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