SBER IRB Definitions

An overview of relevant terms and any recent changes to them as defined by the Common Rule.


    What is Research?

    The definition of research has changed to mean a “systematic investigation, including research development, testing, and evaluation, designed to develop or contribute to generalizable knowledge.” With this definition, HHS has provided guidance on what is no longer research including

    1. “Scholarly and journalistic activities (e.g. oral history, journalism, biography, literary criticism, legal research, and historical scholarship);
    2. Public health surveillance activities;
    3. Collection and analysis of information, biospecimens, or records for criminal justice or criminal investigative purposes; and
    4. Certain activities in support of intelligence, homeland, security, defense, or other national security missions. 

    As before, however, please check with the IRB to determine whether your research falls within the definition of research.

    What is a Human Subject?

    A living individual about whom an investigator conducting research obtains

    1. information or biospecimens through intervention or interaction with the individual, and uses, studies, or analyzes the information or biospecimens; or
    2. uses, studies, analyzes, or generates identifiable private information or identifiable biospecimens

    Relevant Definitions