Working Group Rosters: NCI Concise Informed Consent Template Project

Working Group Rosters: NCI Concise Informed Consent Template Project

Role / Working Group 1
(Beginning of template – background, required tests, intervention sections) / Working Group 2
(Risks and benefits sections) / Working Group 3
(Alternatives, privacy, injury, cost, rights, signature) / Working Group 4
(Possible attachments) / Working Group 5
(Companion studies) /
Working Group
Co-Chair / Shlomo Koyfman, MD
Radiation Oncologist, Cleveland Clinic / Roy Smith, MD
Professor of Medicine, University of Pittsburgh
Former NCI CIRB Chair / Edward Goldman, JD
Associate Professor, University of Michigan School of Public Health / Barbara LeStage, MHP
Patient Advocate
Former NCI CIRB
Member of hospital IRB / Lisa Carey, MD
Professor of Medicine
University of North Carolina, Chapel Hill
Working Group
Co-Chair / Joan Westendorp,
RN, MSN, OCN, CCRA
Chief Nursing Officer,
West Michigan Cancer Center / Michael Paasche-Orlow, MD, MA, MPH
Assistant Professor,
Boston University School of Medicine / Nancy Morton,
MT, MPH
Consultant, Research and Compliance / Mary McCabe,
RN, MA
Director, Cancer Survivorship Program, Memorial Sloan- Kettering Cancer Center
Chair of Ethics Committee, MSKCC
Member, MSKCC IRB / Laura Beskow,
MPH, PhD
Assistant Research Professor,
Duke Institute for Genome Sciences & Policy
Center for Genome Ethics, Law & Policy
CIRB liaison / Bernard Parker, MD
NCI CIRB member
CAPT, USPHS Commissioned Corps
Medical Eval. Officer,
Medical Affairs Branch,
Office of Commissioned Corps Support Services / Dave Parda, MD, FACP
Chair, NCI CIRB
Chair, Dept of Radiation Oncology,
Allegheny General Hospital,
Pittsburgh / Collette Johnston
Patient advocate,
NCI CIRB
Former member, Huntsman Cancer Institute IRB
CIRB liaison / (Joan Westendorp, RN, MSN, listed above under Co-Chairs, is also part of the NCI CIRB.)
IRB Chair / Christopher Daugherty, MD
IRB Chair and Professor, Hematology/Oncology, University of Chicago / Donald Bennett,
MD, PhD
Former IRB Chair, Adventist Midwest Health, Illinois
Current IRB member, FHCRC / J Michael Hamilton, MD
Chair, NCI intramural IRB
Senior Medical Director, Oncology, INC Research / Christopher Daugherty, MD
IRB Chair and Professor, Hematology/Oncology, University of Chicago
IRB Chair / Howard M. Lederman, MD, PhD
IRB Chair and
Professor, Johns Hopkins University / (Charles Sklar, MD, listed below under Investigators, is also Vice Chair of the MSKCC IRB)
IRB Chair / (Dr. Parda, also listed above, is NCI CIRB Chair.
Dr. Smith, also listed above, is former NCI CIRB Chair.)
Investigator / Robin Zon, MD, FACP
Principal Investigator, Northern Indiana CCOP / Siu-Fun Wong, PharmD, FASHP, FCSHP
Chair, SWOG Pharmacy Committee
Professor, Dept of Pharmacotherapy and Outcomes Science, Loma Linda University, School of Pharmacy / Dawn Hershman,
MD, MS
Chair, SWOG Cancer Control Subcommittee
Associate Professor Medicine, Columbia University / Charles Sklar, MD
Director, MSKCC
Long-Term Follow-Up Program
Vice Chair, MSKCC IRB / Barry Anderson,
MD, PhD
Vice President, Clinical Research Affairs, Theradex®
Princeton NJ
Former Senior Investigator at NCI CTEP
Investigator / (Dr. Hamilton, listed above under IRB Chairs, is also an investigator.) / David Mankoff,
MD, PhD
Chair, ACRIN Experimental Imaging Sciences Committee
Professor of Radiology, University of Washington
Research nurse / Marilee Rose, MS, BSN
Administrative Director,
Metro-Minnesota CCOP / Connie Szczepanek, RN, BSN
Director, Grand Rapids Clinical Oncology Program (GRCOP) / Karen Iseminger,
PhD, FNP
Director of Ethics,
St. Vincent Health, Indiana / Peggy Anthony,
RN, MHS
Nurse Manager,
Medical University of South Carolina
Chair, ACRIN Patient Advocacy Committee / Jennifer Loud, RN,CRNP,DNP
Assistant Branch Chief,
Clinical Genetics Branch
NCI Division of Division of Cancer Epidemiology and Genetics
NCI Clin Ctr IRB
Research nurse / Debra Wujcik,
PhD, RN, FAAN
Director, Cancer Clinical Trials at Meharry
Administrator, Meharry Minority-Based CCOP
Associate Professor, Vanderbilt University
Former member of IRB
Patient advocate / Deborah Collyar
Patient Advocate
President, PAIR: Patient Advocates In Research / Jane Perlmutter,
PhD, MBA
Patient Advocate / Chesley Cheatham, M.Ed., MCHES
Senior Health Education Specialist and
Advocate for health literacy, MD Anderson Cancer Center / Peggy Devine
Patient Advocate
Founder & President,
Cancer Information & Support Network, Inc.
/ Cindy Geoghegan
CEO, Y-ME National Breast Cancer Organization™
Patient advocate / (Colette Johnston, listed above under CIRB liaisons, is also a patient advocate.)
Other role (bioethicist, policy expert) / Suanna Steeby Bruinooge
Director, Research Policy Division, American Society of Clinical Oncology (ASCO) / Christine Grady,
RN, PhD
Deputy and Acting Chief, Department of Bioethics, NIH Clinical Center / Marianna Bledsoe, M.A.
Senior Program Manager for Biorepositories and Biobanking, Department of Veterans Affairs
NCI representative / Rose Mary Padberg, RN, MA
Public Health Advisor for Clinical Trials,
NCI Office of Communications and
Education (OCE) / Leslie Ford, MD
Associate Director for Clinical Research,
NCI Division of Cancer Prevention (DCP) / Kathleen Foster,
RN, BA
Nurse Specialist, Clinical Trials, NCI DCP / Marge Good,
RN, BSN, MPH, OCN
Nurse Consultant, Community Oncology and Prevention Trials Research Grp, NCI DCP
Former Administrator of Wichita CCOP / Tracy Lively, PhD
Deputy Associate Director, NCI Cancer Diagnosis Program (CDP)
NCI representative / Edward Trimble,
MD, MPH
Director, NCI Center for Global Health (CGH)
Formerly Head of Gynecologic Cancer Therapeutics and Quality of Cancer Care Therapeutics, and Head of Surgery Section, CTEP Clinical Investigations Branch (CIB) / Barbara Galen,
MSN, CRNP, CNMT
Program Director, NCI Cancer Imaging Program (CIP) / Judy Smith,
RN, MSN, AOCN
Nurse Consultant, Lung and Upper Aerodigestive Cancer Research Group
NCI DCP / Jean Lynn,
RN, MPH, OCN
Program Director, NCI Coordinating Center for Clinical Trials (CCCT) / Sandy Mitchell,
PhD, CRNP
Research Scientist and Program Director, Outcomes Research Branch, Applied Research Program, NCI Division of Cancer Control and Population Sciences
(DCCPS)
NCI representative / Jo Anne Zujewski, MD
Head of Breast Cancer Therapeutics, NCI CTEP Clinical Investigations Branch / Wendy Nelson,
PhD, MPH
Program Director, Basic and Behavioral Research Branch, Behavioral Research Program,
NCI DCCPS / Rocio Paul,
MSHS, RAC, CCRP
Clinical Trials Monitoring Specialist, CTEP Clinical Trials Monitoring Branch (CTMB) / Diane St Germain,
RN, MS, CRPNP
Nurse Consultant, Community Oncology and Prevention Trials
Research Group,
NCI DCP
NCI representative / Richard Piekarz,
MD, PhD
Senior Investigator,
CTEP Investigational Drug Branch (IDB)
Cooperative Group representative / CALGB:
Michele Seiler, MS
Senior Protocol Coordinator / CALGB:
Andrea Eiring,
MSM, PA, CCRC
CALGB Regulatory Affairs Manager / ACOSOG:
Beth Martinez
Group Administrator / GOG:
Katie Campbell
Director of Regulatory Affairs / ACOSOG:
Megan Branda, MS
Master Statistician
Cooperative Group representative / ECOG:
Robert Catalano, PharmD
Regulatory Officer / ECOG:
Bruce Giantonio, MD
ECOG Executive Officer / ACRIN:
Maria Oh
Director, Protocol Development and Regulatory Compliance / NSABP:
Barbara Harkins,
RN, MN
Director, Protocol Development and Management / NCCTG:
Lynn Flickinger, MA
Senior Protocol Development Coordinator
Cooperative Group representative / SWOG:
Sandi Fredette
Protocol Coordinator Lead; Training Manager / GOG:
Jennifer Klein
Regulatory Affairs / NSABP:
Judy Langer
Regulatory Specialist / RTOG:
Erica Thorson, MPH
Regulatory Associate / NSABP:
Teresa Bradley, PhD
Interim Director, Regulatory Affairs
Cooperative Group representative / NCCTG:
Karen Hurtis
Regulatory Manager / SWOG:
Dana Sparks, MAT
Director of Operations and Protocols / NSABP:
Joyce Mull, MPM
Former Director, Regulatory Affairs
Cooperative Group representative / RTOG:
Marie D’Amico, CCRP
Manager, Regulatory Compliance
CTEP Lead Contact for Project /
Jeanne Adler, RN, MPH, CCRP
Nurse Consultant
Head, CIRB Strategy and Operations
NCI CTEP Clinical Investigations Branch (CIB)
Support Coordinator /
Rebecca Enos, RN, MPH
NCI Contractor, The EMMES Corporation
Rockville, Maryland

Page 1 of 6