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J Adolesc Health. 2014 Sep;55(3):352-7. doi: 10.1016/j.jadohealth.2014.03.007. Epub 2014 May 17.

Human subjects protection: an event monitoring committee for research studies of girls from breast cancer families.

Author information

1
Division of Hematology/Oncology, Department of Medicine, The University of Pennsylvania, Philadelphia, Pennsylvania.
2
Division of Hematology/Oncology, Department of Medicine, The University of Chicago, Chicago, Illinois.
3
Division of Oncology, Department of Pediatrics, The Children's Hospital of Philadelphia, Philadelphia, Pennsylvania.
4
Department of Pediatrics/Children's Mercy Hospital Bioethics Center, University of Missouri-Kansas City School of Medicine, Kansas City, Missouri.
5
Department of Clinical Genetics, Fox Chase Cancer Center, Philadelphia, Pennsylvania.
6
Department of Medicine/Lunenfeld-Tanenbaum Research Institute, Mount Sinai Hospital, The University of Toronto, Toronto, Ontario, Canada.
7
Division of Oncology, Department of Internal Medicine/Huntsman Cancer Institute, The University of Utah School of Medicine, Salt Lake City, Utah.
8
Department of Pediatrics/Institute of Human Nutrition, Columbia University Medical Center, New York, New York.
9
College of Social Work/Family and Preventative Medicine, The University of Utah, Salt Lake City, Utah.
10
Cancer Prevention Institute of California, Fremont, California; Department of Health Research and Policy, Stanford University School of Medicine, Stanford, California.
11
Department of Health Research and Policy, Stanford University School of Medicine, Stanford, California.
12
Dalla Lana School of Public Health/Lunenfeld-Tanenbaum Research Institute, Mount Sinai Hospital, The University of Toronto, Toronto, Ontario, Canada.
13
Department of Epidemiology, Mailman School of Public Health, Columbia University, New York, New York.
14
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.

Abstract

PURPOSE:

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.

KEYWORDS:

Children and adolescents; Data safety monitoring; Event monitoring committee; Human subject protections; Research ethics

PMID:
24845866
PMCID:
PMC4234071
DOI:
10.1016/j.jadohealth.2014.03.007
[Indexed for MEDLINE]
Free PMC Article
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