Human subjects protection: an event monitoring committee for research studies of girls from breast cancer families.
OBJECTIVE
Researchers must monitor the safety of research participants, particularly in studies involving children and adolescents. Yet, there is limited guidance for the development and implementation of oversight committees for psychosocial, behavioral intervention, and observational studies.


METHODS
We implemented a model for an Event Monitoring Committee (EMC) in three related studies recruiting 6- to 19-year-old girls from families with and without breast cancer.


RESULTS
The EMC model can be valuable for investigators and local institutional review boards when additional oversight is desired. Recommendations are provided and intended to be broadly applicable to a wide range of research activities designed to improve the health of children, adolescents, and families. EMC goals, membership, and procedures for monitoring and assessing risks and benefits should be defined but should also be flexible and tailored to the study design and population. The EMC model also provides an independent comprehensive, study-wide oversight mechanism for multicenter psychosocial, behavioral intervention, and observational studies.


CONCLUSIONS
An EMC provides an alternative oversight approach where additional independent assessment and oversight of study-related risks are desired, particularly in the setting of vulnerable populations, children and adolescents, or where risks nontraditional to the medical field (i.e., social, emotional, or cultural) are possible.
Division of Hematology/Oncology, Department of Medicine, The University of Pennsylvania, Philadelphia, Pennsylvania.
Diana
D
Harris
Division of Hematology/Oncology, Department of Medicine, The University of Chicago, Chicago, Illinois.
Linda
L
Patrick-Miller
Division of Oncology, Department of Pediatrics, The Children's Hospital of Philadelphia, Philadelphia, Pennsylvania.
Lisa
L
Schwartz
Department of Pediatrics/Children's Mercy Hospital Bioethics Center, University of Missouri-Kansas City School of Medicine, Kansas City, Missouri.
John
J
Lantos
Division of Hematology/Oncology, Department of Medicine, The University of Chicago, Chicago, Illinois.
Chris
C
Daugherty
Department of Clinical Genetics, Fox Chase Cancer Center, Philadelphia, Pennsylvania.
Mary
M
Daly
Department of Medicine/Lunenfeld-Tanenbaum Research Institute, Mount Sinai Hospital, The University of Toronto, Toronto, Ontario, Canada.
Irene L
IL
Andrulis
Division of Oncology, Department of Internal Medicine/Huntsman Cancer Institute, The University of Utah School of Medicine, Salt Lake City, Utah.
Saundra S
SS
Buys
Department of Pediatrics/Institute of Human Nutrition, Columbia University Medical Center, New York, New York.
Wendy K
WK
Chung
College of Social Work/Family and Preventative Medicine, The University of Utah, Salt Lake City, Utah.
Caren J
CJ
Frost
Cancer Prevention Institute of California, Fremont, California; Department of Health Research and Policy, Stanford University School of Medicine, Stanford, California.
Esther M
EM
John
Department of Health Research and Policy, Stanford University School of Medicine, Stanford, California.
Theresa H M
TH
Keegan
Dalla Lana School of Public Health/Lunenfeld-Tanenbaum Research Institute, Mount Sinai Hospital, The University of Toronto, Toronto, Ontario, Canada.
Julia A
JA
Knight
Department of Epidemiology, Mailman School of Public Health, Columbia University, New York, New York.
Mary Beth
MB
Terry
Division of Hematology/Oncology, Department of Medicine, The University of Pennsylvania, Philadelphia, Pennsylvania; Department of Medical Ethics and Health Policy, The University of Pennsylvania, Philadelphia, Pennsylvania. Electronic address: angela.bradbury@uphs.upenn.edu.
Angela R
AR
Bradbury
D000293:Adolescent; D035843:Biomedical Research / Q000941:ethics*; D001943:Breast Neoplasms; D002648:Child; D028744:Ethics Committees, Research; D005260:Female; D006801:Humans; D007258:Informed Consent / Q000941:ethics*; D018579:Patient Selection / Q000941:ethics*; D012107:Research Design; D035842:Research Subjects; D014481:United States; D035862:Vulnerable Populations; D055815:Young Adult
Children and adolescents; Data safety monitoring; Event monitoring committee; Human subject protections; Research ethics