SHORE HEALTH SYSTEM INSTITUTIONAL REVIEW BOARD MHE Boardroom April 10, 2012

Transcription

1 SHORE HEALTH SYSTEM INSTITUTIONAL REVIEW BOARD MHE Boardroom April 10, IRB members 6 or more = a quorum ATTENDANCE Chairman: Robert Cattaneo, JD - non-scientist Joan Banks non-scientist Kim Billingslea, BSN,RN,NE-BC - scientist Craig Caldwell, MD - scientist Kevin Chapple, PharmD - scientist Vice Chairman: Brian Childs, PhD - non-scientist Geoff Holmes, MBA - scientist Ruth Sullivan, RNC,CRRN,CNA - scientist John Charles Turner, PhD - scientist Thomas W. Wilson, MA - scientist Recording: Mava Mayo, IRB Secretary Guests: Sharon Richter, Regional Cancer Center Dorney Brown, Regional Cancer Center - Regional Cancer Center John P. Foley, MD Marcia D.E. Shapiro, MSN, RN 1. Approval of Minutes The March 13, 2012 IRB Minutes were approved by 7 members; 3. SHS IRB #12-02 Memory Loss Clarification: Questions were asked at the meeting based on News Reports, not the protocol or Informed Consent. 2. Request for Approval of New Research Protocol SHS IRB #12-03 ECOG E2809: Androgen Receptor Modulation Phase II, Randomized Study of MK-2206 Bicalutamide Combination in Patients With Rising PSA at High-Risk of Progression After Primary Therapy. John P. Foley, MD - Dr. Foley: A phase II study for prostate cancer patients who have received treatment but failed. MK-2206 Bicalutamide blocks a large proportion of the stimulation for growth of cancer. Side Effects include: breast enlargement in the male; liver damage; hot flashes. - Dr. Caldwell questioned the Informed Consent, pg inflammation of the injection site? the drug is oral. Sharon Richter will attempt to determine from ECOG what was meant by inflammation may occur where a drug was given SHS Institutional Review Board 4/10/2012 1

2 7 members approved the above mentioned protocol and informed consent for a period of one year; 3. Request for Approval of New Research Protocol SHS #031201: Evaluation of Medication History Differences by Anxiety Level for Emergency Department Patients. Marcia D.E. Shapiro, MSN, RN - Protocol discussed by the IRB due to the collection of patient demographics. It was determined that no personal patient information would be compromised. 7 members determined the above mentioned protocol to be Exempt due to minimal risk; 4. Renewal of Previously Approved Protocol SHS IRB #10-06 Endocrine progenitor cells in the adult human pancreas JHU protocol NA Michael Shamblott 7 members approved renewal of the above mentioned protocol for a period of one year; 5. Renewal of Previously Approved Protocol SHS IRB #10-07 Transplantation of Lungs from Non-Heart-Beating Donors After Functional Assessment Ex Vivo. Bartley P. Griffith 7 members approved renewal of the above mentioned protocol for a period of one year; 6. Approval of Changes to Protocol Update #14 SHS IRB #08-01 CALGB 80405: A Phase III Trial of Irinotecan/5-FU/Leucovorin or Oxaliplatin/5-FU/Leucovorin with Bevacizumab, or Cetuximab, or with the combination of Bevacizumab and Cetuximab for Patients with Untreated Metastatic Adenocarcinoma of the Colon or Rectum. SHS Institutional Review Board 4/10/2012 2

3 - Oxaliplatin CAEPR update (pp 85-89) - Closed to accrual Attachment NK2b, IRB minutes members approved Update #14 of the above mentioned protocol for a period of one year; 7. Approval of Changes to Protocol Amendment #5 SHS IRB #10-02 NSABP B-43: A Phase III Clinical Trial Comparing Trastuzumab Given Concurrently with Radiation Therapy and Radiation Therapy Alone for Women with HER2- Positive Ductal Carcinoma In Situ Resected by Lumpectomy. - The issue from the March IRB was: the heart stops pumping blood. - Pages were missing from the protocol and Informed Consent Form. Dorney Brown will send new pages to the IRB Secretary for review at the May IRB. A complete Informed Consent was received by the IRB Secretary on 4/17/12. 7 members approved Amendment #5 of the above mentioned protocol and Informed Consent; 8. Approval of Changes to Protocol Update #03 SHS IRB #10-17 CALGB C80702: A Phase III Trial of 6 Versus 12 Treatments of Adjuvant FOLFOX Plus Celecoxib or Placebo for Patients with Resected Stage III Colon Cancer. 7 members approved Update #3 of the above mentioned protocol for a period of one year; 9. Approval of Changes to Protocol and Consent Form Amendments 1&2 and Update 1 SHS IRB #11-04 NSABP B-47: A Randomized Phase III Trial of Adjuvant Therapy Comparing Chemotherapy Alone (Six Cycles of Docetaxel Plus Cyclophosphamide or Four Cycles of Doxorubicin Plus Cyclophosphamide Followed by Weekly Paclitaxel) to Chemotherapy Plus Trastuzumab in Women with Node-Positive or High-Risk Node-Negative HER2-Low Invasive Breast Cancer. SHS Institutional Review Board 4/10/2012 3

4 7 members approved Amendments 1&2 and Update 1 of the above mentioned protocol and informed consent for a period of one year; 10. Approval of Changes to Protocol and Consent Form Addendum 1 & 2 SHS IRB #11-10 NCCTG N107C: Phase III Trial of Post-Surgical Stereotactic Radiosurgery Compared with Whole Brain Radiotherapy (WBRT) for Resected Metastatic Brain Disease. John P. Mastandrea, MD 7 members approved Addendum 1&2 of the above mentioned protocol and informed consent for a period of one year; 11. Report of Adverse Events Gemcitabine SHS IRB #05-02 NSABP B-38: A Phase III, Adjuvant Trial Comparing three Chemotherapy Regimens in Women with Node-Positive Breast Cancer: Docetaxel/Doxorubicin/ Cyclophosphamide (TAC); Dose-Dense (DD) Doxorubicin/Cyclophosphamide Followed by DD Paclitaxel (DD AC-P): DD AC Followed by DD Paclitaxel Plus Gemcitabine (DD AC-PG). 7 members acknowledged receipt of Gemcitabine AE# BE ; KR f/u 1; BR f/u 1; DE ; FR ; HU f/u 2; US f/u 1; DE f/u 1; GB f/u 1; DE f/u 1; DE f/u 1. SHS IRB #05-02 NSABP B-38: A Phase III, Adjuvant Trial Comparing three Chemotherapy Regimens in Women with Node-Positive Breast Cancer: Docetaxel/Doxorubicin/ Cyclophosphamide (TAC); Dose-Dense (DD) Doxorubicin/Cyclophosphamide Followed by DD Paclitaxel (DD AC-P): DD AC Followed by DD Paclitaxel Plus Gemcitabine (DD AC-PG). 7 members acknowledged receipt of Gemcitabine AE# GB ; FR f/u 2; GR ; GB ; DE f/u 2; DE ; KR f/u 2; DE f/u 1. SHS Institutional Review Board 4/10/2012 4

5 MEMORANDUM: RE: Action Letter Dated December 15, January 2012 SHS IRB #06-13 ECOG E5202; SHS IRB #07-13 ECOG E5103; SHS IRB #08-01 CALGB 80405; SHS IRB #10-04 CALGB 40502; SHS IRB #11-02 ECOG E These 2 patients are pre-menopausal and are at risk. Action from the March 13, 2012 IRB Meeting: Motion made to table this question until getting Dr. De Shield s input. Will discuss at the April 10, 2012 meeting. Motion passed. Action from the April 10, 2012 IRB Meeting: Sharon Richter: - One patient did not receive bevacizumab. - One patient fertility was already compromised by the other chemo drugs. - Ruth Sullivan made a motion: There is no need to notify the patient, based upon the original consent that the patient signed. Motion Passed. Adjourned 1300 SHS Institutional Review Board 4/10/2012 5