Annual Principal Investigator Worksheet About Local Context
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1 Cmpleting the NCI CIRB Annual Principal Investigatr Wrksheet Abut Lcal Cntext and the Study-Specific Wrksheet Abut Lcal Cntext at the University f Iwa All investigatrs cnducting research with the Natinal Cancer Institute s Central IRB (NCI CIRB) as the IRB f recrd are required t cmplete an Annual Principal Investigatr Wrksheet Abut Lcal Cntext and the Study-Specific Wrksheet Abut Lcal Cntext and submit these dcuments t the NCI CIRB fr apprval. The NCI CIRB will use the infrmatin in these wrksheets t dcument hw lcal investigatrs will cmply with site-specific elements f study cnduct. Annual Principal Investigatr Wrksheet Abut Lcal Cntext T ensure that the infrmatin prvided t the NCI CIRB is cnsistent with University f Iwa plicies and guidance, the investigatr must submit a draft f the Wrksheet fr review by the UI s Human Subjects Office prir t submitting the Wrksheet t the NCI CIRB. The Wrksheet may be submitted t the NCI CIRB nly after the Human Subjects Office has cnfirmed that it is acceptable. Step I: Obtain CTEP (Cancer Therapy Evaluatin Prgram) Identity and Access Human Subject Prtectin training is required befre yu can receive a CTEP identity and access. If yu have nt yet cmpleted yur Human Subject Prtectin training, review this page n the UI s Human Subjects Office website fr instructins t cmplete the training. Yu must btain and maintain this CTEP IAM accunt and ID number in rder t be a member f a cperative grup/netwrk grup. T btain a CTEP IAM accunt and ID number, please fllw the instructins belw: G t When the Warning Ntice bx appears, click I Agree. If the screen says The user sessin has timed ut. Click the wrd Here n the screen t cntinue. Under User Accunt Maintenance, select Request New Accunt. Fllw the 4 Steps they give yu t create yur accunt. CTEP will then send yu an with yur CTEP ID number. 1
2 Once yu receive yur CTEP ID number, frward the CTEP ID number t Clarine Halvrsen. Ms. Halvrsen will add yur number t the ALLIANCE Membership Rster Frm and submit it t the ALLIANCE. The ALLIANCE will send yu an nce they have cmpleted yur membership. Yur lg in username and passwrd will be the same nes yu use t lg int the CTSU (created when yu btained yur CTEP IAM accunt and ID number abve). When the ALLIANCE cntacts yu by , please ntify Ms. Halvrsen as she will need t g int the CTSU website t assign a rle fr yu in the rster. Step II: Obtain a username and passwrd t access the NCI CIRB's IRBManager The UI s Human Subjects Office has prvided the NCI CIRB with a list f principal investigatrs (PIs) and research staff wh may be invlved n NCI CIRB studies and need access t secure CIRB resurces. Persnnel n that list shuld receive a username and passwrd frm the NCI CIRB Operatins Office. The username and passwrd allw UI persnnel t lg in t the NCI CIRB s IRBManager system (an nline submissin tl akin t the UI s HawkIRB system). PIs r research staff wh have nt received a username and passwrd frm the NCI CIRB shuld cntact Anna Mertes in the UI Human Subjects Office. Step III: Access the Annual Principal Investigatr Wrksheet abut Lcal Cntext Fllw the directins in the NCI CIRB Instructin Manual fr Wrksheet Cmpletin in IRB Manager (available at t lg in t IRBManager and pen a new Annual Principal Investigatr Wrksheet abut Lcal Cntext. Nte that a study team member may enter infrmatin in the Wrksheet n the PI s behalf, but nly the PI can submit the cmpleted frm. Step IV: Incrprate recmmended language Answers fr many f the questins in the Annual PI Wrksheet will be specific t each PI. Hwever, because recruitment practices, infrmed cnsent prcess, use f legally authrized representatives, and inclusin f vulnerable subject ppulatins must be cnsistent with University f Iwa plicies and guidance, study teams shuld be aware f the infrmatin prvided belw. In applicable instances, the infrmatin shuld be incrprated int these sectins f the Wrksheet. Questin 4 (Research nurses): If these nurses and clinical research assistants are fr the mst part nt hired by the Department f Nursing (DON) but rather hired specifically fr research studies by PIs. Unless the PI is a nurse r the prject is fcusing n nursing staff r nursing practice, the Nursing Research Cmmittee wuld nt review NCI CIRB studies. 2
3 Questin 5 (Cnflicts f interest): If the answer t this questin is yes, University f Iwa IRB s review will be required. If the PI r any member f the research team has a cnflict f interest related t studies n the CIRB menu that result in an actual r perceived financial cnflict f interest, the UI will nt defer IRB versight t anther IRB. Cntact Anna Mertes in the UI Human Subjects Office. Questin 8 (Recruitment): A descriptin similar t what wuld be included in a HawkIRB applicatin shuld be adequate here. Be sure t specify whether medical recrds will be reviewed prir t cnsent t check ptential eligibility. The NCI CIRB will nt serve as a UIHC Privacy Bard. The UI IRB will be required t review, apprve, and issue all partial and full waivers f authrizatin under HIPAA. Questin 9 (Recruitment materials): If any recruitment materials require a lcal IRB Stamp, uplad as attachments in the Recruitment Materials sectin f the HawkIRB applicatin. The HSO will stamp the dcuments upn apprval f the NCI CIRB. Questin 10 (Cmpensatin t participants): If cmpensatin is available all institutinal plicies that apply must be fllwed. Questin 16 (Cnsent prcess fr nn-english speaking subjects): Explain in the respnse Cnsent Dcuments and ther printed and/r electrnic study materials must be prvided in a language that is understandable t the subject. This will require translatin int each language spken by subjects the Principal Investigatr wishes t enrll in the study. The HRPP will review the English versin f all dcuments prir t submissin t the NCI CIRB. The NCI CIRB will review and apprve all nn-english translatins f the cnsent dcuments. Questin 17 (Wh prvides cnsent): Nte that, just as fr studies under the UI IRB s purview, subjects wh lack cnsent capacity shuld nt be enrlled unless there is justificatin fr including these vulnerable subjects, and an apprpriate plan fr surrgate cnsent is prvided. D nt select LAR fr Q17 unless yur research includes patient ppulatins expected t have impaired decisin-making capacity. Questin 19 (institutin s plicy n impaired adults): Fr Impaired Adults: Fr studies cnducted in the state f Iwa, the first persn n the list belw wh is reasnably available and cmpetent must sign as the legally authrized representative even if 3
4 anther persn n the list is mre cnveniently available. Guardians (Iwa Cde 600A.2 (8 and 9)) 1. The designated prxy (such as a Durable Pwer f Attrney fr Health Care) 2. Curt-appinted guardian 3. Spuse (des nt include Cmmn-law spuse) 4. Adult child 5. Parent 6. Adult sibling Questin 20 (institutin s prcess fr receiving and addressing cncerns frm study participants and thers abut the cnduct f the research): Include the fllwing infrmatin: UI template cnsent language directs subjects t discuss questins and cncerns abut the research with their study dctr; cntact infrmatin is prvided fr investigatrs at the UI. It als states the fllwing: If yu have questins, cncerns, r cmplaints abut yur rights as a research subject r abut research related injury, please cntact the Human Subjects Office, 105 Hardin Library fr the Health Sciences, 600 Newtn Rd, The University f Iwa, Iwa City, IA , (319) , r irb@uiwa.edu. General infrmatin abut being a research subject can be fund by clicking Inf fr Public n the Human Subjects Office web site, T ffer input abut yur experiences as a research subject r t speak t smene ther than the research staff, call the Human Subjects Office at the number abve. The UI Human Subjects Office s website als prvides infrmatin where anyne can reprt a cncern abut human subjects research. Questin 21 (pharmacy infrmatin): A yes respnse t this questin will trigger a required review by the Pharmacy and Therapeutics Cmmittee. Questin 23 Apprpriate institutinal data security measures will be required depending n respnse selected in this questin. Questin 26 (intentin t use a legally authrized representative [LAR] t enrll subjects): In mst, if nt all, cases, the respnse t this questin shuld be n. Just as fr studies under the UI IRB s purview, subjects wh lack cnsent capacity shuld nt be enrlled unless there is justificatin fr including such subjects, and an apprpriate plan fr surrgate cnsent is prvided. D nt select yes fr Q26 unless yur research includes patient ppulatins expected t have impaired decisinmaking capacity. 4
5 Questin 27: In studies cnducted in the state f Iwa, the first persn n the list belw wh is reasnably available and cmpetent must sign as the legally authrized representative even if anther persn n the list is mre cnveniently available. The designated prxy (such as a Durable Pwer f Attrney fr Health Care) Curt-appinted guardian Spuse (des nt include Cmmn-law spuse) Adult child Parent Adult sibling Questin 29 (Vulnerable ppulatins): If the study invlves children AND pregnancy testing, select Other under Safeguards and include the fllwing UIHC Plicy language frm the Infrmed Cnsent Dcument: Pregnancy Testing fr Females Under the Age f 18 All females wh are physically able t becme pregnant will be required t have a pregnancy test befre [describe each time the testing will ccur in relatin t study prcedures]. If the test shws that yu are pregnant, yu will nt be able t [have this test/cntinue in the study.] This testing will ccur in a private area withut any f yur family members with yu. If yu are 12 years f age r lder we will nly tell yu the results f the test. Yu can decide whether r nt t tell yur parents r guardian the results f the pregnancy test, hwever, if yu are pregnant we will need t tell yur parents yu cannt [have fill in the study prcedure/cntinue in the study.] If the pregnancy test shws that yu are pregnant we will ask yu whether r nt yu want us t talk with yur parents r guardian abut yur pregnancy. If yu are under 12 years f age and the pregnancy test shws that yu are pregnant, we are required t reprt the pregnancy t the prper authrities. IMPORTANT: N matter hw ld yu are - if we think that yur pregnancy may have happened because f abuse, we will tell the prper authrities and yur parents r guardian will be tld abut yur pregnancy. 5
6 Step V: Prir t submitting the Wrksheet t the NCI CIRB, submit t the HSO fr lcal review If yu are cmpleting yur Annual Principal Investigatr Wrksheet Abut Lcal Cntext, review by the Human Subjects Office is required befre the Wrksheet is submitted t the NCI CIRB. This is a curtesy t study teams, intended t ensure that infrmatin related t recruitment and cnsent prcess are cnsistent with institutinal plicies and prcedures. T submit fr review: When yu reach the end f the Wrksheet, select Print and save the Wrksheet as a PDF. Then select Save fr Later. D nt submit t the NCI CIRB at this pint. Attach a cpy f the Wrksheet t yur Prfile in HawkIRB. Instructins t cmplete this can be fund at the end f this dcument in Appendix A. The frm will be reviewed within tw business days f receipt. Any questins r recmmended revisins will be sent t the study team via . The Human Subjects Office will send an t the study team cnfirming that the Wrksheet may nw be submitted t the NCI CIRB nce the review is cmplete. Fllw the NCI CIRB Instructin Manual fr Wrksheet Cmpletin in IRB Manager t submit the Wrksheet t the NCI CIRB. Step VI: Receive NCI CIRB cnfirmatin f apprval fr the Annual Principal Investigatr Wrksheet When the UI PI submits the Annual Principal Investigatr Wrksheet Abut Lcal Cntext t the CIRB, it is reviewed in detail by the NCI CIRB s Lcal Cntext Subcmmittee. This subcmmittee determines if the Wrksheet is acceptable and the PI is eligible t cnduct studies under the NCI CIRB s versight. Study-Specific Wrksheet Abut Lcal Cntext The Study-Specific Wrksheet Abut Lcal Cntext is required by the NCI CIRB t be cmpleted fr each study which a principal investigatr wishes t cnduct. The cmpleted Wrksheet shuld be upladed t the crrespnding HawkIRB applicatin. Yu can uplad this dcument within the Persnalize tab in HawkIRB. Steps t take: PersnalizeUpdate My PrfileUplad NCI CIRB Wrksheet The Wrksheet will ask fr specific changes t any questins that were answered n the Annual Principal Investigatr Wrksheet. Each Study-Specific Wrksheet will be reviewed by the Human Subjects Office. Any changes (such as cnflict f interest) may prevent submissin t the NCI CIRB. 6
7 BOTH AN ANNUAL PRINCIPAL INVESTIGATOR WORKSHEET AND A STUDY-SPECIFIC PRINCIPAL INVESTIGATOR WORKSHEET MUST BE APPROVED BY THE NCI CIRB BEFORE A NEW STUDY MAY BE CONDUCTED. See Natinal Cancer Institute Central Institutinal Review Bard (NCI CIRB) fr University f Iwa requirements fr pening new CIRB studies, as well as the NCI CIRB Instructin Manual fr Wrksheet Cmpletin in IRB Manager ( 7
8 Appendix A Hw t uplad yur cmpleted Annual Principal Investigatr Wrksheet abut Lcal Cntext t HawkIRB Step 1: Lg int HawkIRB and click n the Persnalize tab at the tp Step 2: Click Update my Prfile 8
9 Step 3: At the bttm f yur prfile page yu will see a new windw Uplad NCI CIRB Wrksheet 9
10 Step 4: After yu have cmpleted this frm, save it as a PDF and uplad it t yur attachments Remember, yu will need t dwnlad the Annual Principal Investigatr Wrksheet abut Lcal Cntext frm the NCI CIRB website. Only the PI will be able t access this frm and nly the PI can submit it int his/her prfile in HawkIRB. If yu have questins, please cntact Anna Mertes at uirb-external@uiwa.edu r
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