Human Subjects Protection: An Event Monitoring Committee for Research Studies of Girls From Breast Cancer Families

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

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.

Publication types

  • Research Support, N.I.H., Extramural
  • Research Support, Non-U.S. Gov't

MeSH terms

  • Adolescent
  • Biomedical Research / ethics*
  • Breast Neoplasms
  • Child
  • Ethics Committees, Research
  • Female
  • Humans
  • Informed Consent / ethics*
  • Patient Selection / ethics*
  • Research Design
  • Research Subjects*
  • United States
  • Vulnerable Populations
  • Young Adult

Supplementary concepts

  • Breast Cancer, Familial