Advarra IRB Sequence of Submission and Review Checklist and Review Process for Study Teams

Transcription

1 Advarra IRB Sequence f Submissin and Review Checklist and Review Prcess fr Study Teams 1. Start by cntacting the KUMC IRB ffice t cnfirm that the study is eligible fr review by the Advarra IRB. 2. The applicable regulatry ffice (Research Institute r Cancer Center) submits a request in the eirb system t use an external IRB, fllwing step 3 belw. 3. Uplad the fllwing dcuments int the eirb submissin: a. Generic Request t Use an External IRB. b. Study Prtcl c. Cnsent previusly apprved by Advarra fr the study as a whle. d. Prpsed KUMC cnsent draft, created by custmizing the previusly-apprved cnsent dcument(s) accrding t the Advarra-apprved lcal cntext checklist which is included in this packet. e. Any submissins t Ancillary Review cmmittees (e.g., RSC r nursing impact) f. Signed Administrative Certificatin frm (unless the prject will be electrnically ruted, e.g., Internal Medicine.) g. PRMC review, fr studies in the Cancer Center i. PRMC apprval is required befre IRB submissin (r request t rely) fr industry-spnsred trials. ii. PRMC apprval can ccur in parallel t IRB submissin (r request t rely) fr cperative grup studies. 4. IRB r Cmpliance Staff are respnsible fr the fllwing steps: a. Cnfirm current human subjects training and current cnflict f interest (COI) disclsures fr all members f the study team. Per ur agreement with Advarra, these must all be current befre the Advarra IRB submissin. b. Initiate a COI review if there are relevant COI disclsures c. Ntify ancillary reviewers within the eirb system d. Cnfirm that the cnsent frm(s) have been apprpriately adapted fr lcal cntext. e. Cnfirm that the prvisins related t payment fr injury are aligned with KUMC cntract language f. Return the submissin t the study team/regulatry ffice if additins r crrectins t the cnsent frm(s) are required g. Hld the release t Advarra until all ancillary reviews are cmpleted and any additinal cnsent frm changes have been made 5. When the abve steps have been cmpleted, IRB staff will cmplete and sign the Transfer f Obligatins frm. It will be upladed as a cmment in the Histry tab f the study. 6. IRB staff will put the study int Clarificatins Requested status s that respnses can be submitted after Advarra IRB review. 7. Once Advarra IRB apprves the invlvement f KUMC investigatrs and apprves a versin f the cnsent frm fr KUMC, the regulatry ffice uplads the KUMC-specific Advarra IRB apprval letter and the KUMC-specific cnsent frm int eirb. 8. After all apprvals have been btained and upladed, then reliance n the external IRB is cnfirmed. 9. IRB staff will generate a cnfirmatin letter and attach it in the Histry sectin. 10. The study may begin when it has been activated by the regulatry ffice and the spnsr. May 2018 Page 1 f 2

2 After Initial Review: 1. After the external IRB is cnfirmed, then Advarra IRB is the IRB f recrd fr all future amendments, cntinuing reviews, adverse events, etc. 2. During the study, the lcal study r regulatry ffice is respnsible fr filing a SITE Mdificatin in the eirb system if there are changes that culd impact the lcal cntext review. These may include: a. New KUMC principal investigatr b. Changes t financial relatinships that culd create a cnflict f interest fr the study. c. Cntractual changes related t payment fr study-related injury d. Changes impacting HIPAA privacy r data security e. Changes impacting csts t participants 3. Fr persnnel changes, the regulatry ffice shuld create a SITE Mdificatin in the eirb system. New persnnel must be current n human subjects training and cnflict f interest disclsures. A persnnel acknwledgement letter will be available in the eirb system. 4. Internal serius adverse events r a ptentially serius issues f nn-cmpliance shuld be reprted in eirb thrugh the Reprt f New Infrmatin (RNI) functin. 5. Fllwing Advarra s cntinuing review, the regulatry ffice shuld update the eirb system with the new Advarra IRB renewal letter, uplad the latest versin f the prtcl (if it has been revised since initial apprval), and enter the new study expiratin date. This can be dne by editing the STUDY page and saving. It des nt require that anything is submitted. May 2018 Page 2 f 2

3 CUSTOMIZING THE ADVARRA-APPROVED CONSENT TEMPLATE FOR UNIVERSITY OF KANSAS MEDICAL CENTER (KUMC) Main Cnsent Frm [The changes belw are made using a header frmat. Adjust as apprpriate when a Questin/Answer frmat is used.] Overview/ Intrductin Name and cntact inf f the KUMC investigatr Medical recrds bar cde n page 1 nly Number f subjects t be enrlled at KUMC Mdify the cntact infrmatin n page 1 (utilizing the new Advarra merge table) Spnsr / Study Title: Prtcl Number: Principal Investigatr: (Study Dctr) Telephne: Additinal Cntact(s): (Study Staff) Address: Spnsr Name / Prtcl Title Prtcl Number «PiFullName» «IcfPhneNumber»; ask fr the [medical specialty] attending physician n call and tell the physician that yu are in this research. «AdditinalStaffMemberCntacts» «PiLcatins» Backgrund and Purpse Discussin regarding hw the test article wrks and why it might be [mre effective, reduce symptms, imprve survival, etc.] is included. Prcedures Fr KUMC, present the study grups in a bulleted list, nting the dse assciated with each grup. If applicable, explain that cmmunicable diseases will be reprted t Kansas Department f Health as required by law. Expectatins We specify the language change, yu will be asked t rather than expected t In the list f examples, we specify the subject will be asked t take the study prduct as instructed rather than expected

4 Risks Fr KUMC, the risk sectin begins with the fllwing paragraph: The study [drug/device/bilgic/interventin] may cause side effects r ther prblems. The researchers will be checking yur medical infrmatin during the study t watch fr side effects. Hwever, yu shuld tell the research team abut anything that is bthering yu r any changes in yur health since the last visit. The researchers may be able t take steps t reduce side effects. Yu may experience nne, sme, r all f the side effects listed belw. There may be ther side effects r risks that are nt yet knwn. If applicable, allergic risks shuld be described using the KUMC template language. Sample language fr an utpatient study is as fllws: Allergic Reactin Risks Smetimes, peple have serius allergic reactins t drugs. A severe allergic reactin culd be life-threatening and may result in death. Symptms f allergic reactins include: Swelling f the muth, thrat r eyes Rash Difficulty breathing Cughing Wheezing Sudden drp f bld pressure Seizures Flushing A fast pulse Sweating Yu shuld call 911 if yu think yu are having a severe allergic reactin. Please als cntact the study team if yu have any f these r ther side effects during the study. Risks f Study Prcedures N lcal changes fr mst study prcedures As applicable, this sectin shuld use the radiatin risks specified by the KUMC Radiatin Safety Cmmittee. Pregnancy Risks Fr KUMC, the pregnancy risk sectin begins with the fllwing paragraph, if the study invlves females f child-bearing ptential: If there is knwn teratgenicity, discuss that infrmatin at the beginning f this sectin. Otherwise, begin this sectin as fllws: The [study drugs/ prcedures, etc.] used in this study might hurt an unbrn child r a child wh is breast-feeding. Yu cannt be in this study if yu are pregnant r nursing a baby. Yu cannt be in this study if yu are trying t get pregnant. Yu will have a pregnancy test befre the study starts. Yu must use birth cntrl during the study and fr weeks after yur last dse f study drug. The apprved methds f birth cntrl are: [list per the Advarra template] Fr KUMC, please add abstinence as an apprved methd. Retain all ther Advarra pregnancy risk language. Csts Use the study-specific cst language apprved by the KU hspital billing grup Cmpensatin fr Participatin

5 Fr KUMC, change the term cmpensatin t payment We have specified language n hw t describe payments, the ClinCard system, the RI, 1099 language, reimbursements, if applicable, and use f a secure cmputer: Yu will receive $xx.xx fr each cmpleted study visit. If yu cmplete the entire study, payment may be up t $xxx.xx. If yur participatin in this study ends early, yu will be paid nly fr the visits yu have cmpleted. Yu will be given a ClinCard, which wrks like a debit card. After a study visit, payment will be added nt yur card by cmputer. The mney will be available within 1 business day. Yu can use the ClinCard at an ATM r at a stre. N ne at KUMC will knw where yu spent the mney. Yu will be given ne card during the study. If yur card is lst r stlen, please call (866) The KUMC Research Institute will be given yur name, address, scial security number, and the title f this study t allw them t set yu up in the ClinCard system. Study payments are taxable incme. A Frm 1099 will be sent t yu and the Internal Revenue Service if yur payments are $600 r mre in a calendar year. If reimbursements are ffered, insert the fllwing paragraph: Reimbursement fr travel expenses may be available. [Insert details]. All reimbursements will need t be pre-apprved by the study team. Yu will be asked t keep yur receipts in rder t receive reimbursement. Yur persnal infrmatin will be kept n a secure cmputer. It will be remved frm the cmputer after the study is ver and the mney n the card has been used. Yur infrmatin will nt be shared with ther businesses. It will be kept cmpletely cnfidential. OR Yu will nt receive any mnetary cmpensatin fr yur participatin in this study. Regardless f whether participants are being paid, when the study invlves specimens, fr KUMC, add this paragraph abut wnership f samples: The specimens cllected during this study will be prvided t the study spnsr. If a cmmercial prduct is develped frm this research, the prfits will belng t the spnsr. There are n plans t prvide financial payment t yu shuld this ccur. Surce f Funding fr the Study This sectin is specifically added fr KUMC if nt already present The first paragraph discussed payments ging t the team and the RI The spnsr, [spnsr name], will pay the research team and KUMC Research Institute, Inc. fr cnducting this study. Payments will be used fr research purpses nly. If needed, a COI disclsure paragraph wuld als g in this sectin, using language specified by the KUMC Cnflict f Interest Cmmittee Cmpensatin fr Injury As nted abve, please change cmpensatin t payment

6 IRB staff will check with the KUMC Research Institute t cnfirm the prpsed language matches what has been negtiated in the cntract IRB staff will cnfirm this sectin cntains a statement that subjects d nt give up any legal rights by signing this frm. When the spnsr will be paying fr study-related injuries, add the fllwing paragraph: Fr the spnsr t pay these medical expenses, they will need t knw sme infrmatin abut yu like yur name, date f birth, and scial security number. This is because [the spnsr] has t check if yu receive Medicare, and, if yu d, reprt the payment it makes t Medicare. [The spnsr] will nt use this infrmatin fr any ther purpse. This sectin ends with ur standard institutinal paragraph: If yu think yu have been harmed as a result f participating in research at the University f Kansas Medical Center (KUMC) r ne f its affiliates, yu shuld cntact the Directr, Human Research Prtectin Prgram at Mail Stp #1032, University f Kansas Medical Center, 3901 Rainbw Blvd., Kansas City, KS Yu may als telephne (913) Cnfidentiality/Privacy Authrizatin Whether the HIPAA authrizatin is embedded in the main bdy f the cnsent frm r presented as a stand-alne dcument, the fllwing parties must be listed as having access t identifiable data: Grups at KUMC that mnitr research studies. Advarra IRB The University f Kansas Health System Medical Recrd Department, The KUMC Research Institute Vluntary Participatin/Withdrawal The sectin uses the standard Advarra sectin with the fllwing additins: As a secnd paragraph, insert the fllwing text: Yu have the right t cancel yur permissin fr researchers t use yur health infrmatin. If yu want t cancel yur permissin, please write t [PI Name]. The mailing address is [PI Name], University f Kansas Medical Center, 3901 Rainbw Bulevard, Kansas City, KS If yu cancel permissin t use yur health infrmatin, yu will be withdrawn frm the study. The researchers will stp cllecting any additinal infrmatin abut yu unless they need infrmatin abut a side effect f [the study drug, device, treatment]. They are permitted t use and share infrmatin that was gathered befre they received yur cancellatin. At the end f this sectin, the fllwing paragraph is inserted: Neither the spnsr, nr the investigatr, nr the University f Kansas Medical Center will be bligated t prvide yu with any [study drug] r treatment if the study is stpped early. Yur physician will decide abut future treatment, if it is needed. Cnsent/signature blck The KUMC-specific language and signature lines are as fllws: The study dctr r the research team has given yu infrmatin abut this research study. They have explained what will be dne and hw lng it will take. They explained the incnveniences, discmfrts and risks described in this cnsent dcument.

7 By signing this frm, yu say that yu freely and vluntarily cnsent t participate in this research study. Yu have read the infrmatin and had yur questins answered. Yu will be given a signed cpy f the cnsent frm t keep fr yur recrds. _ Print Participant s Name Signature f Participant Time _ Print Name f Persn Obtaining Cnsent _ Signature f Persn Obtaining Cnsent Cnsent fr Parental Permissin When needed, please refer t the KUMC bilerplate signature blck fr parents. CONSENT The study dctr] r the research team has given yu and yur child infrmatin abut this research study. They have explained what will be dne and hw lng it will take. They explained any incnvenience, discmfrt r risks that yur child may experience during this study. By signing this frm, yu say that yur child is freely and vluntarily cnsenting t participate in this research study. Yu have read the infrmatin and had yur questins answered. Yu will be given a signed cpy f the cnsent frm t keep fr yur recrds. / / _ Child s Name: Child s Age: Parent s Name: _ (please print) Parent s Signature: Name f Persn Obtaining Cnsent: (please print) Signature f Persn Obtaining Cnsent: _ CHILD ASSENT If the study subjects will include children ages 7 17 wh are expected t have capacity t agree t research, insert a brief Child Assent sectin here. A stand-alne adlescent assent als may be apprpriate as determined by the reviewing IRB.]

8 Cnsent fr Surrgate Decisin-Makers When needed, please refer t the KUMC bilerplate signature blck fr surrgates that aligns with Kansas state law. CONSENT The study dctr r their assciates have given yu infrmatin abut this research study. They have explained what will be dne and hw lng it will take. They explained any incnvenience, discmfrt r risks that may be experienced during this study. If the participant becmes able t cnsent t research during the curse f the study, the infrmatin in this frm will be presented t them fr their cnsent. On behalf f the persn fr whm yu are making decisins, yu freely and vluntarily cnsent t participate in this research study. Yu have read and understand the infrmatin in this frm and have had an pprtunity t ask questins and have them answered. Yu will be given a signed cpy f the cnsent frm t keep fr yur recrds. As legal guardian r representative, I,, Type/Print Name f Guardian/Representative authrize the participatin f _ in this research study. Type/Print Name f Participant I understand that I may nt authrize participatin in this study if the individual has previusly expressed wishes t the cntrary, either rally r in writing. I am (please initial ne f the fllwing categries): Legal guardian r Durable Pwer f Attrney fr Healthcare Decisins Adult r emancipated minr s spuse (unless legally separated) Adult child Parent Adult relative by bld r marriage Signature f Legal Guardian/ Representative Print Name f Persn Obtaining Cnsent Signature f Persn Obtaining Cnsent _

9 If the adult subjects may be capable f prviding assent, add an assent sectin with details specific t the study as determined apprpriate by the reviewing IRB. A sample fllws: ADULT ASSENT I am being asked t be in a research study because I have. The investigatr and/r his assistants have explained the study t me and my caregiver. If I decide t be part f this study, I will have XX visits at the University f Kansas Medical Center. I will receive a study drug thrugh my vein. I will have sme medical tests and answer questins that test my memry and thinking. Bld will be taken several times by sticking a needle in my arm, and I will have t give several urine samples. My caregiver has read the cnsent frm and has agreed fr me t d this research study. If I sign my name, I am saying that I want t be in the study. I knw that I dn t have t d it even if my caregiver has given their permissin. I knw that I can stp being in this study even if I signed my name. If I want t stp at any time, all I have t d is tell my caregiver, the study dctr, r his assistants. Print Subject s Name Signature f Subject Optinal Sub-study If applicable, this sectin is placed after the main cnsent signature blck t help participants understand it is ptinal. Fr ptinal sub-studies, use the Advarra template language plus the fllwing paragraphs as applicable: Even thugh these prtectins are in place, nce yur samples and infrmatin leave KUMC they may be used by ther researchers r rganizatins wh are nt required t fllw HIPAA rules. While it might nt be prtected by HIPAA, there may be ther laws that prtect yur infrmatin frm imprper use. KUMC is nt respnsible fr any sample r data that leaves its cntrl. Yu may withdraw yur cnsent t use the remaining samples and assciate health infrmatin at any time by telling yur study dctr. In this case, the sample will be [insert whether the sample will be destryed r returned]. Samples r related infrmatin that have already been used by researchers cannt be returned r destryed. Hwever, n new infrmatin abut yu will be cllected. Reprts abut this ptinal research will nt be given t yu r yur dctr. These reprts will nt be put int yur medical recrd. The future research will nt have an effect n yur care. If results are published, yur name and ther persnal infrmatin will nt be given End this sectin with the standard Advarra paragraph that subjects may decide nt t participate and the checkbxes t indicate preference. Add a full signature blck fr the participant and the persn btaining cnsent