Does self-experimentation get a free pass from research regulations?

Plain English

Self-experimentation is not automatically outside the scope of human subjects research regulation. A researcher who studies their own reaction to a substance and intends to generalize or publish the findings can still be conducting human subjects research under the Common Rule's definitions, because the researcher is also the subject from whom data is obtained.

Separately, FDA rules governing investigational drugs and devices are not written around an exception for testing on oneself. Distributing or shipping an unapproved test article, and obtaining it in the first place, can raise legal questions independent of who consumes it.

The idea that 'it's my own body, so no rules apply' is a common misconception, not a settled legal safe harbor, and the analysis depends heavily on institutional context and what happens with the resulting product or data.