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School of Public Health
College of Health Sciences, Makerere University

Institutional Review Board (IRB)

The School of Public Health (MakSPH) has a Research and Ethics Committee- The MakSPH Research and Ethics Committee (SPHREC). The board handles research proposals by staff, students, and partners.

Researchers intending to submit proposals to SPHREC for review must follow the requirements outlined here.

All protocol submissions, reviews, and approvals are now done online via the link https://nrims.uncst.go.ug/ However, Principal Investigators are still required to submit one set of all the study documents in hard copy, upon approval of the study.

  1. REQUIREMENTS FOR INITIAL REVIEW IN AN REC MEETING AT THE MAKERERE UNIVERSITY SCHOOL OF PUBLIC HEALTH

Please make all your submission via https://nrims.uncst.go.ug and;

  1. You are also required to submit soft copies to sphrecadmin@musph.ac.ug.
  2. Except for Makerere University registered students, CVs of the study Investigators must be submitted
  3. Research protocol, Investigator brochure, or device specifications (where applicable)
  4. Data collection instruments such as Questionnaires, interview guides & any assessment instruments in English, and translations of these to the appropriate local language(s).
  5. Proposed informed consent document(s) in English, and translations of these to the appropriate local language (s), “thumbprint” should be provided for illiterate participants. (Contacts for the REC Chair should be included in the Consent Form i.e DR. JOSEPH KAGAAYI, jkagaayi@musph.ac.ug, 256-773-785-333/ 256-312-291-397, for participants to contact him in case they have any questions concerning their rights while they participate in the study. This should be clearly stated in the consent form). Informed consent forms should follow the UNCST National Guidelines for Research involving Humans as Research Participants, section 5.3. available on the UNCST website.
  6. Proposed subject instruction in English, and translations to the appropriate local language(s).
  7. Any other supporting material, such as advertisements for the recruitment of Research participants.
  8. A description of the consenting process or a copy of the investigative site’s Standard Operating Procedures for obtaining informed consent.
  9. Insert a version number and version date on the protocol, consent forms and data collection tools. This is essential for version control and monitoring document use. Include page numbers on the proposal for easy review and provision of feedback.
  10. A CERTIFICATE OF HUMANS’ SUBJECTS PROTECTION FOR EACH STUDY INVESTIGATOR must be attached.
  11. The investigator pays review fees to the School of Public Health research account and attaches the proof of payment(receipt) when submitting the soft copies via nrims. Refer to the standard fees structure. (Link for download)
  12. The proposal should be submitted at least two weeks before the date of the meeting. REC meetings are usually held every last Tuesday of the month. The mode of operation is a first come first served basis.
  13. You need to be available for presentation on the day of the meeting, use the PowerPoint template (download the PowerPoint template)
  14. All research activities should include a local Investigator (Ugandan) to be part of the study. A written approval from the home institution must be submitted with the REC application for international students and they should also have a Ugandan Supervisor on the proposal, preferably from the Makerere University, College of Health Sciences.
  15. MakSPHREC format for writing proposals should be followed for ease of review.  (Link for download)
  16. Proposals for MakSPH students must be signed by their supervisors, have a clearance letter from their reviewer of the proposal and also send soft copies of the submissions to sphrecadmin@musph.ac.ug. (MakSPH Students are not required to pay the IRB fees)
  17. Proposals for Ph.D. candidates must be signed by their supervisors
  18. Proposals that are reviewed and required to present again to the Full board are charged an additional 200 US$. While proposals that are provided comments but only require a reviewer(s) to oversee, before approval is granted, are not required to pay the resubmission fee.
  1. REQUIREMENTS WHEN RESPONDING TO REC COMMENTS

After review by the REC, the Research team will receive feedback with a recommendation to address comments (if applicable) before approval is granted.

Steps to follow:

  1. Attach a cover letter addressed to the REC Chairperson providing itemized responses to comments and guidance for the changes made to the protocol
  2. Attach a copy of the revised protocol with track changes
  3. Attach a clean copy of the revised protocol.
  4. Submit the soft copies to sphrecadmin@musph.ac.ug and on the nrims portal https://nrims.uncst.go.ug/.
  1. REQUIREMENTS FOR CONTINUING REVIEW

Approvals from the MakSPHREC, run for one year from the approval date, and therefore Principal Investigators need to request for renewal of approval if the study is continuing. This request needs to be submitted at least 2 months before the date of expiry of the approval. The date of expiry is indicated in the approval letter.   

Steps to follow:

  1. Investigators are required to submit the Continuation or Termination of Approved Protocol form to the REC at least 2 months before the expiration date of the study
  2. MakSPHREC template for continuing review should be followed, (Download Continuing Review Template)
  3. Submit a cover letter addressed to the chairperson of the REC requesting for renewal
  4. The previously approved protocol should be submitted together with the request.
  5. The Investigator should pay $100 to the School of Public Health research account and attach the payment receipt when submitting the documents.
  6. Submit the soft copies to sphrecadmin@musph.ac.ug  and on the nrims portal https://nrims.uncst.go.ug/
  1. REQUIREMENTS FOR AMENDMENT OF THE PROTOCOL

An amendment refers to any change made to the previously approved proposal, questionnaire, consent form, or any other related document. Approval of any such proposed changes is required before implementation.

Steps to follow for amendment:

  1. A cover letter requesting for approval of the amendment and a description of the changes proposed indicating the rationale.
  2. Submit by email the soft copies of the previously approved protocol, study instruments, and consent forms.
  3. Submit by email a copy of the amended protocol, study instruments, and consent forms with highlighting proposed changes [tracked version]
  4. The Investigator should pay $200 to the School of Public Health research account and attach the proof of payment while submitting the soft copies by email to sphrecadmin@musph.ac.ug and on the nrims portal https://nrims.uncst.go.ug/
  5. REQUIREMENTS FOR EXPEDITED REVIEW OF A PROTOCOL

An expedited review refers to the review of a proposal in the quickest way possible, there’s no requirement for a meeting, the chair can either review the submitted proposal or assign it to any other designated MakSPHREC reviewer(s), the PI should expect to get REC comments within two weeks, and address them (if any) before approval is granted. However not all studies can fit the criteria for expedited review, the MakSPHREC chair and Administrator have to review the proposal in line with the MakSPH-REC Standard Operating Procedures (SOPs) to determine if it meets the criteria for expedited review.

Steps to follow for Expedited review applications:

  1. Submit a cover letter addressed to the REC Chairperson requesting for expedited review, concisely explaining why you think the study qualifies for expedited review.
  2. The Investigator should wait to hear from the REC administration confirming to them if their study qualifies for expedited review, (the Investigator will be notified within two days)
  3. The Investigator should pay $300 to the School of Public Health research account and attach the proof of payment while submitting the soft copies by email to sphrecadmin@musph.ac.ug  and on the nrims portal https://nrims.uncst.go.ug/

 

  1. REQUIREMENTS FOR EXEMPTION FROM IRB REVIEW

Requests for exemption are also reviewed expeditiously and only apply to proposals that only employ document review and many other specifications in the SOPs (download Extract of Exemption screening form)

  1. The Investigator downloads MakSPHREC SOPs from the School of Public Health website (MakSPHREC SOPS download).The SOPs can be downloaded from the REC section on the website
  2. The Investigator can print out pages 63 – 66 and check if their study complies with the guidelines, and draft a cover letter addressed to REC Chairperson requesting for exemption from REC review based on the SOPs they have reviewed.
  3. Investigator submits the proposal and fills in Page 66 extracted from the MakSPHREC SOPs and submits it sphrecadmin@musph.ac.ug  and on the nrims portal https://nrims.uncst.go.ug/
  4. This kind of review is charged $300, paid to the School of Public Health research account, and the proof of payment attached while submitting the soft copies by email to sphrecadmin@musph.ac.ug  and on the nrims portal https://nrims.uncst.go.ug/