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.