MAIN LINE HOSPITALS, INC. INSTITUTIONAL REVIEW BOARD POLICY AND PROCEDURE MANUAL

Transcription

1 Main Line Health, Inc. and Main Line Health Inc. Subsidiaries This plicy applicable t: Wrking Tgether t Serve the Cmmunity All Subsidiaries All Hspitals BMRH All Acute Care Hspitals Mirmnt Treatment Center MAIN LINE HOSPITALS, INC. INSTITUTIONAL REVIEW BOARD POLICY AND PROCEDURE MANUAL Reviewed and Revised 2014 Reviewed and Revised 2016

2 TABLE OF CONTENTS INTRODUCTION 1 GENERAL PROCEDURES Plicy N. I 2 Subject: MAIN LINE HOSPITALS EDUCATION REQUIREMENTS FOR INDIVIDUALS INVOLVED IN HUMAN SUBJECTS RESEARCH ACTIVITIES AT MAIN LINE HOSPITALS (Revisin Date: 09/07/17) Plicy N. II 5 Subject: OVERVIEW OF THE INSTITUTIONAL REVIEW BOARD (Revisin Date: 06/25/16 ) Plicy N. III 11 Subject: CONFLICTS OF INTEREST: RESEARCHERS AND RESEARCH STAFF (Revisin Date: 06/25/16) Plicy N. IV 15 Subject: CONFLICTS OF INTEREST: IRB MEMBERS AND CONSULTANTS (Revisin Date: 06/25/16) Plicy N. V. 18 Subject: RESEARCH DETERMINATION AND ACTIVITIES REQUIRING IRB REVIEW (Revisin Date: 01/08/18) Plicy N. VI 23 Subject: CONVENED IRB REVIEW PROCESS (Revisin Date: 06/25/16) Plicy N. VII 31 Subject: EXPEDITED REVIEW PROCESS (Revisin Date: 06/25/16) Plicy N. VIII 35 Subject: EMERGENCY USE OF AN INVESTIGATIONAL TEST ARTICLE (Revisin Date: 06/25/16) Plicy N. IX 40 Subject: EXPANDED ACCESS TO FDA-REGULATED INVESTIGATIONAL TEST ARTICLES (frmerly, cmpassinate use ) (Revisin Date: 06/25/16) Plicy N. X 43 Subject: HUMANITARIAN USE DEVICE/HUMANITARIAN DEVICE EXEMPTION (Revisin Date: 06/25/16) Plicy N. XI 46

3 Subject: EXEMPT REVIEW PROCESS (Revisin Date: 06/25/16) Plicy N. XII 49 Subject: INFORMED CONSENT DOCUMENTATION (Revisin Date: 06/25/16) Plicy N. XIII 53 Subject: PLANNED EMERGENCY RESEARCH (Revisin Date: 06/25/16) Plicy N. XIV 57 Subject: SIGNIFICANT RISK/NONSIGNIFICANT RISK (SR/NSR) DEVICE DETERMINATIONS BY THE IRB (Revisin Date: 06/25/16) Plicy N. XV 60 Subject: CONTINUING REVIEW PROCESS (Revisin Date: 06/25/16) Plicy N. XVI 62 Subject: EXPIRATION OF IRB APPROVAL AND FINAL REPORT PROCESS (Revisin Date: 06/25/16) Plicy N. XVII 64 Subject: MODIFICATIONS AND AMENDMENT PROCESS (Revisin Date: 06/25/16) Plicy N. XVIII 67 Subject: UNANTICIPATED PROBLEMS INVOLVING RISKS TO SUBJECTS OR OTHERS (Revisin Date: 06/25/16) Plicy N. XIX 73 Subject: IRB Reprting f Unanticipated Prblems Invlving Risks t Subjects r Others, Terminatins r Suspensins f IRB Apprval and Serius r Cntinuing Nn-Cmpliance (Revisin Date: 09/13/16) Plicy N. XX 76 Subject: NONCOMPLIANCE (Revisin Date: 06/25/16) Plicy N. XXI 80 Subject: SUSPENSIONS OR TERMINATIONS OF IRB APPROVAL OF RESEARCH (Revisin Date: 06/25/16) Plicy N. XXII 82 Subject: INVESTIGATIONAL TEST ARTICLES (Revisin Date: 06/25/16) Plicy N. XXIII 86 Subject: HIPAA-USE OF PROTECTED HEALTH INFORMATION (PHI) Revisin Date: 09/13/16) Plicy N. XXIV 95

4 Subject: DECISIONALLY IMPAIRED TO CONSENT AND SURROGATE CONSENT (Revisin Date: 06/25/16) Plicy N. XXV 100 Subject: RESEARCH INVOLVING PREGNANT WOMEN, NEONATES AND FETUSES (Revisin Date: 06/25/16) Plicy N. XXVI 103 Subject: RESEARCH ACTIVITIES INVOLVING PRISONERS AS SUBJECTS (Revisin Date: 06/25/16) Plicy N. XXVII 106 Subject: RESEARCH INVOLVING CHILDREN AS SUBJECTS (Revisin Date: 06/25/16) Plicy N. XXVIII 111 Subject: RESEARCH ACTIVITIES INVOLVING EXPOSURE OF RESEARCH SUBJECTS TO IONIZING RADIATION (Revisin Date: 06/25/16) Plicy N. XXIX 114 Subject: SUBJECT RECRUITMENT AND ADVERTISING (Revisin Date: 09/13/16) Plicy N. XXX 117 Subject: PAYMENT TO RESEARCH SUBJECTS AND RESEARCH PERSONNEL (Revisin Date: 11/06/14) Plicy N. XXXI 119 Subject: IRB RECORD KEEPING (Revisin Date: 06/25/16) Plicy N. XXXII 121 Subject: QUALITY ASSURANCE AND COMPLIANCE REVIEWS OF APPROVED RESEACH, IRB RECORDS, INVESTIGATORS AND RESEARCH STAFF (Revisin Date: 09/13/16) Plicy N. XXXIII 124 Subject: JURISDICTION OVER CLINICAL RESEARCH (Revisin Date: 09/13/16) Plicy N. XXXIV 127 Subject: MAIN LINE HOSPITALS INSTITUTIONAL REVIEW BOARD (MLH IRB) POLICY AND PROCEDURES MAINTENANCE (Revisin Date: 09/13/16)

5 MAIN LINE HOSPITALS INSTITUTIONAL REVIEW BOARD POLICY AND PROCEDURE MANUAL The IRB Prcedures cntained herein prvide the IRB and research investigatrs with the necessary infrmatin t cmply with the Main Line Hspitals plicy and principles relating t investigatins invlving human subjects. The Prcedures cntain the framewrk fr the cnduct f ethical human research while citing the legal bligatins which cntrl its parameters. MLH IRB Plicy and Prcedure Manual 1

6 Main Line Health, Inc. and Main Line Health Inc. Subsidiaries This plicy applicable t: Wrking Tgether t Serve the Cmmunity All Subsidiaries All Hspitals BMRH All Acute Care Hspitals Mirmnt Treatment Center MAIN LINE HOSPITALS INSTITUTIONAL REVIEW BOARD POLICY AND PROCEDURE MANUAL Plicy N. Subject: I EDUCATION REQUIREMENTS FOR INDIVIDUALS INVOLVED IN HUMAN SUBJECTS RESEARCH ACTIVITIES AT MAIN LINE HOSPITALS POLICY Main Line Hspitals, IRB (MLH IRB) is respnsible fr prviding, thrugh the Office f Research Prtectins (ORP) an educatin prgram n the ethics f cnducting human subjects research and the federal regulatins pertaining t such research fr all persnnel invlved in the cnduct f research studies using human subjects at Bryn Mawr Hspital, Lankenau Medical Center, Pali Hspital, Riddle Hspital and Bryn Mawr Rehabilitatin Hspital and ther sites under the jurisdictin f the MLH IRB. Training requirements described in this plicy apply t all investigatrs and staff engaged in research reviewed by the MLH IRB r a designated external IRB. The MLH IRB requires all individuals respnsible in the design, cnduct and reprting f a study t cmplete and remain current with the training requirements befre apprval will be granted. This includes, but is nt limited t, investigatrs, sub-investigatrs, staff, crdinatrs and nurses invlved in the cnduct f a study. This plicy als applies t all MLH IRB administrative staff, and all MLH IRB members. Each persn cvered by this plicy must successfully cmplete the educatin prgram and remain current with the training requirements as described belw. PROCEDURES Cmputer Based Training and Cntinuing Educatin: ORP uses a subscriptin n-line service t cmplete the training requirement fr human subjects investigatrs, research supprt staff, MLH IRB members, and MLH IRB Administrative staff. The prgram is spnsred by the Cllabrative MLH IRB Training Initiative (CITI). Cmpletin f the apprpriate curriculum is required t cnduct r be invlved in human subjects research. Investigatrs and their research supprt staff, MLH IRB administrative staff, and MLH IRB members are required t remain current with all training requirements. The Educatin Prgram fr individuals invlved in Human Subjects Research at MLH cnsists f the categries listed belw. 1. Research Persnnel including Investigatrs and Staff: A. Human Subjects Training - An n-line cmputer based training prgram cnsisting f mdules and grups in human subjects research that must be cmpleted by all current and new investigatrs and their research supprt staff. The training grups vary based n the type f research which is cnducted MLH IRB Plicy and Prcedure Manual 2

7 (See TRAINING sectin belw). Successful cmpletin f the curriculum is required. Recertificatin f the training must be cmpleted every three years 1. B. Gd Clinical Practices (GCP) - An n-line cmputer based training prgram n GCP that must be cmpleted by NIH-funded research investigatrs and their research supprt staff. Successful cmpletin f the curriculum is required. Recertificatin f the training must be cmpleted every three years. C. Cnflict f Interest (COI) - An n-line cmputer based training prgram n COI that must be cmpleted research investigatrs and their research supprt staff. Refer t the MLH IRB Plicy n Cnflicts f Interests: Researchers and Research Staff (II) fr mre infrmatin n the MLH IRB requirements fr COI training. Successful cmpletin f the curriculum is required. Recertificatin f the training must be cmpleted every fur years and as required in the MLH IRB Plicy n Cnflicts f Interests: Researchers and Research Staff (II). 2. IRB Members and IRB Administrative Staff: A. MLH IRB Members and MLH IRB Administrative Staff - An n-line cmputer based training fr MLH IRB Members and MLH IRB Administrative Staff. Recertificatin f the training must be cmpleted every three years. TRAINING REQUIRMENTS The link t the n-line CITI Training curse is available n the ORP website at r directly at There are several grups t chse frm as utlined belw. Mre than ne grup may be required depending n the type f research that is cnducted. Grup 1 - Bimedical Research: Fr research persnnel wh engage in Bimedical research. Recertificatin f the training must be cmpleted every three years 1. Grup 2 - Scial and Behaviral Research: Fr research persnnel wh engage in Scial and Behaviral research which des nt invlve bimedical prcedures. This type f research typically invlves questinnaires, interviews, fcus grups, direct r participant bservatin and may include certain types f nn-invasive specimen cllectin. This grup des NOT satisfy the educatinal requirements fr Bimedical Research. Research persnnel wh engage in bimedical research must als cmplete the Grup 1 Mdule. Recertificatin f the training must be cmpleted every three years 1. Grup 3 - Data r Specimen ONLY Research: fr research persnnel wh engage exclusively in secndary data analysis f data, human tissues and/r samples. This grup des NOT satisfy the educatinal requirements fr Bimedical r Scial and Behaviral Research. If yu are planning t cnduct Bimedical r Scial and Behaviral research yu are required t take Grup 1 and/r Grup 2. Grup 4 MLH IRB Members and MLH Administrative staff. This grup des NOT satisfy the educatinal requirements fr Grups 1, 2 r 3. Recertificatin f the training must be cmpleted every three years. 1 Tw refresher curses, three years apart are permitted prir t re-taking the riginal curse. MLH IRB Plicy and Prcedure Manual 3

8 Grup 5 Gd Clinical Practices. Fr research persnnel wh engage in NIH Funded Research. This grup des NOT satisfy the educatinal requirements fr Grups 1, 2 3 r 4. Recertificatin f the training must be cmpleted every three years. Cnflict f Interest fr ALL research persnnel. Recertificatin f the training must be cmpleted every fur years and as required in the MLH IRB Plicy n Cnflicts f Interests: Researchers and Research Staff (II). Refer t the plicy fr mre infrmatin n the IRB requirements fr cnflict f interest training. Mnitring: Training status will be checked fr all study persnnel upn receipt f new study and cntinuing review submissins. If training requirements are nt satisfied fr all persnnel invlved in a new study, the study apprval is held until all training requirements are met. If training requirements are nt satisfied fr all persnnel invlved in the study when a cntinuing review submissin is made, ORP will make up t five attempts t request cmpletin f the training. If training requirements are nt satisfied within 1 week f the final request, the individual(s) will be remved frm the study. Originatin Date: 12/2003 Revisin Date: 09/07/17 MLH IRB Plicy and Prcedure Manual 4

9 Main Line Health, Inc. and Main Line Health Inc. Subsidiaries This plicy applicable t: Wrking Tgether t Serve the Cmmunity All Subsidiaries All Hspitals BMRH All Acute Care Hspitals Mirmnt Treatment Center MAIN LINE HOSPITALS INSTITUTIONAL REVIEW BOARD POLICY AND PROCEDURE MANUAL Plicy N. Subject: II OVERVIEW OF THE INSTITUTIONAL REVIEW BOARD IRB STRUCTURE The Bard f Trustees f Main Line Hspitals, Inc. has apprved the establishment f an Institutinal Review Bard (Main Line Hspital IRB (MLH IRB)), cmpsed ftw subcmmittees under a Federal-Wide Assurance (FWA) with the Office f the Human Research Prtectins (OHRP), Divisin f the Department f Health and Human Services (DHHS). Entities included under the FWA are Main Line Hspitals, Inc., which includes Lankenau Medical Center, Bryn Mawr Hspital, Bryn Mawr Rehabilitatin Hspital and Pali Hspital, Riddle Hspital, and the Lankenau Institute fr Medical Research. The Institutin has ne MLH IRB with tw subcmmittees (e.g. Bryn Mawr Hspital and Lankenau Medical Center ) with sme verlapping membership. Either subcmmittee may review research cnducted at any site included under the FWA r within the Main Line Health System. Fr the purpses f these Prcedures, either subcmmittee shall be referred t as the IRB r the Cmmittee. The Chair f the MLH IRB and the Vice-Chair(s) f the MLH IRB will be appinted by the Main Line Hspitals Bard f Trustees thrugh the Institutinal Official (IO). Each Vice- Chair shall assume the duties f the MLH IRB Chair, in the IRB Chair s absence r at the MLH IRB Chair's discretin. Refer t Administrative Plicy N. I 25- IRB: Cmpliance, Federal Regulatins Gverning the Prtectin f Human Research Subjects fr additinal infrmatin n the authrity f the IRB. IRB MEMBERSHIP The Main Line Hspitals Bard f Trustees appints the MLH IRB Chair and members f the MLH IRB. The names and Curriculum Vitaes f the appintees (alternates and regular members) are submitted fr apprval t the Quality and Patient Safety Cmmittee (QPSC) f the [Main Line Hspitals] Bard by the Main Line Hspitals IO fr the MLH IRB thrugh the Office f Research Prtectins (ORP) Directr. In nminating MLH IRB members fr appintment, the IO and/r ORP Directr will ensure that all f the fllwing cnditins are met fr the MLH IRB: The MLH IRB will cnsist f at least five members. MLH IRB members will have prfessinal cmpetence and varying backgrunds, experience and expertise as necessary t prmte MLH IRB Plicy and Prcedure Manual 5

10 cmplete and adequate review f research activities cmmnly cnducted by the rganizatin. The MLH IRB will be sufficiently qualified thrugh the experience, expertise, and diversity f its members, including cnsideratins f race, gender, cultural backgrunds, and sensitivity t issues such as cmmunity attitudes, t prmte respect fr its advice and cunsel in safeguarding the rights and welfare f human subjects The MLh IRB will include persns knwledgeable abut institutinal cmmitments and regulatins, applicable laws, and standards f prfessinal cnduct and practices If the MLH IRB regularly reviews research that invlves a vulnerable categry f subjects such as children, pregnant wmen, mentally disabled persns, r ecnmically r educatinally disadvantaged persns, the IO will nminate ne r mre individuals wh are knwledgeable abut and experienced in wrking with these subjects. When the MLH IRB reviews research invlving prisners, a prisner representative must be present. Refer t MLH IRB Plicy n Research Invlving Prisners as Subjects (XXVI) fr infrmatin n MLH IRB requirements fr prisners. N MLH IRB has members wh are all males r females N MLH IRB will cnsist entirely f members f ne prfessin The MLH IRB will include at least ne member whse primary cncerns are in scientific areas and at least ne member whse primary cncerns are in nnscientific areas The MLH IRB will include at least ne member wh is nt therwise affiliated with rganizatin and wh is nt part f the immediate family f a persn affiliated with the rganizatin. The MLH IRB will include at least ne member wh represents the perspective f research subjects (e.g. nn-affiliated member) There is n limitatin n the n the length f service that any MLH IRB member may serve. N individual respnsible fr Main Line Health, Main Line Hspitals, r ther MLH Affiliate business develpment, including thse with respnsibilities fr grants, cntracting, raising funds, garnering supprt fr research, and business develpment may be appinted as an MLH IRB member r be invlved in the daily peratin f the review prcess. The MLH IRB may invite individuals with cmpetence in special areas t assist in the review f prtcls that require expertise beynd r in additin t that available n the MLH IRB. These individuals (cnsultants) may nt vte with the MLH IRB. Other individuals als attend cnvened meetings as necessary. These individuals advise the MLH IRB n the acceptability f prpsed research in terms f regulatry requirements, institutinal cmmitments, applicable laws, and standards f prfessinal practices and cnduct (e.g. MLH Chief Cmpliance Officer). MLH IRB members including alternates, receive human subjects prtectins educatin related t federal regulatins and guidance, Human Research Prtectin Prgram plicies and prcedures, and IRB review prcesses. Minimally, initial training in human subjects prtectin, with cntinuing educatin every three years is required (e.g., cmpletin f Cllabrative Institutinal Training Initiative mdules). MLH IRB members als receive additinal educatin/new infrmatin at meetings and via annuncements. Member qualificatins are reviewed as needed and n less than nce every tw years. A MLH IRB Plicy and Prcedure Manual 6

11 current membership rster is maintained by ORP and the FWA is updated as required. N member may participate in the MLH IRB s initial r cntinuing review f any prject in which the member has a cnflicting interest, except t prvide infrmatin requested by the MLH IRB. IRB MEETINGS There are a minimum f tw scheduled MLH IRB meetings a mnth. Additinal meetings may be scheduled as needed. QUORUM ORP staff attending MLH IRB meetings are respnsible fr determining that meetings are apprpriately cnvened befre the discussin and vte fr each review. Fr cnvened MLH IRB Meetings, a qurum is defined as fllws: The majrity (i.e., mre than half) f the MLH IRB members listed n the membership rster are present At least ne member is present whse primary cncerns are in nnscientific areas At least ne member is present whse primary cncerns are in scientific areas Fr Fd and Drug Administratin (FDA)-regulated research, a member is present wh is a licensed physician Attendance f an unaffiliated member at least 9 f 12 meetings per year. Attendance f at least ne member wh represents the perspective f research subjects (e.g. nn-affiliated member) at least 9 f 12 meetings per year. When the MLH IRB regularly reviews a vulnerable categry f research such as children, pregnant wmen, r handicapped r mentally disabled persns, a member is present representing ppulatin s interest and their vte will cunt twards qurum. When the MLH IRB reviews research invlving prisners, the prisner representative is present. Refer t the MLH IRB Plicy n Research Invlving Prisners as Subjects (XXVI) fr mre infrmatin n the IRB requirements fr prisners. If bth an MLH IRB member and his/her respective alternate(s) are present, nly ne may vte and be cunted tward qurum. Cmments frm members unable t attend a meeting that have been prvided in advance (e.g., by fax r ) may be cnsidered by the attending MLH IRB members, but may nt be cunted as vtes r tward the qurum fr cnvened meetings. Any member may participate by telecnference r videcnference, prvided he/she has received all materials befre the meeting and can actively and equally participate in the discussin. If qurum is nt met, then MLH IRB vting cannt take place; and the items n the agenda will be tabled/deferred until the next cnvened IRB meeting. If qurum is lst during a cnvened meeting (e.g., due t a member leaving the meeting), then n further vting can take place until qurum is restred; and the remaining items n the agenda will be tabled/deferred until qurum is restred r the next cnvened MLH IRB meeting. ORP staff attending MLH IRB meetings are respnsible fr recrding the attendance f members as they enter and leave the rm. If qurum is lst, ORP staff will ntify the IRB MLH IRB Plicy and Prcedure Manual 7

12 Chair r Vice-Chair that n further actins can be taken until/unless qurum is restred. ALTERNATES Federal regulatins allw rganizatins t appint an alternate(s) t substitute fr an MLH IRB member(s) wh is unable t attend s that MLH IRB business may mve frward in a timely manner. Alternates are appinted by the same prcess and fr the same length f time as MLH IRB members. IRB alternates functin as regular bard members when they are in attendance. An alternate may substitute fr the primary MLH IRB member fr an entire meeting r at any time during a meeting. Each alternate member is paired with ne r mre regular members with cmparable experience and expertise, as pssible. The MLH IRB rster identifies the primary member(s) fr whm each alternate may substitute. Minimally, alternates and members are paired by scientific class, as physician scientists (when applicable), ther scientists, and nn-scientists. The MLH IRB rster will identify the member(s) fr whm each alternate can substitute. When an alternate substitutes fr a regular MLH IRB member, the alternate receives and reviews the same materials that the regular member received (r wuld have received), and MLH IRB minutes dcument that an alternate replaced a primary member. IRB MEMBERSHIP ROLES AND RESPONSIBILITIES 1. MLH IRB Chair The MLH IRB Chair is selected based n experience and expertise frm amng current and frmer MLH IRB members. The MLH IRB Chair is a vting member and has primary respnsibility fr the fllwing: Prviding leadership t the MLH IRB t help ensure the rights and welfare f human subjects participating in research reviewed by the MLH IRB Cnducting cnvened meetings and reviewing and apprving the minutes dcumenting MLH IRB discussins and findings Cmmunicating with investigatrs and/r administratrs t reslve cntrversial and/r prcedural matters relating t research apprval and cnduct Annually cmpleting Cnflict f Interest Disclsure Frm and disclsing any ptential cnflicts prir t MLH IRB review f the research fr which a cnflict may exist Managing cnflicts f interest by ensuring that IRB members with cnflicts are nt present fr review f research fr which a cnflict may exist Maintaining cnfidentiality f MLH IRB-related infrmatin Administering Bard decisins and maintaining the independence f the IRB Signing crrespndence cmmunicating and dcumenting IRB decisins Reviewing and apprving research by expedited and exempt prcedures with the ORP Directr r designee Making research determinatins with the ORP Directr r designee. Refer t the MLH IRB Plicy n Research Determinatin and Activities Requiring IRB Review (V) Participating in the develpment f meeting agendas, plicies, prcedures, and educatinal effrts t supprt the human research prtectin prgram Maintaining a current knwledge f and assuring cmpliance with relevant regulatins, laws, and plicies related t the prtectin f human subjects Remaining current with IRB training requirements (CITI) Regularly cnsulting with the ORP Directr and ORP staff regarding MLH IRB issues Assisting with investigatins and review f alleged nncmpliance with human subjects prtectins requirements as required in the MLH IRB Plicy n MLH IRB Plicy and Prcedure Manual 8

13 Nncmpliance (XX) Assisting with institutinal effrts t prmte a culture f shared respnsibility fr the safety and welfare f research subjects 2. Vice-Chair(s) The Vice-Chair(s) supprt the rle and respnsibilities f the MLH IRB Chair. The Vice- Chair(s) attend MLH IRB meetings and chair cnvened meetings when required. The Vice- Chairs assume duties as delegated by the Chairs. In additin, the Vice-Chair(s) are vting members and respnsibilities include all f the fllwing: Annually cmpleting the Cnflict f Interest Disclsure Frm and disclsing any ptential cnflicts prir t MLH IRB review f the research fr which a cnflict may exist Maintaining a current knwledge f and assuring cmpliance with relevant regulatins, laws, and plicies related t the prtectin f human subjects. Remaining current with MLH IRB training requirements (CITI). Maintaining cnfidentiality f MLH IRB-related infrmatin Reviewing and apprving research by expedited prcedures, when designated by the MLH IRB Chair t perfrm this review. 3. MLH IRB Members MLH IRB member respnsibilities include all f the fllwing: Attending IRB meetings and actively participating in the review f research, unless arrangements have been made fr the alternate s attendance Cmpleting initial training in human subjects prtectin fr MLH IRB members prir t vting n any research and remaining current with MLH IRB training requirements. Understanding and applying the principles f the Belmnt Reprt and the federal regulatins related t the prtectin f human subjects Prviding timely written cmments n research underging MLH IRB review, when required Annually cmpleting the Cnflict f Interest Disclsure Frm and disclsing any ptential cnflicts prir t MLH IRB review f the research fr which a cnflict may exist Maintaining cnfidentiality f MLH IRB-related infrmatin Timely declaratin f ptential cnflicts f interests at cnvened meetings Reviewing and apprving research by expedited prcedures, when designated by the MLH IRB Chair t perfrm this review. MEMBERSHIP ROSTER Official Rsters fr each MLH IRB Sub-Cmmittee cntain the fllwing infrmatin fr each member and alternate: Name Earned degree(s) Representative Capacity Scientist status (scientist r nn-scientist) Affiliatin Status Experience Emplyment r ther relatinship with the Institutin Alternate Members Primary members fr whm alternate members can substitute VOTING MLH IRB Plicy and Prcedure Manual 9

14 Each member present is entitled t ne vte. In the absence f a primary member, the alternate member wh is substituting, vtes. The Cmmittee decisin is by a majrity vte. Other individuals having special expertise relevant t a particular matter, wh may be invited t attend specific meetings t assist in the review, may nt vte. REVIEW OF IRB COMPOSITION AND PERFORMANCE The cmpsitin f each Sub-Cmmittee is reviewed at least annually by the ORP and the MLH IRB Chair t determine if adjustment f the membership r cmpsitin is necessary t meet regulatry and rganizatinal requirements. The MLH IRB Chair and ORP Directr, with input frm ORP staff, evaluate individual MLH IRB member perfrmance in terms f attendance, knwledge and verall review quality n less than nce every tw years. Feedback (face-t-face r in writing) is prvided t MLH IRB members by the MLH IRB Chair and/r ORP Directr. Feedback may be prvided t supervisry authrities as required. The IO and ORP Directr, with input frm MLH IRB members and ORP staff as necessary, evaluate the MLH IRB Chair s and Vice-Chair s perfrmance and prvide feedback n less than nce every tw years. The IO is respnsible fr addressing perfrmance issues with the MLH IRB Chair and Vice-Chair(s) and fr nminating a new Chair and Vice-Chair(s) when necessary. Feedback (face-t-face r in writing) is prvided by the IO. Feedback may be prvided t supervisry authrities as required. ORP staff will prmptly update the rster with OHRP when changes in IRB membership are made. Rsters are psted n the ORP website. MINUTES Minutes are recrded by ORP t shw the fllwing: attendance nting when alternate member replaces a primary member; separate deliberatins fr each item actins taken by the MLH IRB the vte n MLH IRB actins including the number f members vting fr, against, and abstaining; the basis fr requiring changes in r disapprving research; deferrals; a written summary f the discussin f cntrverted issues and their reslutin; infrmatin prvided by a cnsultant the names f MLH IRB members wh leave the meeting because f a cnflicting interest, nting that cnflict f interest is the reasn fr absence fr initial and cntinuing review, the apprval perid required determinatins and prtcl-specific findings justifying determinatins fr: waiver r alteratin f the cnsent prcess research invlving pregnant wmen, fetuses and nenates research invlving prisners research invlving children research invlving subjects with diminished capacity t cnsent significant/nn-significant risk device determinatins All Minutes f these MLH IRB are apprved by the MLH IRB Chair and are maintained by ORP. Minutes f the MLH IRB are available t the IO. Originatin Date: 08/13/01 Revisin Date: 06/25/16 MLH IRB Plicy and Prcedure Manual 10

15 Main Line Health, Inc. and Main Line Health Inc. Subsidiaries This plicy applicable t: Wrking Tgether t Serve the Cmmunity All Subsidiaries All Hspitals BMRH All Acute Care Hspitals Mirmnt Treatment Center MAIN LINE HOSPITALS INSTITUTIONAL REVIEW BOARD POLICY AND PROCEDURE MANUAL Plicy N. Subject: III CONFLICTS OF INTEREST: RESEARCHERS AND RESEARCH STAFF POLICY Main Line Hspitals Institutinal Review Bard (MLH IRB) prmtes bjectivity in research by ensuring investigatr s and research staff s financial cnflicts f interest r even the appearance f cnflicts f interest are managed, minimized r eliminated when apprpriate. The MLH IRB ensures an existing financial cnflict f interest des nt adversely affect the prtectin f subjects r the integrity f the research. SCOPE The plicy applies t all investigatrs and research staff cnducting research under the jurisdictin f the MLH IRB regardless f the surce f funding. In additin t the requirements utlined in this plicy, human subjects research that is spnsred by the Department f Health and Human the Department f Health and Human Services (DHHS) must cmply with the Lankenau Institute fr Medical Research Financial Cnflict f Interest Plicy fr Public Health Services funded research. Institutinal cnflicts f interest are nt addressed in this plicy. DEFINITIONS 1. Investigatrs and Research Staff: Includes thse individuals invlved in the design, cnduct r reprting f human subjects research and their immediate family members 2. This includes but is nt limited t, the investigatrs, Subinvestigatrs, study crdinatrs, staff, nurses and any thers invlved in the cnduct f a research study. 2. Financial Cnflict f Interest (FCOI): Means any Significant Financial Interests that culd directly and significantly affect the design, cnduct, r reprting f research. 3. Financial Interest: Means anything f mnetary value, whether r nt the value is readily ascertainable. 4. Financial Interests which must be disclsed: Means any persnal, prfessinal, financial r wnership interest r ther beneficial interest in the research, spnsr, prduct r service being tested r held by the investigatrs r research staff including immediate family and may include any f the fllwing interests: a. Ownership r interest f any value including but nt limited t stcks and ptins (exclusive f interests in a publicly traded, diversified mutual fund). b. Cmpensatin f any value including but nt limited t salary, hnraria, paid authrship, cnsultant fees, ryalties, equity r ther incme. 2 Immediate family member means: spuse and dependent children MLH IRB Plicy and Prcedure Manual 11

16 c. Prprietary interest f any value including but nt limited t, patents, trademarks, cpyrights, licensing agreements r ther intellectual prperty rights and interests. d. Per subject r ther recruitment bnuses paid in additin t the negtiated research budget. e. A financial interest r cmpensatin f any value which will be affected by the utcme f the research. f. Serves r has ever served as a bard member, executive, emplyee, cnsultant, advisr r speaker. g. Any ther interest r ptential interest that may cnflict with his/her duties in the research and may affect a subject s vluntary and infrmed chice t participate in the research. 5. Significant Financial Interest (SFI) means: A financial interest cnsisting f ne r mre f the fllwing that reasnably appears t be related t a specific research study: a. With regard t any publicly traded entity, a SFI exists if the value f any remuneratin received frm the entity in the twelve mnths preceding the disclsure and the value f any equity interest in the entity as f the date f disclsure, when aggregated fr the preceding 12 mnths and immediate family members, exceeds $10,000. Fr purpses f this definitin, remuneratin includes salary and any payment fr services nt therwise identified as salary (e.g. cnsulting fees, hnraria, paid authrship); equity interest includes any stck, stck ptin, r ther wnership interest as determined thrugh reference t public prcess r ther reasnable measures f fair market value. b. With regard t any nn-publicly traded entity, a SFI exists if the value f any remuneratin received frm the entity in the twelve mnths preceding the disclsure, when aggregated fr the preceding 12 mnths and immediate family members exceeds $10,000. c. With regard t any nn-publicly traded entity, a SFI exists when any equity interest (e.g., stck, stck ptin, r ther wnership interest) is held r; d. Intellectual prperty rights and interests (e.g. patents, cpyrights), upn receipt f incme related t such rights and interests. PROCEDURE A. Disclsure: Cnflict f InterestDisclsure Frms are submitted t the Office f Research Prtectins (ORP): a. at the time f submissin f a new human subjects research prtcl investigatr and research staff are required t cmplete a Cnflict f Interest Disclsure Frm. b. with an active human subjects research prtcl investigatr and research staff are required t cmplete a Cnflict f Interest Disclsure Frm at least annually at time f Cntinuing Review submissin. c. with an active human subjects research prtcl investigatr and research staff must update new significant financial interests within 30 days f changes in financial circumstances (i.e. acquisitin r discvery) by prviding an updated Cnflict f Interest Disclsure Frm. B. Training: Investigatrs and research staff will receive training related t financial cnflict f interest at least every fur years n-line thrugh the Cllabrative Institutinal Training Initiative (CITI). Training will be required immediately when: a. Financial cnflict f interest plicies are revised in a manner that changes investigatr r researcher staff requirements. MLH IRB Plicy and Prcedure Manual 12

17 b. An investigatr is new t the rganizatin. c. An investigatr r researcher staff member is nn-cmpliant with financial cnflict f interest plicies and prcedures. C. Evaluatin and Management f Financial Cnflicts f Interest: ORP will review each Cnflict f Interest Disclsure Frm received and identify any investigatr r research staff wh makes a disclsure n the Cnflict f Interest Disclsure Frm. The Chair f the MLH IRB and ORP Directr will evaluate thse frms which cntain a disclsure and may require actin when necessary, such as disclsure in the infrmed cnsent. If the IRB Chair r the ORP Directr declares a cnflict, Cnflict f Interest Disclsure Frm will be referred t the Main Line Hspitals Designated Institutinal Official (IO) fr evaluatin. When an SFI appears t be an FCOI r any ther interest and has the ptential t adversely affect the prtectin f subjects in terms f the criteria fr IRB apprval r will adversely affect the integrity f the research, it will be initially be referred t the Research COI Subcmmittee (RCOI)fr further evaluatin If the RCOI determines that an individual with a Financial Interest has a Financial Cnflict f Interest it will submit its findings and recmmendatins t the COI Cmmittee fr further deliberatin. When an FCOI has the ptential t adversely affect the prtectin f subjects in terms f the criteria fr IRB apprval r will adversely affect the integrity f the research an FCOI management plan is required. Management plans may include withut limitatin remving the affected persns frm directly engaging in aspects f the trial that culd be influenced inapprpriately by the FCOI including, but nt limited t, btaining infrmed cnsent, mnitring f study, design f the study, versight respnsibilities, partial r cmplete divestment. In additin, a determinatin shall be made whether the research study may be reviewed by the MLH IRB and whether the study may be cnducted at Main Line Health. Disclsures alne may nt be sufficient and the IRB will make the final determinatin f what is required t assure subjects are prtected and fully infrmed. FCOIs are evaluated and management plans are develped prir t IRB review. IRB PROCEDURES FCOI management plans develped by the MLH COI Cmmittee are prvided t ORP and presented t the MLH IRB at the time f review. The MLH IRB has the final authrity t determine whether the research may be apprved. The MLH IRB and ORP are respnsible fr implementing and mnitring the FCOI management plan. Investigatrs and research staff will be required t submit an annual reprt describing cmpliance with their FCOI Management Plan. Annual reprts will be reviewed by the IRB Chair and ORP Directr. Deviatins frm the FCOI Management Plan will be handled under the MLH IRB Plicy n Nncmpliance (XX). RECORD KEEPING Cnflict f Interest Disclsure Frms, FCOI Management Plans related t human subjects research, and related dcuments will be maintained in ORP. Recrds will be maintained fr a minimum f three years after cmpletin f the research (refer t the MLH Administrative Plicy I.96 n Recrds Management (Retentin and Destructin). MLH IRB Plicy and Prcedure Manual 13

18 REGULATORY REFERENCES FDA Regulatins: 21 CFR 54 Financial Disclsure by Clinical Investigatrs Originatin Date: 08/13/01 Revisin Date: 06/25/16 MLH IRB Plicy and Prcedure Manual 14

19 Main Line Health, Inc. and Main Line Health Inc. Subsidiaries This plicy applicable t: Wrking Tgether t Serve the Cmmunity All Subsidiaries All Hspitals BMRH All Acute Care Hspitals Mirmnt Treatment Center MAIN LINE HOSPITALS INSTITUTIONAL REVIEW BOARD POLICY AND PROCEDURE MANUAL Plicy N. Subject: IV CONFLICTS OF INTEREST: IRB MEMBERS 3 AND CONSULTANTS POLICY Main Line Hspitals Institutinal Review Bard prmtes bjectivity in research by ensuring IRB Members, and cnsultants wh are participating in the review f a research study are free f actual r perceived cnflicts f interest. N regular r alternate IRB member r cnsultant (r their immediate family member) may participate in any type f review (including unanticipated prblems and nncmpliance) f research in which the member has a cnflict f interest, except t prvide infrmatin as requested. Due t institutinal cnflict f interest, n individual respnsible fr Main Line Health, Main Line Hspitals, r ther MLH Affiliate business develpment, including thse with respnsibilities fr grants, cntracting, raising funds, garnering supprt fr research, and business develpment may be appinted as an IRB member r be invlved in the daily peratin f the review prcess. DEFINITIONS A cnflicting interest f an IRB member, IRB cnsultant r their immediate family member 4 includes the fllwing: 1. Is a member f the research team; 2. Has a financial interest in the research with a value that cannt be readily determined; 3. Has received r will receive cmpensatin with a value that may be affected by the utcme f the study; 4. Has prprietary interest in research, such as a patent, trademark, cpyright, r licensing agreement r ryalties frm such rights; 5. Has any financial interest in the research; 6. Has received any payments frm the spnsr f the research; 7. Is an executive r directr f the agency r cmpany spnsring the research; 8. Has an interest that the IRB member believes cnflicts with his r her ability t bjectively review a prtcl; 9. Has a clse persnal r prfessinal assciatin with a member f the research team. A financial interest means anything f mnetary value, whether r nt the value is readily ascertainable. The financial interests that are cnsidered cnflicting interests fr IRB members and cnsultants are the same as thse fr researchers and research staff. 3 IRB Members include all IRB vting and, the Main Line Hspitals, Inc. Designated Institutinal Official. 4 Immediate family member means spuse and dependent children. MLH IRB Plicy and Prcedure Manual 15

20 PROCEDURE These prcedures cver thse research prtcls reviewed at a cnvened IRB and reviewed using expedited prcedure and include the review f unanticipated prblems invlving risk t subjects r thers, review f nncmpliance with the regulatins r the requirements f the IRB and any ther ad hc reviews requested by the IRB. A. IRB Members IRB members are required t cmplete a Cnflict f Interest Frm annually. 1. Review by Cnvened IRB: a. IRB members shuld review the list f prtcls fr an upcming meeting and shuld disclse a cnflicting interest as sn as pssible t the Office f Research Prtectins (ORP) Staff, ORP Directr r the IRB Chair. b. An IRB member with a cnflicting interest n a prtcl shuld nt accept the prtcl fr review, and shuld return it t ORP fr reassignment t anther reviewer. c. If an IRB member recgnizes a cnflicting interest at the IRB meeting, the IRB member must infrm the IRB Chair f the cnflicting interest. d. If ther IRB members need t request infrmatin abut the prtcl frm the IRB member with the cnflicting interest, the IRB member may remain in the rm during the presentatin f the prtcl but must then leave the rm befre the final discussin and vte. e. The ORP Staff will recrd in the minutes the name f the IRB member as being absent based n a cnflicting interest. The IRB member will nt be cunted as part f the qurum fr the prtcl. If qurum is nt maintained, n further actin may be taken by the IRB n the prtcl. 2. Review by Expedited Prcedure: a. IRB members shuld review the assigned item fr review and shuld disclse a cnflicting interest as sn as pssible t the ORP Staff, ORP Directr r the IRB Chair. b. An IRB member with a cnflicting interest n a prtcl shuld nt accept the item fr review, and shuld return it t ORP fr reassignment t anther reviewer. B. IRB Cnsultants 1. Prir t engaging a cnsultant fr review f a research prtcl, the ORP Staff, ORP Directr r the IRB Chair will make an initial assessment whether there is a cnflict f interest n the part f an IRB cnsultant. 2. When requesting a cnsultant t review a prtcl, the ORP Staff will prvide the cnsultant with the IRB Member and Cnsultant COI Plicy in additin t the relevant materials fr review and ask if the cnsultant has a ptential cnflict f interest with the prtcl, as defined in this plicy. 3. The IRB cannt use the services f a cnsultant in the review f a research prtcl, in which the cnsultant has a cnflict f interest, as defined in this plicy. 4. The ORP will reassign any prtcl with which a cnsultant has a cnflict f interest. DOCUMENTATION All COI and related dcuments will be maintained in ORP. REGULATORY REFERENCES FDA Regulatins: 21 CFR (e) DHHS Regulatins 45 CFR 46 Prtectin f Human Subjects (e) MLH IRB Plicy and Prcedure Manual 16

21 Originatin Date: 05/29/2008 Revisin Date: 06/25/16 MLH IRB Plicy and Prcedure Manual 17

22 Main Line Health, Inc. and Main Line Health Inc. Subsidiaries This plicy applicable t: Wrking Tgether t Serve the Cmmunity All Subsidiaries All Hspitals BMRH All Acute Care Hspitals Mirmnt Treatment Center Plicy N. V. MAIN LINE HOSPITALS INSTITUTIONAL REVIEW BOARD POLICY AND PROCEDURE MANUAL Subject: RESEARCH DETERMINATION AND ACTIVITIES REQUIRING IRB REVIEW POLICY Research invlving human subjects requires the review f an Institutinal Review Bard fr any research r clinical investigatin that invlves human subjects as defined belw. Research that des nt meet the regulatry definitin f human research r clinical investigatins des nt require IRB apprval. DEFINITIONS 1. Research: a. Department f Health and Human Services (DHHS) Regulatins - a systematic investigatin, including research, develpment, testing and evaluatin designed t develp r cntribute t generalizable knwledge. i. Systematic investigatin - A study fllwing a methdical plan t establish factual infrmatin cncerning the truth f a specific hypthesis r thery. ii. Generalizable knwledge - Knwledge that may be justifiably transferred r extraplated t a brader ppulatin r situatin than that in which it has been derived b. DHHS Regulatins clinical trial means a research study in which ne r mre human subjects are prspectively assigned t ne r mre interventins (which may include placeb r ther cntrl) t evaluate the effects f the interventins n bimedical r behaviral health-related utcmes. c. Fd and Drug Administratin (FDA) Regulatins a clinical investigatin means any experiment that invlves test article(s) and ne r mre human subjects. i. Test article - Any drug (including a bilgical prduct fr human use, medical device fr human use), human fd additive, clr, adaptive, electrnic prduct, r any ther article subject t regulatin under the jurisdictin f the FDA. 2. Human subject: a. DHHS Regulatins - A living individual abut whm an investigatr (whether prfessinal r student) cnducting research (1) btains infrmatin r bispecimens thrugh interventin r interactin with the individual and uses studies r analyzes the infrmatin r bispecimens r (2) btains, use, studies, analyzes r generates identifiable private infrmatin r identifiable bispecimens. i. interventin includes bth physical prcedures by which infrmatin r bispecimens are gathered (e.g. venipuncture) and manipulatins f the subject r the subject s envirnment that are perfrmed fr research purpses. ii. Interactin includes cmmunicatin r interpersnal cntact between investigatr MLH IRB Plicy and Prcedure Manual 18

23 and subject. iii. private infrmatin includes infrmatin abut behavir that ccurs in a cntext in which an individual can reasnably expect that n bservatin r recrding is taking place, and infrmatin that has been prvided fr specific purpses by an individual and that the individual can reasnably expect will nt be made public (e.g., a medical recrd). iv. identifiable private infrmatin is private infrmatin fr which the identity f the subject is r may readily be ascertained by the investigatr r assciated with the infrmatin. v. identifiable bispecimen is a bispecimen fr which the identity f the subject is r may be readily ascertained by the investigatr r assciated with the bispecimen. b. FDA Regulatins - An individual wh is r becmes a participant in research either as a recipient f the test article r as a cntrl. A subject may be either a healthy human r a patient. 3. Research invlving human subjects 5 : a. DHHS Regulatins - Meets the definitin f research invlving human subjects as referenced in Sectins 1 and 2 abve. b. FDA Regulatins - Meets the FDA definitin f clinical investigatin invlving human subjects as referenced in Sectins 1 and 2 abve. PROCEDURE Any individual wh is unsure whether r nt a prpsed activity shuld be classified as research shuld cntact the IRB fr guidance with a written descriptin f the prject. Investigatrs have the ptin t btain frm the IRB dcumentatin that the activity is nt subject t IRB review. T btain dcumentatin, investigatrs must submit a descriptin f the prpsed activity in writing. The IRB Chair r Office f Research Prtectins (ORP) Directr r their designees make the determinatin. A. Activities which require IRB review include, but are nt limited t: 1. Any experiment that invlves a test article and ne r mre human subjects, that are regulated by the Fd and Drug Administratin r supprt applicatins fr research r marketing permits fr prducts regulated by the FDA. Prducts regulated include fds, including dietary supplements, medical devices, drugs, bilgical prducts human fd additives, clrs, adaptive and electrnic prducts. 2. Cllectin and use f data abut a series f standard prcedures r treatments fr disseminatin r generalizatin if the activity meets the definitin f research invlving human subjects. 3. Patient care r the assignment f nrmal subjects t any interventin that is altered fr research purpses in any way. 5 Althugh nt meeting the regulatry definitin f research invlving human subjects, the privacy rights f nnliving individuals are prtected under the Privacy Rule. Review by the MLH IRB, acting as the Privacy Bard fr research may be required. Refer t Administrative Plicy VII 17 n HIPAA: Use f Prtected Health Infrmatin fr Research fr mre infrmatin. MLH IRB Plicy and Prcedure Manual 19

24 4. A diagnstic prcedure fr research purpses that is added t a standard treatment. 5. Systematic investigatins f innvatins in diagnstic, therapeutic prcedure r instructinal methd in multiple subjects in rder t cmpare standard prcedure. The investigatin is designed t test a hypthesis, permit cnclusins t be drawn, thus t develp r cntribute t generalizable knwledge. 6. Emergency Use f an Investigatinal Test Article. One time emergency use f an investigatinal test article may prceed withut prspective IRB review and apprval. The patients receiving an investigatinal test article in an emergency setting are generally nt cnsidered research subjects and data btained frm patients may nt be classified as human research and may nt be included in any reprt f research activities subject t DHHS regulatins. NOTE: The investigatr has additinal respnsibilities, including ntifying the IRB, befre and/r after the emergency use f an investigatinal test article. Refer t Plicy VIII Emergency Use f an Investigatinal Test Article fr mre infrmatin 7. Emergency Medicine Research. Prspectively planned emergency medicine research with investigatinal drugs, devices, r bilgics requires IRB apprval. If the investigatr intends t request a waiver f the requirement fr infrmed cnsent, additinal requirements must be met including cmmunity cnsultatin and public disclsure. 8. In Vitr Device (IVD) Studies. Current FDA guidance indicates that IRB review is required fr any IVD study invlving human specimens/samples, even when the specimens are leftver human specimens, the research invlves n identifiers r the bilgical materials cannt be linked t any identifying infrmatin. (FDA regulatins d nt cntain exceptins frm the requirements f infrmed cnsent n the grunds that the specimens are nt identifiable and r that they are remnants f human specimens cllected fr rutine clinical care r analysis that wuld therwise have been discarded. Nr d FDA regulatins allw IRBs t decide whether r nt t waive infrmed cnsent fr research invlving leftver r unidentifiable specimens.) See 2006 FDA Guidance n Infrmed Cnsent fr In Vitr Diagnstic Device Studies Using Leftver Human Specimens that are Nt Individually Identifiable. 9. Individually Identifiable Data and Human Tissue. Use f data r human tissue fr research which is identifiable requires IRB review. 10. Investigatr Initiated Research. An investigatr wh bth initiates and cnducts, alne r with thers, a research prject r clinical trial regardless f surce f funding r supprt. 11. Resident/Fellw Research. Directed r independent human research prjects which emply systematic data cllectin with the intent t cntribute t generalizable knwledge. 12. Access/review f prtected health infrmatin fr research purpses. Prtected health infrmatin belnging t Main Line Health, Main Line Hspitals, r ther MLH Affiliate may nt be used internally r disclsed t any persns r MLH IRB Plicy and Prcedure Manual 20