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New definitions for human subjects research effective Jan. 21, 2019

The Final Rule includes a new definition of research and identifies scholarly and journalistic activities as categories deemed not to be research.

The Final Rule includes a new definition of research and identifies scholarly and journalistic activities as categories deemed not to be research. The new definition of research excludes “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… It is not the particular field that removes the activity from the definition, but rather that the purpose and design of the particular activity is to focus on specific individuals and not to extend the activity’s findings to other individuals or groups… For example, a medical case report could fall within this category, if the point of the report were to describe an unusual and interesting case-specific medical complaint and its treatment.” In contrast, if a purpose of a project is to gather information from individuals in order to understand the beliefs, customs and practices, not only of those individuals, but also of the community or group to which they belong, the project would be deemed research according to the new definition.

For more information about the Final Rule and upcoming changes, visit the HRPP website or contact the Human Subjects Office at 706-542-3199 or