What are the requirements for and the NIH interpretation of Exemption 2 (E2)?
HHS regulations state: “Research involving the use of educational tests (cognitive, diagnostic, aptitude, achievement), survey procedures, interview procedures or observation of public behavior, unless: (i) information obtained is recorded in such a manner that human subjects can be identified, directly or through identifiers linked to the subjects; and (ii) any disclosure of the human subjects’ responses outside of the research could reasonably place the subjects at risk of criminal or civil liability or be damaging to the subjects’ financial standing, employability, or reputation.” 46.101(b)(2) NIH Interpretation: In order to be exempt from the requirement of IRB review and approval under exemption 2, researchers must propose the use of tests or procedures involving human subjects who: • cannot be identified, either directly or indirectly; OR • may be identified, but would not be put at risk if information is disclosed
