The School of Public Health (MakSPH) has an institutional review board; a board that handles research proposals by staff and students and also from partners.
Those intending to submit proposals to MakSPH for review should read this information before submission to acquaint themselves with the requirements and the process.
Requirements for Initial review
- A submission form has to be filled by the principal investigator and signed by the supervisor.
- The investigator submits 10 hard copies of the proposal and attaches the submission form to each proposal.
- Insert a version number and date on the protocol, consent forms and data collection tools. This is essential for version control and monitoring document use.
- Send a soft copy of your proposal and study tools to
- The investigator pays $250 to accounts officer (MakSPH Building First Floor Room 119) and brings a photocopy of the receipt when submitting the proposal
- The investigator submits the proposal two weeks before the date of the meeting (preferably the early weeks of the month); meetings are usually held every last Tuesday of the month.
- Research activities involving institutions and agencies outside of MakSPH must receive written approval from the appropriate official within the agency. The written approval must be submitted with the IRB application and a staff member of the school should be part of the study.
- MakSPH IRB format for writing proposals must be followed for ease of review.
- For MPH Full time /MPHDE/ MPHN/MHSR/Dip. RCQHC, two copies of the proposal should be submitted with IRB form signed by the students’ supervisors. (These do not pay IRB fee).
- Proposals by SPH/CDC HIV/AIDS Fellows must be signed by their academic mentors. (These pay IRB fees)
- Proposals by PhD candidates must be signed by their supervisors (these pay IRB fee).
Complete submission should entail the following
- Submission Requirements for Initial Review (Checklist)
- Except for Makerere University registered students, CV of the Investigators on the study is required.
- Questionnaires & assessment instruments, plus copies of these documents translated in the appropriate local language (where necessary).
- Proposed informed consent document(s); plus copies of these documents translated to the appropriate local language (where necessary); “thumbprint” should be provided for illiterate participants.
- Proposed subject instruction); plus copies of these documents translated to the appropriate local language (where necessary)
- Any other supporting material, such as examples of recruitment advertising etc
- Description of the consenting process or a copy of the investigative site’s Standard Operating Procedures for obtaining informed consent.
Requirements when responding to IRB Comments;
- A cover letter providing itemized responses to IRB comments and guidance for the changes made to the protocol if any,
- A revised protocol with track changes,
- A clean copy of the revised protocol
Requirements for continuing Review;
- Investigators are required to submit the Continuation or Termination of Approved Protocol form to the IRB before the expiration date of the study
- MakSPH IRB template for continuing review should be followed
- A cover letter requesting continuing review should be submitted to the secretariat.
- Previously approved protocol should be submitted together with the request.
- The Investigator pays $100 to accounts Officer and brings the Photocopy of the receipt when submitting the documents.
Requirements for Expedited Review of Protocol
- A cover letter addressed to the IRB Chairman requesting for expedited review, explaining why you think the study qualifies for expedited review and why it should be reviewed expeditiously should be attached.
- A submission form should be attached to 3 copies of the proposal to be submitted for review.
- The Investigator should wait to hear from the Committee confirming to them if their study qualifies for expedited review, (the Investigator can be notified within two days)
- The Investigator pays $400 to Accounts Officer and brings the Photocopy of the receipt to the IRB Coordinator.
Requirements for Exemption from IRB Review;
- The Investigator downloads HDREC SOPS from the School of Public Health (MakSPH) Website. The SOPs can be downloaded from the IRB section (Review Board) on the website.
- Once the HDREC SOPs are downloaded the Investigator can print out pages 63–66 and review them to see if their study complies with the guidelines and then drafts a cover letter addressed to IRB Chairman requesting for exemption from IRB Review basing on the SOPs they have reviewed.
- Investigator submits 3 Copies of the proposal and fills in Page 66 extracted from the HDREC SOPs and submits it as well.
Requirement for Amendment of the protocol;
- A cover letter explaining in the need for the amendment and rationale, and a description of the changes you want to effect
- A Previously approved protocol, study instruments and consent forms should be submitted.
- Amended protocol, study instruments and consent forms with track changes should also be submitted
- The Investigator pays $200 to accounts Officer and brings the photocopy of the receipt when submitting the documents
Institutional Review Board- (IRB)- MPH PhD
Standard Operating Procedures (SOPs)
College of Health Sciences School of Public Health Standard Operating Procedures (SOP’s) for the Higher Degrees, Research and Ethics Committee (HDREC)
Institutional Review Board- (IRB)- Research Proposal
Makerere University School of Public Health Higher Degrees, Research and Ethics Committee, Research proposal submission form.