Pregnancy Follow-Up Consent Form

Pregnancy Follow-Up Consent Form

TITLE

Protocol #

Sponsor:

Investigator: [First, Last name], MD

Saint Luke’s Hospital

816-932-xxxxx

You are beingaskedtoparticipate in this additional research studybecause:

•Yourecentlybecame pregnantwhile participatinginthe above namedstudy withinXX days after thelast dose ofthestudy treatment______.

•Your partner receivedthestudy treatment______, as part ofaclinical study, and you became pregnantwithinXX days ofhis last dose ofthestudy treatment.

Because you became pregnantwhileyou were(or your partner was) participatinginthemain research study,thesponsor of the study wouldliketocollectinformation aboutyour pregnancy. Providingthis informationis entirely voluntary.This formdescribes the possiblerisks and benefits of providing this information about your pregnancy,as well as gives you informationaboutwhy the sponsor wants to monitor your pregnancy. Pleasereadthis formcarefully and ask as manyquestions as you needto, before decidingaboutthis research. You can ask questions nowor anytime duringthestudy.

You will be informed ofanynewinformationthatmight causeyoutochangeyour mind about participating.

WhyamIbeing asked to takepart in thisresearch about my pregnancy?

You are beingaskedtotake partinthis research to give information about your pregnancybecauseyourecently became pregnantwhileyou(or your partner) were participatinginthemaintreatment studyreceivingthestudytreatment ______(or within XX days ofthelast dose of______).

Therisks toyou or your babyfrom getting pregnant while you or your partner were in the main study are notknown. Therefore,thestudysponsor, [Sponsor], wouldliketocollectinformation aboutyou andyour babyto [Please adjust bullets below as applicable to your study]:

•Determineifthereis anyrisk tothemother or babyfromthemother’s use ofthe studydrug.

•Determineifthereis anyrisk tothemother or babyfromthefather’s use ofthe studydrugsinceyou became pregnant.

It is important for you to understand how your(andyourbaby’s)personalhealth informationmaybeusedorgiventootherssothatyoucandecidewhethertopermit theuseanddisclosure(sharing)ofyour(andyourbaby’s)healthinformationfor this study. Itisimportantthat anysymptoms arereported promptlyto thedoctor monitoringyourpregnancy,regardless ofwhether or notyouthink these symptoms arerelatedtothestudy treatment, ______.

What willIbe asked to do?

Wewouldliketocollect as muchinformationabout your health as possibleduring your pregnancy and delivery to help determineifthereis anyrisk toyou, or the baby from participating in the main study.Theresearchers wouldliketofollow you and your baby’s clinical course duringthe pregnancyand up until delivery.Researchers will ask questions andrecordinformation about:

•The outcome ofthe pregnancy,includingspontaneous or voluntarytermination

(miscarriage or abortion).

•Details ofthe birth andthe presence or absence of:

anybirth defects,congenital abnormalities, or maternal and/or newborn complications.

What arethepossiblerisksordiscomforts?

Therearenomedicalrisksassociatedwiththecollectionofinformation about your pregnancy.Themainriskofthisresearch isthepossiblelossof confidentialityofyour,and/oryourbaby’s medicalrecordinformation.

Theremay be pregnancyrisks associated with the study treatment that are not yet known.

Aretherebenefitsto being in thisstudy?

Youwill not benefitfromparticipating. Researchers hopethattheinformation thatmaybe useful for other patients whomaybecome pregnantwhile onthis research study.

Willit cost anything to bein the safetymonitoring activity?

Youwill not bechargedfor beinginthesafetymonitoringactivity. Ifyou and/or your babyhave anymedical expenses at Saint Luke’s Hospitalrelatedtoyour pregnancy, delivery, or the care ofyour babybefore or after the baby’s birth,theywill be billedtoyou or your medical /hospital insurance and/or third partyprovider.

______(thestudysponsor)and Saint Luke’s Hospitalwill not beresponsiblefor any costs relatedtoyour pregnancy, delivery, or the care ofyour babybefore or after the baby’s birth.

WillIget paid to participatein this research?

Thereis no paymentfor participating.

Willtheresearchersget paid fordoing this research?

Saint Luke’s Hospital of Kansas Citywill receive payments fromthesponsor, [Sponsor],for conductingthis study. Payments will be usedfor research purposes only.

What happensif Iget hurt or sickduring in thestudy?

If you or your baby gets hurt or sick during the research, then neither [Sponsor] nor Saint Luke’s Hospital will pay any money to you, or pay your medical bills. You or your insurance or government program will be responsible for paying any bills to treat any illness or injury if you or your baby gets hurt or sick during this research.

Payments will not be offered for other expenses (such as time off work, lost wages, childcare, etc.). You do not give up any legal rights by signing this form.

Do Ihaveto bein this research?

No. Your agreementto provideyour andyour baby’s healthinformationis voluntary. You canchoosewhether or nottosignthis form. Evenifyou decide nottoparticipate,youcanstill cometo Saint Luke’s Hospital for services andtreatmentwhichwould be billedtoyou or your medical /hospital insurance and/or third partyprovider inthe ordinarymanner.

If you are the partner of a study participant, your partner can continue participating in the main study even if you decide not to participate in this study.

What other choicesdo Ihave?

This is notatreatmentstudy. Youcanchoose nottoparticipate.

Howwillmyprivacybeprotected?

Theresearchers will protectyour information, as allowed bylaw. Absolute confidentialitycannot beguaranteed because persons outsidethestudyteam may needtolook atyour studyrecords. Your healthinformationis protected byafederal privacylawcalledHIPAA. Bysigningthis consent form,you aregivingpermission for Saint Luke’s Hospital to use andshareyour healthinformation. Ifyou are nota patient Saint Luke’s Hospital,youmight berequiredtocomplete additional paperwork in order to obtainyour medical records.Ifyou decide nottosigntheform, your informationwill not becollected andyoucannot beinthesafetymonitoringactivity.

Theresearchers will onlyuse andshareinformationthatis neededfor theresearch. To dotheresearch,theywill collect health informationfrommonitoring your pregnancyandfromyour medical record.Youmay beidentified byinformationsuch as name, address, phone, date ofbirth,social security number, or other identifiers. Your healthinformationwill be used at Saint Luke’s Hospitalby Dr. ______,members oftheresearchteam,the Health Information

Management Department of Saint Luke’s Hospital, the officials at Saint Luke’s Hospitalwho overseeresearch,includingmembers ofthe Saint Luke’s Institutional Review Boardand other committees and offices thatreviewandmonitor research studies.

Bysigningthis form,you aregivingyour doctor andtheresearchteampermissionto shareinformation aboutyouwith persons or groups outside Saint Luke’s Hospital. Your information will besharedwithrepresentatives of[Sponsor] (thesponsor ofthe study),themonitoringcompanythatinspects studydata, other business partners ofthe sponsor who helpwiththestudy,theU.S.Food andDrugAdministration(FDA) and similar agencies inforeigncountries (includingHealthCanada andthe European Medicines Agency),theDepartment ofHealth andHuman Services (DHHS),andU.S. agencies that oversee humanresearch(ifastudyauditis performed).

Thesegroups or agencies maymakecopies ofstudyrecords for audit purposes. The purpose for using and sharing your information is to evaluate if the study treatment affects you and your baby.

TheHIPAA privacylawmaynot applyto everyonewhoreceives your health information. Your informationmight not be protected byHIPAAifpersons outside Saint Luke’s Hospital discloseit. Insomecases,theremaybe other laws that protectyour information fromimproper use.

Your permissionto use andshareyour healthinformationwill not expire unless you cancel it. Anyresearchinformationthatis placedinyour medical recordwill bekept indefinitely.

Whileyou are participatinginthis research,youmaysee andcopyany studyinformationthatis placedinyour Saint Luke’s Hospitalmedical record. However,somestudy informationis kept onlybytheresearcher. Therecords kept onlybytheresearcher maynot be availabletoyou until the end ofthestudy.

Theresearchers maypublishtheresults oftheresearch. Iftheydo,theywill onlydiscuss groupresults. Your name andthat ofyour babywill not be usedin anypublication or presentation aboutthestudy.

Can I stop being in the safetymonitoring activity?

Youmaystop beinginthestudyat anytime. Your decisiontostop will not preventyoufromgettingtreatment or services at Saint Luke’s Hospitalor health benefits.

You havetherighttocancel your permissionfor researchers to useyour (or your baby’s) health information.Ifyouwanttocancel your permission, pleasewritetoyouDr.[Principal Investigator] at Dr.[Principal Investigator],insert physicians address.If

youcancel permissionto useyour healthinformation,youwill bewithdrawnfromthestudy.The researchers will stopcollectinganyadditional information aboutyou unless theyneed information aboutaside effect ofthestudydrug. Theymayuse andshareinformation thatwas gathered beforetheyreceivedyour cancellation.

Who can Italkto about the safetymonitoring?

Youcan ask questions at anytime aboutthe use andsharingofyour andyour baby’s information. Beforeyousignthis form,[Principal Investigator],MD, or other members ofthestudy teamshould answer all your questions. Youcantalk totheresearchers ifyou have any morequestions,suggestions,concerns or complaints after signingthis form. Ifyou have anyfurther questions aboutyour rightsandthe use ofsharingofyour and/oryour baby’s information, or ifyouwanttotalk withsomeonewhois notinvolvedinthestudy, youmaycall theSaint Luke’s Institutional Review Board at(816) 932-3361. Youmayalsowrite theSaint Luke’s Institutional Review Board at 4401 Wornall Rd, Kansas City MO 64111.

Consent

[Principal Investigator] or theresearchteamhas givenyouinformation aboutthis research. Theyhave explainedwhatwill be done and howlongitwill take. Theyexplained anyinconvenience, discomfort or risks thatmaybe experienced during this research.

Bysigningthis form,yousaythatyoufreelyandvoluntarilyauthorize participationin this research. You agreethat you can becontacted bythestudy doctor and be asked about thepregnancy,the birth and health of yourbaby.You have readtheinformation and hadyour questions answered. You willbegiven a signed copyof the consentformto keep for yourrecords.

Print Participant’s Name

Signature ofParticipantTimeDate

PrintName ofPersonObtainingConsent

Signature ofPersonObtainingConsentDate