Table 1.

Proposed Exclusions in the 2015 Notice of Proposed Rulemaking⁸

Category	Exclusion	2018 Common Rule Adoption
Exclusion of activities that are deemed not research	Program improvement activities	Not meaningfully addressed
	Oral history, journalism, biography, and historical scholarship activities	Oral history, journalism, biography, literary criticism, legal research, and historical scholarship deemed not researcha
	Criminal justice activities	Deemed not researcha
	Quality assurance and quality improvement activities	Not meaningfully addressed
	Public health surveillance	Deemed not researcha
	Intelligence surveillance activities	Deemed not researcha
Exclusion of activities that are low risk and already subject to independent controls	Educational tests, survey procedures, interview procedures, or observation of public behaviors	Included in exemption categories 1, 2, and 3
	Research involving the collection or study of information that has been or will be collected	Partially addressed by exemption category 4
	Research conducted by a government agency using government-generated or government-collected data	Included in exemption category 5
	Certain activities covered by HIPAA	Included in exemption category 4
The following activities are excluded because they are considered to be low-risk human subjects research activities that do not meaningfully diminish subject autonomy.	The secondary research use of a nonidentified biospecimen that is designed only to generate information about an individual that already is known	Not meaningfully addressed

^aSee 45 CFR §46.102(l)(1)-(4).³

HIPAA, Health Insurance Portability and Accountability Act.