recognized local organization that is relevant to the area of the proposed research. He or she must be qualified and competent to actively lead and/ or supervise the research study. A collaborative agreement shall be signed by a legally authorized person at the local institution.
• Proof of research protocol approval from the Principal Investigator’s department in form of minutes for PhD and Master students: (Applicable to PhD and Master students studying within Uganda)
• COVID 19 and Ebola risk management plan
• Community Engagement Plan
• Data Sharing and Use Agreement (if applicable)
• Material Transfer Agreement (if applicable)
• Data and Safety Monitoring Board (DSMB), Safety Monitoring Committee (SMC) and Community Advisory Boards (CABS): Refer to the 2025 National guideline for research section 3.7.3
• Research participant’s time and transport reimbursement payment logs
• Proof of payment of review fees depending on the review category chosen (Contact MAKSHSREC Admin for review fees amount).
• And any other trial relevant documents
• Templates/forms can be downloaded from the website
• Incomplete submission will be rejected until all submission requirements are met.
• Submit two weeks prior to the next REC meeting.
• Review meetings are held twice a month (first & last Tuesdays of every month)

REQUEST FOR AMENDMENT

• Submit online via NRIMS portal: https://nrims.uncst.go.ug/
• Complete and signed Amendment application form 103
• Amended documents with track changes
• Amended clean documents
• Previous REC approval letter
• Proof of payment of amendment review fees (Contact MAKSHSREC Admin for amendment review fees amount)

2. REQUEST FOR RENEWAL

• Submit online via NRIMS portal: https://nrims.uncst.go.ug/
• Complete and signed Renewal application form 102
• Progress Report (highlight completed activities and the pending activities to be carried out in the period of extension)
• Previous REC approval letter
• Previously approved and stamped research proposal
• Approved stamped consent form both English & Translated version (if applicable)
• Approved stamped assent form both English & Translated version (if applicable)
• Approved stamped data collection tools (both English translated version (if applicable)
• Approved & stamped data sharing agreement (if applicable
• Approved stamped Material Transfer Agreement (if applicable)
• Approved stamped Community engagement plan (if applicable)
• Approved stamped COVID-19 risk management plan for the study
• Summary of SAEs reported (if applicable)
• DSMB report (if applicable)
• Other relevant documents
• Proof of payment of renewal review fees Contact MAKSHSREC Admin for amendment review fees amount

3. SUBMISSION OF SERIOUS ADVERSE EVENT REPORTS

• Complete and signed Adverse Event reporting form 104 (SAE should be submitted within 7 days from occurrence)
• Submit online via NRIMS portal: https://nrims.uncst.go.ug/

4. SUBMISSION OF PROTOCOL VIOLATIONS & PROTOCOL  DEVIATION

• Complete and signed Protocol Violation/ Deviation form 105
• Submit online via NRIMS portal: https://nrims.uncst.go.ug/

5. SUBIMISSION OF A STUDY CLOSE OUT/TERMINATION REPORT

• Complete and signed Study close out/termination report FORM 106
• Study findings report/ thesis
• Submit online via NRIMS portal: https://nrims.uncst.go.ug/

6. STUDY MONITORING AND EVALUATION CHECKLIST [REGULATORY BINDER]

The following should be in the study master file(s):

• MAKSHSREC approval letter
• UNCST approval letter
• Standard Operating Procedures for the approved study (if applicable)
• Approved stamped research protocol
• Approved informed consent and assent forms (if applicable)
• SAE reports and unanticipated Problems
• Protocol violations/deviations reports
• Approved Data Safety Monitoring Board, etc.
• Minutes of the research team meetings
• Approved research instruments and other relevant recruitment materials
• Signed informed consent/assent by research participants (if applicable)
• Proof of training in HSP, GCP, GLP etc.
• Study staff Logs and CVs
• FDA Form 1572 and 1571/IDE/NDA (for clinical trials)
• Sponsor details
• Payment logs for research participant’s time, transport reimbursement and insolvencies (if applicable)
• Drug/ Device accountability Log (if applicable)
• Laboratory documentation e.g. lab notebooks (if applicable)
• Product Information (where applicable)
• Certificate of insurance for research participants (if applicable)
• Study brochures
• And many other relevant information related to the study