CUNYHRPPGuidance:SuggestedLanguageforInformedConsentDocuments

Pleaseusethesuggestedlanguageincludedinthisguidancedocumentasapplicableandappropriate.Notethatyoumayneedtoeditsomeofthislanguagetoensureaccuracyin relationtoyourspecificresearchprotocol.

AudioRecording/VideoRecording/Photographs

Confidentialitysection

Youhavetherighttoreviewtherecording/photographstakenaspartofthisresearchto determinewhethertheyshouldbeeditedorerasedinwholeorinpart.

Instruction: Explain who will have access to the tapes;whether they will be used foreducationalorotherpurposes;andif/whentheywillbeerased.

CertificateofConfidentiality

Confidentialitysection

Tohelpusprotectyourprivacy,wehaveobtainedaCertificateofConfidentialityfromthe NationalInstitutesofHealth.WiththisCertificate,theresearcherscannotbeforcedtodiscloseinformationthatmayidentifyyou,evenbyacourtsubpoena,inanyfederal,state,or localcivil,criminal,administrative,legislative,orotherproceedings.Theresearcherswilluse theCertificatetoresistanydemandsforinformationthatwouldidentifyyou,exceptasexplainedbelow.

TheCertificatecannotbeusedtoresistademandforinformationfrompersonnelofthe UnitedStatesGovernmentthatisusedforauditingorevaluationofFederallyfundedprojectsorforinformationthatmustbedisclosedinordertomeettherequirementsofthefederalFoodandDrugAdministration(FDA).

ACertificateofConfidentialitydoesnotpreventyouoramemberofyourfamilyfromvoluntarilyreleasinginformationaboutyourselforyourinvolvementinthisresearch.Ifan insurer,employer,orotherpersonobtainsyourwrittenconsenttoreceiveresearch information,thentheresearchersmaynotusetheCertificatetowithholdthatinformation.

Instruction:Whenmandatoryreportingapplies

The Certificateof Confidentialitydoesnot preventtheresearchers fromdisclosingvoluntarily, withoutyourconsent,informationthatwouldidentifyyouasaparticipantintheresearch projectunderthefollowingcircumstances:<defineapplicablemandatoryreporting requirements.>

Youcantalkthisoverwithyourparentsbeforeyoudecidewhetherornottoparticipate.We willalsoaskyourparentstogivetheirpermissionforyoutotakepartinthisstudy.Evenif yourparentssay“yes”,youcanstilldecidenottodothis.

CUNYEmployeesasResearchParticipants

IfyouareaCUNYemployee,yourwillingnesstoparticipateinthisresearchstudy,oryour requesttowithdrawfromtheresearchstudy,willnotaffectyouremploymentwithCUNY.

CUNYStudentsasResearchParticipants

IfyouareaCUNYstudent,yourwillingnesstoparticipateinthisresearchstudy,oryour requesttowithdrawfromtheresearchstudy,willnotaffectyourgradesoracademicstanding withCUNY.

Deception/WithholdingInformation

Inintroductoryparagraph(note:onlyoneofthethreeparagraphswillapply)

Forscientificreasons,thisconsentformdoesnotincludecompleteinformationaboutthe purposeofthisresearch.Youwillbefullydebriefedfollowingyourparticipationinthe research.

Wecannottellyoueverydetailofthisstudyaheadoftime,butifyouarewillingtoparticipate undertheseconditions,wewillexplaintheproceduretoyoufullyafteryourparticipation.

Researchdesignsoftenrequirethatthefullintentofthestudynotbeexplainedpriortoparticipation.Althoughwehavedescribedthegeneralnatureofthetasksthatyouwillbe askedtoperform,thefullintentoftheresearchwillnotbeexplainedtoyouuntilafterthe completionofthestudy.Atthattime,wewillprovideyouwithafulldebriefing,whichwillincludeanexplanationofthepurposeoftheresearchandotherrelevantbackgroundinformationpertainingtotheresearch.Youwillalsobegivenanopportunitytoaskanyquestionsyoumighthave.

FocusGroups

Confidentialitysection

Allparticipantswillbeaskednottosharetheinformationdiscussedduringthegroupdiscussionwithanyoneoutsideofthegroup.However,completeconfidentialitycannotbe guaranteed.

SignatureofParticipantsection

Onthechecklistbelow,pleaseindicateifyouwouldpermittheresearcherstocontactyouin thefutureforparticipationinotherresearchstudies.

Iagreetoallowtheresearcherstocontactmeforfutureresearchstudies.

Idonotagreetoallowtheresearcherstocontactmeforfutureresearchstudies.

Randomization

Proceduressection

Randomizationisaprocedureusedtoassignresearchparticipantsbychancetooneoftwoor

moregroups.Itisusedtomakesurethatstudyresultsarenotinfluencedbytheselectionof participantsinonegroupascomparedtoanother.Inthisresearch,youhavea<x>chanceof beingassignedtooneofthefollowinggroups:<defineeachgroupandrelatedprocedures>.

Storeand/orShareDataforFutureResearch

SignatureofParticipantsection

Onthechecklistbelow,pleaseindicateifyouwouldpermittheresearcherstostoreand/or

shareyour<describedatatobestored/shared>forfutureresearch.

I agree to allow my <insert data type> to be stored for future research by the researchersofthisstudy.

Iagreetoallowmy<insertdatatype>tobesharedwithotherresearcherforfuture

research.

Idonotagreetoallow<insertdatatype>tobestoredorsharedforfutureresearch.

Storeand/orShareSamplesforFutureResearch

SignatureofParticipantsection

Onthechecklistbelow,pleaseindicateifyouwouldpermittheresearcherstostoreand/or shareyour<describesamplestobestored/shared>forfutureresearch.

Iagreetoallowmy<insertsampletype>tobestoredforfutureresearchbythe researchersofthisstudy.

Iagreetoallowmy<insertsampletype>tobesharedwithotherresearcherforfuture research.

Idonotagreetoallowmy<insertsampletype>tobestoredorsharedforfuture research.

Proceduressection

Youmayrefusetoansweranyquestionsthatyoudonotwanttoanswerandstillremainin thestudy.

PotentialRisksorDiscomfortssection

Some of the questions the researchers ask you may be upsetting, or you may feel

uncomfortableansweringthem.Ifyoudonotwishtoansweraquestion,youcanskipitandgotothenextquestion.