South Jersey Healthcare Institutional Review Board and Clinical TrialsThe South Jersey Healthcare Institutional Review Board (IRB) is an independent committee, comprisingindividuals with diverse medical and non-medical backgrounds, that reviews and approves all clinicalstudy related documents. The IRB approves protocols, informed consent forms, physician credentialsand eligibility, and patient recruitment materials, such as print advertisements and public serviceannouncements.The mission of the South Jersey Healthcare IRB is to facilitate quality research, with quality in thiscontext emphasizing balancing risks and benefits for human subjects. Every month the SJH IRBmembers continue their ongoing education regarding the protection of participants in research trials byreading and reviewing recently published articles.This year, the SJH IRB added new members to the board. Carl Minniti Jr. MD, a Medical Oncologist fromThe Minniti Center in Mickleton, NJ, joined as an additional Primary Reviewer. Marge Pollock, MSN,WHNP, BC, is the Administrative Director of Women and Children’s Services at SJH. Bruce Boxer, PhD,MBA, RN, CPHQ, is the Director of Quality/Magnet Coordinator at SJH.In 2010, the South Jersey Healthcare IRB approved eight new clinical trials. Of the eight, six were cancertrials, and two were nursing studies. The new cancer studies treat breast, colon, cervical and ovariancancers. The following oncologists participated in the recruitment of patients and the opening of newcancer clinical trials during 2010: Tami Bach, MD; David Blom, DO; Joseph Fanelle, MD; Carl Minniti, Jr.,MD; Benjamin Negin, MD; Shailja Roy, MD; Kush Sachdeva, MD; Glenda Smith, MD; and RamaSudhindra, MD.Through our partnership with Fox Chase Cancer Center (FCCC), our site was able to open apharmaceutical industry sponsored research trial. FER-BR-033 A Randomized Trial of Ixempra vs Taxol inAdjuvant Therapy of Triple-Negative Breast Cancer (TITAN) is sponsored through the Sarah CannonResearch Institute (SCRI). The study’s primary endpoint compares Disease Free Survival (DFS). OverallSurvival (OS) and Safety Assessments are the secondary endpoints. To date, two SJH patients have beenaccrued to this study. Through this successful opening, SJH plans to open more FCCC ExtramuralResearch studies in 2011.South Jersey Healthcare participates in the Central IRB (CIRB) Initiative. CIRB is designed to help reducethe administrative burden on local IRBs and investigators while maintaining a high level of protection forhuman research participants. The CIRB Initiative is sponsored by National Cancer Institute (NCI) inconsultation with the Department of Health and Human Services Office for Human Research Protections(OHRP). Currently, SJH has three NCI CIRB approved trials open.The South Jersey Healthcare IRB continued mentoring the SJH Nursing Research Council in 2010. Thisrelationship has opened a positive pathway for nursing research studies at SJH. The SJH IRB is impressedby the SJH nurses’ constant enthusiasm to create new and valid nursing studies in their desire toimprove SJH patient care.
2010 South Jersey Healthcare Cancer Committee MembersPhysician RepresentativesRama Sudhindra, MDCancer Committee Chair, Medical OncologistJoseph Fanelle, MDRadiation OncologistMedical Director, Dept. of Radiation OncologyRobert Frelick, MD, FACPMedical OncologistAndrew S. Heller, MDSurgeon (General, Thoracic, Critical Care, Vascular)Robert Lazarus, MDRadiologistLarry Mapow, MDPathologistCarl J. Minniti, Jr. MDMedical OncologistCondapuram Pasupathy, MDSurgeonKush Sachdeva, MDMedical OncologistRaghuraj S. Tomar, MDInternal MedicineNon-Physician RepresentativesElizabeth Sheridan, FACHE, MA, RN, NEA-BC, Chief Operating Officer, Chief Nurse Executive,AdministrationJeanine Aussenberg, PharmD, PharmacyMaria Basche, MS, RD, NutritionRuth Ann Bishop-Sotak, RN, MA, CBCNBreast Cancer Care CoordinatorColleen M. BodhuinAdministrative Assistant, Cancer ServicesEvelyn Corwonski, RHIT, CTR, SupervisorOncology Data ServicesJackie Craig, Community Executive