CSUDH Institutional Review Board (IRB)

FORM E

CSUDHInstitutionalReviewBoard(IRB)

ParentalPermissionforChildtoParticipatein Research(template)

Notetoinvestigators:Informedconsentistheknowingconsentofanindividualorhis/herlegallyauthorizedrepresentativeandmustbeobtainedwithoutundueinducement,force,fraud,deceit,duress,orotherformsofconstraintorcoercion.

Theconsentdocumentshouldbewordedinthesecondpersonandmustbeadjustedfortheeducationalbackground,age,language,orothercharacteristicsofthesubjectpopulation.Avoidjargon.Forthegeneralpublic,itisrecommendedthatyounotexceeda5thgradereadinglevel.Separateformsareusedtoobtainparentalpermissionforaminorchild’sparticipationandforthechild’sagreementtoagreetoparticipate.

Usethefollowingformatinnon-exemptresearchthatwillinvolveminorchildren.Theitemsinbolditalicsshouldbeincludedverbatim,howeveryoudonotneedtoputthem initalicsin yourconsentdocument.Usethesectionheadingsidentifiedinthetemplate.

TEMPLATE

CaliforniaStateUniversity,DominguezHills

ParentalPermission/InformedConsenttoParticipateinResearch

(insertthestudytitle)

Youarebeingaskedtoallowyourchildtoparticipateinaresearchstudy.Beforeyougiveyourpermission,itisimportantthatyoureadthefollowinginformationandaskasmanyquestionsasnecessarytobesureyouunderstandwhatyourchildwillbeaskedtodo.

Investigators:Providethenameandacademicdegreesofallinvestigatorsinvolvedinthestudy,thedepartment,institution,andphonenumber.Ifyouareastudent,includethenameofthepersonsupervisingyourresearch.

PurposeoftheStudy:Provideanexplanationofwhatthestudyisdesignedtoaccomplishusinglanguagethatiscleartothetargetaudience.Includethenumberofsubjectsbeingrecruitedandtheeligibilitycriteriausedtoidentifyprospectiveparticipants.

DescriptionoftheStudy:Describetheproceduresthatwillinvolvethesubject,thelocation wheretheresearchwillbeconducted,andtheexpecteddurationofeachactivity.(Forinstance,“If youagreetoallowyourchildto participate,s/hewillbeaskedtosortseveralcoloredshapesthatappearonacomputerscreen.Thiswilltakeplaceduringnormalschoolhoursinyourchild’sclassroom andwilltakeno morethanfifteenminutes.”)Iftherewillbeinterviews orquestionnaires,indicatethetypesofquestionsortopicsthatwillbecovered.Ifthereareanyprocedurethatisexperimental(anewdrugordeviceorintervention),identifyanddescribeitbriefly.Ifnoneoftheproceduresisexperimentalinnature,includeastatementlikethefollowing:“Noneoftheprocedures[orquestionnaires,ifapplicable]usedinthisstudyisexperimentalinnature.Theonlyexperimentalaspectofthestudyisthegatheringofinformationfortheanalysis.”

RisksorDiscomforts:Riskscanbesocialorpsychologicalaswellasphysical.Donotassumethattherearenorisksalthoughtheymaybeminimal.Identifytherisksordiscomfortsthesubjectmightencounterasaresultofparticipation.Outlinetheprovisionsyouhavemadetominimizeor

eliminatethem.(Forexample,“Yourchildmayfeeluncomfortabletalkingabouthis/herfeelingsorbehaviorsormaybecomefrustratedwhentryingtocompleteanactivitythatisbeingmeasured.Tominimizethisdiscomfort,wewilltellyourchildthats/heneedonlyraiseher/hishandtodiscontinueparticipation,eithertemporarilyorpermanently.”)

BenefitsoftheStudy:Describeanybenefitsthesubjectcanexpectasaresultofparticipatinginthestudy,butincludethefollowingstatement:“Icannotguaranteethatyouoryourchildwillreceiveanybenefitsfrom thisstudy.”Iftherearenobenefitsthatcanreasonablybeexpected,sayso.Iftherearebenefitstoscienceorsociety,includeastatementtothateffect.

AlternativeMethodsofTreatment:IFtheprojectinvolvesmedicalorotherinterventions,identifyappropriatealternativeproceduresorcoursesoftreatmentthatmightbeavailableoradvantageoustothesubjects.

Confidentiality:Describetheextent,ifany,towhichconfidentialityofrecordsidentifyingthesubjectwillbemaintained(includinghowthedatawillbeusedandstoredand whowillhaveaccesstoit).Ifvideooraudiotapesaretobeusedtorecordinformation,describehowtheywillbeused,whowillhaveaccess,howlongtheywillbestored,andwhentheywillbeerased.

Remember,confidentialityreferstorecordingbutconcealingthesubject’sidentityorcodeslinkedtotheindividual’sidentity.Anonymitymeansthattheidentityofthesubjectisnotknowntotheresearchers,andisneverrecordedorassociatedwiththedatacollected.

IncentivestoParticipate:Occasionallyincentives(cash,t-shirts,ticketstoamusementsortoystores)areofferedtoparticipantstocompensatethemfortheirtimeandeffort.Ifappropriate,describewhatisbeingofferedtotheparentand/orchildandwhatisrequiredofthesubjecttoobtainit.Ifthereis apaymentoffered,statetheamountandanyformulaforproratingthefundsshouldthesubjectdiscontinueparticipationbeforecompletingthestudy. The California law (Penal Code 319) prohibits rewarding or compensating study participants with entry into a chance giveaway (drawing, lottery, raffle, or the like) for any material prize (cash, gift cards, etc.). However, if the chance to win is not contingent on participating in the study, such drawings can be permitted. In this case insert the following statement, “You can participate in the drawing even if you do not complete or participate in the study by asking the investigator to include you.” If there is no incentive, just say so.Ifthereisnospecialincentive,justindicatethat theparticipantwillnotbepaidtoparticipateinthisstudy.

VoluntaryNatureofParticipation:Participationinthisstudyisvoluntary.YourdecisionofwhetherornottoallowyourchildtoparticipatewillnotinfluenceyourfuturerelationswithCaliforniaStateUniversity,DominguezHills[includethenameofanyotherinstitutions(s)involvedintheresearch,ifappropriate].Ifyoudecidetoallowyourchildtoparticipate,youarefreetowithdrawyourconsentandtodiscontinuehis/herparticipationatanytimewithoutpenaltyorlossofanybenefitstowhichyouareotherwiseentitled.

QuestionsabouttheStudy:Ifyouhavequestionsregardingthisstudyoryourchild’srightsasahumansubjectandparticipantinthisstudy,youmaycalltheinvestigator(nameandcampusphonenumber),ortheInstitutionalReviewBoardfortheProtectionofHumanSubjectsatCSUDH,310-243-3756.YoumayalsowritetotheOfficeofGraduateStudiesandResearch,CaliforniaStateUniversity,DominguezHills,1000E.VictoriaStreet,Carson,CA90747.

SpecialIssuesthattypicallyapplytomedicalresearchorresearchinvolvingphysicalintervention:

CostsforParticipation:Iftherearecostsassociatedwithparticipation(e.g.,tests,officevisits,etc.),specifyindetailtheextentofthesecostsandwhoisresponsibleforpayingthem.

Compensationforinjury(includethissectionifyourstudyinvolvesmorethanminimalrisk):Indicatewhetheranymedicaltreatmentsreavailableifinjuryoccursinthecourseoftheresearch,andifso,whattreatmentisavailableandwherefurtherinformationcanbeobtained.(Samplesareprovidedbelow.)

Yoursignaturebelowindicatesthatyouhavereadtheinformationinthisdocumentandhavehadachancetoaskanyquestionsyoumayhaveaboutthestudy.Yoursignaturealsoindicatesthatyouagreetoallowyourchildtobeinthestudyandhave beentoldthatyoucanchangeyourmindandwithdrawyourconsentatanytime.Youhavebeengivenacopyofthisconsentform.*Youhavealsobeengivenacopyof“TheResearchParticipant’sBillofRights.”Youhavebeentoldthatbysigningthisconsentformyouarenotgivingupanyofyourlegalrights.

*Includeonlyforresearchinvolvingmedicalexperimentation.

NameofParticipant(pleaseprint)

SignatureofParentorGuardianDate

SignatureofInvestigatorDate

If youwillbevideotapingthechild,youshoulduseaseparatesignaturelineforthat;somepeoplewillagreetoparticipation,butnottohavingavideotaperecord.

SampleStatement–ifinjuryisnotcoveredbythestudy:

Itisunlikelythatparticipationinthisprojectwillresultinharmtoparticipants.Ifanycomplicationsarise,wewillassistyourchildinobtainingappropriateattention.If yourchildneedstreatmentorhospitalizationasaresultofbeinginthisstudy, youareresponsibleforpaymentofthecostforthatcare.If youhaveinsurance,youmaybill yourinsurancecompany.You willhavetopayanycostsnotcoveredbyyourinsurance.

CaliforniaStateUniversity,DominguezHillswillnotpayforanycareorlostwages,orprovideotherfinancialcompensation[includeCSUDHFoundationiftheresearchisfunded].However,ifyoufeelyou haveaclaim thatyouwishtofileagainsttheState[ortheFoundation],pleasecontacttheOfficeofAcademicAffairs(310-243-3307)toobtaintheappropriateclaimforms.

SampleStatement–ifinjuryiscoveredbythestudy:

Itisunlikelythatparticipationinthisprojectwillresultinharmtoparticipants.Ifyourchildneedsanytreatmentorhospitalizationasaresultofbeinginthisstudy,allreasonableandcustomarymedicalexpenses,abovewhat yourinsurancewillbepaidby

aslongas:

• You/yourchildhavefollowedallofthedirectionsofthestudyinvestigator;
• You/yourchildhavenotifiedtheinvestigatorimmediatelyoftheinjury;
• You/yourchildhavefollowedmedicaladviceregardingtheinjury;and
• You/yourchildhavenotdeliberatelycausedtheinjury.