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

• Published in: Journal of adolescent health Vol. 55; no. 3; pp. 352 - 357
• Main Authors: Harris, Diana, M.Be., Ph.D, Patrick-Miller, Linda, Ph.D, Schwartz, Lisa, Ph.D, Lantos, John, M.D, Daugherty, Chris, M.D, Daly, Mary, M.D., Ph.D, Andrulis, Irene L., Ph.D, Buys, Saundra S., M.D, Chung, Wendy K., M.D., Ph.D, Frost, Caren J., Ph.D, John, Esther M., Ph.D, Keegan, Theresa H.M., Ph.D, Knight, Julia A., Ph.D, Terry, Mary Beth, Ph.D, Bradbury, Angela R., M.D
• Format: Journal Article
• Language: English
• Published: New York, NY Elsevier Inc 01.09.2014; Elsevier
• Subjects: Adolescent; Biological and medical sciences; Biomedical Research - ethics; Breast Neoplasms; Child; Children and adolescents; Data safety monitoring; Ethics Committees, Research; Event monitoring committee; Female; Fundamental and applied biological sciences. Psychology; Gynecology and obstetrics; Gynecology. Andrology. Obstetrics; Human subject protections; Humans; Informed Consent - ethics; Mammary gland diseases; Medical sciences; Multiple tumors. Solid tumors. Tumors in childhood (general aspects); Patient Selection - ethics; Pediatrics; Psychology and medicine; Psychology. Psychoanalysis. Psychiatry; Psychology. Psychophysiology; Research Design; Research ethics; Research Subjects; Tumors; United States; Vulnerable Populations; Young Adult; United States; Research ethics; Event monitoring committee; Children and adolescents; Human subject protections; Data safety monitoring; Social environment; Human; Breast disease; Breast cancer; Malignant tumor; Mammary gland diseases; Ethics; Scientific research; Adolescent; Family environment; Female; Safety; Child; Cancer
• ISSN: 1054-139X; 1879-1972
• DOI: 10.1016/j.jadohealth.2014.03.007

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.