Table 1.

Proposed Exclusions in the 2015 Notice of Proposed Rulemaking8

CategoryExclusion2018 Common Rule Adoption
Exclusion of activities that are deemed not researchProgram improvement activitiesNot meaningfully addressed
Oral history, journalism, biography, and historical scholarship activitiesOral history, journalism, biography, literary criticism, legal research, and historical scholarship deemed not researcha
Criminal justice activitiesDeemed not researcha
Quality assurance and quality improvement activitiesNot meaningfully addressed
Public health surveillanceDeemed not researcha
Intelligence surveillance activitiesDeemed not researcha
Exclusion of activities that are low risk and already subject to independent controlsEducational tests, survey procedures, interview procedures, or observation of public behaviorsIncluded in exemption categories 1, 2, and 3
Research involving the collection or study of information that has been or will be collectedPartially addressed by exemption category 4
Research conducted by a government agency using government-generated or government-collected dataIncluded in exemption category 5
Certain activities covered by HIPAAIncluded 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 knownNot meaningfully addressed
  • aSee 45 CFR §46.102(l)(1)-(4).3

  • HIPAA, Health Insurance Portability and Accountability Act.