Protection of Research Subjects: Do Special Rules Apply in Epidemiology?

Abstract

Imagine, if you will, a place where health, hospitalization, education, military, employment, law enforcement, housing, tax and financial records, as well as disease registries and the data sources for the census, vital statistics, and all aspects of people's private activities, are meticulously kept, fully linked together, and easily accessible to qualified researchers. What is that place? Epidemiologists’ heaven.Of course, formidable problems face epidemiologists trying to reach heaven. The data sources on many aspects of our lives are incomplete and the means of linking them are typically nonexistent or partial at best. But even if the data all existed, there would be a further “catch”: epidemiologists would probably find themselves facing great obstacles in gaining access to the data.Epidemiologists sometimes think of “ethics” as the source of those obstacles, which are believed to be embodied in the federal rules for the protection of research subjects—colloquially called 45 CFR Part 46—especially as they are interpreted by some institutional review boards (IRBs).