These individuals together have extensive experience conducting large trials, are widely respected clinical scientists, had overcome considerable challenges in the implementationof the study, and had no stake in the outcome.
Overall responsibility for the design and implementationof the study was given to the National Institute of Child Health and Development, with input from a number of advisory and oversight committees, the Director of the NIH, and with the involvement of other government agencies (the Department of Health and Human Services, the Centers for Disease Control and Prevention, and the Environmental Protection Agency).