Before a clinical trial begins, there is an extensive review process to determine scientific merit and patient safety. Below is a list of committees that evaluate clinical trials before they open at Huntsman Cancer Institute (HCI).

Clinical Research Executive Committee

The Clinical Research Executive Committee (CREC), comprised of senior clinical research leaders at HCI, oversees and directs clinical research at HCI, including policy setting for the Clinical Cancer Investigations Committee (CCIC) and Data and Safety Monitoring Committee (DSMC). It also establishes priorities for the Clinical Trials Office (CTO), reviews general accrual and resource allocation issues, and facilitates integration of research into the HCI multidisciplinary clinics. This committee reviews minority recruitment efforts and assists in the development of future plans to enhance patient accrual.

CREC Members:

• Sunil Sharma, MD - Co-Chair 
  Chief of Medical Oncology
  Senior Director of Clinical Research
  Jon and Karen Huntsman Presidential Professor in Cancer Research 
  Professor, Department of Internal Medicine
• John Sweetenham, MD – Co-Chair
  Senior Director of Clinical Affairs
  Executive Medical Director, HCI
  Professor, Department of Internal Medicine
• Wallace Akerley, MD - DSMC 
  Senior Director of Community Oncology Research, HCI 
  Chair, Data and Safety Monitoring Committee 
  Professor, Department of Internal Medicine
• Donna Branson, BS - Minority Outreach
  Director, Patient and Public Education and Outreach
• Michael B. Cohen, MD
  Vice Chair for Faculty Development
  Associate Director, ARUP Laboratories R&D Institute
  Professor, Department of Pathology
• Michael Deininger, MD, PhD - Faculty representative (2 year term Nov. 2013)
  Chief, Division of Hematology and Hematologic Malignancies
  Professor of Medicine
• David Gaffney, MD, PhD - CCIC
  Chair, Clinical Cancer Investigations Committee
  Professor, Department of Radiation Oncology
• John Hoffman, MD – Imaging representative
  Director, Nuclear Medicine and Molecular Imaging Program
  Professor of Radiology and Neurology
• Sheri Holmen, PhD - MDG representative (2 year term Nov. 2013)
  Associate Professor
  Department of Surgery
• Jennifer Katz, BS, CCRP
  Clinical Trials Administrative Director,
  Dean's Office Research Unit
• Richard Lemons, MD, PhD - Pediatric representative
  Professor, Department of Pediatrics 
  Chief, Pediatric Hematology/Oncology 
  Primary Children’s Medical Center
• Scott Lloyd, MBA, CPA - Finance and Administration
  Senior Director, Finance and Administration
• Ben Tanner, MHA
  Director, Clinical Operations/Chief Operating Officer
  Huntsman Cancer Hospital
• *Ellen Wilson, PhD – Ad hoc
  Senior Scientific Writer and Project Manager

* Non-voting members

Protocol Review Monitoring System

The Clinical Cancer Investigations Committee (CCIC) was established to provide scientific review for all cancer trials as required by National Cancer Institute (NCI) Cancer Center Support Grant (CCSG) guidelines. All clinical trials at the University of Utah that involve cancer patients or subjects at risk for cancer (screening or prevention studies) must undergo an initial review by the CCIC. Two reviewers with no involvement in the trial under review, a biostatistician, a research pharmacist, a research nurse, and a patient advocate provide written reviews.

CCIC Members:

• David Gaffney, MD, PhD, Chair
  Professor
  Radiation Oncology 
• Leigh Neumayer, MD, Vice Chair
  Professor of Surgery
• Michael A Pulsipher, MD,
  Professor of Internal Medicine (Hematology)
• Neeraj Agarwal, MD
  Assistant Professor
• Kenneth M Boucher, PhD 
  Research Associate Professor (Biostats)
  Oncological Sciences
• Lisa Cannon-Albright, PhD
  Biomedical Informatics
• Adam Cohen, MD
  Assistant Professor (Breast, Neuro-oncology)
• Howard Colman, MD, PhD 
  Neurosurgery
• Jennifer Demko, RN, BSN, OCN
  Research Nurse, (Nursing)
• Tom Greene, PhD
  Professor (Clinical Epidemiology)
  Department of Internal Medicine
• Karen A Heichman, PhD
  VP Director/ARUP
• Elke A. Jarboe, MD
  Assistant Professor
• Rian Davis, Pharm D, PhD
  College of Pharmacy
• Paul Shami, MD
  Professor (Hematology)
• Sadie Gabler
  (Patient Advocate)
• David Stenehjem, PharmD
  Research Assistant Professor
• Sunil Sharma, MD, FACP
  Senior Director of Clinical Research
  Professor of Internal Medicine (Oncology)

Ad Hoc Reviewers:

• Saundra Buys, MD
• Kathi Mooney, RN, PhD
• Margaret Clayton, PhD APRN-BC
• Brad Cairns, PhD
• David Jones, PhD
  

Data and Safety Monitoring Committee

The Data and Safety Monitoring Committee (DSMC) was established by HCI in response to NCI and NIH requirements. Data and safety monitoring functions are separate and distinct from the study review and approval performed by the Institutional Review Board (IRB) and the scientific review conducted by the CCIC.

DSMC members:

• Wallace Akerley, MD, Co-chair
  Professor of Medicine
  Senior Director of Community Oncology Research
  Medical Director, Clinical Trials Office
• Jennifer Katz, BS, CCRP, Co-chair
  Clinical Trials Administrative Director, Dean's Office Research Unit
• William Dunson, MD
  Assistant Professor 
  Medical Director, HCH Outpatient Clinics 
  Medical Director, Internal Medicine Acute Care Clinic
• Zeinab Afify, MD 
  Associate Professor 
  Pediatric Hematology/Oncology
• Nan Hu, PhD
  Assistant Professor
  Cancer Control and Population Sciences
• Theresa L. Werner, MD 
  Assistant Professor
  Division of Oncology
• Martha Glenn, MD
  Associate Professor
  Division of Hematology
• Ginger Bair*
  Administrative Program Coordinator
• Heather Cronin, MSC* 
  Research Compliance Officer
  Clinical Research Compliance
• Adriann Kern, CCRP*
  Research Compliance Officer
  Clinical Research Compliance
• Scott Low, BS, MBA, CCRP*
  Research Compliance Officer
  Clinical Research Compliance
• Shanon Matkin, CCRP*
  Research Compliance Officer
  Clinical Research Compliance
• Kelli Thorne, MPH*
  Research Compliance Officer
  Clinical Research Compliance

* non-voting member