FDA Aims to Find Common Ground With HHS Research Rule

Researchers who must follow two different sets of federal rules for protecting study volunteers now have a better idea of how to navigate the inconsistencies between them.

The advice is the first official guidance document to come from the federal government on the recently revised Common Rule, which applies to federally funded research on human subjects that’s funded by nearly 20 agencies, including the National Institutes of Health.

The guidance document, released Oct. 12 by the Food and Drug Administration, outlines what it expects for clinical research that is subject to both the FDA’s human subject protection regulations and ...