Hotline: +256 41 4530020

SCHOOL OF MEDICINE

COLLEGE OF HEALTH SCIENCES
MAKERERE UNIVERSITY

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SOMREC

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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.

Initial review requirements

Masters’ students

  • Signed proposal by the applicant (PI) and supervisors
  • Clearance letter from the Head of Department.
  • Signed Minutes of the Departmental Proposal presentation meeting
  • Curriculum Vitae (CV) for both the applicant (PI) and supervisors
  • Informed Consent form (SOMREC format) if applicable
  • Data collection tools
  • Proof of Payment (SOMREC fees)
  • Valid Certificate in Human Subject Protection (HSP)/Research Ethics/Good Clinical Practice (GCP)
  • Admission letter
  • Work plan
  • Study Budget
  • Plagiarism report
  • COVID-19/Ebola Risk Management Plan (If applicable)
  • Community Engagement Plan (If applicable)
  • A clearance letter from the primary holder of data if it is a retrospective study even when the data holder is part of the supervisory team
  • Start the application process at the NRIMS portal 🗗

 

 

PhD Students

  • Clearance letter from the Head of Department clearly stating your supervisors and Doctoral committee members
  • Signed Minutes of the Departmental Proposal presentation meeting
  • Curriculum Vitae (CV) for both the applicant (PI) and supervisors
  • Informed Consent form (SOMREC format) if applicable
  • Signed proposal by the applicant (PI) and supervisors
  • Data collection tools
  • Proof of Payment (SOMREC fees)
  • Valid Certificate in Human Subject Protection (HSP)/Research Ethics/Good Clinical Practice (GCP)
  • Admission letter
  • Work plan
  • Study Budget
  • Plagiarism report
  • COVID-19/Ebola Risk Management Plan (If applicable)
  • Community Engagement Plan (If applicable)
  • Dissemination plan
  • A clearance letter from the primary holder of data if applicable even when the data holder is part of the supervisory team
  • Start the application process at the NRIMS portal 🗗

 

 

Staff/Faculty/Non-staff requirements

  • Signed proposal
  • Data collection tools
  • Curriculum Vitae (CV) for both local and international PI’s including Co-PI’s
  • Valid Certificate in Human Subject Protection (HSP)/Research Ethics/Good Clinical Practice (GCP)
  • Informed consent forms (SOMREC format)
  • Proof of payment
  • Investigator’s brochure (for randomized controlled trial (RCT))
  • A complete Clinical Trial checklist (RCT)
  • COVID-19/Ebola Risk Management Plan
  • Community Engagement Plan
  • Dissemination Plan
  • Statistical Plan (RCT)
  • DSMB Charter (RCT)
  • MTA if the study involves shipping of samples
  • Data sharing agreement and Data sharing plan
  • Budget
  • Workplan
  • A clearance letter from the primary holder of data if it is a retrospective study even when the data holder is a co-investigator
  • Start the application process at the NRIMS portal 🗗
Response to Review comments requirements
  • 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 (Masters’ students)
Amendments requirements
  • Cover letter (signed by the PI)
  • 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.
  • Clearance from the primary supervisor(s) (Applicable to Masters’ and PhD Students)
  • Proof of payment (PhD Students, staff/faculty and Collaborators)
  • Submit through NRIMS portal 🗗 and a copy of the submission should be sent to rresearch9@gmail.com
Renewal requirements
  • Cover letter (signed by the PI).
  • Form 102.
  • Progress report.
  • Initial approval letter.
  • Initial approved study.
  • Initial Informed consent forms.
  • Approved data collection tools.
  • Proof of payment (PhD Students, staff/faculty and Collaborators).
  • Submit through NRIMS portal 🗗 and a copy of the submission should be sent to rresearch9@gmail.com.
Contact Information
  • Monday – Friday: 9:00 - 16:00
  • Hotline: +256 41 4530020
  • Email: deansom.chs@mak.ac.ug

Upper Mulago Hill Road, Mulago

P. O. Box 7062
Kampala, Uganda

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