WCGME-IRB The Wright Center for Graduate Medical Education Institutional Review Board Mark V. White, M.D., Chairman * Robert H. Angeloni, MPA, Co-Chairman Minutes of the meeting held Thursday, October 23, 2014 Members Present Members Excused or Absent Robert H. Angeloni, MPA (Co-Chairman) Daniel J. West, Jr., PhD Scott Bolesta, PharmD Michael Costello, JD Mark V. White, MD, MPH (Chairman) Martin Hyzinski, M. D. Staff and Guests Ann Marie Lavelle, BSN Julie A. Nardella, PhD, MSN/Ed, RN IRB Administrator Waheed Khan, MD Nanci Dobson, RN, CWCA, CCRP Karen Parry, CRA John Walsh Lee Ann Haefele, BSN Fred R. Leri, PharmD Vee Pauli, RD Paula Roe-Prior, PhD, RN John Szarek, PhD Mushfiq Tarafder, MPH Margarete Zalon, PhD Ex-officio Members Present Cathy Betz Deb Henninger The monthly meeting of The Wright Center for Graduate Medical Education Institutional Review Board began at 8: 00 AM on Thursday, October 23, 2014 in the Small Meeting Room, McGowan Conference Center, 2nd floor, Regional Hospital of Scranton. A quorum of voting members was present. There are 14 regular voting members. 11 regular voting members were present at the beginning of the meeting. AGENDA ITEM 1. Review of the minutes of September 25, 2014. Page 1 of 12 MAIN DISCUSSION POINTS Minutes were mailed to each member with the current meeting agenda and materials. FINAL DISCUSSION/RESOLUTION The minutes and report of action were accepted. Yes 11 No 0 Abstain 0 October 23, 2014 IRB Minutes AGENDA ITEM 2. MAIN DISCUSSION POINTS Addenda / Memoranda / Editorial and Administrative Changes: FINAL DISCUSSION/RESOLUTION All reports were reviewed and accepted as presented. Specific discussion items are listed below. Yes 11 No 0 Abstain 0 2.1. Scranton Hematology-Oncology Protocol #: Editorial: Administrative Changes: NSABP B-43 B-47 Updated Investigator’s Brochure (IB) for Herceptin (Trastuzumab), Version 14, dated October 2013 NSABP B-42 Amendment #6 FULL BOARD REVIEW E1609 Addendum #10 Expedited Review Addendum #11 FULL BOARD REVIEW Addendum #12 Expedited Review E7208 Page 2 of 12 Updated Ramucirumab Investigator’s Brochure (IB), Version 11.0, dated 13 May 2014 October 23, 2014 IRB Minutes 3. AGENDA ITEM DISCUSSION POINTS AND RESOLUTION Amendments requiring full board review and approval: Modified consent forms and associated documentation if not summarized below, are mailed to each member for review with the current meeting agenda. All items were reviewed and accepted as presented. Specific discussion items are listed below as necessary. Note: All amendments submitted for full board review are available to board members from the Wright Center main web page at: http://thewrightcenter.org. 3.1 Scranton Hematology Oncology Ammendment #6 for protocol NSABP B-42 “ A Clinical Trial to Determine the Efficacy of Five Years of Letrozole Compared to Placebo in Patients Receiving Five Years of Hormonal Therapy consisting of An Aromatase Inhibitor (AI) in Prolonging Disease-Free Survival in Postmenopausal Women with Hormone Receptor Positive Breast Cancer” requires full board review and approval due to administrative changes in the Protocol due to the transition to NRG Oncology and NCI-requested changes. There are no changes to the content of the Optional Registration Program Sample Consent Form or the Main Study Sample Consent Form. The date of the consent forms has been changed to match the most recent version of the protocol. 3.2 Amendment #11 for protocol E1609 “A Phase III Randomized Study of Adjuvant Ipilimumab Anti-CTLA4 Therapy Versus High Dose Interferon a-2b for Resected High-Risk Melamoma requires full board review due to changes in The Informed Consent to include: Version date on the cover page, change in header from ECGO-ACRIN to ECOG-ACRIN, update with all mentions of interferon to “interferon alfa-2b” for consistency. Addendum changes Also include the following changes in the Pediatric Informed Consent/Parental Permission Form: Updated Version date on the cover page, global changes throughout the consent with named pediatric arms D, E, and F, Updated all mentions of interferon to “interferon alfa-2b” for consistency, addedto possible side effects of Ipilimumab Nonsteroidal anti-inflammatory Drugs (NSAIDS) per CTEP recommendation, and Added “will participate” to the end of the paragraph referencing how many people will take part in the study. Yes 11 No 0 Abstain 1 Page 3 of 12 October 23, 2014 IRB Minutes AGENDA ITEM 4. DISCUSSION POINTS AND FINAL RESOLUTION Adverse Drug Reactions – IND Safety Reports: All reports were reviewed and accepted as presented. Yes 11 No 0 Abstain 0 4.1. Scranton Hematology-Oncology Organization and Protocol Number: Millennium C16010 and C16040 Patient Identifier: Date: 09/08/2014 Initial: FU: Adverse Event / Safety Report: MLN9708 Safety Updates: 2014MPI001252 fu3 Other serious criteria: medically significant, Pseudomonas septicemia 2014MPI001373 fu4 Collapse-syncopal episode, fall 2014MPI001887 Other serious criteria: medically significant, heart failure 2014MPI002241 fu1 Herpes zoster 2014MPI002285 Dehydration 2014MPI002350 Other serious criteria: medically significant, Arrhythmia worsening 2014TJP010770 fu2 Bronchitis 2014MPI002201 fu1 Death 2014MPI000137 fu6 Transverse myelitis 2014MPI001328 fu3 Other serious criteria: medically significant, seizures 2014MPI001860 fu1 Pulmonary infection, mood Page 4 of 12 October 23, 2014 IRB Minutes Organization and Protocol Number: Patient Identifier: Date: Initial: FU: Adverse Event / Safety Report: alteration 2014MPI002355 Arrhythmia worsening 09/12/2014 2014MPI000608 fu1 Other serious criteria: medically significant, pneumonia 2014MPI001032 fu4 Other serious criteria: medically significant, lung infection, cardiopulmonary arrest, multiple myeloma progression, thromboembolic event, dehydration 2014MPI001828 fu3 Other serious criteria: medically significant, adenocarcinoma sigmoid colon 2014MPI001887 fu1 Other serious criteria: medically significant, heart failure 2014MPI001976 fu1 Other serious criteria: medically significant, idiopathic thrombocytopenic purpura 2014MPI002419 Other serious criteria: medically significant, Alkaline phosphatase- high 2014MPI002445 Worsening pain 2014TJP008873 fu3 Deep vein thrombosis 09/18/2014 Page 5 of 12 2013MPI000238 fu6 Dyspnea (etiology unknown) October 23, 2014 IRB Minutes Organization and Protocol Number: Patient Identifier: Date: Initial: FU: Adverse Event / Safety Report: 2013MPI000325 fu4 Atrial fibrillation, constipation 2014MPI000608 fu2 Other serious criteria: medically significant, pneumonitis 2014MPI000916 fu1 Dyspnea (etiology unknown) 2014MPI001527 Patient deceased, abdominal pain 2014MPI002458 Pneumonia 2014MPI002458 fu1 Pneumonia 2014MPI002459 Confusion 09/24/2014 2014MPI001328 fu4 Other serious criteria: medically significant, seizures 2014MPI001987 fu1 Other serious criteria: medically significant, medication error, no adverse event 2014MPI002350 fu1 Other serious criteria: medically significant, arrhythmia worsening 2014MPI002402 Other serious criteria: medically significant, myelodysplasia 2014MPI002419 fu1 Other serious criteria: medically significant, alkaline phosphatase high 2014MPI002525 Other serious criteria: medically significant, acute kidney injury, hypoglycemia 2014MPI002574 Hypokalemia, atrial fibrillation Page 6 of 12 October 23, 2014 IRB Minutes Organization and Protocol Number: Patient Identifier: Date: Initial: FU: Adverse Event / Safety Report: 2014MPI002583 Febrile neutropenia 09/26/2014 2014MPI001828 fu4 Other serious criteria: medically significant, adenocarcinoma sigmoid colon 2014MPI002584 General alteration state 2014MPI002586 Febrile syndrome related to bacteremia 2014MPI002596 Other serious criteria: medically significant, septic shock 2014TJP006966 fu3 Invasive brochopulmonary aspergillosis IBCSG-24-02 09/08/2014 Triptorelin and Tamoxifen Safety Updates: 10002485 Uterine Leiomyoma 10002498 Deep vein thrombosis E1609 E3612 09/10/2014 MDX-010 Safety Reports: 2510839 fu1 Gr. 3 Uveitis 09/24/2014 2485819 Gr. 5 Colonic perforation 1265130 fu1 Gr. 4 Blood and lymphatic system disorders: hypercellular marrow Page 7 of 12 October 23, 2014 IRB Minutes Organization and Protocol Number: Patient Identifier: Date: Initial: FU: Adverse Event / Safety Report: 2705907 Gr. 3 Blood and lymphatics: Idiopathic thrombocytopenic purpura (SAE report reads thrombotic thrombocytopenic purpura) NSABP B-43, B-47 09/02/2014 Trastuzumab Safety Updates: 1368748 fu3 Fulminant hepatic failure, Hepatitis B infection 09/08/2014 1451498 Cardiac arrest 1451583 Dehydration, nausea, vomiting NSABP B-44, B-46 09/29/2014 Bevacizumab Safety Updates: 2278957 Gr. 4 hypomagnesemia Dendreon P10-3 09/17/2014 Provenge (sipuleucel-T) Suspension Safety Updates: 2013PROUSA02703 Deep vein thrombosis S1207 09/22/2014 Everolimus Safety Updates: PHHO2014JP009849 Hepatic artery occlusion, cholangitis Page 8 of 12 October 23, 2014 IRB Minutes Organization and Protocol Number: Patient Identifier: Date: Initial: FU: Adverse Event / Safety Report: PHHO2014ES011418 Other serious criteria: medically significant, ascitis, edemas E1305 E3612 E5103 E5202 E5204 E5508 GOG 0218 GOG 0252 09/24/2014 2278957 Gr. 4 hypomagnesemia AGENDA ITEM 5. Bevacizumab Safety Updates: MAIN DISCUSSION POINTS Full Continuing Review: 1o reviewer is: Mark V. White, MD. Note: All combination reports submitted are available to board members from the Wright Center main web page at: http://www.thewrightcenter.org. 2o reviewer is: Robert H. Angeloni, MPA. FINAL DISCUSSION/RESOLUTION All studies were accepted as presented. Yes: 11 No:0 Abstain: 0 5.1 “A Randomized Phase II Study of Irinotecan and Cetuximab with or Without the Anti-Angiogenic Antibody, Ramucirumab (IMC-1121B), in Advanced, K-ras Wild-Type Colorectal Cancer Following Progression on Bevacizumab-Containing Chemotherapy” was submitted for full continuing review. The study is open to enrollment and extension with review in one year was requested. AGENDA ITEM 6. MAIN DISCUSSION POINTS Expedited Reviews: 1o reviewer is: Mark V. White, MD. All items submitted for expedited review are available to board members from the Wright Center main web page at: http://www.thewrightcenter.org and in the WCGME-IRB Administrative Office. 2o Page 9 of 12 reviewer is: Robert H. Angeloni, MPA. FINAL DISCUSSION/RESOLUTION All reports were accepted as presented. Yes 11 No 0 Abstain 0 October 23, 2014 IRB Minutes AGENDA ITEM MAIN DISCUSSION POINTS FINAL DISCUSSION/RESOLUTION 6.1 Expedited Continuing Reviews: 6.1.1 Martin Hyzinski, M.D. Protocol No.: B 35. Study Title: “A Clinical Trial Comparing Anastrozole with Tamoxifen in Postmenopausal Patients with Ductal Carcinoma in Situ (DCIS) Undergoing Lumpectomy with Radiation Therapy” was submitted for expedited continuing review. The study is permanently closed to enrollment but following patients. Extension with review in one year was requested. 6.1.2. Martin Hyzinski, M.D CALGB 49907 “A Randomized Trial of Adjuvant Chemotherapy with Standard Regimens, Cyclophosphamide, Methotrexate and Fluorouracil - (CMF) or Doxorubicin and Cyclophosphamide – (AC), Versus Capecitabine in Women 65 Years and Older with Node Positive or Node-Negative Breast Cancer” was submitted for expedited continuing review. The study is permanently closed to enrollment but following patients. Extension with review in one year was requested. 6.1.3. Martin Hyzinski, M.D. Protocol No.: P 10-3 “PROCEED: A Registry of Sipuleucel-T Therapy in Men with Advanced Prostate Cancer ‘ was submitted for expedited continuing review. The study is permanently closed to enrollment but following patients. Extension with review in one year was requested. 6.1.4. Martin Hyzinski, M.D. Protocol No.: E 1697 ”Phase III Randomized Study of Four Weeks High Dose IFN-alpha2b in Stage T2b N0, T3a-bN0, T4a-b N0, and T1-4, N1a, 2a (Microscopic) Melanoma” was submitted for expedited continuing review. The study is permanently closed to enrollment but following patients. Extension with review in one year was requested. 6.1.5. Martin Hyzinski, M.D. Protocol No.: E 2188. “Phase III Comparison of Adjuvant Chemotherapy with or Without Endocrine Therapy in High-Risk, Node Negative Breast Cancer Patients” was submitted for expedited continuing review. The study is permanently closed to enrollment but following patients. Extension with review in one year was requested. 6.1.6. Martin Hyzinski, M.D. Protocol No.: E 4494.” Phase III Trial of CHOP versus CHOP and Chimeric Anti-CD20 Monoclonal Antibody (IDEC-C2B8) in Older Patients with Diffuse Mixed, Diffuse Large Cell and Immunoblastic Large Cell Histology Non-Hodgkin's Lymphoma” was submitted for expedited continuing review. The study is permanently closed to enrollment but following patients. Extension with review in one year was requested. 6.1.7. Martin Hyzinski, M.D. Protocol No.: E 5103. “A Double-Blind Phase III Trial of Doxorubicin and Cyclophosphamide Followed by Paclitaxel with Bevacizumab or Placebo in Patients with Lymph Node Positive and High Risk Lymph Node Negative Breast Cancer” was submitted for expedited continuing review. The study is permanently closed to enrollment but following patients. Extension with review in one year was requested. 6.1.9. Martin Hyzinski, M.D. Protocol No.: GOG 0252. “A Phase III Clinical Trial of Bevacizumab with IV Versus IP Chemotherapy in Ovarian, Fallopian Tube, and Primary Peritoneal Carcinoma NCI-Supplied Agent(s): Bevacizumab (NSC #704865, IND #7921)” was submitted for expedited continuing review. The study is permanently closed to enrollment but following patients. Extension with review in one year was requested. 6.2 Protocols Terminated/Final Combination Reports 6.2.0. William J. Heim, M. D. Protocol MA.21 “ A Clinical Trial Comparing 3 Combinations of Chemotherapy: EC + Filgrastim + Epoetin Alfa Followed by Paclitaxel Versus AC Followed by Paclitaxel Versus CEF in Premenopausal and Early Postmenopausal Woman Who Have Had Surgery for Axillary Node Positive or High Risk Node Negative Breast Cancer” was submitted as a final report. The study is permanently closed to enrollment and was submitted as a final report. No further review is necessary. Page 10 of 12 October 23, 2014 IRB Minutes AGENDA ITEM MAIN DISCUSSION POINTS FINAL DISCUSSION/RESOLUTION 6.3. The following expedited reviews were conducted by the Chairman and/or the Co-Chairman. They are presented for the Board’s information. Complete documentation for these studies is available for inspection by IRB Members in the WCGME-IRB Administrative office. 6.3.1 Youngjin Cho, PhD “Histological Evaluation of osteoporotic bone for AFAP1 and Src protein expression”. The study was reviewed and approved by Mark V. White, M. D. on September 18, 2014. This one year study was approved for one year and must receive continuing review by September 17, 2015 in order to be continued. The study has been assigned the number TCMC09082014YC. AGENDA ITEM 7. New / Full Review: MAIN DISCUSSION POINTS FINAL DISCUSSION/RESOLUTION All Protocols and related documentation submitted for initial review are available to board members from the Wright Center main web page at: http://www.thewrightcenter.org and in the WCGME-IRB Administrative Office. 7.1 No full reviews submitted for this month. AGENDA ITEM 8. Other Business: 8.1. A discussion a scientific candidate for the remaining open seat on the IRB commenced. Review of the CV and qualifications for prior member Dr. Robert Wright were presented and a vote was conducted. This prior member is appointed to the board. Yes: 11 No: 0 Abstain: 0. 8.2. Discussion of member reappointment processes for open IRB seats was initiated by Dr. Mark V. White, Chairman of the WCGME-IRB. Prior members expressing interest will be sent a letter of invitation to rejoin the board will be sent to the prospective member. A vote for reinstatement will be conducted and the member, on notification of reappointment, will provide updated CV and documentation protection of human subject training to the IRB to ensure process consistency. Yes: 11 No: 0 Abstain: 0. Several other administrative items were placed before the members for consideration, future discussion and possible action, including: a. IRB member identification of research areas of expertise to facilitate review processes. Dr. White, Chairman, requested that members highlight areas of expertise to align the assignment of primary and secondary reviewer. Paula Roe-Prior, PhD, also discussed the importance of a content expert in ensuring review. Yes 11 No 0 Abstain 0. Mark V. White, MD, Chari of the WCGME-IRB initiated the discussion on CITI or equivalent training requirements for IRB members, PIs, coinvestigators. CITI training purchase in process for members and Scott Bolesta discussed the use of a cost efficient alternate method of certification for PIs and co-investigators. Discussion ensued and CITI or NIH human subject certification will be accepted for PIs and co-investigators. The WCGMEIRB web site will be updated to reflect the same Yes 11 No 0 Abstain 0. Mark V. White, MD, Chair of the WCGME-IRB initiated dialogue on backup scientific reviewers in cases where additional expertise is indicated or in the 8.3. 8.4 8.5 Page 11 of 12 October 23, 2014 IRB Minutes event of multiple new full reviews. The assignment of the same will be on a case-by-case basis and will be initiated by the Chair and/or Co-chair. Paula Roe-Prior and Scott Bolesta initiated discussion related to the submission of full reviews three weeks in advance of the review. The 2015 calendar will be adjusted to reflect the same and the revised review process will be implemented as of January 1, 2015. Yes 11 No 0 Abstain 0. AGENDA ITEM 9. Meeting adjourned at 9:05 AM Yes 11 No 0 Abstain 0 A twelve month running list of WCGME-IRB meetings. IRB Meeting Date: IRB Meeting Date: Materials Due By: 22 January 2015 05 January 2015 July - Recess 26 February 2015 09 February 2015 28 August 2014 11 August 2014 26 March 2015 09 March 2015 25 September 2014 08 September 2014 23 April 2015 06 April 2015 23 October 2014 06 October 2014 28 May 2015 11 May 2015 20 November 2014 03 November 2014 25 June 2015 08 June 2015 December - Recess ________________________________ Mark V. White, M.D. WCGME-IRB Chairman, October 23, 2014 Page 12 of 12 Materials Due By: __________________________ Julie A. Nardella, PhD, MSN/Ed, RN WCGME-IRB Administrator, October 23, 2014 October 23, 2014 IRB Minutes