The below template for developing an informedconsent document to use in your research study is meant to provide structure and guidance to the process,not to serve as your exact informed consent document. Please remember to consult your institution and IRB for specific consent requirements, instructions and templates.
For the purposes of this document, guidelines within the template will be provided in italics. If this document is used to develop your informed consent form,please remember to delete the italicized instructions and insertyourspecificinformation.
InformedConsentDocumentTemplateandGuidelines
InformedConsentForm
ArkansasTechUniversity
TitleofProject:(complete title of the project as it appears on the protocol and abstract)
PrincipalInvestigator:(only one person may be named as principal investigator)
OtherInvestigators:
Participant’sPrintedName:
TheIntroductoryParagraph
ExampleIntroductoryParagraph:
Weinviteyou totakepartinaresearchstudy(title) at(location/institution), whichseeks to (purpose of study). Takingpartinthisstudyisentirelyvoluntary.Weurgeyou discuss any questionsaboutthisstudywithour staffmembers.Talktoyour familyandfriendsaboutitand takeyour timeto makeyour decision.If you decidetoparticipateyou mustsignthisformto show thatyou wanttotakepart.
Section1. PurposeoftheResearch
Thissectionisrequiredinallconsentforms.Itfocusesonexplainingtotheparticipantwhythey wereaskedtoparticipateinthestudyandthepurposeoftheresearchstudy.
Example Section 1: Purpose of the Research
You arebeingofferedtheopportunitytotakepartinthisresearchstudybecause(state why the individual was selected, e.g., condition, age, or healthy volunteer).
Thisresearchstudyisbeingdoneto findout……..
OR
Thepurpose of thisresearchisto……
OR
Thepurpose of thisresearchstudyistoobtaininformationon thesafetyandeffectivenessof
(name of drug, device, etc.).
Approximately(number)peoplewilltakepartinthisresearch(nationwide or worldwide)and about(number)peopleareexpectedtotakepartat(your institution).
Section2. Procedures
Thissectionisrequiredinallconsentforms.Itoutlinestheproceduresofthestudyandexplains exactlywhatwillhappentotheindividualshouldtheychoosetotakepartinthestudy.Itshould clearlyidentifywhatpartsoftheprocedure,ifany,areexperimental.
Section 3. TimeDurationoftheProceduresandStudy
Thissectionisrequiredinallinformedconsentforms.Thepurposeofthissectionistoclearly outlinethetimecommitmentaparticipantiscommittingtoinchoosingtotakepartinthestudy.
ExampleofaTimeDurationSection:
If you agreeto take part in this study, your involvement will last approximately (give length of time of participation).
Section4. Discomforts and Risks
This section is required in all informed consent forms. For certain research studies, it may suffice to say that there are noknow risks associated with the research. However, in most studies, this section will outline inlay terms what risks or discomforts may be associated with each procedures or drug administered. List by regimen the physical and nonphysical risks of
participating in the study in percentages andnumbers whenever possible. Nonphysical risks may include such things as the inability to work, potential anxiety related to the sensitive nature of
the questions asked, etc. List the known human experiences related to thetreatment and proceduresinvolved,includingbruising or discomfort from blood draws, as well as any relevant animal data. Highlight or otherwiseidentifysideeffectsthatmay be irreversible, long-term or life threatening. The use of lists or a table format is recommended.
Example of a Discomforts and Risk Section for a Drug Study:
Whileon thestudy,you areatrisk for thefollowingsideeffects.Most of themarelisted
belowbuttheywillvaryfromperson toperson. Drugs willbegivento makesomeof the sideeffectsless serious anduncomfortable.Many sideeffectsgo awayafterthedrug is stoppedbut,insomecases,thesideeffectsmaybeserious and/orlasting.
Drug XYZ side effects.
More likely:
•Decreasedappetite
•Difficultysleeping
•Headache,dizziness
Less likely:
•Hallucinationsor delusions
•Nauseaand/orvomiting
(The following text should be addedfor trials with a placebo arm)
If you areinthetreatmentgroup thatreceivesplacebo(inactivesubstance)your symptomsor conditionmayworsen or notimprove.
Other Possible Risks Associated With Participating In This Study
Venipuncture: Therisks of drawingbloodincludetemporarydiscomfortfromtheneedle stick,bruising,bleeding,andrarely,infection.
Subcutaneous Injections: Injectionstotheskinmaybeless convenientthansomeother formsof treatment,such as oralmedications.In addition,injectionsmaycause momentary discomfortandotherlocalsymptoms,such as bleeding,bruising,and,rarely, infection.
(Also, if applicable, the following should be added)
Therealsomaybeothersideeffectsor discomfortsthatwe cannotpredict,especiallytoa fetusor embryo.Becausethedrugs inthisstudymayaffectanunborn baby,you should notbecomepregnantor fatherababywhileon thisstudy.Your doctorwilldiscussthis withyou. You shouldnotbreast-feedababywhileon thisstudy.
Section5. PotentialBenefits
Thissectionmustbeinallinformedconsentforms.However,thewayitisincludedmay varydependingonthetypeofresearch.Thepurposeofthissectionistodescribethe benefitsofparticipatingfortheparticipantandforothers.Thefollowingshouldbeincluded inthissection;
•Thissectionshouldaddresstwoparts:1)potentialbenefitstotheparticipant;and2) potentialbenefitstoothers.Thetwoideascanbeintegrated,butforthepurposesofthe examplebelow,theyhavebeenseparatedintoseparateparagraphs.
•NOTE:Paymentgiventotheparticipantforparticipationinthestudyisnota benefit,itisacompensationforparticipant’stimeandanyexpensesthats/hecouldincuras aresultofparticipationinthestudy,andshouldnotbeincludedinthissection.
ExampleofPossibleBenefitsSection:
Possiblebenefitstotheparticipant:
(Forclinicalresearchstudieswheredirectbenefitispossible)Thepossiblebenefityoumay experiencefromthe(researchdrug/device/procedure)describedinthisresearchincludes(list anybenefitsthatmaybereasonablyexpected).However,thereisnoguaranteethatyouwill benefitfrombeinginthisresearch.
(Forresearchwithnodirectbenefit)Youwillnotbenefitfromtakingpartinthisresearch study.
Possiblebenefitstoothers:
(Address potentialbenefitstoothers)The results of this research may guide the futuretreatment of…
or
Medical science may gainfurther understanding of….
Section6.StatementofConfidentiality
Thissectionisrequiredinallinformedconsentforms.Thissectionmustoutlinehowallconfidential informationandormaterialswillbetreated,stored,andmaintainedandforwhatlengthsoftime,
aswellashowmaterialswillbedisposedofattheendofthestudyperiod.Privacyand confidentialitymeasuresmustbeaddressedinthissection.
6a. Privacy and confidentiality measures
ExampleStatementofConfidentiality:
Yourresearchrecordsthatarereviewed,stored,andanalyzedat(your institution)willbekept inasecuredareain(listwhererecordsarestored).(Includethefollowingifspecimensare collectedforresearchpurposes)Yoursamplescollectedforresearchpurposeswillbelabeled with(listallthatapply:acodenumber,yourinitials,etc.)andwillbestored(listwherethe sampleswillbestoredandhowtheyaresecured).
(Forresearchrecords/samplesthataresentoutsideofyour institution,describemethodsthat willbeusedtoensureconfidentiality.Ifrecordsandspecimensaresenttodifferententitiesor labeleddifferently,describetheirconfidentialitymeasuresseparately)Forresearchrecords(and specimens)sentto(outsideentity),youwillnotbeidentifiedbyname,socialsecuritynumber, addressorphonenumber.Therecords(andspecimens)mayinclude(listallthatapply:acode
number,yourinitials,dateofbirth,etc.).Thelistthatmatchesyournamewiththecodenumber willbekeptinalockedfilein(notelocation,suchasPI’soffice).
OR
Forresearchrecords(andspecimens)sentto(outsideentity),youwillbeidentifiedby(listall thatapply:name,socialsecuritynumber,address,phonenumber,dateofbirth,anyotherdirect personalidentifier,codenumber).Thelistthatmatchesyournamewiththecodenumberwillbe keptinalockedfilein(notelocation,suchasPI’soffice).
(Remembertoincludeseparatedescriptionsforrecordsandspecimensiftheyarelabeled differentlyorstoreddifferentlyorsenttoseparateentities.)
The following statement is consideredmandatory for all research studies:
In theeventof anypublicationor presentationresultingfromtheresearch,no personally identifiableinformationwillbeshared.
The following statement is for those studies that do not include section 6b.
Wewillkeepyourparticipationinthisresearchstudyconfidentialtotheextentpermittedby law.However,itispossiblethatotherpeoplemaybecomeawareofyourparticipationinthisstudy.Forexample,thefollowingpeople/groupsmayinspectandcopyrecordspertainingtothis research.
•TheOfficeofHumanResearchProtectionsintheU.S.DepartmentofHealthand
HumanServices(fordrug/devicestudies,addtheU.S.FoodandDrugAdministration)
•The(your institution)InstitutionalReviewBoard(acommitteethatreviewsand approvesresearchstudies)and
•The(your institution)IRBOffice
•TheNationalInstitutesofHealth,thestudysponsor
Someoftheserecordscouldcontaininformationthatpersonallyidentifiesyou.Reasonable effortswillbemadetokeepthepersonalinformationinyourresearchrecordprivateand confidentialbutabsoluteconfidentialitycannotbeguaranteed.
6b.Theuseofprivatehealthinformation:
•Section6bismandatoryiftheresearchcreates,obtains,uses,and/ordiscloses identifiable healthinformationabouttheresearchparticipants.The18identifiers arelistedunderHIPAAregulations.
•DonotincludeanypartofSection8bunlesstheresearchfitstheabovecriteria.
ExampleStatementofUseofPrivateHealthInformation:
Healthinformationaboutyouwillbecollectedifyouchoosetobepartofthisresearchstudy. Healthinformationisprotectedbylawasexplainedinthe(your institution)PrivacyNotice.If youhavenotreceivedthisnotice,pleaserequestacopyfromtheinvestigator.At(your institution)yourinformationwillonlybeusedorsharedasexplainedandauthorizedinthis consentformorwhenrequiredbylaw.Itispossiblethatsomeoftheotherpeople/groupswho receiveyourhealthinformationmaynotberequiredbyFederalprivacylawstoprotectyour informationandmayshareitwithoutyourpermission.
Toparticipateinthisresearchyoumustallowthestudyteamtouseyourhealthinformation.If youdonotwantustouseyourprotectedhealthinformation,youmaynotparticipateinthis study.(Whenspecifictherapyisonlyavailablethroughtheresearch,includethesesentences: Theresearch-relatedtherapyisinvestigational;therefore,itisnotavailableunlessyouallowthe useofyourhealthinformationthatiscollectedduringthisresearchstudy.)
(Forblindedstudies)Peopleusuallyhavearighttoaccesstheirmedicalrecords.However, whiletheresearchisinprogress,youmaynotbeallowedtoseeorcopycertaininformationthat isrelatedtothisresearchstudy.Thisisonlyfortheperiodoftheresearch.Youwillbeallowed toseethatinformationwhentheentireresearchprojectiscomplete.
Yourpermissionfortheuse,retention,andsharingofyouridentifiablehealthinformationwill (Describethedateoreventthatwilltriggertheexpirationofthisauthorizatione.g.,“expire uponcompletionoftheresearchstudy”or“expirewhenFDAapprovalofthestudydrugis obtained”or“willcontinuefortheperiodoftimenecessaryforthepreparationofarelated follow-upresearchstudy”or“continueindefinitely”or“willcontinueuntiltheNIAnotifiesthe investigatorthattheinformationisnolongerneeded.”).Atthattimetheresearchinformation
notalreadyinyourmedicalrecordwillbedestroyed(or“willberetaineduntil
inorderto
”or“informationidentifyingyouwillberemovedfromsuchresearchresultsat(your institution)”).Anyresearchinformationinyourmedicalrecordwillbekeptindefinitely.
Ifyouchoosetoparticipate,youarefreetowithdrawyourpermissionfortheuseandsharingof yourhealthinformation(ifapplicable,add:andyoursamples)atanytime.Youmustdothisin writing.WritetoDr.(PI)andlet(him/her)knowthatyouarewithdrawingfromtheresearch study.(His/Her)mailingaddressis(address).
Ifyouwithdrawyourpermission:
•Wewillnolongeruseorsharemedicalinformationaboutyou(ifapplicable,addthe following:oryoursamples)forthisresearchstudy,exceptwhenthelawallowsustodo so.
•Weareunabletotakebackanythingwehavealreadydoneoranyinformationwehave alreadysharedwithyourpermission.
•Wemaycontinueusingandsharingtheinformationobtainedpriortoyourwithdrawalif itisnecessaryforthesoundnessoftheoverallresearch.
•Wewillkeepourrecordsofthecarethatweprovidedtoyouaslongasthelawrequires.
Theresearchteammayusethefollowingsourcesofhealthinformation.
•(Listanyandallmedicalinformationcollectedfromorabouttheparticipantin connectionwiththisresearchstudy,e.g.bloodandothertissuesamplesandrelated tests,yourmedicalhistoryasitrelatestotheresearchstudy,x-rays,MRIs, questionnaires,etc.)
•Indicatethespanoftimefromwhichtherecordsarepulled,e.g.,“sinceyourdiabetes wasdiagnosed”,“thelastfiveyears”,“onlyduringthetimespanoftheresearch study”.)
Representativesofthefollowingpeople/groupswithin(your institution)mayuseyourhealth informationandshareitwithotherspecificgroupsinconnectionwiththisresearchstudy.
•Theprincipalinvestigator, (name)
•The(your institution)InstitutionalReviewBoard
•The(your institution)InstitutionalReviewBoard
•(IfusingtheInvestigationalDrugPharmacy)The(your institution)Pharmacy
•(Ifapplicable)The(yourinstitution)FinancialAnalystforClinicalResearch
•(Listeveryotherclassofpersonsorgroupaffiliated with (your institution)(e.g.,the researchteam,thestudycoordinators,etc.)whomightneedtouseand/ordisclosethe participant’sinformationinconnectionwiththisstudy.)
Theabovepeople/groupsmayshareyourhealthinformationwiththefollowingpeople/groups outside(your institution)fortheiruseinconnectionwiththisresearchstudy.Thesegroups, whilemonitoringtheresearchstudy,mayalsoreviewand/orcopyyouroriginal(your institution)records.
•TheOfficeofHumanResearchProtectionsintheU.S.DepartmentofHealthand
HumanServices
•(ListeveryotherclassofpersonsorgroupNOTaffiliatedwith your institution (e.g. fellowresearchersinthisstudyat(listotherinstitutions),outsidedataanalysts appointedforthisstudy,theDataSafetyMonitoringBoardappointedforthisstudy,the NationalInstitutesofHealth,theFoodandDrugAdministration,etc.,towhomthe participant’sinformationmightbedisclosed.)
•(Ifthestudyisinternational)Representativesfromregulatoryagenciesinothercountries mayalsoreviewyourresearchrecord,includingresearch-relatedmedicalreportsand information,alongwiththeNIAand/ortheFDA.
Section7. CostsforParticipation a. Costs:
Iftherearecoststotheparticipantthatmayresultfromparticipationinthe research,includeastatementdescribinganyadditionalcostsassociatedwithstudy participation.
b. Treatment and compensation for injury:
Include your institution’s mandatorywordingfortreatmentforinjury(seebelow).
ExampleCostforParticipationSection:
(Ifthereisnoriskofphysicalinjurytotheparticipant,donotincludethissection.)Everyeffort topreventinjuryasaresultofyourparticipationwillbetaken.Itispossible,however,thatyou coulddevelopcomplicationsorinjuriesasaresultofparticipatinginthisresearchstudy.Inthe eventofinjuryresultingfromthisresearch,medicaltreatmentisavailablebutwillbeprovided attheusualcharge.Itisthepolicyofthisinstitutiontoprovideneitherfinancialcompensation norfreemedicaltreatmentforresearch-relatedinjury.
Add, as a separate paragraph, one of the following statements regardingpayment for direct costs of treating research-related injuries.
(Iftheinstitutionwillcoverallcostsofresearch-relatedinjuriesbutdidnotprovideconsent formwording,includethisstatementasaseparateparagraph)Ifcomplicationsorinjuries occurthataretheresultofamedication,procedureortestrequiredforthisstudy,theinstitution
(includethenames)willreimbursethestandardchargesforthetreatmentofthesecomplications orinjuries.Thecompensationdescribedinthissectionwillbetheonlyformof compensation providedtoyou for complicationsor injuriesrelatedtothisstudy.
OR
(Iftheinvestigatorinstitutionwillcovercostsofresearch-relatedinjuriesnotcoveredbythe participant’sinsurancecarrierbutdidnotprovideconsentformwording,includethisstatement asaseparateparagraph)Ifcomplicationsorinjuriesoccurthataretheresultofamedication, procedureortestrequiredforthisstudy,theinvestigator,(includethenameofinstitutionif appropriate)willreimbursethestandardchargesforthetreatmentofthesecomplicationsor injuries,providedthesechargeshavenotbeenreimbursedbyyournon-governmentalmedical insuranceorotherthirdparty.Thecompensationdescribedinthissectionwillbetheonly
formof compensationprovidedtoyou for complicationsor injuriesrelatedtothisstudy.
OR
(Iftheinvestigatorinstitutionhasnotagreedtocovercostsofresearch-relatedinjuries,include thisstatementasaseparateparagraph)Costsforthetreatmentofresearch-relatedinjurieswill bechargedtoyourinsurancecarrierortoyou.Someinsurancecompaniesmaynotcovercosts associatedwithresearchstudies.Ifforanyreasonthesecostsarenotcoveredbyyourinsurance,
theywillbeyourresponsibility.Youwillalsoberesponsibleforanydeductible,co-insurance and/orco-pay.
(End this section with the following statement)Youwillnotloseanylegalrightsbysigning thisform.
Section8.CompensationforParticipation
Thissectionisrequiredinallresearchstudies.Itshouldclearlydescribeany monetary compensation(totalamount,averagetotalamount,amountpervisit,amountperhour, etc.).
Example of Compensation for Participation Section:
You willbegiven$ on eachvisittocompensateyou for timeandexpensesfor
participatinginthisstudy.
(If participants do not receive anyreimbursement for participation)Youwillnotreceive anycompensationfor beinginthisresearchstudy.
Section 9. Research Funding
•Funding disclosure: Disclose what grantors, institution(s)(e.g., NIA)or companies are involved in the research through funding or grants. If none, say so.
•Conflict of Interest: Include information about any consultative or financial relationships the investigators may have with the NIA.
Example Research Funding Section:
Theinstitutionandinvestigatorsarereceivinga grantfromNIA (list any other grantors)to supportthisresearch.
(For funding disclosure) Theinstitutionwillbereimbursedby theNIA for use ofthissite’s facilitiesandfor thework theresearchstaffdoes for thisresearch.
Section10.VoluntaryParticipation
ExampleVoluntaryParticipationSection:
Takingpartinthisresearchstudyisvoluntary.Ifyouchoosetotakepartinthisresearch,your majorresponsibilitieswillinclude(Brieflylistmajorresponsibilities.NOTE:Donotincludethis sentenceiftherearenomajorresponsibilitiesfortheparticipant).Youdonothaveto
participateinthisresearch.Ifyouchoosetotakepart,youhavetherighttostopatanytime.If youdecidenottoparticipateorifyoudecidetostoptakingpartintheresearchatalaterdate, therewillbenopenaltyorlossofbenefitstowhichyouareotherwiseentitled.
(Optional,ifappropriate)Your investigatormaytakeyou outof theresearchstudywithout your permission.Somepossiblereasons for thisare:(list possible reasons, for example: you did not follow the studyinstructions,etc.). Also, theNIA mayendtheresearchstudyearly.If
your participationintheresearchends early,you maybeaskedtovisittheinvestigatorfor a finalvisit.
(Optional,ifappropriate)(For clinical studies)Ifyou willbeparticipatinginanotherclinical trialat[Institution]or elsewherewhileinthisresearch,you shoulddiscuss theprocedures and/ortreatmentswithyour physicianor theinvestigators.Thisprecautionisintendedto protectyou frompossiblesideeffectsfrominteractionsof researchdrugs, treatmentsor testing.
(Optional,ifappropriate)Duringthecourseoftheresearchyouwillbeprovidedwithany significantnewfindingsthatmayaffectyourwillingnesstocontinueparticipatinginthis research.
Section11.ContactInformationforQuestionsorConcerns
•Clarifytheparticipant’srightto have questions answered.
•Indicate whom to contact in case of further questions about the research or to report a research-related injury.
•Indicate contact information for questions about participant rights and privacy issues.
ExampleContactInformationforQuestionsorConcernsSection:
Youhavetherighttoaskanyquestionsyoumayhaveaboutthisresearch.Ifyouhave questions,complaintsorconcernsorbelieveyoumayhavedevelopedaninjuryrelatedtothis research,contact(PrincipalInvestigator)at(phonenumber).(Ifclinicalprotocol,addthenext phrase)orthe(study)doctoron24-hourcallat(phonenumber).
(Allinformedconsentformsshouldincludethisparagraph).Ifyouhavequestionsregarding yourrightsasaresearchparticipantoryouhaveconcernsorgeneralquestionsaboutthe
research(addthenextphraseifusingidentifiablehealthinformation:oraboutyourprivacyand theuseofyourpersonalhealthinformation),contacttheresearchparticipantsprotection advocateinthe(yourinstitution’s)IRBOfficeat(phonenumber).Youmayalsocallthis numberifyoucannotreachtheresearchteamorwishtotalktosomeoneelse.
FormoreinformationaboutparticipationinaresearchstudyandabouttheInstitutionalReview Board(IRB),agroupofpeoplewhoreviewtheresearchtoprotectyourrights,pleasevisit ArkansasTechUniversity’sIRBwebsiteat(website).Includedonthiswebsite,underthe heading“ParticipantInfo”,youcanaccessfederalregulationsandinformationaboutthe protectionofhumanresearchparticipants.Ifyoudonothaveaccesstotheinternet,copiesof thesefederalregulationsareavailablebycallingthe(yourinstitution)at(phonenumber).
Signature and Consent/Permission to be in the Research
Beforemakingthedecisionregardingenrollmentinthisresearchyoushouldhave:
•Discussedthisstudywithaninvestigator,
•Reviewedtheinformationinthisform,and
•Hadtheopportunitytoaskanyquestionsyoumayhave.
Yoursignaturebelowmeansthatyouhavereceivedthisinformation,haveaskedthequestionsyou currentlyhaveabouttheresearchandthosequestionshavebeenanswered.Youwillreceiveacopy ofthesignedanddatedformtokeepforfuturereference.
Participant:Bysigningthisconsentform,youindicatethatyouarevoluntarilychoosingtotake partinthisresearch.
SignatureofParticipantDateTimePrintedName
Participant’sLegallyAuthorizedRepresentative:Bysigningbelow,you indicatethatyou give permissionfor theparticipanttotakepartinthisresearch.
SignatureofParticipant’sLegallyDateTimePrintedName
AuthorizedRepresentative
(Signatureof Participant’sLegallyAuthorizedRepresentativeisrequiredfor peopleunableto giveconsentfor themselves.)
DescriptionoftheLegallyAuthorizedRepresentative’sAuthoritytoActforParticipant
Person Explaining the Research:Your signaturebelowmeansthatyou haveexplainedthe researchtotheparticipant/participantrepresentativeandhaveansweredanyquestionshe/shehas abouttheresearch.
SignatureofpersonwhoexplainedthisresearchDateTimePrintedName
Onlyapprovedinvestigatorsforthisresearchmayexplaintheresearchandobtaininformed consent.
Awitnessorwitness/translatorisrequiredwhentheparticipantcannotreadtheconsentdocument, anditwasreadortranslated.
INSTRUCTIONS: Thefollowingappliestooptionalpartsof theresearchonly,e.g.,storageof leftovertissuefor futureresearch,optionalsub-studies, etc.
In additiontothemainpartof theresearchstudy,thereisanoptionalpartof theresearch.You canparticipateinthemainpartoftheresearchwithoutagreeingtotakepartinthisoptionalpart.
(For research involving optional storage of tissue for future research) OptionalTissueStorage for FutureUse
As partof thisstudy,we areobtaining(tissue and/or blood and/or cells)fromyou. If you agree,the (researchers) would liketostoreleftoversample(s)of your (tissue and/or blood and/or cells)so that your (tissue and/or blood and/or cells)canbestudiedinthefutureafterthisstudyisover.(Add the following statement if storage is optional)Thesefuturestudiesmayprovideadditionalinformation thatwillbehelpfulinunderstanding[disease/condition],butitisunlikelythatthesestudieswillhave a directbenefittoyou. Theresultsof thesetestswillnothaveaneffecton your care.Neitherthe investigatornor you willreceiveresultsof thesefutureresearchtests,nor willtheresultsbeputin your healthrecord.Sometimestissueisused for geneticresearchaboutdiseasesthatarepassed on in families.Evenifyour sample(s)(is / are)used for thiskindof research,theresultswillnotbeputin your healthrecords.Itispossiblethatyour (tissue and / or blood and/or cells)mightbeused to developproductsor teststhatcouldbepatentedandlicensed.Thereareno planstoprovidefinancial compensationtoyou shouldthisoccur.If you haveanyquestions,you shouldcontact(PI name)at (phone number).
(For linked samples)Your leftoversampleswillbelabeledwith(listallthatapply:“acodenumber”, “yourinitials”,etc.). Thesesampleswillbestored(describehowthesampleswillbesecured:“Dr. (PI’sname)’slockedlaboratory)at xxxx.Ifyouconsenttothecollectionofsamplesofyour (e.g.,blood,tissue,bonemarrow)forfutureresearch,theperiodfortheuseofthesamplesisunknown. If you agreetoallowyour (tissue and/or blood and/or cells)tobekeptfor futureresearch,you will be freetochangeyour mindatanytime.You shouldcontact(PI name)at(phone number)andlet (him/her)know you wish towithdrawyour permissionfor your (tissue and/or blood and/or cells)to beused for futureresearch.Any unused (tissue and/or blood and/or cells)willbedestroyedandnot used for futureresearchstudies.
(For unlinked samples)Your sampleswillnot belabeledwithanyof your personalinformation, such as your nameor acodenumber.Onceyou giveyour permissiontohaveyour leftoversamples stored,theywillbeavailablefor use infutureresearchstudiesindefinitelyandcannotberemoved duetotheinabilitytoidentifythem.
(Addthefollowingtissueoptionsorvariationsifstorageisoptional)You shouldinitialbelowto indicateyour preferencesregardingtheoptionalstorageof your leftover(tissue and/or blood and/or cells)for futureresearchstudies.
a.Your sample(s)maybestoredandused for futureresearchstudiestolearnabout,prevent,treat
or cure(disease/condition).
Yes No
b. Your sample[s]maybestoredandused for researchaboutotherhealthproblems.
Yes No
c.Your sample(s)maybesharedwithotherinvestigator/groupswithoutanyidentifying information.
Yes No
Participant:Bysigningbelow,youindicatethatyouhavereadtheinformationwrittenaboveand haveindicatedyourchoicesfortheoptionalpartoftheresearchstudy.
SignatureofParticipantDateTimePrintedName
Participant’sLegallyAuthorizedRepresentative:Bysigningbelow,you indicatethat youhave readtheinformationwrittenaboveandhaveindicatedyourchoicesfortheoptionalpartofthe researchstudy.
SignatureofParticipant’sLegallyDateTimePrintedName
AuthorizedRepresentative
(Signatureof Participant’sLegallyAuthorizedRepresentativeisrequiredfor peopleunableto giveconsentfor themselves.)
DescriptionoftheLegallyAuthorizedRepresentative’sAuthoritytoActforParticipant
Person Explaining the Research:Your signaturebelowmeansthatyou haveexplainedthe optionalpartof theresearchtotheparticipant/participantrepresentativeandhaveansweredany questionshe/shehas abouttheresearch.
SignatureofpersonwhoDateTimePrintedName explainedthisresearch
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