FacultyofMedicine,General Sir John Kotelawala Defence University
Applicationfor Ethics Review(PartI)–BasicIn formation
forofficialuse
Application No: / Date Received: / / / /Reviewed By: / ERC MeetingDate: / / / /
Decision: / Date Informed: / / / /
1. Title ofProject
2. Investigators
Applicationsfrominvestigatorsbasedoverseaswillonlybeconsiderediftheprojectisdonein
collaboration with investigatorsbasedin institutionsinSriLankawhotakeequal responsibilityforthe conductofthe studyandwhowillappearasco-authorsinanypublicationarisingoutofthe study.
Title, Name and Designation ofInvestigators / RolePrincipal
Investigator
Pleasenotethata shortcurriculumvitaeofallinvestigatorsshouldbeattachedto theapplication.
3. ContactDetailsof the PrincipalInvestigator
Address:Telephone numbers:
Fax number:
Emailaddress:
4. Funding
Name and AddressofFundingSource(s) Amount
5. Proposedstarting andending dates:*‡
StartDate End Date
*Frominitialrecruitmentofparticipantsuntilcompletionofalldatacollection.
‡Retrospectiveapprovalwillnotbe givenforprojectsalreadystartedorcompleted.
6. HasethicsapprovalforthisstudybeenrequestedearlierfromKDU/ERCoranother similar committee?
Yes No
Ifyes, give details(namesofcommitteesand outcome ofreview)
Pleasenotethatforstudiessponsoredbyforeignfundingagenciesorsponsorsethicsreviewand approvalisrequired fromthe countryofthefunding agencyor the sponsor.
7. Scientificreview
Has thisresearch proposalbeen subjected to scientificreviewbyanyothercommittee? Yes No
Ifyes, give details(namesofcommitteesand outcome ofreview) Whatisthename ofthe committee?
8. Clinicaltrials
8.1. Whatphase clinicaltrialisbeingconducted?
Phase I Phase II Phase III
Phase IV(postmarketing) Other
IfOTHER specify:
8.2. Is ita multicentretrial?
Yes No
Ifyes, listthe othertrialsites
Pleaseattachethicsapprovalfromthesponsoringcountryor countryoftheoverseasprincipal investigator(ifany)
8.3. Is the clinicaltrial registered witha clinicaltrialsregistry?
Yes No
Ifyes, give details(name ofregisterand registrationnumber)
8.4. Data SafetyMonitoringBoard (onlyifavailable)
Name and Designation ofMembers / RolePleaseattachthecurriculumvitaeofallmembersoftheDSMB.
8.5.Details of Indemnity and Insurance coverage for participants, investigators and ethics committee
Ethical Review Committee, Faculty of Medicine, KDU
Adapted from Ethical Review Committee, Faculty of Medicine, University of Colombo
9. ConflictofInterest
9.1. Do you believe thisprojecthasa ConflictofInterest:
Commercially
Financially
Intellectually
Other(explain):
9.2Doesanymemberoftheresearchteamhaveanyaffiliationwiththeprovider(s)of funding/support, or afinancial interest inthe outcome of the research?
Yes No
Ifyes, pleaseexplain:
9.3Ifthereisadualityofinterestidentifiedabovedescribetheinterestandstatewhetherit constitutesa potentialconflictof interest.
FacultyofMedicine,General Sir John Kotelawala Defence University
EthicsReviewApplication(PartII) -Protocol Checklist
forofficialuse
Application No:
1. Title ofProtocol
2. Name ofPrincipalInvestigator
3. A ListofDocumentsSubmittedforReview
Ethical Review Committee, Faculty of Medicine, KDU
Adapted from Ethical Review Committee, Faculty of Medicine, University of Colombo
4. ProtocolChecklist
Please indicate the following:
Collaborative partnership / Applicable / Protocol Section Number / Reviewer checkedYes / No
1. / The collaborationsyou have established withinstitutions
wherethestudyistobe conducted
2. / The collaborations you have established with the
communitywhere the studyisto beconducted
3. / The benefits to institutions, communities, and
participantsin yourresearch
Reviewers’comments:
SocialValue / Applicable / Protocol Section Number / Reviewer checkedYes / No
1. / Thebeneficiariesofyourresearchandthebenefitto
them
2. / The plan fordisseminationofstudyfindings
Reviewers’comments:
Scientific Validity / Applicable / Protocol Section Number / Reviewer checkedYes / No
1. / Thescientificimportanceofyourstudyinrelationto
improvinghealthcare and/orknowledge on the subject.
2. / Thejustificationforareplicationstudy,ifyourstudyis
a replicationstudy.
3. / Howthe sample size was calculated
Reviewers’comments:
AssessmentofRisks/Benefits / Applicable / Protocol Section Number / Reviewer checkedYes / No
1. / The risks toresearch subjects
2. / Benefitstoresearch subjects
3. / Stepstakento minimize risks
4. / Stepstakento enhancebenefits
5. / Justification of the potentialbenefitsagainstthe risks
6. / Supportprovidedtotheresearchparticipants(medical,
psychologicaland other)
Reviewers’comments:
Ethical Review Committee, Faculty of Medicine, KDU
Adapted from Ethical Review Committee, Faculty of Medicine, University of Colombo
Consent / Applicable / Protocol Section Number / Reviewer checkedYes / No
1. / The procedureforinitialcontactofparticipants
2. / The procedureforobtaininginformed consent
3. / The information (written/oral)provided toparticipants
4. / The procedureforensuringthatsubjectshave
understood the informationprovided.
3. / The procedureforobtainingproxyconsent.
4. / The procedureforwithdrawingconsent.
5. / Incentives/rewards/compensation providedto
participants.
6. / The procedureforre-consentingif the researchprotocol
changesduringthe course of research.
Reviewers’comments:
Confidentiality / Applicable / Protocol Section Number / ReviewerChecked
Yes / No
1. / Howthe dataand sampleswillbe obtained
2. / Howlongdataand sampleswillbe kept
3. / Justification forcollectionofpersonalidentification data
4. / Who willhave accesstothe personaldata ofthe research participants
5. / Howthe confidentialityofparticipantswillbeensured
6. / The procedurefordata andsample storage
7. / The procedurefordata andsample disposal
Reviewers’comments:
Rights of the participants / Applicable / Protocol Section Number / ReviewerChecked
Yes / No
1. / Procedureforsubjectstowithdrawfromtheresearchat
anytime
2. / Procedure for subjects to ask questions and register
complaints
3. / The contactperson forresearchsubjects
4. / Provisionsforparticipantsto be informed of results
5. / Provisiontomakethestudyproductavailabletothe studyparticipantsafterresearch
Reviewers’comments:
Ethical Review Committee, Faculty of Medicine, KDU
Adapted from Ethical Review Committee, Faculty of Medicine, University of Colombo
Fair participantselection / Applicable / Protocol Section Number / Reviewer checkedYes / No
1. / Thejustification forthe selection of the studypopulation
2. / The inclusionandexclusion criteria
Reviewers’comments:
Responsibilitiesof theresearcher / Applicable / Protocol Section Number / ReviewerChecked
Yes / No
1. / The provision ofmedicalservicesto research
participants
2. / The provisionsforcontinuationofcareaftertheresearch
iscompleted
3. / Declaration of conflicts of interests and how the
investigatorsplan to manage theconflicts
4. / Theethical/legal/socialandfinancialissuesrelevantto
the study.
Reviewers’comments:
Vulnerable populations / Applicable / Protocol Section Number / ReviewerChecked
Yes / No
1. / Justification forconductingthe studyinthispopulation
Reviewers’comments:
Researchfundedbyforeign agencies/companies / Applicable / Protocol Section Number / ReviewerChecked
Yes / No
1. / Justification forconductingthe studyin SriLanka
2. / Relevanceofthe studyto SriLanka
3. / Postresearch benefits toSriLanka
4. / Thestepstakentotakeintoaccountculturalandsocial
customs, practices, and taboos inSriLanka
5. / The sharingof rights tointellectualproperty
6. / The fate of data and biological samples including
whethertheywillbetransferredabroadandwhatwill happentothemafterthe conclusionofthestudy
7. / Howtheresultsofresearchwillbeconveyedtorelevant
authoritiesin SriLanka
8. / Theagreementbetweenthesponsor/fundingagencyand
theinvestigator / Please
Attach
9. / Thematerialstransferagreement,ifbiologicalmaterial
isto betransferredabroad / Please
Attach
Reviewers’comments:
Ethical Review Committee, Faculty of Medicine, KDU
Adapted from Ethical Review Committee, Faculty of Medicine, University of Colombo
Communitybasedresearch / Applicable / Section inProtocol / Reviewer
Checked
Yes / No
1. / The impactand relevance of the researchon the
communityin whichitistobe carried out
2. / The stepstaken to consult withthe concerned
communityduringthe design of theresearch
3. / The procedure usedto obtain communityconsent
4. / The contributiontocapacitybuildingofthecommunity
5. / Theprocedureformakingavailableresultsofresearch
to the community
Reviewers’comments:
Clinicaltrials / Applicable / Section inProtocol / Reviewer
Checked
Yes / No
1. / Justification forwithdrawinganytherapyfrom
participantsto preparethemfor thetrial
2. / Justificationforwithholdingstandardtherapyfromtrial
participants(e.g. controlgroup)
3. / Justificationforprovidingcarewhichisnotthestandard
ofcare
4. / Procedurefordealingwithadverse events
5. / Procedurefor reportingadverseevents
6. / Provisionsforsafetymonitoring
7. / Provisions/criteria fortermination of the trial
8. / Previsionsformakingthe trialdrugavailableto
participantsafter the trialiffoundto be effective
Reviewers’comments:
InformationSheet(IFS)/InformedConsentForm(ICF) Check List / SectionIFS/ICF / Reviewer
Checked
Listthesectionsin IFS/ICFwhere you have dealtwiththe
following:
1. / Purpose ofthestudy
2. / Voluntaryparticipation
3. / Duration, procedures of the study and participant’s
responsibilities
4. / Potentialbenefits
5. / Risks, hazardsand discomforts
6. / Reimbursements
7. / Confidentiality
8. / Termination ofstudyparticipation
Reviewers’comments:
Ethical Review Committee, Faculty of Medicine, KDU
Adapted from Ethical Review Committee, Faculty of Medicine, University of Colombo
Are the investigator’squalificationsand experienceappropriateto conductthe study? Yes No
Recommendation:
Approve
Reject
ConditionalApproval(pleasestatetheconditions)
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Reviewers’comments:
Reviewer:……………………………… Signature:………………………… Date:……./……./…….
Ethical Review Committee, Faculty of Medicine, KDU
Adapted from Ethical Review Committee, Faculty of Medicine, University of Colombo
FacultyofMedicine,General SirJohn Kotelawala Defence University
Applicationfor Ethics Review–DocumentChecklist
forofficialuse
Application No:
Application Checklist
IdeclarethatIhave attached thefollowingdocuments(Pleasetickthe checkbox and confirm). If any of the following sections are not relevant, please indicate N/A in the given space.
1. ApplicationForm:PartI [2copies]
2. ApplicationForm:PartII [2copies]
3. Thecompleteresearchprotocolincludingasectiononethicsconsiderations[3copies]
4. Informationsheet forresearchparticipants(Shouldbeprovidedinallthreelanguages–Sinhala,Tamil,and
English-iftheparticipantisbeinginterviewedoris fillingup theform).[3 copieseach]
5. Consentforms(Shouldbeprovidedinallthreelanguages:Sinhala,Tamil,andEnglish).[3 copieseach]
6. Datacollectionbooklets/forms/questionnaires.(Shouldbeprovidedinallthreelanguages–Sinhala,Tamil, andEnglish)[3 copies]
7. ClinicalTrialsContract(requiredforclinicaltrials)
8. MaterialsTransferAgreement(requiredforallresearchinvolvingtransferofbiologicalsamplesabroad)
9. Indemnity/Insurancecoverage(requiredforclinicaltrials)
10.Ethicsapprovalfromsponsoringcountryorcountryoftheoverseasinvestigator(ifany)
11.Briefcurriculumvitaeofallinvestigators[3 copies]
12.CurriculumvitaeofallDSMBmembers [3 copies]
13.Softcopiesofalldocuments(The documents should be in a compressed folder(zip/rar)havebeen submitted via email to
*The above documents should be handed over to Secretary, Ethical Review Committee, Faculty of Medicine, KDU.
Deadline for submission is first Thursday of each month for a new protocol and second Thursday for a re-submisision.
Iunderstand thattheapplication forethicsclearance willnotbeaccepted unlessalldocuments aresubmitted.IdeclarethatIamnotseekingapproval forastudythathas alreadycommenced orhasalreadybeen completed. Iunderstand thatatleasttwomonthsarerequired forethics reviewand granting ethicsclearance.
………………………………………………………… ……………………………
Signature ofPrincipalInvestigator Date
Ethical Review Committee, Faculty of Medicine, KDU
Adapted from Ethical Review Committee, Faculty of Medicine, University of Colombo