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Send a paragraph describing the project to the IRB Office or call (781) 736-8133.

Defining Human Subjects Research

Often, questions arise as to whether a project constitutes research that must undergo IRB review.  To help understand what is meant by Human Subjects Research under the regulations, it is helpful to begin by reviewing the definitions that the regulations provide.  After reviewing these definitions, if you are still unsure if your projects falls under the regulations, please do not hesitate to contact the IRB Office.

The federal regulations in 45 CFR 46.102, give the following definitions:

Research

A systematic investigation, including research development, testing, and evaluation, designed to develop or contribute to generalizable knowledge.

(Generalizable knowledge generally refers to published papers, public oral presentations, posters at a conference, a dissertation or thesis, etc. If a project is only to be conducted for a class project, it is not considered generalizable research. But please keep in mind that if you are planning to use your class project as the basis for further research later on (that you would like to publish), and it meets the definition of "human subjects research," you will need IRB approval.)

Human Subject

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.
Intervention

Physical procedures by which data are gathered (for example, venipuncture) and manipulations of the subject or the subject's environment that are performed for research purposes.

Interaction

Communication or interpersonal contact between investigator and subject.

Private information

Information about behavior that occurs in a context in which an individual can reasonably expect that no observation or recording is taking place, and information which has been provided for specific purposes by an individual and which the individual can reasonably expect will not be made public (for example, a medical record).

Identifiable

The identity of the subject is or may readily be ascertained by the investigator or associated with the information

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