Clarification on activities not part of human subjects research

The definition of research used by the Federal government in the “Common Rule” (regulations governing human subjects research) excludes several types of scholarly, journalistic, or governmental activities that might otherwise be included in a common-sense definition of “research.” Such activities are:

  1. Scholarly and journalistic activities (e.g., oral history, journalism, biography, literary criticism, legal research, and historical scholarship), including the collection and use of information, that focus directly on the specific individuals about whom the information is collected.
  2. Public health surveillance activities, including the collection and testing of information or biospecimens, conducted, supported, requested, ordered, required, or authorized by a public health authority.
  3. Collection and analysis of information, biospecimens, or records by or for a criminal justice agency for activities authorized by law or court order solely for criminal justice or criminal investigative purposes.
  4. Collection and analysis of information, biospecimens, or records by or for a criminal justice agency for activities authorized by law or court order solely for criminal justice or criminal investigative purposes.

If your scholarly or journalistic activity fits solidly within #1 above, you do not need IRB approval. If you have any doubts or questions, please contact the IRB. Note that #2-4 apply only to activity performed by or on behalf of an authorized (Federal, State or local) government authority, and so are unlikely to apply to activity at Bates College.

If none of the above apply to your work, then you are engaged in human subjects research. However, some types of human subjects research are exempt from IRB review. Please proceed to the list of exemptions.