Pregnancy Follow-UpConsentForm

TITLE

Protocol #

Sponsor:

Investigator: [First, Last name], MD

University of Kansas Medical Center

913-588-xxxxx

You are beingaskedtosignthis consentformbecause:

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

Or

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

Sinceyou became pregnantwhileyou(or your partner) were participatinginthemain study,thesponsor wouldliketocollectinformation aboutyour pregnancy. Providingthis informationis entirely voluntary.This formdescribes the possiblerisks and benefits as well as informationfor safetymonitoringofyour pregnancy. Pleasereaditcarefullyand 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 this safetymonitoring activity?

You are beingaskedtotake partinthis safetymonitoringactivitybecauseyourecently became pregnantwhileyou(or your partner) were participatinginthemaintreatment studyreceivingthestudytreatment______(or withinXX days ofthelast dose of______).

Therisks toyou or your babyare notknown. Therefore,thestudysponsor,[Sponsor], wouldliketocollectinformation aboutyou andyour newbornbabyto [Please adjust bullets below as applicable to your study]:

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

OR

•Determineifthereis anyrisk tothemother or babyfromthefather’s use ofthe

studydrugsinceyou became pregnant.

Thepurposeofthis formistoinformyouofhow your(andyourbaby’s)personalhealth informationmaybeusedorgiventootherssothatyoucandecidewhethertopermit theuseanddisclosure(sharing)ofyour(andyourbaby’s)healthinformationfor the purposesstatedinthis form. Itisimportantthat anysymptoms arereported promptlyto thedoctor monitoringyourpregnancy,regardless ofwhether or notyouthink these changes arerelatedtothestudytreatment, ______.

What willIbe asked to do?

Wewouldliketocollect as muchinformation as possibleto help determineifthereis anyrisk toyou, or the baby.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.Themainriskofthissafety monitoring activity isthepossiblelossof confidentialityofyour,and/oryourbaby’s medicalrecordinformation.

Theremay be pregnancyrisks associated with the study treatment that are notyet known.

Aretherebenefitsto being in this safetymonitoring activity?

Youwill not benefitfromthis safetymonitoring. 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 KUMC relatedtoyour 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 KUMC will not beresponsiblefor any costs relatedtoyour pregnancy, delivery, or the care ofyour babybefore or after the baby’s birth.

WillIget paid to participatein the safetymonitoring activity?

Thereis no paymentfor this safetymonitoringactivity.

Willtheresearchersget paid fordoing the safetymonitoring activity?

Theinstitution(KUMC ResearchInstitute,Inc.) will receive payments fromthesponsor, [Sponsor],for conductingthis study. Payments will be usedfor research purposes only.

What happensif Iget hurt or sickduring in the safetymonitoring activity?

If you or your baby gets hurt or sick during the safety monitoring activity, then neither [Sponsor] nor KUMC 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 safety monitoring activity.

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. If you think you have been harmed as a result of this research at the University of Kansas Medical Center (KUMC), you should contact the Director, Human Research Protection Program, Mail Stop #1032, University of Kansas Medical Center, 3901 Rainbow Blvd., Kansas City, KS 66160.

Do Ihaveto bein the safetymonitoring activity?

Your agreementin providingyour andyour baby’s healthinformationis voluntary. You canchoosewhether or nottosignthis form. Evenifyou decide nottojointhesafety monitoringactivity,youcanstill cometo KUMC 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 study even if you decide not to participate in the safety monitoring activity.

What other choicesdo Ihave?

This is notatreatmentstudy. Youcanchoose notto beinthesafetymonitoring activity.

Howwillmyprivacybeprotected?

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

Theresearchers will onlyuse andshareinformationthatis neededfor thesafety monitoringactivity. To dothesafetymonitoringactivity,theywill collect health informationfromthesafetymonitoringactivities andfromyour medical record.Youmay beidentified byinformationsuch as name, address, phone, date ofbirth,social security number, or other identifiers. Your healthinformationwill be used at KUMC by Dr. ______,members oftheresearchteam,TheUniversityof Kansas Hospital Medical RecordDepartment,the KUMC ResearchInstitute and officials at KUMC who overseeresearch,includingmembers ofthe KUMC Human Subjects Committee and other committees and offices thatreviewandmonitor research studies.

Bysigningthis form,you aregivingyour doctor andtheresearchteampermissionto shareinformation aboutyouwith persons or groups outside KUMC. 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 KUMC 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 safetymonitoringactivity,youmaysee andcopyany studyinformationthatis placedinyour KUMC medical record. However,somestudy informationis kept onlybytheresearcher. Therecords kept onlybytheresearcher maynot be availabletoyou until the end ofthestudy.

Theresearchers maypublishtheresults ofthesafetymonitoringactivity. 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 beinginthesafetymonitoringactivityat anytime. Your decisiontostop will not preventyoufromgettingtreatment or services at KUMC or 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], 3901RainbowBoulevard, Kansas City, KS, 66160.Ifyoucancel 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 theHuman Subjects Committee at(913) 588-1240. Youmayalsowrite theHuman Subjects Committee atMail Stop #1032,UniversityofKansas Medical Center, 3901RainbowBlvd., Kansas City, KS 66160.

Consent

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

Bysigningthis form,yousaythatyoufreelyandvoluntarilyauthorize participationin this researchsafetymonitoringactivity. You agreethatyoucan becontacted bythestudy doctor and be asked aboutthepregnancy,the birth and health ofyourbaby.You have readtheinformation and hadyour questions answered. You willbegiven a signed copyof theconsentformto keep for yourrecords.

Print Participant’s Name

Signature ofParticipantTimeDate

PrintName ofPersonObtainingConsent

Signature ofPersonObtainingConsentDate