irb application template section i: protocol description · 2020. 5. 14. · health scenarios...

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IRB APPLICATION TEMPLATE

SECTION I : PROTOCOL DESCRIPTION

1. StudyTitle.PerceptionsofMentalHealth,Treatment,andRecovery 2. PrincipalInvestigator(personconductingtheresearch).Professionaltitleandemail.PrimaryInvestigator:Dr.AnnaFreud,Ph.D.,PrimaryResearcher,[email protected]:Dr.RosaKlein,[email protected]

3. Writeanoriginal,brief,non-technicaldescriptionofthepurposeofyourresearch.

Includeanarrativethatexplainsthemajorpartsofyourstudyandhowthedatawilladvanceyourresearchhypothesisorquestion.NOTE:Thissectionshouldbeeasytoreadforsomeonenotfamiliarwithyouracademicdiscipline.Providerelevantbackgroundinformationandscientificjustificationforyourstudy.Youmayprovidecitationsasnecessary.Pleaseadheretoa350-wordlimit(notincludingcitations).

Mentalhealthrecoveryspurspsychoeducationcurriculumdevelopment(Peebles,Mabe,Fenley,Buckley,Bruce,Narasimhan,Frinks&Williams,2009).Inthisstudy,weaimtounderstandhowtherapistsusepsychoeducationtodescribetheirperspectivesinmultiplecontexts(online,patient-therapistinteractions,interviews,etc.).Specifically,weareinterestedinpsychoeducationusedtodescribedepressionandhowtheymayimpacthowlistenersperceiveone’smentalstateortheprocessofrecoveryortreatment.Weaimtoinvestigatewhetheramentalhealthpsychoeducationmayunderminemotivationtoseekhelp(orcontinuetreatment).Thisisafour-partstudy.

• PART1PUBLICDATA:Exploreweb-basedandpublicdatadocumentingthewayspopularmediaandtargetedadvertisingsportraymentalhealth(intextandvisually).

• PART2EXISTINGDATA:Explorepsychoeducationaldescriptionstodocumenthowtopicsofmentalhealthandwellnessaretaughtinschools.

If there is more than one researcher on the project, include all names here. If it helpful for framing your study, you can include 1-2 references.

Some information that you would include in your protocol description may not be applicable to the consent form. For example, researchers must describe their intentions for the study to the IRB. However, this kind of statement would likely not be included in the consent form as it may bias participant answers. Visit TC IRB’s website/How to Submit/Guides/Writing for the IRB for further tips.

This part of the protocol deals specifically with existing data. If the protocol had only included Parts 1 and 2, it would fall under Exempt Category 4 – Existing Data. Visit TC IRB’s website/How to Submit/Guides/Existing Data for more information.

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• PART3ANONYMOUSONLINESURVEYS:Wewillsurveyadultscompetenttoconsentabouttheirimpressionsofpsychoeducationofmentalhealth.Thepurposeofthispartistodeterminewhetherexposuretopsychoeducationaboutmentalhealthcanimpactone’smotivationtoconfrontachallengingproblem.Thisstudywillincludevignettesoffictitiousmentalhealthpatientsandmentalhealthpsychoeducation.Wehavethreepopulationsofinterestforthisportionofthestudy:

o MTurk–Weplantocollectanonymoussurveydataconcerningpeople’simpressionofmentalhealth.

o PersonswithDepression–Weplantocollectanonymoussurveydatafrompeoplewhoself-identifyascurrentlydepressedordepressedwithinthelast6months.

o Therapists–Weplantocollectanonymoussurveydatafrompeoplewhoself-identifyaspracticingtherapists.

• PART4INTERVIEWSANDFOCUSGROUPS:Usingapopulationofconvenienceandsnowballsampling,weplantoindividuallyinterviewandconductfocusgroupsessionswiththepublicandtrainedtherapiststogaugetheirimpressionsofmentalhealthpsychoeducation.Wewillaudiorecordtheseinterviewshowever;wewillnotrecordidentifiersaftertheaudiorecordingistranscribed.Forthefocusgroupsessions,participants’identitywillbeknowntoothers,andtheresearcherscannotguaranteethatothersinthesegroupswillrespecttheconfidentialityofthegroup.Wewillaskallfocusgroupattendeestokeepallcommentsmadeduringthefocusgroupconfidentialandnotdiscusswhathappenedduringthefocusgroupoutsidethemeeting.

4. Stateyourresearchquestion(s).Yourplannedresearchprotocolshouldbeonethatcan

realisticallyaddressyourresearchquestion(s).• Howdoesclassroompsychoeducationportraymentalinpopularmedia?• Howispsychoeducationaboutmentalhealthcreated?

5. Providetheinclusioncriteriafortheparticipantpopulation(e.g.,bygender,class,race,

occupation,orage).Providearationaleforselectingthispopulationforresearchpurposes.

The writer can upload their survey and vignettes with their protocol application in TC Mentor IRB.

Qualtrics is recommended for survey data collection and is available through Teachers College. Researchers should not use SurveyMonkey as it is not available through MyTC. Amazon Mechanical Turk (MTurk) is a way to collect participant data online.

TC IRB is concerned with the protection of participants. This type of activity may impact a participant’s privacy and confidentiality. The researcher should openly acknowledge any risks and explain ways to mitigate the risk.

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Thisstudywillnotexcludeparticipantsbygender,class,race,oroccupation.However,weplantoonlyrecruitadultsforthisstudy(over18yearold)andforoneportionofthestudyweseektorecruitmentalhealthprofessionals(e.g.,therapists).6. Federalguidelinesstatethatresearchcannotexcludeanyclassesofparticipants

withoutscientificjustification.Indicatewhowillbeexcludedfromyourstudyandwhy(e.g.,personsunder18yearsofage).

Personsunder18yearsofagewillbeexcludedfromthestudyastheyarenotabletoconsenttoparticipate.7. Providethemaximumnumberofparticipantsyouplantoenrollforeachparticipant

populationandjustifythesamplesize.1,000onlinesurveysofadults50interviewsand/orfocusgroupsessionsofadults8. Describeyourrecruitmentmethods.Howandwherewillparticipantsberecruited

(e.g.,flyers,announcements,word-of-mouth,snowballing,etc.)?Submitacopyofallrecruitmentletters,scripts,emails,flyers,orsocialmediapostsyouplantousetorecruitparticipantsforyourstudyasseparatedocumentswithyourapplication.YouwillneedtoincludeyourIRBProtocolnumber(e.g.,18-123)onallrecruitmentmaterials,includingannouncements,onlineposts,andemailtext,etc.

PART1PUBLICDATA:Norecruitment,publicdata.

PART2EXISTINGDATA:Norecruitment,existingdata.

PART3ANONYMOUSSURVEYS:

• Mturk–ThroughAmazon’sMechanicalTurk.• PersonswithDepression–Flyers,socialmedia(Twitter,Facebook,etc.),population

ofconvenience,andsnowballsampling.

If a study has strict exclusion criteria, researchers must justify their choice to include this criterion. Only adults competent to consent can be given consent forms.

It is recommended that researchers overestimate the number of participants they will be able to recruit for their study, within reason. Recruiting below the maximum number of participants will not affect your protocol. However, if researchers seek to recruit more than the stated number of participants on an IRB protocol, they must submit a modification to raise the maximum number of participants. Recruiting more than your maximum number of participants can result in a protocol deviation.

These sections match those described in question 3. When dealing with multi-part studies, it is helpful to the reviewers if you follow a consistent pattern so that activities, participants, and parts can be easily matched.

Recruitment materials should be uploaded with your protocol application to TC Mentor IRB as separate files.

Population of convenience is a type of non-probability sampling that involves a sample being drawn from population easily accessible to the researcher. This type of sample usually does not produce results with high external validity and is often used for pilot studies. For information on recruitment visit TC IRB’s website/How to Submit/Guides and Resources.

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• Therapists–Flyers,socialmedia(Twitter,Facebook,etc.),populationof

convenience,andsnowballsampling.

PART4INTERVIEWSANDFOCUSGROUPS:Flyers,socialmedia(Twitter,Facebook,etc.),populationofconvenience,andsnowballsampling.9. Describethelocation,setting,andtimingofdatacollection(e.g.,face-to-faceinterviewat

amutuallyconvenientlocation,atthestartofthesemester).Includethestate,city,schooldistrict,etc.Note:IfyouarerecruitingparticipantsfrominstitutionsotherthanTeachersCollegeincludeasitepermissionform(templatelocatedinMentor/Documentation)orapendingIRBapprovalfromtheinstitution(s)withthissubmission.IfyouareconductinganypartofyourresearchwithinNYCDEPARTMENTOFEDUCATION(DOE)Schools,itisrequiredthatyoureceiveapprovalfromTeachersCollegeIRBpriortosubmittingyourapplicationtotheDepartmentofEducationIRB(DOEIRB).

PART1PUBLICDATA:Nospecificlocation,publicdata.

PART2EXISTINGDATA:Nospecificlocation,existingdata.PART3ANONYMOUSONLINESURVEYS:

• MTurk–Online.• Personswhoself-identifyasdepressed–Online.• Therapists–Online.

PART4INTERVIEWSANDFOCUSGROUPS:Audiorecorded,face-to-face,inpersoninterviewswilloccuratatimeandplacethatisconvenientfortheparticipant.

SECTION I I : DESCRIPTIONOF STUDYACTIVITIES & PROCEDURES 10. Listwhatyourparticipantswillbeaskedtododuringyourstudyandyourdata

collectionprocess(e.g.,fillouta25-question,closed-ended,papersurvey).Note:Submitcopiesofallinstruments,surveys,interviewquestions,observationchecklists,etc.thatyouplantousefordatacollectionasseparatedocuments.Indicatewhetherdataarecollectedaspartofaninitialparticipantscreeningortheactualstudy.Ifyouhavemultipleparticipantgroups(e.g.,parents,teachers,andstudentsorcontrolgroupsandexperimentalgroups),pleasespecifywhichgroupyouareaskingtocompletewhichtask(s).Ifapplicable,submitseparatetranslatedcopiesofallquestionnaires,interviewquestions,consentforms,andrecruitmentmaterials,foreachparticipantpopulation.Uploadacopyoftheback-translation(translationintothetargetlanguageandbackinto

Snowball sampling occurs when a research participant recruits other participants for a test or study. This method is usually used when potential participants are difficult to find.

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English)documentusingGoogle-Translatetovalidatetranslationaccuracy.Alternatively,thetranslatorcansignthe“translationverification”forminMentor/Documentation.

PART1PUBLICDATA:Wewillanalyzepublicsourcestotracepsychoeducationdescriptionsofmentalhealth.

PART2EXISTINGDATA:Researcherswillreviewexistingdatatoexplorepsychoeducationinmentalhealth.Thisexistingdatamayincludedatapreviouslycollectedfromotherresearchers.Whereapplicable,wewillengageinadatasharingagreement.

PART3ANONYMOUSONLINESURVEYS(usingQualtrics):

• MTurk–ThestudywillconductedthroughAmazon’sMechanicalTurk.Adult

participantswillberandomlyassignedandaskedtoreadaboutcommonmentalhealthscenarios(e.g.,apersonwithdepression)andmentalhealthpsychoeducation.Afterreadingthedescription,participantswillbeaskedtorespondtosurveyquestionsaboutthescenario(howlikelytheyperceiveapathtowardsrecovery,etc.),andquestionsaboutthementalhealthpsychoeducation.Thesemeasureswillallowustodeterminetheeffectsofthepsychoeducationonperceptionsofmentalhealth.Participantswillalsobeaskedtocompleteademographicsurvey.

o ForMTurkworkers,wewillpaythemupto$1.50fortheirparticipation.§ Paymentwillbedependentonthetimeallottedtocompletethe

surveyandthetotalscenariosparticipantsareaskedtoreview.o Therewillbeattentioncheckswithinthesurveytodetermineifparticipants

arepayingattention.§ Ifparticipantsdonotpassallattentioncheckstheywillnotgetpaid.

• Personswhoself-identifyashavingdepression–Adultparticipantswillbeaskedif

theyhavefeltdepressedwithinthelast6months.Then,theywillberandomlyassignedtoreadaboutacommonmentalhealthscenario(e.g.,apersonwithdepression).Theywillthenbeaskedsurveyquestionsabouttheirimpressionsofthepsychoeducation.Participantswillalsobeaskedtocompleteademographicsurvey.

A template for data sharing is available in Mentor IRB/Documentation.

Any participant compensation should be detailed in the protocol. Consider the following questions: 1. How much compensation is appropriate for the tasks? 2. Are there criteria that must be met for participants to receive the compensation? 3. Are there situations in which the participants may be disqualified from receiving

compensation (e.g., failed attention checks)?

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• Therapists–Adultparticipantswillbeaskediftheyarecurrentlypracticingasatherapistandtoidentifytheirareaofspecialty.Then,theywillberandomlyassignedtoreadaboutacommonmentalhealthscenario(e.g.,apersonwithdepression).Theywillthenbeaskedsurveyquestionsabouttheirimpressionsofthepsychoeducation.Participantswillalsobeaskedtocompleteademographicsurvey.

• PART4INTERVIEWSANDFOCUSGROUPS:Adultparticipantswillbeaskedtoread

aboutcommonmentalhealthscenario(e.g.,apersonwithdepression).Theywillthenbeaskedinterviewquestions(individuallyandinafocusgroup)abouttheirimpressionsofthepsychoeducation.Participantswillalsobeaskedtocompleteademographicsurvey.Audiorecorded,face-to-face,inpersoninterviewswilloccuratatimeandplacethatisconvenientfortheparticipant

11. Pleasecheckthebox(s)thatbestdescribesthespecificnatureofyourdata.

12. Pleasecheckthebox(s)thatbestdescribeyourstudyactivities.

InMicrosoftWord,double-clicktheboxortypean“X”tomarkyourselection.

Audiorecordings Clinicaltrials,Experiments,orRandomizedControlledTrials

DocumentsandRecords Ethnographies,OralHistory,andCaseStudies

InterviewsorFocusGroupSessions Online(e.g.,Qualtrics,RedCap,orotherweb-basedcollectionmethod)

InMicrosoftWord,double-clicktheboxortypean“X”tomarkyourselection.

Iwillpersonallycollectnewdata. Iwillaccessexistingdata.

Somebodyelsewillcollectthedataviaproxy(pleaseexplain).

Iwilluseaweb-baseddatacollectionsite(e.g.,Amazon’sMechanicalTurk(MTurk)orResearchMatch).

Other(pleaseexplain).

If your study has multiple activities, please make sure to check all that apply.

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Observations ProgramEvaluations

Other(pleaseexplain) Videorecordings

13. Pleaselisttheactivity,occurrence,anddurationinwhichyourparticipantswillbe

engaging.NameofTaskorProcedure(e.g.,individualaudiorecordedinterview)

Numberofoccurrences(e.g.,twice)

ActivityDuration(e.g.,30minutes,eachtime)

Totaltimeperparticipant(e.g.,oneday,twointerviews,60minutestotal)

Describethedatacollected

PUBLICDATA N/A N/A N/A Publicsourcestotracepsychoeducationdescriptionsofmentalhealth

EXISTINGDATA N/A N/A N/A Analyzede-identifiedtranscriptsaboutmentalhealth.

ANONYMOUSONLINESURVEYS

• Amazon’sMechanicalTurk(MTurk)

1 Nottoexceed30minutes

Nottoexceed30minutes

UsingQualtrics,randomlypresentpsychoeducationtoMTurkworkers.


• PersonswithDepression



UsingQualtrics,presentpsychoeducationtoadultswhoself-identifyashavingdepressionandaskabouttheirthoughtsandbeliefs.


• Therapists



UsingQualtrics,presentpsychoeducationtotherapistsandaskabouttheirthoughts.

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INTERVIEWSANDFOCUSGROUPS

• Audiorecorded,face-to-face



Adultparticipantswillbeaskedtoreadaboutacommonmentalhealthexperiences.Participantswillbeaskedabouttheirimpressions.

Totalhoursofparticipationforalltasks:PART1PUBLICDATA:Nospecifictime,publicdata.

PART2EXISTINGDATA:Nospecifictime,existingdata.

PART3ANONYMOUSSURVEYS:

• MTurk–Online–onetime,nottoexceed30minutes(likelywilltake20minutes).• PersonswithDepression–Online–onetime,nottoexceed30minutes(likelywill

take20minutes).• Therapists–Online–onetime,nottoexceed30minutes(likelywilltake20

minutes).

PART4INTERVIEWSANDFOCUSGROUPS:Audio-recorded,face-to-face,onetime,nottoexceed90minutes.

Totaldurationofparticipation(e.g.,days,months,and/oryears):Thestudyactivitieswilloccuronceperparticipant.Participantinteractionwillnotexceed

90minutes.14. Ifyouwillbeaudio/videorecording,pleasestatehowyouwillensurethatall

participantshaveconsentedtoberecorded.Howwillyouensurethatindividualswhoarenotparticipatinginyourstudy(e.g.,otherchildreninaclassroom)willnotalsoberecorded?

INTERVIEWSANDFOCUSGROUPS:Duringtheinterviews,participantswillbeaskediftheyagreetoaudiorecording.Onlyparticipantswhoagreetotheaudiorecordingwillbeallowedtoparticipate.Aftertheaudiorecordingistranscribed,itwillbedeleted.Thetranscriptswillnotcontainanypersonalidentifiers.15. Statewhetherparticipantswillbecompensatedfortheirparticipation.NOTE:Ifyou

plantousealotterysystem,pleasestateoddsofwinninghereandintheconsentform.Also,ifyouwillbeofferingcoursecreditforstudyparticipation,youmustdiscussthishere

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andincludethealternativeassignmentforthosewhodeclinetoparticipateinthestudy.Willcompensationbepro-ratediftheparticipantdoesnotcompleteallaspectsofthestudy?Ifyoupayparticipantsaftertheirparticipation,pleasemakeitclearhowyouwilllinknames/contactinformationconfidentiallytoanyrecordofthecompensation.

MTurkworkerswillbepaidupto$1.50fortheirparticipationonline.Nootherparticipantwillbepaid.16. Willdeceptionbeused?Ifso,pleaseprovidearationaleforitsuse.NOTE:Uploada

debriefingscriptasaseparatedocument.Includeastatementthatgivesyourparticipantstheopportunitytowithdrawtheirparticipationatthattime.StudiesinvolvingdeceptionaregivenFullBoardReviewunlessthedeceptionisminorandrisksareminimal.

Nodeceptionwillbeused.17. Willyouhaveacontrolgroup,oracomparisongroup?Ifso,pleasedescribeyour

proceduresandexplainthepurposeofusingacontrolgroup.Yes,participantswillberandomlyassignedintomentalhealthdescriptionsframedusingpsychoeducationscenarios.

18. Willyouneedbilingualinterpretersorinterviewers,andifso,whatwillyoudoto

ensureparticipantconfidentiality?Whatareyourproceduresforrecruitinginterpretersandinterviewers?

Nobilingualinterpretersareneeded.

SECTION I I I : DESCRIPTIONOF RESEARCHRISKS & BENEFITS

19. Describethepotentialriskstoyourparticipants.Riskscanbephysical,psychological,economic,orsocial.Whatisthelikelihoodoftheserisksoccurring,and/ortheirseriousness(e.g.,exposureofsensitivedata)?Howwillyouworktominimizetheserisks?NOTE:TheIRBregardsnoresearchinvolvinghumanparticipantsasrisk-free.Youmaydescribeminimalrisksforyourstudy(suchasdiscomfort,boredom,fatigue,etc.),orstatethattheresearchwillinvolveminimalrisk,similartoanactivity(named)thatparticipantswouldperformintheirdailylives.

ANONYMOUSSURVEYS:Thisisaminimalriskstudy.Participantswhomayexperiencementalhealthconcernsormaybedepressedmayfindsomeofthequestionsuncomfortable.Allparticipantsareadultscompetenttoconsentandcanchoosetoskipanyquestionorstopatanytime.Noidentifierswillbecollectedonthesurveys.

Studies including bilingual interpreters that are not part of the research lab should download the Transcription Nondisclosure Template (on TC Mentor IRB/Documentation) and adapt it for their translators.

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INTERVIEWSANDFOCUSGROUPS:Thisisaminimalriskstudy.Participantsmayfeeluncomfortablerespondingtoquestionsaboutmentalhealth.Allparticipantsareadultscompetenttoconsentandcanchoosetoskipanyquestionorstopatanytime.Participantswillbeassignedpseudonymsinsteadofusingtheirrealname.Forthefocusgroupsessions,participantswillbeinformedthatotherfocusgroupparticipantswillknowtheiridentityandtheresearcherscannotguaranteethatothersinthesegroupswillrespecttheconfidentialityofthegroup.Asaresearcher,Iaskthatallindividualskeepallcommentsmadeduringthefocusgroupconfidentialandnotdiscusswhathappenedduringthefocusgroupoutsidethemeeting.20. Whatareyourplansforensuringnecessaryinterventionintheeventofadistressed

participantand/oryourreferralsourcesifthereisaneedforpsychologicaland/orphysicaltreatment/assistance?

Wedonotpredictdistressedparticipantsaspartofthisstudy.Wewillremindparticipantsthatthestudyisvoluntary,theydonothavetocompletethestudyiftheydonotwantto,andtheycanskipanyquestionthattheydonotwanttoanswer.Theonlinestudyportionofthestudywillnotincludeidentifiers.Fortheinterviewdata(individualinterviewandfocusgroupsession)allidentifierswillberemovedinthefinalreportingofthedata.21. Whatqualificationsandpreparationsenableyoutoestimateandminimizeriskto

participants?AlloftheresearchersareCITItrained.Theresearchershaveyearsofexperienceworkingwithhumansubjects22. Describeanypossibledirectbenefitstoyourparticipants.Mostresearchwillnothave

anydirectbenefitstoparticipants.Occasionally,astudydesignwillincludeadiagnosis,evaluation,screening,counselingortraining,etc.,thathasaconcretebenefittoparticipants,independentofthenatureorresultsofaresearchstudy.

Therearenodirectbenefittoparticipants.

All research staff must be CITI trained before participating in research. The CITI training certificate, awarded at the completion of the CITI course, should be uploaded into TC Mentor IRB/PI Documentation prior to submitting an IRB protocol application. Studies listing researchers who do not have their CITI training in TC Mentor IRB will be subject to revisions.

When the research environment includes bystanders, participants, or non-researchers, you cannot guarantee full confidentiality. It is important that the consent form and protocol acknowledge the limits of confidentiality.

This language can also be included in your consent form.

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SECTION IV : CONFIDENTIALITY PROCEDURES & PARTICIPANTPRIVACY

23. Pleasecheckthebox(s)thatbestdescribesyourdata.Note:Sensitivedatapotentially

posessubstantialthreattoresearchsubjectsandcanbecomeproblematicfortheresearcher,researchedcollection,and/orthedisseminationofresearchdata(Lee&Renzetti,1990).Substantialthreatmayincludethreattoreputation,employment,oraccesstoresources.Sensitivedatamayincludestudiesofdomesticviolence,immigrationstatus,politicalactivism,homicide,death,trauma,assault,and/ormental,sexual,orphysicalhealth(Lee,R.M.,&Renzetti,C.M.(1990).Theproblemsofresearchingsensitivetopics:Anoverviewandintroduction.TheAmericanBehavioralScientist,33(5),510–528).

Completelyanonymousdata(bothsensitiveandnon-sensitive)

Non-sensitivedatawithidentifiers

Sensitivedatawithidentifiers Other(pleaseexplain)

24. Fordatawithidentifierspleasedescribeyourmethodforde-identifyingthedatato

maintainconfidentiality.Note:Thetermde-identifieddatareferstosubjectdatafromwhichallinformationthatcouldreasonablybeusedtoidentifythesubjecthasbeenremovedorreplaced.Forexample,theresearchermayusethesafe-harbormethodtoremovespecifiedidentifiers(name,address,phone,oranyotheruniqueidentifier,etc.)fromadataset;thepartiallyde-identifiedmethodtoremovemost,butnotallidentifiersfromthedataset(mayrequireadatauseagreement);orthegenerationofvariablesmethodtoreplacestudysubjects’identifiers,likeusingauniquecodeorpseudonym.Tobetrulyde-identifieddata,theinvestigatorcannothavecodesthatlinktoidentifiers.

Alldatawillbede-identified.Therewillbenonamesusedinreportingofanydata.25. Ifyouareworkingwithsensitiveidentifiabledata,pleaseexplainwhyidentifiersare

necessarytocarryoutyourresearch.Sensitiveidentifiabledatashouldneverbesentasanemailattachment.NOTE:Ifyouarecollectingprivate,identifiableheathinformationaspartofyourresearch,pleaseseeourwebsitewww.tc.edu/irbunderFormsandGuidelinesfortheHealthInsurancePortabilityandAccountabilityAct(HIPAA)document.

Notapplicable.

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SECTIONV : DATASECURITY 26. Pleaserespondtothefollowingsections.

Pleasecheckthebox(s)thatbestdescribeshowyouwilltransferyourdata.

IwilluseaVirtualPrivateNetwork(VPN)forsecuredatatransferorotherformofencryption(e.g.,TeachersCollege’ssecureremotenetworkaccess).

Notapplicable(e.g.,datawillnotbeaccessedremotelyortransferred.Itwillexistonlyonalocallystoredpassword-protectedharddrive).

Pleasecheckthebox(s)thatbestdescribeshowyouwillstoreyourdata.

Onapassword-protectedlocalorexternalcomputerharddrive.

OnTeachersCollege’slocalpassword-protectednetwork.

OnTeachersCollege’sGoogleDrive,inapassword-protectedfolder.

InTeachersCollege’sDropbox(facultyonly).

Other(e.g.,cloud-based,password-protectedstorage)(pleaseexplain).

Pleasecheckthebox(s)toaffirmyourdatasecurityplans.

Iwillencryptmydata(e.g.,concealdatabyconvertingitintoacode).

Iwilluseantimalwareprotectionsandautomaticsoftwareupdates.

Iwillblockunauthorizedaccesstomydata(e.g.,firewall).

IwilldisablefileandmediasharingifIdonotneedit.

Iwilldeleteoldfilesfromcloud-basedbackupsandlocalharddrives.

Iwilltakecareofprivacysettingsimmediatelyuponsetup.

27. TeachersCollegeclassifiesalldataassociatedwithongoingresearchstudiesas

confidential,meaningonlyprojectstaff,academicadvisors,collaboratorsandother

Please see TC IRB’s Data Security Plan for more information related to transferring and storing data.

Researchers should select as many options as possible to protect their data. For a guide, please review TC IRB’s Data Security Plan.

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individualsatthecollegeonaneed-to-knowbasismayhaveaccesstoit.Confidentialdataataminimumshouldbestoredonapassword-protectedcomputer,orinapassword-protectedfileorfolderifthecomputerisshared.Paperandotherphysicalmediashouldbekeptunderlockandkey.Allcomputersaccessingdatashouldhaveanti-virussoftwareinstalled.

Pleasechecktheboxbelow:

Yes,IacknowledgeandunderstandhowTeachersCollegeclassifiesresearchdata.

SECTIONVI : INFORMEDCONSENTPROCEDURES

Informedconsentisaprocess,notjustaform.

28. Whatareyourproceduresforobtainingaparticipant’sinformedconsenttotakepartintheresearch?

Participantswillbepresentedwithaninformedconsentform(eitherinpersonoronline)basedonwhichstudyactivitytheyarerecruitedtocomplete.Theywillbeaskedtoreadtheconsentformandiftheyagreetoparticipate,theywillbeaskedtoeithersign(inperson)orclick,“Iagree”(online).29. Howwillyoudescribeyourresearchtopotentialparticipants?Participantswillbeinformedthisisastudyexploringtheimpactofmentalhealthpsychoeducation.Theywillalsobeinformedthattheresearchersareinterestedinunderstandingtheirperceptionsofmentalhealth,treatment,andrecovery.30. Whatwillyoudotoensureparticipants’understandingofthestudyandwhatit

involves?Allparticipantsforthenewdatacollectionportionwillbepresentedwithaninformedconsentform(onlineorin-person)beforeparticipatinginthestudy.Theywillalsobegiventheresearchers’contactinformationiftheyhavequestionsaboutthestudy.31. Usethissectiontoprovidearequestforafullorpartialwaiverofinformedconsent,

andjustifythisrequest.Indicate“notapplicable,”ifyouarenotrequestingawaiver.Note:YoumaycitecriteriafromthefollowinglinkregardingFederalregulationsandguidelines:www.hhs.gov/ohrp/humansubjects/guidance/45cfr46.html#46.116

Notapplicable.NoteforResearchers:TemplatesareavailableinMentor/Documentation.Draftsofformswillnotbeaccepted.Pleaseproofreadallfiles.

This wording should match the description included in your consent forms.