The Food and Drug Administration continues its efforts to harmonize its human subject protection regulations with those of the Office for Human Research Protections. You’ll recall that OHRP regs apply to all federally funded or supported research, and FDA regs apply to studies looking at FDA-regulated products, including industry sponsored studies.
Revisions that are in the works include those relating to single institutional review board review of multisite studies and institutional review boards and the protection of human subjects (we were expecting the FDA to require consent processes to begin with a “key information” presentation, and here is the proposed rule). The FDA says it is also finalizing a previously issued proposed rule about waiving or altering informed consent for minimal risk studies. Please click on the link above to find out more.
Note that at this time these are all proposed rule changes, so they won’t take effect immediately. However, it’s never too early to start thinking about how to prepare for them.