Form TD2: Research Ethics Protocol Form for Graduate ...
Transcript of Form TD2: Research Ethics Protocol Form for Graduate ...
Form TD2: Research Ethics Protocol Form for Graduate Student Thesis, Dissertation, or Pilot ProjectResearch ethics protocols for theses, dissertations, and pilot projects are approved by the Faculty of Graduate Studies (FGS).
• SubmitpapercopiesoftherelevantformstoyourGraduateProgramforreviewandsignature.• GraduateProgramswillforwardformstoFGSThesis&DissertationCoordinator.• Allsubmissionsmustinclude:
º TD1(Thesis/DissertationProposalSubmission)Formsignedbythestudent,supervisor,andGraduateProgramDirector,
º thesis/dissertationproposal• Incasesrequiringpreliminaryresearch(e.g.,pilotproject),submitthepilotprojectresearchproposal
insteadofthethesis/dissertationproposal.º Informedconsentformº Ifapplicable,otherdocumentationrequiredforyourspecificresearchethicsprotocol
• Theaveragetimetoprocessminimalriskprotocolsisapproximately40workingdaysfromthedateofreceiptbyFGS.IN-COMPLETEORILLEGIBLEPROTOCOLSWILLBERETURNEDTOTHERESEARCHER,WHICHWILLDELAYTHEPROCESS.
• ResearchinvolvingAboriginal/IndigenousPeoples;thatismorethanminimalrisk;orthatinvolvesclinicaltrials,isap-provedbytheYorkUniversityHumanParticipantsReviewCommittee(HPRC).UseHPRCForm
• Researchethicsprotocolsforacourse,oraMajorResearchPaper(MRP),areapprovedbyyourGraduateProgram’sDelegat-edResearchEthicsCommittee.ConsultwithyourGraduateProgramforappropriateforms.
• Formoreinformationonresearchethicsrelatedmatters,pleasevisittheOREwebsite:http://research.info.yorku.ca/re-search-services/research-ethics/orFGSResearchEthics:http://gradstudies.yorku.ca/current-students/thesis-dissertation/research-ethics/
• Contact:ResearchOfficer([email protected])
Privacy: Personal information in connection with this form is collected under the authority of The York University Act, 1965 and will be used for educational, administrative and statistical purposes. If you have any questions about the collection, use and disclosure of personal information by York University, please contact: Faculty of Graduate Studies, 230 York Lanes, (416) 736-2100 x 55521.
Part A – General Information
A. Student Information
StudentName Date(mm/dd/yyyy)
E–mail Phone Studentnumber
Program Degree
Checkone:ThesisDissertationPilotProject
TitleofResearchProjectTitleofResearchProject
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Part A – General Information continued
A. Student Information continuedNameofSupervisor
IsthisarevisedversionofaprotocolpreviouslysubmittedtoFGSand/orHPRC?NoYes
Proposedstartdateforresearchinvolvinghumanparticipants(mm/dd/yyyy):
1. Is this research defined as:MinimalRisk?MorethanMinimalRisk?
IfMorethanMinimalRisk,doNOTusethisTD2form.SubmitHPRCProtocol.
TheHPRCusesthedefinitionofminimalriskasoutlinedintheSSHRC/NSERC/CIHRTri-CouncilPolicyStatement(TCPS)“EthicalConductforResearchinvolvingHumans”(December2014):“Ifpotentialsubjectscanreasonablybeexpectedtoregardtheprobabilityandmagnitudeofpossibleharmsimpliedbyparticipationintheresearchtobenogreaterthanthoseencounteredbythesubjectinthoseaspectsofhisorhereverydaylifethatrelatetotheresearchthentheresearchcanbere-gardedaswithintherangeofminimalrisk”(p.1.5).AnexpandedversionofthisdefinitionisavailablefromOREuponrequest.
NOTE:FullboardreviewisrequiredforALLresearchthatismorethanminimalrisk.AfullboardreviewrequiresameetingoftheHumanParticipantsReviewCommittee(HPRC)forthepurposesofprovidingfinalapprovalandwhich,asaconsequence,maytakelongertoreview.
2. Does this research involve clinical trials?NoYes
IfYes,doNOTusethisTD2form.SubmitHPRCProtocol.
3. Does your research involve Aboriginal/Indigenous Peoples? NoYes
The following questions may assist in determining whether your research involves Aboriginal/Indigenous Peoples:a.WilltheresearchbeconductedonAboriginalland(Canada;international)forwhichpermissionand/orapprovalfroman
authority(suchasbandcouncil,FirstNationsResearchEthicsBoard,etc.)mayberequired? No Yesb.WillrecruitmentcriteriaincludeAboriginalidentityaseitherafactorfortheentirestudyorforasubgroupofthestudy?
No Yesc. WilltheresearchseekinputfromparticipantsregardinganAboriginalPeoples’culturalheritage,artefacts,ortraditional
knowledge? No Yesd.WillresearchinwhichAboriginalidentityormembershipinanAboriginalcommunitybeusedasavariableforthepurpose
ofanalysisoftheresearchdata? No Yese.WillinterpretationofresearchresultsrefertoAboriginalcommunities,peoples,language,historyorculture?
No Yes
(Note:“Research”doesnotincludeliterarycriticismand/orhistory(excludingoralhistory)and/orprimarilytextualactivities)
Ifyouhaveanswered“yes”toanyoftheabovenotedquestions,thenyourresearchinvolvesAboriginal/IndigenousPeoples.IfYes,doNOTusethisTD2form.SubmitHPRCProtocol.ResearchersarerequiredtofamiliarizethemselveswiththeGuidelinesforResearchinvolvingAboriginalPeoplesandcompletetheChecklistforResearchers—ResearchInvolvingAboriginalPeoples.NotethatresearchinvolvingAboriginal/IndigenousPeopleswillfirstbereviewedbytheAboriginalResearchEthicsAdvisoryGroup(AREAG)priortobeingforwardedtotheHPRC.ResearchersmayreceiveinitialcommentsfromtheAREAGforwhicharesponsewillberequired.
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4. Is this research part of a faculty–led research project for which a faculty member is the Principal Investigator?NoYes
IfYes,doNOTusethisTD2form.Instead,pleaseattachTD4,StatementofRelationshipbetweenProposalandExistingApproved
Research/Facilities,aswellasacopyoftheHPRCApprovalCertificate.
5. Does this research involve animals or biohazards?No Yes
IfYes,doNOTusethisTD2form.Allstudentresearchinvolvinganimalsorbiohazardsmustbeunderfacultysupervision.PleaseattachTD4,StatementofRelationshipbetweenProposalandExistingApprovedResearch/Facilities,aswellasacopyoftheHPRCApprovalCertificate.
6. Are you conducting secondary data analysis?No Yes
Ifyes,pleasereviewtheSecondaryDataAnalysisGuidelinesandensurethatyoucompletesectionB.8below.
NOTE:SecondaryDataAnalysisisdescribedastheanalysisofdatacollectedforapurposeotherthanthatforwhichitwasoriginallycollectedinordertopursuearesearchinterestwhichisdistinctfromthatoftheoriginalwork.ResearchersareadvisedtoreviewtheSecondaryDataAnalysisGuidelinesforfurtherinformationonrequirementsrelatedtouseofsecondarydataforresearchpurposes.
7. Is any anticipated funding* for this project from any external (i.e., outside York) sources?NoYes
Ifyes,whatisthefundingagencyand/orprogram?
*Thedefinitionof“funded”doesnotincludefundingintheformofstudentOGSscholarships,SSHRCfellowships,NSERCscholar-ships,orCIHRawards.Theseawardsareintendedtosupportstudentsthroughtheirstudiesanddonotrequirereportsfromstudentsonthespecificresearchactivitiesconducted.Thedefinitionof“funded”doesapplytograntsawardedforspecificresearchprojects,whetherthoseprojectsbethestudent’sownresearchprojectsorresearchbeingconductedaspartofafacultymember’sfundedresearchproject.Typically,for“funded”research,grantingagenciesrequirereportsoftheresearchconducted.
8. Does this research involve another institution? Researchinvolvinganotherinstitution(suchasaschool,university,busi-ness,governmentagency)mayrequireadditionalethicsreviewandapprovalorpermissionsifusinginstitutionalresources(suchasinternallistservs,orconductinginterviewsonthepremisesoftheinstitution).NoYes
NOTE:Iftheresearchistobeconductedatasiterequiringethicsapprovaloradministrativepermission,pleaseincludealldraftinformedconsentforms/administrativepermissionrequests.Itistheresponsibilityoftheresearchertodeterminewhatothermeansofclearancearerequired,andtoobtainclearancepriortostartingtheproject.
a. Doanyoftheinstitution(s)/site(s)haveanethicsreviewboard? No Yes
If ‘Yes’, specify the institution(s)/site(s):
b. Doanyoftheinstitution(s)/site(s)requireadministrativepermission?No Yes
If ‘Yes’, specify the institution(s)/site(s) and provide a copy of the letter of permission:
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c. HasanyotherResearchEthicsBoard(REB)clearedthisproject? No Yes
If ‘Yes’, please submit the original application and provide a copy of the clearance letter.
Part B – Research Information1. Project DescriptionIn layperson’s terms, please provide a general and brief description of the research (e.g., hypotheses, goals and objectives, etc.).
2. ParticipantsState who the participant(s) will be:Describetheparticipantsthatwillberecruitedandaboutwhompersonalinformationwillbecollected(i.e.,numbers,age,specialcharacteristics,etc.).Describethesizeofthegroupfromwhichparticipantswillbere-cruitedandtheestimatednumberneededfortheresearch(minimum/maximum).Whereactiverecruitmentisrequired,pleasedescribeinclusionandexclusioncriteria.Wheretheresearchinvolvesextractionorcollectionofpersonalinformation,pleasedescribefromwhomtheinformationwillbeobtainedandwhatitwillinclude(include permission letters).
ThisstudywillbeusingaparticipantpoolPleaseindicatewhichparticipantpool(s):
URPPSchulichMarketingPoolSchoolofAdministrativeStudiesparticipantpoolKUREGlendonParticipantPoolOther:
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(Pleasecheckallthatapply)FinancialIn–kindDrawParticipantPoolBonusPointsOther:
b.Ifinducementsareprovided,pleaseprovidethesourceoffundingforthem:
5. Methodsa.Pleaseindicatealltheresearchmethodsthatapply:
ActionResearch EthnographyObservation SurveyDocumentaryFilmmaking FocusGroup Experimentallabstudy InterviewOral/Lifehistory HumanTissuesExperimentalbehaviouralstudy OnlineResearchOther:
b.Doanyofthemethodsinvolve: AudioRecording? NoYes PhotographicRecording?NoYes VideoRecording? NoYes
• Pleasenotethatexplicitconsentisrequiredtousethesemethodsofrecording.PleaseseeSection10,InformedConsentfordetails.
• Ifyouareusingrecordings,youwillberequiredtoaccountforhowtheywillbesafelystored,eventuallydestroyedorarchived,andhow,ifusedinresearchdissemination,confidentialitywillbemaintained.PleaseseeSection11,DataSecurityfordetails.
c. Whatwillberequiredoftheparticipant(s)?Clearlyspecifyinastep-by-stepoutlineexactlywhattheparticipant(s)willbeaskedtodoineachmethodology.Aseparateoutlineisrequiredforeachmethodology.Includethesettings,typesof
3. Recruitmenta.How will participants be recruited(e.g.,snowballtechnique,randomsampling,previouslyknowntointerviewer,telephonesolicitation,etc.)?
b. Will you be using any advertisements, flyers, posters, email scripts, social media postings, etc. for recruitment purpose?NoYes If‘Yes’,pleaseattachacopyofeachwithyourapplication.
4. Inducementsa. Will you be offering inducements to participate (e.g.,money,giftcertificates,academiccredit,etc.)?NoYesIfyes,pleaseelaborate:
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informationtobeinvolved,andhowdatawillbeanalyzed.Includedetailsaboutidentifyingparticipants,recruitment,proce-duresparticipantswillundertake,etc.Includecopiesofstudyinstruments.Pleasealsoincludetheestimatedtimecommit-mentrequiredofparticipantsforeachmethod.
d.Whatistheexperienceandtrainingoftheresearcherwiththiskindofresearch?Ifapplicable,pleaseprovideadescriptionofthesupervisor’ssupportforthisresearch.
6. RiskPleaseindicatepotentialrisksthattheparticipantsasindividualsoraspartofanidentifiablegrouporcommunitymightexperi-encebybeingpartofthisresearchproject:
a.Physicalrisks(includinganybodilycontact;administrationofanysubstance)? NoYesb.Psychological/emotionalrisks(feelinguncomfortable,embarrassed,anxious,upset)? NoYesc.Socialrisks(includingpossiblelossofstatus,privacyand/orreputation)? NoYesd.Datasecurity(i.e.,risktoparticipantfromdataexposure)? NoYese.Tiedtodeceptioninvolvedinthestudy?(SeeDEBRIEFINGsectionbelow) NoYesf.OTHER: NoYes
g.Noknownoranticipatedrisk:
Ifyouansweredyestoanyoftheabove,pleasedescribehoweachofthepotentialrisksdescribedabovewillbemanagedand/orminimized:
7. BenefitsWhat, if any, are the benefits to the participants? Or, No benefits
a. Discussanypotentialdirectbenefitstotheparticipantsfromtheirinvolvementintheproject;thesemightincludeeducationaboutresearchmethods,usefulknowledgegainedaboutself,etc.
b. Commentonthe(potential)benefitstothescientific/scholarlycommunityorsocietythatwouldjustifyinvolvementofparticipantsinthisstudy.
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8. Secondary Analysis of DataNOTE:SecondaryDataAnalysisisdescribedastheanalysisofdatainvolvinghumanparticipantscollectedforapurposeotherthanthatforwhichitwasoriginallycollectedinordertopursuearesearchinterestwhichisdistinctfromthatoftheoriginalwork.ResearchersareadvisedtoreviewtheSecondaryDataAnalysisGuidelinesforfurtherinformationonrequirementsrelatedtouseofsecondarydataforresearchpurposes.
a. Are you conducting Secondary Data Analysis? No Yes
If “No”, please GO TO QUESTION 9
If “yes” please answer the following questions:
i. Areyouusinganonymous data(datawhichneverincludedpersonalidentifiers)NoYesIf‘Yes,’pleaseprovideadescriptionoftheprovenanceofthedataset:
NOTE:Researchthatreliessolelyonsecondaryanalysisofanonymousdataisexemptfromethicsreview.
ii. Areyouusinganonymized data?(datawhichhasbeenstrippedofpersonalidentifiers;nopotentialfordatalinkage)
NoYesIf‘Yes,’pleaseprovideadescriptionoftheprovenanceofthedataset:
iii. Areyouusingidentifiable data:
NoYesIf‘Yes,’pleaseprovideadescriptionoftheprovenanceofthedataset:
b. Ifyouareconductingsecondaryanalysisusing identifiable data,pleaseaddressthefollowing:
i. Doyouplantolinkthisidentifiabledatatootherdatasets?
NoYesIf‘Yes’,pleasedescribe:
ii. Whattypeofidentifiabledatafromthisdatasetareyouplanningtoaccessanduse?
Studentrecords(pleasespecifyinthespacebelow)Healthrecords/clinic/officefiles(pleasespecifyinthespacebelow)Otherpersonalrecords(pleasespecifyinthespacebelow)
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iii. Whatpersonallyidentifiabledata(e.g.,name,studentnumber,telephonenumber,dateofbirth,etc.)fromthisdatasetdoyouplanonusinginyourresearch?Pleaseexplainwhyyouneedtocollectthisidentifiabledataandjustifywhyeachitemisrequiredtoconductyourresearch.
iv.Describethedetailsofanyagreementyouhave,orwillhave,inplacewiththeownerofthisdatatoallowyoutousethesedataforyourresearch.ATTACHMENTS: Submit a copy of any data use/access agreements.
v.Whenparticipantsfirstcontributedtheirdatatothisdataset,werethereanyknownpreferencesexpressedbyparticipantsatthattimeabouthowtheirinformationwouldbeusedinthefuture?
NoYesIf‘Yes’,pleaseexplain.
vi. Howwillyouobtainconsentfromtheparticipantswhoseidentifiabledatayouwillbeaccessing?Pleaseexplain.
Note: Consent of the participants is required for research involving secondary analysis of data that includes personalidentifiers. Waiver of consent may only be considered if researchers meet the additional criteria. Please consult theSecondaryDataAnalysisGuidelinesforfurtherinformation.
vii. Ifyoudonotintendtoseekconsentofparticipantsforuseofidentifiabledataforsecondaryanalysis,pleaseprovidearationaleastowhy:
9. Conflict of Interesta. Isthereapossibilityofanapparent,actual,orpotentialconflictofinterestonthepartofresearchers,theUniversity,or
sponsors?(e.g.,commercializationofresearchfindings,self-fundedresearch,etc.)
NoYesIf yes, please elaborate and outline how the potential or real conflict of interest will be addressed:
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b. Doanymembersoftheresearchteamhavemultipleroleswithpotentialparticipants(e.g.,researcherandtherapist,researcherandteacher,student/supervisor,teachingassistantandstudents,etc.)
NoYes If‘Yes’,pleasereviewResearchInvolvingInvestigators’Students
i) Describethenatureofthemultiplerolesbetweenresearcher(s)andanyparticipants
ii) Describehowthepotentialconflictofinterestthatwillemergeasaresultofthedualroleswillbeminimizedormanaged
c. Arethereanyrestrictionsregardingaccesstoordisclosureofinformation/results/dataatanypointduringthestudyincludingcompletionthatthefunder/sponsorhasplacedontheresearchers?(Theseincludecontrolsplacedbysponsors,fundingsources,advisoryorsteeringcommittees.)
NoYes
If‘Yes’,pleasedescribe:
10. Informed ConsentThis section pertains to issues around informed consent.
a. Istherearelationshipbetweenparticipantsandeitherofthefollowing:
PrincipalInvestigator: No YesPersonobtainingconsent(ifotherthanthePI): NoYesNotapplicable
If‘Yes’,whatstepswillbetakentoavoidtheperceptionofundueinfluenceinobtainingfreeandinformedconsent?
b. Ongoingconsentisrequirediftheresearchoccursovermultiplesessionsoroveranextendedperiodoftime.Doestheresearchoccurovermultipleoccasionsand/oroveranextendedperiodoftime(i.e.,beyond6months)?
NoYesIf‘Yes’,pleasedescribetheprocessofhowyouintendtoobtainongoingconsent?
c. Issubstituteconsentinvolved(e.g.,recruitingindividualsunder16;thosewithoutcapacitytoconsent)?
NoYesIf‘Yes’,pleaseelaborateonhowconsentandassentwillbeobtained.Pleaseattach1)SubstituteConsentFormforthe
parent/guardian,and2)AssentFormfortheparticipantwhichincludesallinformationrequiredintheconsentformbutiswritteninageappropriatelanguage.
d. Isdeceptioninvolved?Specifically,doyouintendtowithholdanyinformationfromand/orintentionallymisleadtheresearchparticipants?
NoYes
If‘No’,pleasegotoquestion“e”
If‘Yes’:i) Pleaseprovideadescriptionofthenatureofthedeceptionandwhetheritisfullorpartial.Pleaseprovidearationale
astowhydeception(inwholeorpart)isrequired:
ii) PleaseappendacopyofthedebriefingstatementThe debriefing statement needs to explain three elements:
(i) Why the experiment was developed and why the deception was necessary. (ii) What the current research says about the topic, which includes providing two references (text, article, on-line
reference) that the participants can reasonably access and understand (if you have an academic and non-academic population, you may need to provide more than one version of the debriefing statement or make sure that the references can be accessed by the least educated of the population).
(iii) Any additional resources that would be useful for the participant. Resources need to be appropriate and accessible for the participants. For example, if you are conducting a study on parenting, you could include community resources for parenting classes or recommendations for parenting guides. (source: Univ. Virginia, IRB)
Researchersmustre–obtainconsentfromtheparticipantsonc ethedebriefingstatementhasbeenprovided.ParticipantsshallbeprovidedwithandsigntheDebriefingConsentForm.
iii) Ifadebriefingstatementwillnotbeprovidedtotheparticipants,pleaseprovidearationaleastowhyastatementwillnotbeprovided:
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Inlightoftheabove,pleaseaddressthefollowingquestions:
a. Willthedatabetreatedasconfidential? No Yes
If“No”,pleaseprovidearationale:
b. Willtheparticipant(s)beanonymous? No YesIf“No”,pleaseprovidearationale:
11. Data SecurityPrivacy refers to an individual’s right to be free from intrusion or interference by others. It is a fundamental right in a free and democratic society. The ethical duty of confidentiality refers to the obligation of an individual or organization to safeguard entrusted information. Security refers to measures used to protect information. It includes physical, admin-istrative and technical safeguards.
Forafullerdescriptionofresearcherobligationssurroundingconfidentiality,privacyanddatasecurityissues,pleaseconsulttheData Security Guidelines for Research Involving Human Participants.
iv) Forstudiesthatarenotdeceptive,brieflydescribetheprocessandnatureofanyimmediatepost-studyinformationthatwillbeprovidedtoparticipantsandtherationaleforprovidingthisinformation(e.g.,counsellingortraumaresources,informationlinks,etc.):
e. Howwillinformedconsentbeobtained?(Pleasecheckallthatareapplicable):
InformedConsentForm.Pleaseattachdraftversion.AttachSubstituteConsentFormandAssentFormifapplicable.
VerbalConsent.Ifinformedconsentisbeingobtainedverbally,pleaseprovidearationaleregardingwhyverbalconsentmaybenecessaryandanInformedConsentFormisnotbeingused.Pleasenotethatverbalconsentispermissibleinonlyexceptionalcircumstanceswherewrittenconsentisnotfeasibleorinappropriate.PleaseattachdraftVerbalConsentScriptofwhatparticipantswillbeverballytold.
Onlineconsentform.Pleaseattachdraftversion.Ifonlineconsentisbeingobtained,pleaseindicatethewebsitewherethequestionnaire/surveywillbehosted:
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c.Describetheprocedurestobeusedtoensureanonymity/confidentialityofparticipants(whereapplicable)–or–theconfidentialityofdataduringtheconductofresearchanddisseminationofresults,suchasdataanonymization.
d.Pleasedescribehowyouplantostorehardcopydatasecurely,i.e.,consentformsandotherwrittenrecords.Notethatconsentformsmustbestoredfor2years. Lockedfilingcabinet Other
e.Pleasedescribehowyouplantostoreelectronicdatasecurely(suchasvideo/audiorecordingsanddocumentfiles)
Encryptedand/orpassword-protectedUSBkeys,laptopsand/orotherportableelectronicdatadevices SecureServer Other
f. Pleasedescribehowyouplantostoreotherformatsofdata(ifapplicable):
g.Ifyouplantodestroyresearchdata, •provideafirmdatebywhichthedatawillbedestroyed(mm/dd/yyyy):
•providedetailsoftheirfinaldisposal •forhardcopydata(e.g.,cross-cutshredder,etc.)
•forelectronicdata(e.g.,deletionandoverwritingofdrives;destructionofdrives;etc.)
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h.Ifyouplantoretaindataindefinitely,pleaseprovideajustification(e.g.,datauseforfutureresearch):
i. Describeanylimitationstoprotectingtheconfidentialityofparticipantswhetherduetothelaw,themethodsused,thenatureofthesamplepopulation,orotherreasons(e.g.,dutytoreport)thatyouareawareof.
j. Identifyallpartieswhowillhaveaccesstothedata.
PrimaryInvestigator/student Supervisor Other(pleasespecify):
k.Usesofthedata:Pleasedescribeallformsofoutputthatareanticipatedtoresultfromthisresearch(e.g.,presentations,writtenpapers,placingdatainanarchive,creativeworks,documentaryfilms,etc.).Describehowany
potentiallyidentifyinginformationwillbehandledineachformofoutput.
l. Subsequentuseofdata:Willthedatapotentiallybeusedforotherpurposesinthefuture(e.g.,teaching,futureanalysis,publishingofdataset,archivinginaninstitutionalrepository,etc.)?
NoYes
If‘No’,thedatawillbesolelyusedforthepurposesdescribedinthisapplicationandwillnotbeusedforotherpurposesinthefuture.
If‘Yes’,participantsmustbeinformedofthispossibilityduringtheconsentprocess.SubsequentuseofthedatafornewpurposesmayrequireadditionalreviewbytheREB.If‘Yes’,pleasedescribehowthedatawillbepreparedtomakeitsuitableforfutureuse(e.g.,anonymization,storage,archiving,etc.).Pleasedescribewhatfutureusesmightoccur(e.g.,usewithinthePI’sresearchgroup,transmissiontootherresearchers,publicationofthedataset,etc.).Pleaseidentifyanyknownrepositoriestowhichdatamaybesubmitted.(TheREBrecognizesthatallpotentialfutureusescannotbeanticipated,butdoesexpectthatdatawillbepreparedinamannerforfutureusesthatrespectstheconditionsunderwhichthedatawereoriginallycollected.)
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12. Additional InformationIs there any additional information that you would like to add that may assist the HPRC in reviewing your protocol?
Part C – DeclarationsStudent Declaration
Iherebycertifythatallinformationonthisformandallstatementsintheattacheddocumentationarecorrectandcomplete.Ihaveexaminedtheguidelinesandprinciplesdetailedabove,andtheSenatePolicyforResearchInvolvingHumanParticipants,andaffirmthat,tothebestofmyknowledge,thisresearchconformsthereto.IaffirmthatIhaveinformedallmembersofmyresearchteamoftheirresponsibilitiesasitspeakstotheconductofresearchinvolvinghumanparticipantsandasoutlinedintheSenatePolicyforResearchInvolvingHumanParticipants.Ihaveadvisedallresearchteammembersthatallhumanpar-ticipantsintheresearchmusthavesignedawrittenconsentformorhaveprovidedoralconsentfortheirparticipationintheresearch.IherebyundertaketonotifytheHumanParticipantsReviewCommitteeviatheOfficeofResearchEthics(HPRC)ifImakechangesinvolvingtheuseofhumanparticipantsonthisprojectandsubmittherequireddocuments(e.g.Amendmentrequest)toHPRCforreviewandapproval;ifthesechangesarenotminor,myresearchproposalmayberequiredtoundergoafurtherethicsreview.Iunderstandthatanymisrepresentationintheproposalorattacheddocumenta-tionmayleadtoachargeofbreachofacademichonesty.Inthecaseofanadverse/unanticipatedevent,IwillnotifyHPRC.IalsounderstandthatImustretainConsentFormsfortwoyearsfollowingthecompletionoftheresearch.IwillalsonotifyHPRCifanyunforeseenrisksnotspecifiedintheresearchproposalappear.Insuchacase,thestudywillbesuspendedpend-ingclarification.
SignatureofStudent Date(mm/dd/yyyy)
Supervisor Declaration
Iherebycertifythatallinformationonthisformandallstatementsintheattacheddocumentationarecorrectandcomplete.Ihaveadvisedthestudentthatallhumanparticipantsintheresearchmusthavesignedawrittenconsentformorhaveprovidedoralconsentfortheirparticipationintheresearch.IhaveadvisedthestudentthattheHumanParticipantsReviewCommitteeviatheOfficeofResearchEthics(HPRC)willbeadvisedofanychangesinresearchmethodologyoranyincreasedanticipatedriskstohumanparticipantsandthatafurtherethicsreviewandapprovalisrequiredasaresultofsuchchanges.IhaveadvisedthestudentthatConsentFormsmustberetainedfortwoyearsfollowingthecompletionoftheresearch.
Signatureofsupervisor(ofThesis/Dissertation) Date(mm/dd/yyyy)
Section to insert Digital Signatures (if applicable):
ElectronicSignatureofPrincipalInvestigator(PI) Date(mm/dd/yyyy)
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Document ChecklistPleaseattachthefollowingitems,ifapplicable,toTD2,GraduateStudentHumanParticipantsResearchProtocol.
Incomplete forms will not be accepted for review.
1 All TD2 forms must have the following attached: a. InformedConsentForm(s) b. TCPSCertificate2 Other Consent Documents (if applicable):
SubstituteConsentform(Parental/Guardianconsent)—requiredifyourresearchparticipantsareunder16yearsofageorwithoutcapacitytoconsent
AssentForm—requiredifyourresearchinvolvessubstituteconsent
VerbalConsentScript—requiredifyouplantoseekverbalconsentforanyoftheresearchparticipants
On–lineConsentScript—requiredifparticipantsareaskedtoconsentonline
3 External permission and approvals (if applicable):
DecisionsNeededFromOtherREBBoards—requiredifyourresearchrequiresethicsapprovalfromaninstitutionotherthanYorkUniversityExternalREBapprovalrequired—certificateattached
Externalinstitutionalpermissionrequired—documentationprovided
Internalinstitutionalpermission/approvalrequired(e.g.,OIPA)—documentationprovided
Medicaldirective
ResearchAgreement(s)—appendallcopiesDatause/accessagreements(foruseinsecondarydataanalysis)
4 Test Instruments (if applicable):
QuestionnairesandTestInstruments
Draftinterviewquestions,focusgroupquestions
5 Recruitment (if applicable):
RecruitmentMaterials:Posters,Letters,ParticipantPoolAdvertisement,etc.
6 Debriefing (if applicable):
DebriefingLetter—requiredifyourresearchinvolvesdeception(seeSection10,InformedConsentfordetails)
DebriefingConsentDocument—requiredfollowingadministrationofdebriefingstatement(ifyourresearchinvolvesdeception)
7 Other (if applicable):
ProvenanceofAnonymousData
ResearchTeamMemberConfidentialityAgreement
ParticipantImagesInformedConsentAddendum
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