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Describes the problems created for public health by the definitions of research in the Code of Federal Regulations for the Protection of Human Research Subjects. Approach to determine when public health activities are or are not research; Conclusion.

Although the number of tuberculosis cases reported annually in the United States has decreased markedly during the past three and a half decades, the decrease among whites has been considerably greater than among nonwhites. As a result of this widening gap, nearly two-thirds of the cases reported in 1987 occurred in minority populations and, for the first time in history, the number of cases among blacks exceeded the number of cases among non-Hispanic whites. From 1985 to 1987, tuberculosis among blacks increased 6.3 percent and among Hispanics, by 12.7 percent, but it decreased 4.8 percent among non-Hispanic whites. Much of the increase appears attributable to tuberculosis occurring among persons infected with the human immunodeficiency virus (HIV). Although there are many obstacles to the elimination of the disease in minority populations, numerous strategies have been developed and are being implemented to address this situation. [ABSTRACT FROM AUTHOR]

On request of local health officials, the authors investigated isoniazid (INH) hepatitis morbidity and mortality among patients attending an Hispanic prenatal clinic. Among 3,681 women treated with INH during and after pregnancy to prevent tuberculosis (TB), 5 developed INH hepatitis, and 2 of the S women died. Comparison with previously collected Public Health Service data concerning 3,948 nonpregnant women, using the Cox proportional hazards model, revealed a 2.5-fold increased risk of INH hepatitis in the prenatal clinic group. The mortality rate was four times higher in the prenatal clinic group. However, statistical power was low because of the small number of cases, and neither of these findings was statistically significant (P > 0.05). In the absence of controlled studies, the issue of INH safety during the perinatal period remains unresolved. Nevertheless, current American Thoracic Society-Centers for Disease Control recommendations regarding TB screening, implementation of INH chemoprophylaxis programs, and adequate monitoring of individuals on INH should be adhered to. The results of this investigation raise concern that deviations from existing policy may contribute to unnecessary morbidity and mortality. [ABSTRACT FROM AUTHOR]