Welcome to the School of Health Sciences Research and Ethics Committee (SHSREC)

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 is 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  Tel: +256 774313924 or +256 703313924

Physical location: 2nd floor, School of Pharmacy building, next to the University Police - Makerere University Main Campus, accessible via the Eastern Gate.

 MAKSHSREC functions:

  1. To Provide Research Oversight by:
    • Reviewing research protocols
       
  2. Monitor ongoing approved research studies to:
    • Maintain ethical standards of practice in research
    • Protect research participants and researchers from harm or exploitations
    • Preserve the research participants' rights and welfare
    • Ensure adherence to the 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 review
  3. Expedited review
  4. Exemption from review
     

SUBMISSION REQUIREMENTS

  1. NEW APPLICATION TO CONDUCT RESEARCH

A. NON CLINICAL TRIAL RESEARCH SUBMISSION REQUIREMENTS

  • Submit online via NRIMS portal: https://nrims.uncst.go.ug/
  • Complete and signed new application form 101
  • CVs for the study team
  • English informed Consent form following our consent form format (s) if applicable to the study to be conducted
  • Translated informed consent forms if applicable to the study to be conducted
  • English Assent form following our assent form format (s) if applicable to the study to be conducted
  • Translated assent form (s) if applicable to the study to be conducted
  • English consent form for sample /specimen storage & future use, if applicable to the study to be conducted
  • Translated consent/assent forms for future storage of specimens/samples (if applicable)
  • Study tools both English & Translated version (if applicable)
  • Research protocol
  • COVID 19 risk management plan for studies that will involve interviewing research participants (if applicable)
  • Community engagement plan
  • Data Sharing Agreement (if applicable)
  • Material Transfer Agreement (if applicable)
  • Proof of approval if the study originates from outside Uganda (if applicable)
  • Minutes from the department indicating the research protocol is approved- (Applicable to PhD & Master students within Uganda)
  • Signed research protocol by supervisor(s) & student (applicable to Undergraduate, Master & PhD students)
  • Proof of payment of review fees in form of deposit slips.
  • And any other document relevant to the study
  • 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)
     

B. CLINICAL TRIAL SUBMISSION REQUIREMENTS

  • Submit online via NRIMS portal: https://nrims.uncst.go.ug/
  • Complete and signed new application form 101
  • CVs for the study team
  • English informed Consent form following our consent form format (s) if applicable to the study to be conducted
  • Translated informed consent forms if applicable to the study to be conducted
  • English Assent form following our assent form format (s) if applicable to the study to be conducted
  • Translated assent form (s) if applicable to the study to be conducted
  • English consent form for sample /specimen storage & future use, if applicable to the study to be conducted
  • Translated consent/assent forms for future storage of specimens/samples (if applicable)
  • Study tools both English & Translated version (if applicable)
  • Research protocol
  • COVID 19 risk management plan for studies that will involve interviewing research participants
  • Community engagement plan
  • Data Sharing Agreement (if applicable)
  • Material Transfer Agreement (if applicable)
  • Study approval evidence if the study originates from outside Uganda (if applicable)
  • Investigators’ brochure (if applicable)
  • Certificate of insurance for research participants
  • Proof of approval if the study originates from outside Uganda (if applicable)
  • Minutes from the department indicating the research protocol is approved- (Applicable to PhD & Master students within Uganda)
  • Signed research protocol by supervisor(s) & student (applicable to Undergraduate, Master & PhD students within Uganda)
  • Research participant payment logs (if study involves humans as research participants)
  • Proof of payment of review fees in form of deposit slips.
  • And any other document relevant to the study
  • 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
     

B. CLINICAL TRIAL SUBMISSION REQUIREMENTS

  • Submit online via NRIMS portal: https://nrims.uncst.go.ug/
  • Complete and signed new application form 101
  • CVs for the study team
  • English informed Consent form following our consent form format (s) if applicable to the study to be conducted
  • Translated informed consent forms if applicable to the study to be conducted
  • English Assent form following our assent form format (s) if applicable to the study to be conducted
  • Translated assent form (s) if applicable to the study to be conducted
  • English consent form for sample /specimen storage & future use, if applicable to the study to be conducted
  • Translated consent/assent forms for future storage of specimens/samples (if applicable)
  • Study tools both English & Translated version (if applicable)
  • COVID 19 risk management plan for studies that will involve interviewing research participants
  • Community engagement plan
  • Data Sharing Agreement (if applicable)
  • Material Transfer Agreement (if applicable)
  • Study approval evidence if the study originates from outside Uganda (if applicable)
  • Investigators’ brochure (if applicable)
  • Certificate of insurance for research participants
  • Proof of approval if the study originates from outside Uganda (if applicable)
  • Minutes from the department indicating the research protocol is approved- (Applicable to PhD & Master students within Uganda)
  • Signed research protocol by supervisor(s) & student (applicable to Undergraduate, Master & PhD students within Uganda)
  • Research participant payment logs (if study involves humans as research participants)
  • Proof of payment of review fees in form of deposit slips.
  • And any other document relevant to the study
  • 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

  1. 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)
  • Copy of other study documents (if necessary)
  • Proof of payment of renewal review fees
  • And any other document relevant to the study
     

  1. 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/
     

  1. SUBMISSION OF PROTOCOL VIOLATIONS & PROTOCOL DEVIATION

  1. 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/
     

  1. STUDY MONITORING AND EVALUATION CHECKLIST [REGULATORY BINDER]

  • MAKSHSREC approval letter
  • UNCST approval letter
  • Standard Operating Procedures for the approved study (if applicable)
  • Approved stamped Study Protocol
  • Approved informed consent and assent forms
  • SAE reports and Unanticipated Problems
  •  Protocol violations/deviations reports
  • Approved Data Safety Monitoring Board Minutes
  • Minutes of the research team meetings
  • Approved Recruitment Materials of the Study
  • Approved Case Report Forms
  • Informed consent documents signed by research
  • Participants
  • 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
  • Signed informed consent forms by research participants
  • Payment logs/ record of participant reimbursements/payments
  • Drug/ Device accountability Log (if applicable)
  • Laboratory documentation e.g. lab notebooks (if applicable)
  • Product Information (where applicable)
  • And many other relevant information

 

Attachment Size
MAKSHSREC - DATA SHARING AGREEMENT OR PLAN TEMPLATE.pdf (136.86 KB) 136.86 KB
MAKSHSREC - MTA Template Ver 002 -August 2022.pdf (95.75 KB) 95.75 KB
MAKSHSREC -Ammendment_change_Application form_103.pdf (28.6 KB) 28.6 KB
MAKSHSREC -Assent form template.pdf (154.85 KB) 154.85 KB
MAKSHSREC -Community engagement plan template ver 002 August 2022.pdf (93.02 KB) 93.02 KB
MAKSHSREC -COVID-19 Risk Management Plan template.pdf (80.92 KB) 80.92 KB
MAKSHSREC -Genetic Informed consent form template.pdf (119.64 KB) 119.64 KB
MAKSHSREC -Protocol violation or deviation form 105.pdf (96.25 KB) 96.25 KB
MAKSHSREC -Study close out and _termination_of_study_Application form_106[1].pdf (85.83 KB) 85.83 KB
MAKSHSREC_adverse_event_reporting_Application form_104[1].pdf (98.61 KB) 98.61 KB
MAKSHSREC_continuing_annual_review_ A pplication form_102[1].pdf (58.56 KB) 58.56 KB
MAKSHSREC_New_Application_REC Form 101 [1] to_conduct_research.pdf (298.49 KB) 298.49 KB
MAKSHSREC-Recruiment informed consent form template.doc (48.5 KB) 48.5 KB
MAKSHSREC-Sample collection and storage Informed Consent form template.pdf (133.43 KB) 133.43 KB
MAKSHSREC-Time CompensatioLog template.pdf (147.43 KB) 147.43 KB
MAKSHSREC-Transport reimbursment Log template.pdf (149.56 KB) 149.56 KB
NRIMS - Researcher User guide to create account.pdf (1.15 MB) 1.15 MB
MAKSHSREC -UGX and USD bank account detail.pdf (41.88 KB) 41.88 KB

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