Page | 1

ETHICAL CLEARANCE COMMITTEE (ECC)
POST GRADUATE INSTITUTE OF SCIENCE (PGIS)
University of Peradeniya
PO Box 25, Peradeniya, Sri LAnka
Ethical Clearance – Summary form
This application should be accompanied with ‘Application for Ethics Review of Research Projects Involving Animals’and / or ‘Application for Ethics Review of Research Projects Involving Humans’.
(Use only the space provided – Answer all the questions in consultation with your supervisor)
Name of the applicant:
Registration No: (For PGIS students)
Official address:
Phone Nos.:
E-mail:
Title of the project:
Duration of the study / From: / dd / mm / yyyy / To: / dd / mm / yyyy
Nature of Research
Questionnaire only / Yes/No / Questionnaire + Sampling / Yes/No
Observational only / Yes/No / Interventional study / Yes/No
Involving animal subjects / Yes/No / Involving human subjects / Yes/No
Specify animal/s: / Age group of human subjects:
Samples to be collected from humans/animals:
Subject consent obtained / Yes/No/Not required
If yes attach a copy of the consent form
* If children are involved, consent should be obtained from parents.
** If domesticated animals are involved, consent should be obtained from owners.
Methodology
Sample size (if invasive/interventional study use minimum number of animal/human subjects)
Is it an invasive study? / Yes/No
If yes specify:
Interventional techniques / Yes/No
If yes specify:
Study Involving Animal/ Human Subjects
Is it absolutely necessary to use animal/human subjects? / Yes/No
Are the animals housed / looked after adequately? Explain:
Do you intend using local / general anesthesia appropriately to avoid pain? Explain:
What do you intend to do with the samples/animals after the experiments? Explain:
Safety of Investigator/s & Subjects
Explain the precautions taken for safety of the investigator/s and subjects:
List ethical concerns in your study:
1.
2.
3.
4.
5.
Signature of the applicant / Date (dd/mm/yyyy)
Recommendation of the supervisor:
Name of the supervisor: / Official address:
Signature / Date (dd/mm/yyyy)
Comments & Observations of the Reviewer:
Name of the reviewer:
Signature / Date (dd/mm/yyyy)

CEC-PGIS 2017

Page | 1

ETHICAL CLEARANCE COMMITTEE (ECC)
POST GRADUATE INSTITUTE OF SCIENCE (PGIS)
University of Peradeniya
PO Box 25, Peradeniya, Sri LAnka
Application For Ethics Review Of Research Projects Involving Humans–PartI
forofficialuse
ApplicationNo: / Date received:
Reviewed by: / ECC Meeting Date:
Decision: / Date Informed:
Type ofReviewRequested
Regular / Expedite / Pleaseseeguidelinestodeterminewhetherthisapplicationqualifiesforexpeditedreview.
1. / Title of the project:
2. / Investigators:
Applicationsfrominvestigatorsbasedoverseaswillonlybe considerediftheprojectisdoneincollaborationwith investigatorsbasedininstitutionsinSriLankawhotakeequalresponsibilityforthe conductof the studyandwho willappearasco-authorsinanypublicationarisingoutofthestudy.
2.1 / Investigator 1
Title: / Mr. / Ms. / Dr. / Prof.
Name:
Qualifications:
Designation:
Place of work:
Address:
Contact Nos.:
Email:
Principal investigator / Co-investigator / Supervisor
Signature:
2.2. / Investigator 2
Title: / Mr. / Ms. / Dr. / Prof.
Name:
Qualifications:
Designation:
Place of work:
Address:
Contact Nos.:
Email:
Principal investigator / Co-investigator / Supervisor
Signature:
2.3. / Investigator 3
Title: / Mr. / Ms. / Dr. / Prof.
Name:
Qualifications:
Designation:
Place of work:
Address:
Contact Nos.:
Email:
Principal investigator / Co-investigator / Supervisor
Signature:
2.4. / Investigator 4
Title: / Mr. / Ms. / Dr. / Prof.
Name:
Qualifications:
Designation:
Place of work:
Address:
Contact Nos.:
Email:
Principal investigator / Co-investigator / Supervisor
Signature:
2.5. / Investigator 5
Title: / Mr. / Ms. / Dr. / Prof.
Name:
Qualifications:
Designation:
Place of work:
Address:
Contact Nos.:
Email:
Principal investigator / Co-investigator / Supervisor
Signature:
3. / Proposed startingand ending dates:*‡
Start date: / End date:
*Frominitialrecruitmentofparticipantsuntilcompletionofalldatacollection.
‡Retrospectiveapprovalwillnotbegivenforprojectsalreadystartedorcompleted.
4. / Hasethicsreviewforthisstudybeenrequestedearlierfromthiscommitteeoranother similar committee?
Yes * / No
Where *
When *
Result *

CEC-PGIS 2017

Page | 1

ETHICAL CLEARANCE COMMITTEE (ECC)
POST GRADUATE INSTITUTE OF SCIENCE (PGIS)
University of Peradeniya
PO Box 25, Peradeniya, Sri LAnka
Application For Ethics Review Of Research Projects Involving Humans–PartII
forofficialuse
ApplicationNo:
1. / Title of the project:
2. / Funding [Name and address of funding sources(s)] / Amount
3. / Abriefsummaryofthe research proposalinsimplelanguage (maximum500words)
4. / Scientific importanceand validity
4.1 / What is the scientific importance of your study in relation to improving health care of humans and/or knowledge on the subject?
4.2 / Isyourstudyanoriginaloneorareplicationofapreviousstudy?
Original / Replication
Ifitisareplicationstudypleasejustify.
4.3 / Hasthis researchproposalbeensubjectedtoscientific reviewbyanyothercommittee?
Yes / No
IfYES,whatisthenameof thecommittee
4.4 / Aretheinvestigator’squalifications andexperienceappropriateto conductthestudy?
Yes / No
4.5 / Arethefacilities atthesiteadequatetosupportthestudy?
Yes / No
4.6 / Howwilltheresultsof thestudybedisseminated?
5. / AssessmentofRisks/Benefits
5.1 / Istheinvolvementofhumansubjectsnecessarytoobtainthenecessaryinformation?
Yes / No
5.2 / Arethereanyrisks(physical,psychological,social,legal,economic) totheparticipants?
Yes / No
IfYESidentifythemandstatehowyouplantopreventorminimizetheserisks?
5.3 / Arethereanybenefitstotheparticipants?
Yes / No
IfYESidentifythem.IfNOwhatarethebenefitstothe communityorhealth caresystem?
5.4 / Justifythepotentialbenefits againsttherisks.
5.5 / Isstandardtherapygoingtobewithheldfromtheparticipants?
Yes / No / Not applicable
IfYES,justify.
5.6 / Isthestandardofcarethebest available locally?
Yes / No / Not applicable
IfNO,explain
5.7 / Isthemedicalandpsychologicalsupportfortheparticipants adequate?
Yes / No / Not applicable
If no, explain.
5.8 / Whatistheprocedurefordealingwithadverseevents?
5.9 / Whatistheprocedureforreportingadverseevents?
5.10 / Isthereprovisionforcompensationforparticipantswhosustaininjuries?
Yes / No / Not applicable
IfYES/NOexplain.
5.11 / Whataretheprovisionsforsafetymonitoringandterminationofresearch?
5.12 / What is the possibility of an effective intervention, if found, being available to the population?
6. / Respectfor the dignityofthe research participants
Informedconsent
6.1 / Writebrieflyyourprocedureforobtaininginformedconsentfromtheownersofanimalsuse fortheresearch.
6.2 / Whowillobtainconsent?
6.3 / Isit writtenorverbalconsent?
Written / Verbal / Not applicable
Ifwrittenpleaseincludeconsentformwithtranslations.If verbal,pleasestateinsimple words(inSinhala/Tamil/ English)inaseparatesheetwhatinformationyouwouldconvey totheparticipantsandstatebelow howconsentwouldbedocumented
6.4 / Howwillyouensurethatthe participantisadequatelyinformed?Pleaseincludeinformationsheetswithtranslations.
6.5 / Howwillyouensureyourinformationisunderstood(comprehension) andqueries answered?
6.6 / Wouldtheparticipantshavedifficultyunderstandingtheinformationdueto,forexample, age(childrenunder16orsenility),illiteracy,impairedcognitionduetoillness/trauma?
Yes / No
IfYESjustifytheuseof thisgroupanddetailthearrangement forobtainingproxy consent.
6.7 / Areyouofferinganyfinancialorotherincentives/rewards/compensationtotheresearch participants?
Yes / No
IfYESpleaselistthemandstatewhytheydonotconstituteundueinducementforgranting consent?(Allincentivestobeprovidedtoownersmustbeapprovedby theCEC)
6.8 / Howwillyouensurethatconsentisgivenvoluntarilyandnotduetodeception,intimidation orinducement?
6.9 / Aretheresearchparticipantsunderyourcare?
Yes / No
IfYESpleasestatehowyouwouldensuretheywouldnot feelobligedtoparticipateinorder toreceivebettermedicalcare.
6.10 / Willyouobtainfreshinformedconsentiftheproceduresarechangedduringtheresearch?
Yes / No / Not applicable
Confidentiality
6.11 / Howwilldata/samplesbeobtained?
6.12 / Howlongwilldata/samplesbekept?
6.13 / Areyoucollectingtheminimuminformation/samplesrequiredtofulfillthestudy objectives?
Yes / No
6.14 / Whowillhaveaccesstothepersonaldataoftheresearchparticipants?
6.15 / Howwillyousafeguardtheprivacyoftheresearchparticipants?
6.16 / Whatisthedata/samplestorageanddisposalprocedureinrelationtoensuring confidentialityandsecurityofpersonalinformation?
6.17 / Ifyouareplanningtostoredata/samplesforfuturestudy,willyouobtainappropriate consent?
Yes / No
Rightsofthe participants
6.18 / Howwillyouensuretheparticipantsunconditionalrighttowithdrawfromtheresearchat anytime?
6.19 / Outlinetheproceduresyouwillprovidefortheresearchparticipantstoaskquestionsand registercomplaints.
6.20 / Whoisthecontactpersonfortheresearchparticipants?
6.21 / Is there provision for participants to receive information that is relevant to their participation?
Yes / No / Not applicable
IfYES/NOExplain.
6.22 / Isthereprovisionforthesubjectstobeinformedofresultsofclinicalresearch?Explain.
Yes / No / Not applicable
IfYes/NOExplain.
6.23 / Isthereprovisiontomakethestudyproduct ifanyavailabletothestudyparticipants followingtheresearch?
Yes / No / Not applicable
IfYES/NOExplain
7. / Fair participant selection
7.1 / Whatisyourstudypopulation?
7.2 / Justifyyourchoiceofstudypopulation.
7.3 / Istheselectionofparticipants(inclusionandexclusioncriteria)appropriatesothatrisksare minimizedandbenefitsaremaximizedandtheburdenofresearchequitabledistributed?
Yes / No / Not applicable
IfYES/NOExplain.
7.4 / Howisthe initialcontactandrecruitmenttobeconducted?
7.5 / Istheresearchconductedonavulnerablegroup?
Yes / No
IfYESpleasefillupsection9.
7.6 / Istheresearchanexternallysponsoredresearch?
Yes / No
IfYESpleasefillupsection10.
7.7 / Isyourresearch acommunity research?
Yes / No
IfYESpleasefillupsection11.
7.8 / Isyourresearchaclinical trial?
Yes / No
IfYESpleasefillupsection12.
8. / Responsibilitiesoftheresearcher
8.1 / Whataretheresponsibilitiesoftheresearcherforprovisionofmedicalservicestoresearch participants?
8.2 / Whataretheprovisionsforcontinuationofcareaftertheresearchis over?
8.3 / Haveyoufollowedanyapplicablelegalregulationsorotherguidelines?
Yes / No / Not applicable
IfNOExplain.
8.4 / Haveyouobtainedpermissionfromtherelevant authorities?
Yes / No / Not applicable
IfYESnametheauthorities.IfNOwhoareyouplanningtogetpermissionfrom?
8.5 / Pleasedeclareanyconflictsofinterestincludingpaymentsreceivedbyyouorco- researchersandotherrewards(Pleaselistthemandstatehowyouwouldpreventthem frominfluencingtheconductofthestudy).
8.6 / Doyouseeanyotherethical/legal/social/financialissuesinyourstudy?(Pleaselistthem andstatehowyouwouldpreventthemfrominfluencingconductofthestudy).
8.7 / I donotwishthefollowingreviewers/ECCmemberstoreviewmyapplication.
8.8 / Iamwillingtoprovide6monthlyreportsofmyresearchtotheEthicsCommittee.
Yes / No / Not applicable
9 / Vulnerablegroups(those socially disadvantaged on account of illiteracy, economic status, social status etc. and those with limited autonomy such as prisoners, service personnel etc.)
9.1 / Whatisthejustificationforusingthevulnerablegroupinsteadofthegeneralpopulation?
9.2 / Whatistheprocedureforobtaining(proxy)consent?
9.3 / Whatistheprocedureforwithdrawalfromresearchduetorefusal(dissent)ofresearch participant?
9.4 / Areyouprovidingadequatemedicalandpsychologicalsupport?
Yes / No / Not applicable
If YES/NO Explain.
9.5 / Willthebenefitsofresearchbemadereasonablyavailabletothispopulation?
Yes / No / Not applicable
If YES/NO Explain.
10 / Externallysponsoredresearch
10.1 / HastheresearchprojectbeenapprovedbyanECCinthesponsoringcountry?
Yes / No
IfYES,pleaseattachdocumentaryevidence.IfNO,givereasons.
10.2. / WhyistheresearchcarriedoutinSriLankaandnotinthesponsoringcountry?
10.3 / WhatistherelevanceofthisstudytoSriLanka?
10.4 / WhatarethepostresearchbenefitstoSriLankasuchascapacitybuildingetc?
10.5 / Areyouadheringtoanyspecificlaws/regulations/guidelinesofSriLankaandthe sponsoringcountry/countriesapplicabletothestudy?
Yes / No / Not applicable
IfYES,givedetails.
IfNoExplain.
10.6 / Haveyoutakenintoaccountculturalandsocialcustoms,practices,andtaboosinSriLanka whendesigningyourstudy?
Yes / No / Not applicable
IfYES/NOExplain.
10.7 / Areparticipants receivingthebestcurrenttreatment aspartof theprotocol?
Yes / No / Not applicable
IfNOT,explainwhy?
10.8. / Whatistheancillarycareprovided(treatmentthatis notpartoftheprotocol)?
10.9 / Whataretheprovisionsforcontinuityofcare?
10.10 / Howwilltherightstointellectualpropertybeshared?
10.11 / Areanyof the dataorbiologicalsamplestobe transferredoverseas?
Yes / No
IfYES,describethefateofthedataorbiologicalsamplesattheconclusionofthe study.
10.12 / HowwilltheresultsofresearchbeconveyedtorelevantauthoritiesinSriLanka?
11 / Communitybasedresearch
11.1 / Statetheimpactandrelevanceoftheresearchonthecommunityanimalsinwhichitis to becarriedout.
11.2 / Statethestepstakentoconsultwiththeconcernedcommunityduringthedesignofthe research.
11.3 / Whatprocedureswillbeusedtoobtain communityconsent?
11.4 / Whatprocedureswillbeusedtoobtainindividualconsent?
11.5 / Howwillyousafeguardtheprivacyof theparticipants?
11.6 / Iftheinterventionisshowntobebeneficialwillthesponsorcontinuetoprovideitto participants afterconclusionof thestudy?Ifnot,explainwhy.
Yes / No
11.7 / Willtheinterventionorproductdevelopedorknowledgegeneratedbemadereasonably availableandaffordableforthebenefitof thepopulation?
Yes / No
11.8 / Howdoestheresearchcontributeto capacitybuildingof thecommunity?
11.9 / Howwilltheresultsof theresearchbemadeavailabletotheconcernedcommunity?
12 / Clinicaltrials
12.1 / Whatphaseclinicaltrialisbeingconducted?
Phase I
Phase II
Phase III
Phase IV (post marketing)
Other
If OTHER specify.
12.2 / Isitamulticentertrial?
Yes / No
IfYESGivedetails.
12.3 / Istheclinicaltrialregisteredwithaclinicaltrialregistry?
Yes / No
IfYESnameit.
12.4 / Haveadequateanimaltoxicityandteratogenecitytrialsbeencarriedout?
Yes / No
12.5 / Whatisthejustificationforusingacontrolarm?
12.6 / Doesthecontrolgroupreceivethestandardtherapy?
Yes / No / Not applicable
12.7 / Areallparticipantstreatedequally?
Yes / No / Not applicable
IfNOTExplain.
12.8 / Whatistheprocedurefordealingwithadverseevents?
12.9 / Whatistheprocedureforreportingadverseevents?
12.10 / Willthesponsoringagencyprovidethedrug/ devicetothepatienttillitismarketedin thecountry?
Yes / No
12.11 / Whatarethecriteriaforterminationofthetrial?
12.12 / Isthereprovisionforinsuranceof thetrialparticipants? Explain.
Yes / No

CEC-PGIS 2017

Page | 1

ETHICAL CLEARANCE COMMITTEE (ECC)
POST GRADUATE INSTITUTE OF SCIENCE (PGIS)
University of Peradeniya
PO Box 25, Peradeniya, Sri LAnka
Application for Ethics Review of Research Projects Involving Humans
Ethics Review Evaluation Form–PartIII
forofficialuse
ApplicationNo:
Yes / No / NA / Comments
  1. Isallthedocumentationprovided?

  1. Scientificimportanceandvalidity

  1. Willthestudyleadtoimprovementsinhuman healthandwellbeingorincreaseknowledge?

  1. If the studyis a replication ofaprevious study,isitjustified?

  1. Can the interventionstudied be practically implemented?

  1. Isthereprovisionfordisseminationofresults oftheresearch?

  1. Hastheresearchprotocolbeenapprovedbya competentbody?

  1. Shouldthe study be referred toa technical expert,policymakerorstatisticalexpert?

If your answer for Q 6. Is YES, please informtheSecretary/CEC-PGISas soonaspossible,suggestingasuitableperson.
If NOT,
  1. Aretheobjectivesstatedclearly?

  1. Isthestudydesignappropriateinrelationto theobjectives?

  1. Is the study designed using accepted principles, methods and practices?

  1. Isthereaplausibledataanalysisplan?

  1. Dothesamplesizeandstatisticaltechniques haveadequatepowerto producereliableand validresultsusing thesmallestnumberof researchparticipants?

  1. Are the investigators qualifications, competenceand experienceappropriateto conductthestudy?

  1. Are the facilities at the site adequate to supportthestudy?

  1. Isthemannerinwhichtheresultsofresearch willbereportedandpublishedethical?

  1. AssessmentofRisks/Benefits

  1. Is the involvement of human participants necessarytoobtainthenecessaryinformation?

  1. Aretheresearcherqualifications,competence, andexperiencesuitabletoensuresafeconduct ofthestudy?

  1. Howsafeistheinterventiontobeusedinthe research?

  1. Is thejustificationof predictablerisksand inconveniences weightedagainst theanticipated benefitsfor the researchparticipantandthe concernedcommunities adequately?

  1. Arethereany planstowithdraworwithhold standard therapyforthepurpose ofresearch andsuchactionsifanyjustified?

  1. Is the standard of care the best available locally?

  1. Isthemedicalandpsychological supportfor theparticipantsadequate?

  1. Isthesiteincludingsupportstaff,facilitiesand emergencyproceduresadequate?

  1. Is there provision for compensation for participants who sustain injuries?

  1. Have adequate provisions been made for dealingwithandreportingadverseeffects?

  1. Have adequate provisions been made for safety monitoringandterminationofthe researchproject?

  1. Isthereapossibilityofaninterventionbeing availabletothepopulationiffoundeffective?

  1. Respectforthedignityofthe researchparticipants

  1. Informed consent

  1. Istheprocessforobtaininginformedconsent appropriate?

  1. Aretheparticipantscompetent?

  1. Isthejustificationfortheintentiontoinclude individualswhocannotconsentadequate?

  1. Are the arrangements for obtaining proxy consent for such individuals appropriate?

  1. Willdissentberespected?

  1. Is the written and oral information to be given to the research participants appropriate, adequate, complete and understandable?

  1. Doyouapprovetheincentivesoffered?

  1. Istheconsentgivenvoluntarilyandnotdueto deception,intimidationorinducement?

  1. Willfreshinformedconsentbeobtainedifthe proceduresarechangedduringtheresearch?

  1. Isthereanopportunity fortheparticipant toaskquestionsregardingtheresearch?

  1. Confidentiality

  1. Willtheresearchercollectonlytheminimum information/samples required to fulfill the studyobjectives?

  1. Is the privacy of the research participant safeguarded?

  1. Are data/sample storage and disposal procedures adequate?

  1. Rightsofthe participants

  1. Is theparticipant’srighttounconditionally withdrawfromtheresearchat anytime safeguarded?

  1. Isthere provisionforthe participantstoask questionsandregistercomplaint?

  1. Is there provision for participants to be informedaboutnewly discoveredrisksor benefitsduringthestudy?

  1. Is there provision for the subjects to be informed of results of clinical research?

  1. Is thereprovisiontomakethestudyproduct available to the participantsfollowingresearch?

  1. Fairparticipantselection

  1. Hasthestudy populationbeendetermined, primarily,basedonthescientificgoalsofthe study(andnotonconvenience,ethnicity,age, gender,literacy,cultureoreconomicstatus)?

  1. Is theselectionof participants(inclusionand exclusioncriteria)appropriatesothatrisksare minimizedandbenefitsare maximizedandthe burdenofresearchequitablydistributed?

  1. Does the selectionofparticipants stigmatizeanygroup?

  1. Doesselectionofsubjectsfavouranygroup?

  1. Isthe initial contact and recruitment appropriate?

  1. Is the research conducted on vulnerable individualsorgroups?

  1. Istheresearchexternallysponsored?

  1. Istheresearchacommunityresearch?

  1. Istheresearchaclinicaltrial?

  1. Responsibilitiesoftheresearcher

  1. Isthe medical careto be provided to the researchparticipantsduring andafterthe researchadequate?

  1. Has theresearcher followed any applicable legalregulationsor otherguidelines?

  1. Hastheresearcher obtained permission from therelevantauthorities?

  1. Arethereanyconflicts ofinterest, including paymentsandotherrewards?

  1. Are there any other ethical / legal/ social /financialissuesinthestudy?

  1. Vulnerablegroup

  1. Cantheresearchbeequallywellcarriedoutin another,lessvulnerable,group?

  1. Will the study result in new knowledge relevanttothehealthneedsofthispopulation?

  1. Istheprocedureforobtaining(proxy)consent adequate?

  1. Will thesubject’s withdrawal fromresearch duetorefusal(dissent)bealwaysupheld?

  1. Isthereafavourableriskbenefitratio?

  1. Is the medical and psychological support adequate?

  1. Will thebenefit ofthe research be made reasonablyavailabletothisgroup?

  1. Externallysponsoredresearch

  1. Istherealocalcollaborator?

  1. Hastheresearchprojectbeenapprovedbya
ECCinthesponsoringcountry?
  1. Isthejustificationfor the research to be carriedout in Sri Lankaandnotin the sponsoringcountryadequate?

  1. IstheresearchrelevanttoSriLanka?

  1. Arethepost-researchbenefitstothecountry acceptable?

  1. Are relevantlocallaws/regulations/guidelinesofeachcountry adheredto?

  1. Is the researchresponsive to cultural/social differences?

  1. Are participants receiving the best current treatmentaspart oftheprotocol?

  1. Istheancillarycareprovidedadequate?

  1. Are the provisions for continuity of care adequate?

  1. Are the provisions for intellectual property sharingfair?

  1. If the data/biological samples are to be transferred overseas, is there adequate provisiontosafeguardthe interestsofthe subjects and protect intellectual property rights?

  1. Isthereprovisionforresultsofresearchtobe conveyedtorelevantauthoritiesin SriLanka?

  1. Areanyconflictsofinterestresolved?

  1. Isthere a written agreement betweenthe collaborators?

  1. Communitybasedresearch

  1. Istheimpactandrelevanceoftheresearchon thecommunityinwhichitistobecarriedout acceptable?

  1. Hastheconcernedcommunitybeenconsulted duringthedesignofthestudy?

  1. Iscommunityconsentobtained?

  1. Isindividualconsentobtained?

  1. Istheprivacyoftheparticipantssafeguarded?

  1. Iftheintervention isshowntobebeneficial willthesponsorcontinueto provideitto participantsafterconclusionofthestudy?

  1. Willtheinterventionor productdevelopedor knowledgegeneratedbe madereasonably availableandaffordableforthebenefitof the population?

  1. Does the research contribute to capacity buildingofthecommunity?

  1. Willthe results of theresearchbemade availabletotheconcernedcommunity?

  1. Areanyconflictsofinterestresolved?

J. / Clinicaltrials
  1. If it is a multicentre trial, are all centres followingthesameprotocol?

  1. Istheclinicaltrialregistered withaclinical trialsregistry?

  1. Have adequateanimaltoxicityand teratogenicitytrialsbeencarriedout?

  1. Is their sufficient justification forusing a controlarm?

  1. Doesthe control groupreceive the standard therapy?

  1. Areallsubjectparticipantstreatedequally?

  1. Is the procedure for dealing with adverse eventsadequate?

  1. Istheprocedureforreportingadverseevents adequate?

  1. Willthesponsoringagencyprovidethedrug/ devicetothepatienttillitismarketedin the country?

  1. Arethe criteriafor termination ofthe trialdetailed?

  1. Is there provision for insurance of trial participants?

AdditionalComments:

……………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………..…..………………………………………………………………………………………………………………………………

…………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………

Recommendation: / Approve / Reject / ConditionalApproval*

(*If conditional approval, please statetheconditions)

………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………..………..………………………………………………………………………………………………………………………………

……………………………………………………………………………………………………………………………………………………………………………………………………………………………………………..………..……………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………..………..…

Name of the Reviewer:
Signature / Date (dd/mm/yyyy)

CEC-PGIS 2017

Page | 1

ETHICAL CLEARANCE COMMITTEE (ECC)
POST GRADUATE INSTITUTE OF SCIENCE (PGIS)
University of Peradeniya
PO Box 25, Peradeniya, Sri LAnka
Application for Ethics Review of Research Projects Involving Humans–PartIV
forofficialuse
ApplicationNo:
ApplicationChecklist
IdeclarethatIhaveattachedthefollowingdocuments(pleasetickthecheckboxand confirm):
1. / Summary form: [2copies]
2. / ApplicationForm:PartI.[2copies]
3. / ApplicationForm:PartII.[2copies]
4. / Ethics Review Evaluation Form: Part III[ 1 copy]
5. / Thecompleteresearchproposalincludingthejustification,objectives,andmethods indetail. [2copies]
6. / Information sheet for research participants (Should be provided in all three languages – Sinhala,
Tamil, and English).[2copies]
7. / Consent forms (Should be provided in all three languages – Sinhala, Tamil, and English).[2copies]
8. / Datacollectionbooklets/forms/questionnaires. (Shouldbeprovidedinallthree languages–Sinhala,TamilandEnglish–ifapplicable)[2copies]
9. / Copiesofrelevantpermissionletters.[2copies]
10. / Application check list: Part IV
Iunderstandthattheapplicationfor ethicsclearancewillnot beacceptedunlessall documentsaresubmitted.IdeclarethatIamnotseekingapprovalfora studythathas already commenced or has already been completed. I understandthatat least two monthsarerequiredforethicsreviewandgrantingethicsclearance.
Signature of the applicant / Date (dd/mm/yyyy)

CEC-PGIS 2017