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Welcome to the School of Medicine Research and Ethics Committee (SOMREC)

The School of Medicine Research and Ethics Committee (SOMREC) is in charge of approving all research intended to be carried out within or outside Makerere University. This is an accredited, trusted and approved REC office established to regulate research conducted in Makerere University.

With effect from 1st November 2020, the Chairperson School of Medicine Research Ethics Committee requested that all initial submissions should be done online through the NRIMS system via https://nrims.uncst.go.ug

Those intending to submit proposals to Makerere University School of Medicine for review should read this information before submission to acquaint themselves with the requirements and the process.

  • Certificate of Humans Subjects Protection from the Principal Investigator/Co-investigator, Attached to each application, this is compulsory.
  • The investigator submits a copy of the proposal.
  • Attach consent forms, and data collection tools. This is essential for version control and monitoring document use.
  • The investigator pays review fees to the bank, attaches a copy on the NRIMS system and brings a photocopy of the receipt to the SOM accounts office at Deans Building, level one.
  • The proposal should be submitted two weeks before the date of the meeting (preferably the early weeks of the month); meetings are usually held every month, so for one to be considered for this meeting they should submit early, the mode of operation is first come first serve basis.
  • All research activities should include a local Investigator (Ugandan) to be part of the study. Written approval from the home institution must be submitted with the IRB application for International students and they should also have Ugandan Supervisor on the proposal preferably from Makerere School of Medicine.
  • As for Makerere University School of Medicine/ Fellows; their proposals must be signed by their mentors. (this category is required to pay the IRB fee)
  • For Ph.D. candidates seeking registration from Makerere University School of Medicine, their proposals must be signed by their supervisors.
  • Clearance letter from the Head of Department.
  • Minutes from the proposal presentation at the department.
  • Curriculum Vitae (CV) for both the applicant (PI) and supervisors
  • Informed Consent form (SOMREC format)
  • The proposal signed by the applicant (PI) and supervisors
  • Data collection tools
  • Proof of Payment (SOMREC fees)
  • Certificate in Human Subject Protection/Research Ethics/Good Clinical Practice (GCP) (For those conducting clinical trials)
  • A copy of the admission letter
  • A copy of Plagiarism report
  • COVID-19 Risk Management Plan (if applicable)
  • Proposal
  • Data collection tools
  • Curriculum Vitae (CV) for both local and international PI’s including Co-PI’s
  • Informed consent forms (SOMREC format)
  • Proof of payment
  • Investigator’s brochure (for randomized controlled trial (RCT))
  • A complete Clinical Trial checklist 
  • COVID-19 Risk Management Plan
  • Concept Level
    • Concept paper.
    • Clearance from Head of Department and a letter of recommendation listing the supervisors and doctoral committee members.
    • Proof of payment.
    • Curriculum Vitae (CV) of the applicant (PI), supervisors and Doctoral committee members.
    • Minutes from the department from the concept presentation.
    • A copy of the admission letter
    • A copy of the Plagiarism report
  • Proposal level
    • Approval letter of the Concept Paper (Local Students)
    • Approval letter from the awarding institution (International Students)
    • Full proposal signed by the supervisors
    • Good Clinical Practice (GCP)
    • Informed consent forms (SOMREC format)
    • Data collection tools
    • Proof of payment.
    • Minutes of the proposal presentation at the department or doctoral committee
    • COVID-19 Risk Management Plan
  • Clean copies of all revised documents submitted for review
  • Copies with track changes of all revised documents
  • Rebuttal letter (tabular format with IRB comment, Response and page number (reference))
  • Letter with comments from the REC
  • File name should match the content in the attachments
  • All research related documents should be attached independently on  NRIMS system
  • Attach a letter from the primary supervisor confirming to have read through the revised proposal (students)
  • Form 103.
  • Tracked copy for proposal, data collection tool and Informed consent form.
  • Clean copy for proposal, data collection tool and Informed consent form.
  • Initial approval letter.
  • Proof of payment (staff/faculty only)
  • Form 102.
  • Progress report.
  • Initial approval letter.
  • Initial approved study.
  • Initial Informed consent forms.
  • Proof of payment (for staff/faculty and PhD students).