MAKERERE UNIVERSITY

COLLEGE OF HEALTH SCIENCES

SCHOOL OF HEALTH SCIENCES

IRCINFORMATION FOR PRINCIPAL

INVESTIGATORS

TYPES OF SUBMISSION1. NEW APPLICATION TO CONDUCT RESEARCH2. REQUEST FOR AMENDMENT 3. REQUEST FOR RENEWAL4. SUBMISSION OF SERIOUS ADVERSE EVENT REPORTS5. SUBMISSION OF PROTOCOL VIOLATIONS & PROTOCOL DEVIATIONS6. SUBIMISSION OF A STUDY CLOSE OUT/END REPORT

(Download all the above submission forms from the College website; http://chs.mak.ac.ug/content/institutional-review-boards

TYPES OF REVIEW1. FULL BOARD REVIEW2. EXPEDITED REVIEW

irb@gmail.com (MUST)•SubmitthehardcopiestotheIRBOffice

EXPEDITED REVIEW (NEW APPLICATION TO CONDUCT RESEARCH)•CompleteandsignedIRBapplicationform(REC101- 2 copies)•CVsforallinvestigators(1copyeach)•03copiesof theResearchsummary•03copiesof theFullProposal•03 copies of the Consent form(s) English &Translated version (if applicable)•03copiesof theScreeningtool(if applicable)•03 copies of the Assent form(s) English &Translated version (if applicable)•03 copies of the Consent/assent for futurestorage of specimens, English & Translated version (if applicable) •03copiesof theParentalconsentform,English& Translated version (s) (if applicable)•03 copies of the Recruitment materials (if applicable)•03 copies of the Surveys/questionnaires/instruments, English & Translated version (if applicable)•2copiesof theLetter(s)of support/collaboration(if applicable)•2copiesof theInternational/collaboratingIRBapproval(s) (if applicable)•03 copies of theDrug/Investigators’ brochure(if applicable)•03copiesof anyotherDatacollectiontools•1copyEvidenceof paymentof researchreviewfees (if applicable) please refer to the charge structure. •Send a soft copy of theWHOLE package toirbbiomedicalsciences@gmail.com (MUST)

If a researcher applies for expedited review, it’s advisable towait for feedback from the IRBOfficeonthesubmittedstudywhetheritqualifiesforthistypeof revieworfullboardreview.Incaseitqualifiesforexpeditedreview,theresearcher isexpected to receive communication from the IRBOffice regarding the status of their submissionWITHIN OR AFTER 2 WEEKS.

Masters and PhD proposals DO NOT qualifyfor expedited review. However undergraduate studentsandstaff arefreetoapplyforitgiventheriskexposedtoparticipantsinthestudy.

MONITORING AND EVALUATION CHECKLIST FOR SCHOOL OF HEALTH SCIENCES RESEARCH AND ETHICS COMMITTEE [REGULATORY BINDER]

•StandardOperatingProceduresof theapprovedstudy•ApprovedStudyProtocol•Approvedinformedconsentandassentforms•Acknowledged adverse events/Serious AdverseEvents reports and Unanticipated Problems•AcknowledgedProtocoldeviations•ApprovedDataSafetyMonitoringBoardMinutes•Minutesof theresearchteammeetings•ApprovedRecruitmentMaterialsof theStudy•ApprovedCaseReportForms•Informedconsentdocumentssignedbyresearchparticipants•Studystaff LogsandCVs•AllIRBrelateddocumentations•FDAForm1572and1571/IDE/NDA(forclinicaltrials)•Sponsordetails•Regulatorydocumentation:Investigator•Recordof participantreimbursements/payments•Drug/DeviceaccountabilityLog(whereapplicable)•Laboratorydocumentatione.g.labnotebooks•ProductInformation(whereapplicable)

The Secretariat School of Health Sciences IRCP.O.Box 7072 Kampala, Uganda

Tel: 256 774313924 Fax: 256 414 532204 E-mail: healthsciences.irb@gmail.com

Website: http://chs.mak.ac.ug/content/institutional-review-boards

COMING SOON Establishment of an eIRB system

at the College

APPLICATION PROCEDURE

1. NEW APPLICATION TO CONDUCT RESEARCH (REQUIREMENTS FOR FULL BOARD REVIEW)•CompleteandsignedIRBapplicationform(REC101- 2 copies)•CVsforallinvestigators(1copyeach)•11 copies of Departmental minutes (Mastersstudents)•4copiesof theResearchsummary•11copiesof theFullProposal•11 copies of the Consent form(s) English &Translated version(if applicable)•11 copies of the Assent form(s) English&Translated version (if applicable)•11 copies of the Consent/assent for futurestorage of specimens, English & Translated version (if applicable)•11copiesof theParentalconsentform,English& Translated version (s) (if applicable)•11copiesof theScreeningtool(if applicable)•11 copies of the Recruitment materials (if applicable)•11 copies of the Surveys/questionnaires/instruments English & Translated version (if applicable)•2copiesof theLetter(s)of support/collaboration(if applicable)•2copiesof theInternational/collaboratingIRBapproval(s) (if applicable)•11 copies of theDrug/Investigators’ brochure(if applicable)•11copiesof anyotherDatacollectiontools•1copyEvidenceof paymentof researchreviewfees (if applicable) please refer to the charge structure. •Send a soft copy of the WHOLE package tohealthsciences.irb@gmail.com (MUST).•SubmitthehardcopiestotheIRBOffice

Researchers submitting Studies for full board reviewshouldalwayssubmittheirapplications4-3weeks to the next meeting. Please note that the School of Health Sciences Research and Ethics Committee (SHSREC) ONLY meets twice in a month. ONLY meets twice in a month.

IncompleteapplicationswillNOTbereceivedbytheIRBoffice.

Applicants who DO NOT submit soft copies before handing in the hard copies WILL NOT be scheduled on the agenda for the next meeting.

For researchers who are required to pay reviewfees and fail to do so, no action will be taken on theirsubmissionstillpaymentiseffected.

Researchers who present their proposals to SHSREC are expected to receive feedback from the IRB WITHIN OR AFTER 2 WEEKS. Thereforethemanagementstronglyrequeststhatprevious presenters SHOULD wait for formal communicationviaEMAILfromtheIRBOfficeon updates regarding the comments from the IRB meeting.

2. REQUEST FOR AMENDMENT • Complete and signed Amendment form REC 103(1copy)•A cover letter summarizing the amendmentrequest•Copyof approvedproposalonfile•Copyof revisedproposalwithtrackchanges•Copyof approvedconsent/assentformsonfile(if applicable)•Copyof revisedconsent/assentformswithtrackchanges both English & Translated version (if applicable)•Copyof approvedquestionnaireonfile•Copyof revisedquestionnaire(if applicable)•Copy of approved data collection/ screeningforms (if applicable•Copy of international IRB approval letter (if applicable)•New/revised Drug/investigator Brochure (if applicable)•Copyof previousapprovalletters•Evidenceof paymentof researchreviewfees(if applicable)•Send a soft copy of the WHOLE package tohealthsciences.irb@gmail.com (MUST)•SubmitthehardcopiestotheIRBOffice

3. REQUEST FOR RENEWAL•CompleteandsignedRenewalformREC102•AProgressReport•Copyof approvedproposalonfile•Copyof approvedconsentformbothEnglish&Translated version (if applicable)•Copyof approvedassentformbothEnglish&Translated version (if applicable)•Copyof approvedparental consent formbothEnglish & Translated version (if applicable)•Copyof approvedrecruitmentmaterials•Copy of approved study questionnaire bothEnglish & Translated version (if applicable)•Summary of SAEs reported within the expiryperiod (if applicable)•DSMBreport(if applicable)•Previousapprovalletter•Copyof otherstudydocuments(if necessary)•Evidenceof paymentof researchreviewfees•Send a soft copy of the WHOLE package tohealthsciences.irb@gmail.com (MUST)•SubmitthehardcopiestotheIRBOffice

4. SUBMISSION OF SERIOUS ADVERSE EVENT REPORTS•Complete and signedAdverseEventReportingform REC 104•Sendasoftcopyof thefilledformtohealthsciences.irb@gmail.com (MUST)•SubmitthehardcopiestotheIRBOffice

5. SUBMISSION OF PROTOCOL VIOLATIONS & PROTOCOL DEVIATIONS•Complete and signed Protocol Violation/DeviationformREC107•Sendasoftcopyof thefilledformtohealthsciences.irb@gmail.com (MUST)•SubmitthehardcopiestotheIRBOffice

6. SUBIMISSION OF A STUDY CLOSE OUT/END REPORT•CompleteandsignedStudyTermination reportform REC 105•Sendasoftcopyof thefilledformtohealthsciences.