human subjects research and the irb

Human subjects research is defined by federal regulations as research that involves a living individual about whom an investigator obtains:

  • data through intervention or interaction with an individual or
  • identifiable private information.

In accordance with Meharry’s Federalwide Assurance (FWA#00003675), all research activities involving human subjects, regardless of the funding source for those activities, must be reviewed by the Institutional Review Board (IRB) if the research is sponsored or conducted by Meharry or involves non-public information that can be used to identify human subjects.

The IRB has been charged with aligning Meharry Medical College with this mandate. In short, as Meharry’s scientists are translating laboratory findings into patient treatment, the IRB is translating the Assurance into patient protection. Doing so not only ensures safe outcomes for study volunteers; it also means sound investigative practice for Meharry’s scientists. Doing so frees you, the scientist, to conduct your experiment with confidence your regulatory affairs are in order.