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
- Certificate of Humans Subjects Protection from the Principal Investigator/Co-investigator, Attached to each application, this is compulsory.
- A submission form HDREC (Research Proposal submission form /form 301A)has to be filled in by the principal investigator and signed by the supervisor if the PI is a student. (Download the HDREC Submission form)
- The investigator submits 08 hard copies of the proposal and attaches (staples) the submission form to appear at the front of each copy of the proposal.
- Send a soft copy of the submissions to email@example.com
- 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 as well for easy review and provision of feedback.
- The investigator pays $300 to the accounts officer (1st floor at the School of Public Health Premises, Mulago, Makerere University) and brings a photocopy of the receipt when submitting the proposals.
- 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 last Tuesday of the month, so for one to be considered for this meeting they should submit before the 13th of every month, 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 the Makerere School of Public Health.
- MUSPH IRB format for writing proposals must be followed for ease of review. (Link for download)
- As regards MPH Full time /MPHDE/ MPHN/MHSR, two copies of the proposal should be submitted with the IRB submission form signed by their supervisors should be attached to both proposals at the front page. Submissions should be delivered to the MPH full-time Administrative Secretary (Ms. Enid Kemari). (School of Public Health Masters students are exempted from payment of IRB fees)
- As for MakSPH/CDC 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 Public Health, their proposals must be signed by their supervisors (This category is required to pay the IRB fees of 500 Dollars for both concept and Proposal levels, it’s preferable for them to pay 250 dollars for each stage they reach).
Note FOR EMPHASIS: A complete submission should entail the listed items accordingly:
Submission Requirements for Initial Review (Checklist)
- Except for Makerere University registered students, CV of the Investigators on the study is required
- HDREC Research Proposal submission form, appropriately signed (form 301A)
- A CERTIFICATE IN HUMAN SUBJECTS PROTECTION BY ALL THE INVESTIGATORS IS A MUST
- Research Protocol, Investigator brochure, or device specifications (where applicable)
- Questionnaires & assessment instruments, plus copies of these documents translated to the appropriate local language.
- Proposed informed consent document(s); plus copies of these documents translated to the appropriate local language, “thumbprint” should be provided for illiterate participants. (CONTACTS FOR THE IRB CHAIRPERSON SHOULD BE INCLUDED IN THE CONSENT FORM I.E DR. SUZANNE KIWANUKA, firstname.lastname@example.org, 256-701-888-163/ 256-312-291-397 for participants to contact her in case they have any questions concerning their rights while they participate in the study and this should be clearly stated in the consent form)
- Proposed subject instruction); plus copies of these documents translated to the appropriate local language
- Any other supporting material, such as advertisements for the recruitment of Research participants.
- A description of the consenting process or a copy of the investigative site’s Standard Operating Procedures for obtaining informed consent.
- You need to be physically available for presentation on the day of the meeting, use the PowerPoint template (download the PowerPoint template).
Requirements when responding to IRB Comments;
Usually, after review by the IRB, the research team will receive comments and or suggestions that require them to address or respond to before approval is granted.
This is how you should go about it:.
- A cover letter addressed to the IRB Chair providing itemized responses to IRB comments and guidance for the changes made to the protocol if any
- (02) copies of the revised protocol with track changes
- A clean copy of the revised protocol.
C. 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
- MUSPH IRB template for continuing review should be followed, (Download Continuing Review Template)
- A cover letter addressed to the chairman of the IRB requesting for renewal of approval should be submitted to the IRB.
- Previously approved protocol (02) copies should be submitted together with the request.
- The Investigator pays $100 to the accounts Officer and brings the Photocopy of the receipt when submitting the documents.
D. Requirements for Amendment of the protocol
An amendment refers to any made to the previously approved proposal, and any change/ amendment requires IRB approval before implementation even the change of a question in a questionnaire or change in title would require IRB review, as long as the change is being made to the protocol that has already been approved.
- cover letter requesting for approval of the amendment and a description of the changes proposed indicating the rationale.
- Submit 03 copies of the previously approved protocol, study instruments, and consent forms.
- 03 copies of the amended protocol, study instruments and consent forms with track changes (highlighting proposed changes) should also be submitted
- The Investigator pays $200 to the accounts Officer and brings the photocopy of the receipt when submitting the documents.
E. 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 chairman can either review the submitted proposal or assign it to any other designated HDREC reviewer (s), the P.I should expect to get IRB comments within a week which they have to respond to before approval is granted. However not all studies can fit the criteria for expedited review, the HDREC chairman and Administrator have to review the proposal in line with the HDREC SOPs to determine if it meets the criteria for expedited review.
List of requirements:
- A cover letter addressed to the IRB Chairman requesting for expedited review, explaining why you think the study qualifies for expedited review.
- A submission form should be attached to (03) 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 $300 to Accounts Officer and brings the Photocopy of the receipt to the IRB Coordinator.
F. Requirements for Exemption from IRB Review
Requests for exemption are also reviewed expeditiously and only apply to proposals which don’t involve human subjects, studies that only employ document review and many other specifications in the SOP (download Extract of Exemption screening form)
- The Investigator downloads HDREC SOPS from the school of Public Health Website www.musph.ac.ug the SOPs can be downloaded from the IRB section (Review Board) in the website
- Once the HDREC SOPs are downloaded the Investigator can print out pages 63 – 66 and reviews 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’ve reviewed.
- Investigator submits 3 Copies of the proposal and fills in Page 66 extracted from the HDREC SOPs and submits it as well.
- This kind of review is charged $100 which should also be paid to accounts.
Institutional Review Board- (IRB)- MPH PhD
- MPH PhD student can find here a Template. Click Here to Download the Template Slides
Standard Operating Procedures (SOPs)
- College of Health Sciences School of Public Health Standard Operating Procedures (SOPs) 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.
Guidelines for reviewing proposals MPH. Click Here to Download