Attachment 3 Consultations

SISOMB2016ATTACHMENT3consultation20160219.pdf

The Sister Study: PHASE 3 Environmental and Generic Risk Factors for Breast Cancer

Attachment 3 Consultations

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SISOMB2016 ATTACHMENT 3: CONSULTATION & REVIEW
ATTACHMENT 3: Sister Study Consultation and Review Record

The Sister Study
Internal and External Consultation, Formal Reviews, and Advisory Groups
The Sister Study began development in October 1997. The study concept, drafts of the protocol, and
various components of the study received extensive formal and informal review. Some reviews were
mandated to meet specific administrative milestones; others were designed to better inform the study
design or seek advice on “best practices” for a specific aspect of the proposed work. Most recently, the
study and its progress received an outstanding evaluation by the NIEHS Division of Intramural Research
Board of Scientific Counselors during the review of the Epidemiology Branch in April 2005. Key
milestones in the development and review process are summarized below.
November 1997 — Concept reviewed by Interagency Steering Committee for proposed
NCI/NIEHS/CDC Collaborative Study of Gene-Environment Interaction in the Etiology of Breast
Cancer. Non-NIEHS Steering Committee Members were from CDC, DHHS, NIOSH, and NCI.
1998-1999 — Protocol development and consultation with various experts and consumer groups, e.g.,
National Breast Cancer Coalition and informal focus groups of different racial, ethnic, and economic
backgrounds.
June 1, 1999 — NIEHS Epidemiology Branch Concept Review
1999-2001 — Consultation and external peer review during protocol development from experts at CDC,
USEPA, NCI, NIA, DHHS/OWH, and extramural institutions
February 2001 — Reviewed by NIEHS Board of Scientific Counselors and special ad hoc reviewers
December 2001 — Presented for discussion with NIEHS Breast Cancer Interest Group
May 2002 — Presented for discussion at NIEHS Leadership Retreat with NIEHS upper management and
senior scientists, National Advisory Environmental Health Sciences Council, and invited outside experts.
June 2002 — Epidemiology Branch Protocol Review and Questionnaire Review
August 2002 — Reviewed for Certificate of Confidentiality
October 2002 — Initial review by NIEHS Institutional Review Board Initial Review
October 2002 through July 2003 — Office of Management and Budget Review
November 2002 — Final External Peer Review
January 2003 — Presented for discussion with National Advisory Environmental Health Sciences
Council
January 2003 — Sister Study Minority Recruitment Strategy Meeting with leaders in breast cancer
advocacy for minority populations, and experts in recruitment of minority populations for research.
February and July 2003 — NIEHS Division of Intramural Research Contract Review

NIEHS Board of Scientific Counselors
Review of the Epidemiology Branch and Dr. Fred Miller
June 2-4, 2013
Members of the Board of Scientific Counselors Attending
Kenneth B. Adler, Ph.D. [BSC Chair]
Serrine S. Lau, Ph.D.
Professor, Dept. of Molecular Biomedical Sciences
Professor and Director, Southwest Environmental Health
College of Veterinary Medicine
Sciences Center
North Carolina State University
Dept. of Pharmacology & Toxicology
1060 William Moore Drive
University of Arizona College of Pharmacy
Raleigh, NC 27607
PO Box 210207
Tel.: 919-513-1348
Tucson, AZ 85721-0207
[email protected]
Tel.: 520-626-0460
[email protected]
Juan C. Celedón M.D., Dr.P.H.
Niels K. Jerne Professor of Pediatrics, Dept. of Pediatrics
José E. Manautou, Ph.D.
Professor, Dept. of Pharmaceutical Sciences
Children’s Hospital of Pittsburgh of UPMC
University of Connecticut School of Pharmacy
University of Pittsburgh
69 North Eagleville Road, Unit 3092
One Children's Hospital Drive
Storrs, CT 06269-3092
4401 Penn Ave., Rangos Research Building
Tel.: 860-486-3852
Pittsburgh, PA 15224
[email protected]
Tel.: 412-692-5845
[email protected]
Donald P. McDonnell, Ph.D.
Glaxo-Wellcome Professor and Chairman of
Samuel M. Cohen, M.D., Ph.D.
Professor, Dept. of Pathology and Microbiology
Pharmacology and Cancer Biology
University of Nebraska Medical Center
Duke University School of Medicine
983135 Nebraska Medical Center
Box 3813
Omaha, NE 68198-3135
Durham, NC 27710
Tel.: 402-559-6388
Tel.: 919-684-6035
[email protected]
[email protected]
Monica Justice, Ph.D. [appointment pending]
Professor, Department of Molecular and Human Genetics
Baylor College of Medicine
One Baylor Plaza
Houston, TX 77030
Tel.: 713-798-5440
[email protected]

Jay I. Goodman, Ph.D.
Professor, Dept. of Pharmacology and Toxicology
Michigan State University
B-440 Life Sciences Building
1355 Bogue Street
East Lansing, MI 48824
Tel.: 517-353-9346
[email protected]

Karen M. Vasquez, Ph.D.
Professor, Fellow of the Coulter R. Sublett Chair
The University of Texas at Austin
Division of Pharmacology and Toxicology
Dell Pediatric Research Institute
1400 Barbara Jordan Blvd. R1800
Austin, TX 78723
Tel.: 512-495-3040
[email protected]
Ex-Officio BSC Member
Roland A. Owens, Ph.D.
Assistant Director
Office of Intramural Research, NIH
1 Center Drive MSC-0151
Bldg. 1, Room 158
Bethesda, MD 20892-0151
Tel.: 301-594-7471
[email protected]

1

NIEHS Board of Scientific Counselors
Review of the Epidemiology Branch and Dr. Fred Miller
June 2-4, 2013
Ad Hoc Reviewers
Anthony A. Amato, M.D.
Professor, Dept. of Neurology
Harvard Medical School
Brigham & Women’s Hospital
75 Francis Street
Boston, MA 02115
Tel.: 617-732-8046
[email protected]
Christopher I. Amos, Ph.D.
Professor, Dept. of Community and Family Medicine
Associate Director for Population Sciences
Dartmouth-Hitchcock Norris Cotton Cancer Center
(NCCC) and Geisel School of Medicine
One Medical Center Drive
Lebanon, NH 03756
Tel.: 603-653-6696
[email protected]
John R. Balmes, M.D.
Professor, Dept. of Environmental Health Sciences
School of Public Health
University of California
50 University Hall #7360
Berkeley, CA 94720-7360
Tel.: 510-220-0502
[email protected]
Kim N. Dietrich, Ph.D.
Professor, Dept. of Environmental Health Sciences
Director, Division of Epidemiology and Biostatistics
University of Cincinnati College of Medicine
Kettering Building, Rm G31
3223 Eden Avenue ML #0056
Cincinnati, OH 45267-0056
Tel.: 513-558-0531
[email protected]
Marlene B. Goldman, M.S., Sc.D.
Professor and Director of Clinical Research, Dept. of
Obstetrics and Gynecology
Geisel School of Medicine
Dartmouth-Hitchcock Medical Center
One Medical Center Drive
Lebanon, NH 03756
Tel.: 603-653-9304
[email protected]
Bernard L. Harlow, Ph.D.
Mayo Professor & Division Head, Dept. of Epidemiology &
Community Health
University of Minnesota School of Public Health
1300 S. 2nd Street, Suite 300
Minneapolis, MN 55454
Tel.: 612-626-6527
[email protected]

Margaret A. Honein, Ph.D., M.P.H.
Distinguished Consultant and Chief, Birth Defects Branch
Division of Birth Defects and Developmental Disabilities
National Center on Birth Defects and Developmental
Disabilities
Centers for Disease Control and Prevention
Atlanta, GA 30333
Tel.: 404-498-3921
[email protected]

Claire Infante-Rivard, M.D., Ph.D.
James McGill Professor, Dept. of Epidemiology,
Biostatistics and Occupational Health
McGill University Faculty of Medicine
1130 Pine Avenue West
Montréal, Quebec, Canada H3A 1A3
Tel.: 514-398-4231
[email protected]

Elan D. Louis, M.D.
Professor, Dept. of Epidemiology
Professor and Associate Chairman for Academic Affairs
and Faculty Development of Neurology
Columbia University Mailman School of Public Health
Unit 198, Neurological Institute
710 West 168th Street
New York, NY 10032
Tel.: 212-305-9194
[email protected]

John R. McLaughlin, Ph.D.
Professor and Senior Investigator, Prosserman Centre for
Health Research, Samuel Lunenfeld Research Institute
University of Toronto Dalla Lana School of Public Health
Mount Sinai Hospital
60 Murray Street (5th floor)
Toronto, Canada M5T3L9
Tel.: 416-586-4800 ext. 8304
[email protected]

Westley H. Reeves, M.D.
Marcia Whitney Schott Professor, Dept. of Medicine
Chief, Division of Rheumatology and Clinical Immunology
University of Florida School of Medicine

PO Box 100221
Gainesville, FL 32610
Tel.: 352-392-8601
[email protected]

2

NIEHS Board of Scientific Counselors
Review of the Epidemiology Branch and Dr. Fred Miller
June 2-4, 2013
Beate Ritz, M.D., Ph.D.
Professor and Vice Chair, Dept. of Epidemiology
UCLA Fielding School of Public Health
650 Charles E. Young Drive South 73-320A CHS
Los Angeles, CA 90095
Tel.: 310-206-7458
[email protected]
John Vena, Ph.D.
Department Head & UGA Foundation Professor
Dept. of Epidemiology & Biostatistics
University of Georgia College of Public Health
B.S. Miller Hall Room 105
Health Sciences Campus
101 Buck Road
Athens, GA 30602
Tel.: 706-583-8202
[email protected]
Philip R. Taylor, M.D., Sc.D.
Senior Investigator, Genetic Epidemiology Branch
Division of Cancer Epidemiology & Genetics
National Cancer Institute
6120 Executive Boulevard
MSC 7242
Bethesda, MD 20892-7335
Tel.: 301-496-4375
[email protected]

Martha M. Werler, D.Sc., M.P.H.
Professor, Dept. of Epidemiology
Slone Epidemiology Center
Boston University School of Public Health
715 Albany Street, Talbot Building
Boston MA 02118
Tel.: 617-734-6006
[email protected]

Zuo-Feng Zhang, M.D., Ph.D.
Professor, Dept. of Epidemiology
Head, Cancer Epidemiology Program
UCLA School of Public Health
71-225 CHS, Box 951772
650 Charles E. Young Drive S.
Los Angeles, CA 90095-1772
Tel.: 310-825-8418
[email protected]

3

ATTACHMENT 3: Sister Study Consultation and Review Record

Sister Study Steering Committee
Advisory to the Sister Study investigators in regular monthly meetings
NIEHS senior staff
Address:

PO Box 12233, MD# A3-05
Research Triangle Park NC 27709

Honglei Chen, Investigator, Epidemiology Branch (919-541-3782)
Jack Taylor MD PhD, Senior Investigator, Epidemiology Branch (919-541-4631)
Christine Parks PhD, Research Fellow, Epidemiology Branch (919-541-2577)
Hazel Nichols PhD, Assistant Professor, Univ. of NC at Chapel Hill (919-966-7456)
Lisa DeRoo PhD, Staff Scientist, Epidemiology Branch (919-541-0799)
Jane Hoppin ScD, Staff Scientist, Epidemiology Branch (919-541-7622)
Stephanie London MD DrPH, Senior Investigator, Epidemiology Branch (919-541-5772)

SSS senior staff
Address:

1009 Slater Road, Suite 120
Durham NC 27703

Sandra Deming Halverson PhD, Project Director (919-287-4502)

ATTACHMENT 3: Sister Study Consultation and Review Record

Sister Study Scientific Advisory Board (current)
Leslie Bernstein, PhD (SIS SAB CHAIR)

Julie R Palmer, ScD (SIS SAB Chair Elect)

City of Hope National Medical Center and
Beckman
Research Institute
Professor and Director, Department of Cancer Etiology,
Division of Population Sciences & Dean of Faculty
Development
1500 E Duarte Road, Bldg 173
Duarte, CA 91010
626‐471‐7316
[email protected]

Boston University School of Public Health
Professor and Senior Epidemiologist
Slone Epidemiology Center
1010 Commonwealth Avenue
Boston, MA O2115
617‐734‐6006
[email protected]

Lisa Carey, MD
University of North Carolina School of Medicine
Medical Director, UNC Breast Center
Lineberger Comprehensive Cancer Center
3009 Old Clinic Building, CB 7305
Chapel Hill, NC 27599
919‐843‐7719
[email protected]

Michele Forman, PhD MS MSPH
Dell Pediatric Research Institute
Bruton Professor
Department of Nutritional Sciences
1400 Barbara Jordan Boulevard
Austin, TX 78723‐3092
512‐495‐4701
[email protected]

Patricia Hartge, ScD
National Cancer Institute, NIH
Deputy Director, Epidemiology and Biostatistics Program
Division of Cancer Epidemiology and Genetics
6120 Executive Boulevard, Rm 8090
Rockville, MD 20852
301‐496‐7887
[email protected]

Kirsten Moysich, PhD
Roswell Park Cancer Institute
Associate Professor, Department of Cancer Prevention
and Control
Elm & Carlton Streets
Buffalo, NY 14263
716‐845‐8004
[email protected]

Peggy Reynolds, PhD
Cancer Prevention Institute of California
Senior Research Scientist
2001 Center Street, Suite 700
Berkeley, CA 94704
510‐608‐5180
[email protected]

Jeanne Rizzo, RN
Breast Cancer Fund, San Francisco CA
President and CEO
1388 Sutter Street, Suite 400
San Francisco, CA 94109‐5400
415‐346‐8223 x 26
[email protected]

Kent Thomas, BSPH
US Environmental Protection Agency
Office of Research and Development
National Exposure Research Laboratory
4930 Page Road, MD E205‐04
Durham, NC 27703
919‐541‐7939
[email protected]

Melissa Troester, PhD MPH
University of North Carolina at Chapel Hill
Department of Epidemiology
135 Dauer Drive, CB 7435
Chapel Hill, NC 27599
919‐966‐7408
[email protected]

Shelia Zahm, ScD
Sheila K Zahm Consulting
5600 Lone Oak Drive
Bethesda, MD 20814
301‐496‐8157
[email protected]

Lisa A Newman, MD MPH FACS
University of Michigan Comprehensive Cancer
Center
Director, Breast Care Center and Professor of Surgery
1500 East Medical Center Drive
Ann Arbor, MI 48109
734‐936‐8771
[email protected]

Shumin Zhang, MD ScD
Brigham and Women's Hospital
Associate Professor of Medicine, Harvard Medical School
Co‐Director of Preventative Medicine
900 Commonwealth Avenue East
Boston, MA O2215
617‐278‐0856, [email protected]


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