DOCUMENTATION OF IRB ACTIVITIES Chapter 8

Transcription

1 Human Subjects Prtectin Prgram Office 501 E. Bradway, Suite 200 Luisville KY P: Service Acct: In this chapter: 8.1 Staff Supprt f IRB Membership -IRB Rster Requirements 8.2 Qurum Requirements and Vting at IRB Meetings 8.3 Meeting Times, Materials and Preparatin fr IRB meetings 8.4 IRB Study Files 8.5 Recrds Retentin 8.6 IRB Minutes 8.7 IRB Review f Planned Emergency Research 8.8 The Rle f the Chair(s) and Vice Chair(s) and Their Vting Respnsibilities 8.1 Staff Supprt f IRB Membership The IRB has a qualified staff, dedicated t supprting the IRB in its missin t prtecting human participants in research. The IRB staff are reviewed at least annually by the HSPPO Directr and HSPPO Assistant Directr and the AVPRI t ensure they cntinue t prvide sufficient resurces t the IRB. The IRB staff has knwledge, skills and abilities apprpriate t their respective rles. The HSPPO Directr versees the Assistant Directr (IRB Administratr), the IRB Cmpliance Audit Team, the Research Administrative Systems Analyst (IRB Mdule Administratr) and an administrative assistant, and is respnsible fr the verall management f the HSPPO. See the HSPPO Organizatin Chart. Fr plicies n qualificatins, educatin and peridic evaluatin f HSPPO staff, see Chapter 4. The IRBs maintain dcumentatin f their activities. IRB recrds include IRB study files, minutes fr cnvened IRB meetings, and ther dcumentatin. IRB Rster Requirements AAHRPP Std./ Descriptin Element II.1.A The IRB membership permits apprpriate representatin at the meeting fr the types f research under review, and this is reflected n the IRB rster. The IRB has ne r mre unaffiliated members; ne r mre members wh represent the general perspective f participants; ne r mre members wh d nt have scientific expertise; ne r mre members wh have scientific r schlarly expertise; and, when the IRB regularly reviews research that invlves vulnerable participants, ne r mre members wh are knwledgeable abut r experienced in wrking with such participants. II.1.E The IRB has and fllws written plicies and prcedures requiring research prtcls r plans t be reviewed by individuals with apprpriate scientific r schlarly expertise and ther expertise r knwledge as required t review the research prtcl r plan. IRB Rsters are cnstituted t meet the requirements f 45 CFR and 108; 21 CFR and 108. Page 1 f 16

2 Human Subjects Prtectin Prgram Office 501 E. Bradway, Suite 200 Luisville KY P: Service Acct: An IRB Member database is maintained by the HSPPO and used as the data surce fr all IRB membership rster needs. The IRB Member database includes all infrmatin required under FDA and DHHS regulatins and OHRP guidance (45 CFR and 108; 21 CFR and 108) including: Names f members Names f alternate members (and regular members fr whm they substitute) Gender Earned degrees Scientific status Representative capacity Affiliatin Representative capacity is presented in enugh detail t indicate which apprpriate participants can be represented by each member (e.g., children, pregnant wmen, prisners). When research prtcls include vulnerable participants, a member wh is knwledgeable abut that ppulatin, r wh has experience wrking with similar participants, shuld be assigned t the prtcl review. Scientific status, (including the designatin f nnscientist see Chapter 6.3), is determined during recruitment and annually upn evaluatin f IRB members. Scientific status and area f scientific expertise (e.g., pediatrician, radilgist, psychlgist, anthrplgist, pharmacist) are presented in sufficient detail t allw apprpriate prtcl assignment and in-depth prtcl review. Affiliatin is determined during recruitment and annually upn evaluatin f IRB members. An IRB member is cnsidered affiliated if he r she, r any member f his r her immediate family, has any emplyment r ther relatinship (e.g., current emplyee, cnsultant, Bard f Directrs, current vlunteer, trainee r student) with any f the affiliated entities: University f Luisville and the University f Luisville Research Fundatin University Medical Center, Inc. (University f Luisville Hspital Operated by KentuckyOne Health) Jewish Hspital-St Mary s Healthcare (Jewish Hspital-Operated by KentuckyOne Health) Nrtn Healthcare, Inc. (Nrtn Hspital, Nrtn Children s Hspital and ther clinical sites as named in the Nrtn s FWA). The rle f unaffiliated members is t represent the general perspective f participants. Changes in IRB membership require reprting t OHRP. The HRPP Assistant Directr (r delegate) submits a revised IRB membership list t OHRP whenever membership changes ccur, but at a minimum nce a year and whenever a new IRB is frmed. 8.2 Qurum Requirements and Vting at IRB Meetings AAHRPP Std./ Descriptin Element II.1.A The IRB membership permits apprpriate representatin at the meeting fr the types f research under review, and this is reflected n the IRB rster. The IRB has ne r mre unaffiliated members; ne r mre members wh represent the general perspective f participants; ne r mre members wh d nt have scientific expertise; ne r mre members wh have scientific r schlarly expertise; and, when the IRB regularly reviews research that invlves vulnerable participants, ne r mre members wh are knwledgeable abut r experienced in wrking with such participants. Page 2 f 16

3 Human Subjects Prtectin Prgram Office 501 E. Bradway, Suite 200 Luisville KY P: Service Acct: II.2.C The IRB has and fllws written plicies and prcedures fr cnducting meetings by the cnvened IRB. The IRB Chair is a vting member f the IRB. The Chair determines that qurum is established and maintained, chairs the meeting discussins, and calls fr vtes as apprpriate. Maintenance f qurum and vting at cnvened meetings is based n the fllwing: 1. A majrity f the (vting) members f the IRB (r their designated alternates), including at least ne member whse primary cncerns are in nnscientific areas, must be present t cnduct a cnvened meeting. In rder fr research t be apprved, it must receive the apprval f a majrity f such members present at the meeting. 2. Members may be present in persn r thrugh audi (telephne) r audi-visual telecnference. Members present via telecnference shall be nted as such in the meeting minutes, which shall als indicate that the members received all pertinent infrmatin prir t the meeting and were able t participate actively and equally in all discussins. The standard fr members participating by audi r vide cnferencing is the same fr thse attending in persn, giving all members the pprtunity t participate fully in IRB deliberatins. 3. IRB minutes shall include dcumentatin f qurum and vtes fr each IRB actin and determinatin by recrding vtes as fllws: Ttal number vting; Number fr; Number ppsed; and Number abstaining Members leaving the meeting rm due t a cnflicting interest, r fr any ther reasn, will nt be recrded as part f the qurum fr a particular prtcl. 4. An individual wh is nt listed n the fficial IRB membership rster may nt vte with the IRB. 5. A nn-vting ex-ffici member f, r representative t, a University f Luisville IRB may nt vte with the IRB. 6. Ad hc cnsultants may nt vte with the IRB. 7. A nnscientist must always be present fr any vte t be taken. 8. Regular attendance f unaffiliated members is strngly encuraged. Individual members f the IRB may satisfy mre than ne required type f member (i.e. a nnscientific member may als be the unaffiliated member). 9. When a member and their alternate bth attend a meeting, either persn (but nt bth) may vte n each prtcl. Generally if ne f these individuals was the primary reviewer f a given prtcl fr that review cycle, that persn vtes n the prtcl at the cnvened meeting. Page 3 f 16

4 Human Subjects Prtectin Prgram Office 501 E. Bradway, Suite 200 Luisville KY P: Service Acct: 10. Vting by prxy is nt permitted. 11. If the qurum fails during a meeting, such as due t lack f a majrity f IRB members being present r an absence f a nnscientist member, the IRB cannt take any further actins r vte until the qurum is restred. 12. The IRB Administratr is respnsible fr mnitring the members present at a cnvened IRB meeting t ensure that at the beginning f the meeting and fr each subsequent vte the meeting is apprpriately cnvened. 13. When the IRB reviews research that invlves participants vulnerable t cercin r undue influence, at least ne member must be present wh is knwledgeable abut r experienced in wrking with these participants. 14. When the IRB reviews research that invlves prisners, a majrity must have n assciatin with the prisn invlved, apart frm their membership n the IRB. 15. When the IRB reviews research that invlves prisners, at least ne vting member at the IRB meeting must be a prisner r a prisner representative with apprpriate backgrund and experience t serve in that capacity. See.6 fr infrmatin abut cnvened meeting minutes. 8.3 Meeting Times, Materials, and Preparatin fr IRB Meetings AAHRPP Std./ Descriptin Element II.2.C The IRB has and fllws written plicies and prcedures fr cnducting meetings by the cnvened IRB. Each IRB meets each mnth accrding t a regular schedule. Sme IRB members, wh review prtcls accrding t the expedited review prcedure and cnfirm exemptins meet n an ad hc basis as needed. Individual meetings may be rescheduled, r additinal meetings may be held, as needed by agreement f the IRB Chair and the HSPPO Directr. The deadline fr receipt f research prpsals t the IRBs is the Wednesday befre the Thursday f the fllwing week. Prtcl materials are available nline, via the IRB electrnic submissin system. All IRB Members in attendance have access t individual laptp cmputers t access the IRB ESS, and pertinent material is als prjected. A hardcpy set f the mst cmmnly referenced guidance dcuments are maintained in the IRB Cnference Rm. Prtcl Materials The IRB staff assigns prtcls in sufficient time fr them t be reviewed befre the meeting, generally ne week prir, but nt later than 72 hurs befre an upcming meeting. Assignment is dne via the IRB electrnic submissin system. All submitted study materials are available t the primary reviewers thrugh the IRB ESS. All IRB members are granted view access t the presented prtcl materials, generally ne week but nt later than 3 days prir t the cnvened meeting. Materials necessary fr review may be presented t IRB members less than 72 hurs prir t a meeting nly where determined necessary by the IRB Chair r HSPP Directr. Page 4 f 16

5 Human Subjects Prtectin Prgram Office 501 E. Bradway, Suite 200 Luisville KY P: Service Acct: Fr prtcl materials prvided t members, see Chapter 7. Meeting Dcuments Apprximately five days prir t the IRB cnvened meeting, all members have access t the fllwing electrnically: Agenda List fr the cming meeting, typically cntaining: a statement n cnfidentiality f meetings, cnflict f interest statement(s), vte n previus meeting minutes, educatin and infrmatin items (including reprts t be discussed) Minutes frm the previus meeting. The Agenda details: Prtcls (Initial Submissins, Cntinuatin Reviews, Amendments) which will be presented at the meeting. Lcal Serius Adverse Event Reprts that the Chair/Vice Chair has determined shuld be circulated t all IRB members. UPIRTSOs submitted by any investigatr detailing the incident and the ratinale fr the determinatin that the incident meets the UPIRTSO criteria. A list f actins taken since the previus cnvened meeting fr the IRB is circulated with the meeting agenda. Other items, such as Cmpliance Auditr reprts that are presented at the cnvened meeting r miscellaneus infrmatin shared by the HSPPO Directr r IRB Chair(s). 8.4 IRB Study Files Dmain/ Element II.5.A Descriptin The IRB maintains a cmplete set f materials relevant t the review f the research prtcl r plan fr a perid t time sufficient t cmply with legal and regulatry requirements, spnsr requirements, and rganizatinal plicies and prcedures. The HSPPO emplys an electrnic submissin system, iris, called ESS within this Plicy Manual. Cpies f sme dcuments are als maintained in hard cpy files. Electrnic Submissin System (ESS) The ESS maintains electrnic recrds f all dcuments submitted thrugh the system fr every prtcl event. The ESS cntains a search functin fr lcating and retrieving studies by prtcl number, prtcl title, name f Principal Investigatr (PI), names f c-investigatrs, review type, meeting date, internal funding number, spnsr, IRB number, reviewer r any cmbinatin f the abve categries. Electrnic cpies f all materials submitted t the IRB can be accessed thrugh the ESS n an event by event basis thrugh the ESS Submissins Histry functin, thus all dcuments supprting each prtcl event are accessible t recnstruct the entire histry f a study. A study file cntains, as applicable t the research: Applicatin(s). The study file includes ne r mre f the fllwing applicatin types: Page 5 f 16

6 Human Subjects Prtectin Prgram Office 501 E. Bradway, Suite 200 Luisville KY P: Service Acct: Bimedical IRB r SBE IRB research applicatin (Regular, Expedited and Exempt review) submitted fr all new research prjects; Amendment/Mdificatin Frm, submitted fr mdificatins t apprved research; Cntinuing Review Frm, submitted fr cntinuing review f research; Reprts submitted fr reprtable events; Final Reprt Frm, submitted fr clsing Regular review prtcls, if applicable. IRB cmments and investigatr respnses that ccurred during IRB review are included with each applicatin. Cmments and respnses exchanged via fax r are als included as attachments. The IRB-apprved infrmed cnsent dcument(s). The study file includes all apprved cnsent frms, including the currently apprved cnsent frm. When a sample DHHS cnsent frm is prvided, it is included in the study file. The IRB-apprved Assent frm(s). If a study invlves children frm whm the investigatrs will btain assent, cpies f apprved assent frms will be included in the prtcl file. Scientific evaluatins f the prpsed research. Dcumentatin f scientific review is included in the prtcl file and is required in the ESS befre the study can be submitted. See Chapter 7 fr infrmatin n the SSMR/Department Chair Review. Spnsr Materials. Fr investigatinal drug studies, the Investigatr s Brchure and Spnsr s Prtcl, including current amended editins f these dcuments and all previus versins are included in the prtcl file. Fr investigatinal devices, a reprt f prir investigatins and the Spnsr s Prtcl are filed. Applicatin fr federal grant supprt. Fr research supprted by federal funds, a cpy f the grant prpsal is included in the prtcl file. If the federal funding is subcntracted thrugh anther institutin, the sub-cntract with that institutin is nted in the prtcl file. Advertisements, phne screening scripts and nn-medical ral scripts, flyers, website r ther subject recruitment materials. Questinnaires, surveys, interview scripts, diaries r ther dcuments used in the curse f the study. Participant infrmatinal sheets, brchures and spnsr newsletters. Reprts submitted fr reprtable events. Final reprts submitted fr regular prtcls. Data and Safety Mnitring Bard (DSMB) reprts. Cntinuatin Review reprts. Cnflict f Interest (COI) dcuments, when COI r ICOI is applicable. Crrespndence and cmmunicatin between IRB members, IRB staff and investigatrs. Other IRB crrespndence related t the research. Dcumentatin f all actins including apprvals, disapprvals, waivers r alteratins f cnsents and HIPAA authrizatins (as dcumented in the prtcl applicatin frms). Apprval letter (r Determinatin f Exempt Review fr research subject t exempt review.) Dcumentatin f prtcl clseut if any, including Final Reprt frms fr regular prtcls. Expiratin ntice sent-date. Varius IRB Checklists. Page 6 f 16

7 Human Subjects Prtectin Prgram Office 501 E. Bradway, Suite 200 Luisville KY P: Service Acct: IRB apprvals frm cllabrating institutins are requested and included in the research file. IRB apprval ntices are requested frm cllabrating institutins when the University f Luisville is the crdinating center fr a multi-site study. If the study is a multi-site study, with the University f Luisville as ne f several participants, n ther IRB apprval is gathered r included frm ther participating sites. In rder t allw a recnstructin f a cmplete histry f IRB actins related t the review and apprval f the prtcl, the IRB recrds include cpies f: Prtcls r research plans. Investigatr brchure, if any. Scientific evaluatins, when prvided by an entity ther than the IRB. Recruitment materials. Cnsent dcuments. Prgress reprts submitted by researchers. Reprts f injuries t participants. Recrds f cntinuing review activities. Data and safety mnitring reprts, if any. Mdificatins t previusly apprved research. Unanticipated prblems invlving risks t participants r thers. Dcumentatin f nn-cmpliance. Significant new findings. All crrespndence between the IRB and researchers. Other IRB-related Infrmatin Other infrmatin is maintained by the Human Subjects Prtectin Prgram Office, such as crrespndence between the IRB and utside agencies and institutins, IRB cnvened meeting dcumentatin - minutes, minutes lists, agenda, and agenda lists, infrmatin abut each IRB Member including; cntact infrmatin, backgrund and experience, curriculum vitae, etc. 8.5 Recrd Retentin Dmain/ Element Descriptin II.5.A The IRB maintains a cmplete set f materials relevant t the review f the research prtcl r plan fr a perid t time sufficient t cmply with legal and regulatry requirements, spnsr requirements, and rganizatinal plicies and prcedures. In accrdance with the Cmmn Rule and FDA regulatins (45 CFR (b) and 21 CFR (b)), IRB recrds are retained fr at least three years after the cmpletin f the research, either electrnically r as hard cpy. In accrdance with federal HIPAA privacy regulatins, IRB recrds cntaining prtected health infrmatin (PHI) are retained fr at least six years after the cmpletin f the research. It is University f Luisville plicy t retain recrds fr the greatest amunt f mandated time. Thus, HSPPO retains all research recrds fr at least six years. This plicy applies t all research studies, whether r nt participants were enrlled. Spnsred grants and cntracts may require additinal perids fr recrd retentin. Other dcuments, such as meeting agendas and agenda lists and meeting minutes and minutes lists fr the current IRB year are maintained in the ffice f the IRB Manager. Peridically, these dcuments are sent t an external vendr fr lng-term strage. Page 7 f 16

8 Human Subjects Prtectin Prgram Office 501 E. Bradway, Suite 200 Luisville KY P: Service Acct: General crrespndence frm investigatrs and ther dcuments nt specific t a particular research prtcl are maintained fr a perid f three years in the HSPPO. In rder t allw a recnstructin f a cmplete histry f IRB actins related t the review and apprval f the prtcl, the IRB recrds include cpies f: Prtcls r research plans. Investigatr brchure, if any. Scientific evaluatins, when prvided by an entity ther than the IRB. Recruitment materials. Cnsent dcuments. Prgress reprts submitted by researchers. Reprts f injuries t participants. Recrds f cntinuing review activities. Data and safety mnitring reprts, if any. Mdificatins t previusly apprved research. Unanticipated prblems invlving risks t participants r thers. Dcumentatin f nn-cmpliance. Significant new findings. All crrespndence between the IRB and researchers. Maintenance f and Access t IRB Recrds The ESS resides n a secured server, with passwrd-prtected access. Access t IRB recrds is rutinely prvided t the Executive Vice President fr Research and Innvatin, IRB Chairs, IRB members, and IRB staff) t carry ut HSPP peratins. Research investigatrs are prvided reasnable access t files related t their wn research. 8.6 IRB Minutes Dmain/ Element Descriptin II.5.B The IRB dcuments discussins and decisins n research studies and activities in accrdance with legal and regulatry requirements, spnsr requirements (if any), and rganizatinal plicies and prcedures. II.2.D The IRB r EC has and fllws written plicies and prcedures t cnduct reviews by the cnvened IRB. II.2.D.1 Initial review II.2.D.2 Cntinuing review II.2.D.3 Review f prpsed mdificatins t previusly apprved research The IRB dcuments discussins, decisins, and findings either thrugh the IRB minutes r fr studies subject t expedited review, thrugh dcumentatin in the study file r ther recrds. The IRB minutes dcument: Meeting attendees and invitees Discussins and actins taken by the IRB and the separate deliberatins fr each actin Determinatins made by the IRB and the prtcl-specific findings that justify thse determinatins Vtes fr each actin recrded as numbers fr, against, r abstaining Page 8 f 16

9 Human Subjects Prtectin Prgram Office 501 E. Bradway, Suite 200 Luisville KY P: Service Acct: Other issues requiring cnvened IRB review. Attendance at an IRB Cnvened Meeting Attendance at an IRB cnvened meeting is recrded in the minutes by dcumenting: The IRB members (vting, nn-vting, and ex-fficis) wh are in attendance. Nn-vting members include exffici members r alternate members attending fr infrmatinal purpses The IRB members wh are nt in attendance When an alternate member replaces a primary member in attendance and vting at the cnvened meeting The cntinued presence f qurum fr all vtes, including a member whse primary cncern is in a nnscientific area Attendance f members and alternate members wh participate thrugh videcnference r telecnference, and dcumentatin that thse members received all pertinent material befre the meeting and had the pprtunity t actively and equally participate in all discussins The IRB members wh leave the meeting because f a cnflicting interest The IRB members wh leave the meeting briefly, are nt present during a vte, and are nt cunted as part f the qurum The IRB members wh arrive late r depart early frm the meeting and their arrival r departure times The Human Subjects Prtectins Prgram Office staff present Any thers present (e.g., invited guests, investigatrs invited t address the IRB, and cnsultants) Discussins and Actins Taken By the IRB Discussins and actins taken by the IRB, and the separate deliberatins and basis fr each actin are dcumented in the minutes, such as: Discussin f prtcl events new, cntinuing review, mdificatins, reprts f unanticipated prblems and events and infrmatin requiring prmpt review Apprval f research including the apprval perid fr research, at initial and cntinuing review, (and if apprpriate t the degree f risk determinatin f an apprval perid f less than ne year) Suspensins and terminatins f previusly apprved research Disapprval f research Discussin f cntrverted issues and their reslutin r dispsitin Requests fr cnsultant review r input frm an expert in the field (e.g. requests made during a cnvened meeting) Actins resulting frm review f reprts f unanticipated prblems invlving risks t participants r thers, r ther reprtable events and infrmatin Actins resulting frm determinatins f serius r cntinuing nn-cmpliance If a prtcl is using a DHHS-apprved sample cnsent: The justificatin f any deletin r substantive mdificatin f infrmatin cncerning risks r alternative prcedures cntained in the sample cnsent dcument Determinatins made by the IRB Determinatins made by the IRB are recrded in the minutes with dcumentatin f the prtcl-specific findings justifying thse determinatins as apprpriate, such as: Significant risk and nn-significant risk device determinatins, pursuant t: 21 CFR 812.2(b), 21 CFR (b)(9) and cnsidering FDA Infrmatin Sheet Significant and Nn-significant Risk Medical Device Studies Page 9 f 16

10 Human Subjects Prtectin Prgram Office 501 E. Bradway, Suite 200 Luisville KY P: Service Acct: Apprval f waiver r alteratin f infrmed cnsent, pursuant t:45 CFR (c) and 45 CFR (d) Waiver f infrmed cnsent dcumentatin, pursuant t: 45 CFR (c) and 21 CFR (c)(1) Research invlving adults with impaired decisin-making Waiver f HIPAA Authrizatin, pursuant t 45 CFR (i)(2)(ii) Waiver f HIPAA Authrizatin fr recruitment r screening, pursuant t 45 CFR (i)(2)(ii) Alteratin f HIPAA Authrizatin, pursuant t 45 CFR (i)(2)(ii) Use f shrt frm prcess fr cnsent 45 CFR (b)(2) r 21 CFR 50.27(b)(2) When research invlves children, the fllwing IRB decisins are dcumented: Apprpriate children finding applicable t research: 45 CFR , 45 CFR , 45 CFR , 45 CFR , 45 CFR (OHRP) 21 CFR 50.51, 21 CFR 50.52, 21 CFR 50.53, 21 CFR 50.54, 21 CFR (FDA) Whether the permissin f ne parent/guardian is sufficient r if permissin frm bth parents/guardians is required. Hw assent is t be slicited r btained, unless waived. The participatin f children wh are wards f the state is apprved under: 45 CFR , 45 CFR nly if 45 CFR (a) is satisfied, r 21 CFR 50.53, 21 CFR nly if 21 CFR 50.56(a) is satisfied Apprpriate invlvement f pregnant wmen, fetuses, and nenates pursuant t: -45 CFR , 45 CFR , 45 CFR , and 45 CFR Apprval f research invlving transplantatin f fetal tissue: -42 USC 498A(b)(1) and (2) Apprval f research invlving prisners as participants under the fllwing regulatins: 45 CFR and 45 CFR Determinatin f the level f risk Determinatins f serius r cntinuing nn-cmpliance Unanticipated Prblems and Unanticipated Adverse Device Effect Fr research funded by the Natinal Institute n Disability and Rehabilitatin Research, when the IRB reviews research that purpsefully requires inclusin f children with disabilities r individual with mental disabilities as research participants, the IRB must include at least ne persn primarily cncerned with the welfare f thse research participants. Other Issues Other issues are dcumented in the minutes, including but nt limited t: Other events and infrmatin that require prmpt reprting t the IRB DSMB reprts Apprval f minutes f prir cnvened IRB meetings The apprval f research cntingent n specific minr cnditins by the chair r designee, in the minutes f the first IRB meeting that takes place after the date f the apprval Presentatin f infrmatin frm an utside cnsultant r expert as previusly requested by the IRB Page 10 f 16

11 Human Subjects Prtectin Prgram Office 501 E. Bradway, Suite 200 Luisville KY P: Service Acct: Special situatins such as use f a test article and humanitarian use devices The names f IRB members wh abstain fr reasns ther than cnflict f interest Other items as applicable. Dispsitin f the IRB Minutes The IRB staff writes minutes and makes them available fr IRB review usually within three weeks f the meeting date. Minutes may nt be altered by anyne including a higher authrity nce apprved by the members at a subsequent IRB meeting. The minutes f cnvened IRB meetings are cnsidered cnfidential, and access t them is restricted and secured. 8.7 IRB Review f Planned Emergency Research Dmain/ Element Descriptin II.4.C The IRB has and fllws written plicies and prcedures fr making exceptins t cnsent requirements fr planned emergency research and reviews such exceptins accrding t applicable laws, regulatins, cdes, and guidance. Prir t scheduling a study which qualifies as Emergency Research fr initial IRB review, the IRB Analyst will discuss the study with the Directr/Assistant Directr, HSPPO. The IRB Chair/Vice Chair and the assigned primary reviewer will be ntified by the Directr/Assistant Directr that such a study has been received and will be scheduled fr review after the IRB staff and members have participated in an Emergency Research educatinal presentatin. The planned emergency research presentatin will include: a review f the FDA regulatins; review f the respnsibilities f the principal investigatr; review f the respnsibilities f the spnsr; review f the respnsibilities f the IRB; review f the prcess f cmmunity cnsultatin; a review f the dcumentatin requirements that must be part f the minutes f the IRB meeting recrd; and review f the respnsibility f public disclsure (bth befre the study begins and disclsure f the results f the research). When fllwing FDA regulatins fr Planned Emergency Research: The IRB with the cncurrence f a licensed physician wh is a member f r cnsultant t the IRB and wh is nt therwise participating in the clinical investigatin finds and dcuments each f the fllwing: The research activity is subject t regulatins cdified by the Fd and Drug Administratin (FDA) 21 CFR 50 and will be carried ut under an FDA investigatinal new drug applicatin (IND) r an FDA investigatinal device exemptin (IDE). The applicatin clearly identifies the prtcls that will include participants wh are unable t cnsent. The research participants are in a life-threatening situatin, available treatments are unprven r unsatisfactry, and the cllectin f valid scientific evidence, which might include evidence btained thrugh randmized placeb-cntrlled investigatins, is necessary t determine the safety and effectiveness f particular interventins. Obtaining cnsent is nt feasible because: The participants will nt be able t give their cnsent as a result f their medical cnditin. The interventin under investigatin must be administered befre cnsent frm the participants legally authrized representatives is feasible. Page 11 f 16

12 Human Subjects Prtectin Prgram Office 501 E. Bradway, Suite 200 Luisville KY P: Service Acct: Page 12 f 16 There is n reasnable way t identify prspectively the individuals likely t becme eligible fr participatin in the clinical investigatin. Participatin in the research hlds ut the prspect f direct benefit t the participants because: Participants are facing a life-threatening situatin that necessitates interventin. Apprpriate animal and ther preclinical studies have been cnducted, and the infrmatin derived frm thse studies and related evidence supprted the ptential fr the interventin t prvide a direct benefit t the individual participants. Risks assciated with the investigatin are reasnable in relatin t what is knwn abut the medical cnditin f the ptential class f participants, the risks and benefits f standard therapy, if any, and what is knwn abut the risks and benefits f the prpsed interventin r activity. The clinical investigatin culd nt practicably be carried ut withut the waiver. The prpsed investigatinal plan defines the length f the ptential therapeutic windw based n scientific evidence, and the investigatr has cmmitted t attempting t cntact a legally authrized representative fr each participant within that windw f time and, if feasible, t asking the legally authrized representative cntacted fr cnsent within that windw rather than prceeding withut cnsent. The investigatr will summarize effrts made t cntact legally authrized representatives and make this infrmatin available t the IRB at the time f cntinuing review. The IRB has reviewed and apprved cnsent prcedures and a cnsent dcument cnsistent with These prcedures and the cnsent dcument are t be used with participants r their legally authrized representatives in situatins where use f such prcedures and dcumented is feasible. The IRB has reviewed and apprved prcedures and infrmatin t be used when prviding an pprtunity fr a family member t bject t a participant s participatin in the clinical investigatin cnsistent with the paragraph belw. Additinal prtectins f the rights and welfare f the participants will be prvided, including, at least: Cnsultatin (including, where apprpriate, cnsultatin carried ut by the IRB) with representatives f the cmmunities in which the clinical investigatin will be cnducted and frm which the participants will be drawn. Public disclsure t the cmmunities in which the clinical investigatin will be cnducted and frm which the participants will be drawn, prir t initiatin f the clinical investigatin, f plans fr the investigatin and its risks and expected benefits. Public disclsure f sufficient infrmatin fllwing cmpletin f the clinical investigatin t apprise the cmmunity and researchers f the study, including the demgraphic characteristics f the research ppulatin, and its results. Establishment f an independent data mnitring cmmittee t exercise versight f the clinical investigatin. If btaining cnsent is nt feasible and a legally authrized representative is nt reasnably available, the investigatr has cmmitted, if feasible, t attempting t cntact within the therapeutic windw the participant s family member wh is nt a legally authrized representative, and asking whether he r she bjects t the participant s participatin in the clinical investigatin.

13 Human Subjects Prtectin Prgram Office 501 E. Bradway, Suite 200 Luisville KY P: Service Acct: The investigatr will summarize effrts made t cntact family members and make this infrmatin available t the IRB at the time f cntinuing review. Prcedures are in place t infrm, at the earliest feasible pprtunity, each participant, r if the participant remains incapacitated, a legally authrized representative f the participant, r if such a representative is nt reasnably available, a family member, f the participant s inclusin in the clinical investigatin, the details f the investigatin and ther infrmatin cntained in the cnsent dcument. There is a prcedure t infrm the participant, r if the participant remains incapacitated, a legally authrized representative f the participant, r if such a representative is nt reasnably available, a family member, that he r she might discntinue the participant s participatin at any time withut penalty r lss f benefits t which the participant is therwise entitled. If a legally authrized representative r family member is tld abut the clinical investigatin and the participant s cnditin imprves, the participant is als t be infrmed as sn as feasible. If a participant is entered int a clinical investigatin with waived cnsent and the participant dies befre a legally authrized representative r family member can be cntacted, infrmatin abut the clinical investigatin is t be prvided t the participant s legally authrized representative r family member, if feasible. The prtcl is perfrmed under a separate investigatinal new drug applicatin (IND) r investigatinal device exemptin (IDE) that clearly identified such prtcls as prtcls that might include participants wh are unable t cnsent. The submissin f thse prtcls in a separate IND/IDE is required even if an IND fr the same drug prduct r an IDE fr the same device already exists. If an IRB determines that it cannt apprve a clinical investigatin because the investigatin des nt meet the criteria in the exceptin r because f ther relevant ethical cncerns, the IRB must dcument its findings and prvide these findings prmptly (n lnger than within 30 days) in writing t the clinical investigatr and t the spnsr f the clinical investigatin. Fr Planned Emergency Research NOT subject t FDA regulatins: When research is nt subject t FDA regulatins, but fllws DHHS regulatins, the IRB finds, dcuments, and reprts t DHHS that the fllwing cnditins have been met relative t the research add t plicies and prcedures: The IRB fund and dcumented that the research is nt subject t regulatins cdified by the FDA at 21 CFR 50. The research participants are in a life-threatening situatin, available treatments are unprven r unsatisfactry, and the cllectin f valid scientific evidence, which may include evidence btained thrugh randmized placeb-cntrlled investigatins, is necessary t determine the safety and effectiveness f particular interventins. Obtaining cnsent is nt feasible because: The participants are nt able t give their cnsent as a result f their medical cnditin. Page 13 f 16

14 Human Subjects Prtectin Prgram Office 501 E. Bradway, Suite 200 Luisville KY P: Service Acct: The interventin invlves in the research is administered befre cnsent frm the participants legally authrized representatives is feasible. There is n reasnable way t identify prspectively the individuals likely t becme eligible fr participatin in the research. Participatin in the research held ut the prspect f direct benefit t the participants because: Participants are facing a life-threatening situatin that necessitated interventin. Apprpriate animal and ther preclinical studies have been cnducted, and the infrmatin derived frm thse studies and related evidence supprted the ptential fr the interventin t prvide a direct benefit t the individual participants. The risks assciated with the research are reasnable in relatin t what is knwn abut the medical cnditin f the ptential class f participants, the risks and benefits f standard therapy, if any, and what is knwn abut the risks and benefits f the prpsed interventin r activity. The research culd nt practicably be carried ut withut the waiver. The prpsed research prtcl defines the length f the ptential therapeutic windw based n scientific evidence, and the investigatr has cmmitted t attempting t cntact a legally authrized representative fr each participant within that windw f time and, if feasible, asking the legally authrized representative cntacted fr cnsent within that windw rather than prceeding withut cnsent. The investigatr will summarize effrts made t cntact representatives and make this infrmatin available t the IRB at the time f cntinuing review. The IRB has reviewed and apprved cnsent prcedures and a cnsent dcument in accrd with 45 CFR and These prcedures and the cnsent dcument are t be used with participants r their legally authrized representatives in situatins where use f such prcedures and dcumented is feasible. The IRB has reviewed and apprved prcedures and infrmatin t be used when prviding an pprtunity fr a family member t bject t a participant s participatin in the research cnsistent with the paragraph f this waiver. Additinal prtectins f the rights and welfare f the participants are prvided, including, at least: Cnsultatin (including, where apprpriate, cnsultatin carried ut by the IRB) with representatives f the cmmunities in which the research is cnducted and frm which the participants are drawn. Public disclsure t the cmmunities in which the research is cnducted and frm which the participants are drawn, prir t initiatin f the research, f plans fr the research and its risks and expected benefits. Public disclsure f sufficient infrmatin fllwing cmpletin f the research t apprise the cmmunity and researchers f the study, including the demgraphic characteristics f the research ppulatin, and its results. Establishment f an independent data mnitring cmmittee t exercise versight f the research. If btaining cnsent is nt feasible and a legally authrized representative is nt reasnably available, the investigatr has cmmitted, if feasible, t attempting t cntact within the therapeutic windw the Page 14 f 16

15 Human Subjects Prtectin Prgram Office 501 E. Bradway, Suite 200 Luisville KY P: Service Acct: participant s family member wh is nt a legally authrized representative, and asking whether he r she bjects t the participant s participatin in the research. The investigatr will summarize effrts made t cntact family members and make this infrmatin available t the IRB at the time f cntinuing review. Prcedures are in place t infrm, at the earliest feasible pprtunity, each participant, r if the participant remained incapacitated, a legally authrized representative f the participant, r if such a representative is nt reasnably available, a family member, f the participant s inclusin in the research, the details f the research and ther infrmatin cntained in the cnsent dcument. There is a prcedure t infrm the participant, r if the participant remained incapacitated, a legally authrized representative f the participant, r if such a representative is nt reasnably available, a family member, that he r she may discntinue the participant s participatin at any time withut penalty r lss f benefits t which the participant is therwise entitled. If a legally authrized representative r family member is tld abut the research and the participant s cnditin imprves, the participant is als infrmed as sn as feasible. If a participant is entered int research with waived cnsent and the participant dies befre a legally authrized representative r family member can be cntacted, infrmatin abut the research is prvided t the participant s legally authrized representative r family member, if feasible. Fr the purpses f this waiver family member means any ne f the fllwing legally cmpetent persns: spuses; parents; children (including adpted children); brthers, sisters, and spuses f brthers and sisters; and any individual related by bld r affinity whse clse assciatin with the participant is the equivalent f a family relatinship. See als: HRPP Chapter The Rle f the Chair(s) and Vice Chair(s) and Their Vting Respnsibilities AAHRPP Std./ Descriptin Element II.2.C The IRB has and fllws written plicies and prcedures fr cnducting meetings by the cnvened IRB. The IRB Chair and the IRB Vice Chairs are vting members f the IRB. The Chair determines that qurum is established and maintained, chairs the meeting discussins, and calls fr vtes as apprpriate. The IRB Chair, in this instance used as the individual wh chairs the scheduled IRB meeting, reviews all prtcls presented t the full IRB. The IRB Chair ntes and cmmunicates with ther reviewers any imprtant IRB issues that may be reslved r identified prir t the scheduled IRB meeting. The IRB Chair directs the prceedings and discussin f the full IRB meeting. This includes keeping the discussin fcused n imprtant IRB issues. The Chair and Vice Chairs have an in-depth understanding f ethical issues, state laws, institutinal plicy, and federal regulatins. Page 15 f 16

16 Human Subjects Prtectin Prgram Office 501 E. Bradway, Suite 200 Luisville KY P: Service Acct: The Chair may assist in drafting letters frm the IRB t researchers regarding IRB decisins. The Chair als represents the IRB in defending r discussing IRB decisins with researchers. The Chair r Vice Chairs serve as the reviewer fr research that is reviewed by the Expedited Review prcedure. They may als serve as the final reviewer f revisins made by the researcher t determine that researchers have made the apprpriate requested changes. Prscriptive changes made by the IRB at a full cmmittee meeting may be reviewed by the IRB Chair, Vice Chairs, experienced IRB members and/r an apprpriate IRB designee (HSPPO Directr r Assistant Directr). Page 16 f 16