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Definition of Research and Human Subjects

Definition of Research and Human Subject (from HHS: §46.102)

Research means a systematic investigation, including research development, testing and evaluation, designed to develop or contribute to generalizable knowledge.  Activities which meet this definition constitute research for purposes of this policy, whether or not they are conducted or supported under a program which is considered research for other purposes. For example, some demonstration and service programs may include research activities.

Human subject means a living individual about whom an investigator (whether professional or student) conducting research obtains:

  1. Data through intervention or interaction with the individual, or
  2. identifiable private information.

Human Subjects Projects that are not Research

There may be instances of projects being done with MassBay students or using college facilities that would not meet the definition of research given above and that would not be required to come before the IRB for review and approval. In such cases, the faculty member or Principal Investigator is still expected to conduct the project ethically and in compliance with relevant college policies. Oversight of such activities is outside the purview of the IRB. Course activities and assignments that meet the above definition of research are subject to the same review process as any other research that is within the purview of the IRB.

If you are unsure about whether your project qualifies as research, please contact us for more clarification via email at or at (508) 270-4106.