I’ve been remiss in pointing my readers recently to Zachary Schrag’s Institutional Review Blog, which patiently documents the overreach and misapplication of federal regulations regarding the protection of human subjects to the social and behavioral sciences, including research that by federal regulation is exempt from review by IRBs.
While Schrag is cautiously optimistic that the new head of the Office of Human Research Protections will be an improvement, the continued domination of the process at most levels by biomedical researchers—along with the general sense that, as Schrag notes, “researchers cannot be trusted to apply the exemptions themselves”—is still troubling to those of us who want to conduct human subjects research, particularly secondary data analysis. Technically speaking (even though I dare say most social scientists observe this requirement in the breach), even the analysis of secondary data collected by others and fully anonymized before we see it (e.g. use of data such as the General Social Survey, American National Election Studies series, the Eurobarometer series, etc.) requires IRB oversight and approval beforehand.