According to the federal regulations (45 CFR 46 102.f),

A HUMAN SUBJECT means a living individual about whom an investigator conducting research obtains:

1. data through intervention or interaction with individual;
   
2. identifiable private information.

Intervention includes both 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 includes communication or interpersonal contact between investigator and subject.

Private information includes 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). Private information must be individually identifiable (i.e., the identity of the subject is or may readily be ascertained by the investigator or associated with the information) in order for obtaining the information to constitute research involving human subjects.

 

Some examples of human subjects:

• A person who becomes a participant in research - either as a recipient of a test article or as a control. A subject may be either a healthy individual or a patient.
• data obtained from medical records - even if the data is recorded without identifiers.
• tissue used in research that possesses or is linked* to any kind of identifiable information.
• data obtained from surveys - even if the data is recorded without identifiers.
• data obtained from observation - even if the data is recorded without identifiers.

For more information about what consititutes identifiable information, please review our HIPAA web pages.

Some examples of what would be non-human subjects research:

• tissue obtained from another source (not directly from the patient) that is either:
  • totally anonymous and unlinkable to the person who it was obtained from, or
  • is coded such that the researcher obtaining the sample does not know who it belongs to, AND a confidentiality agreement assures the researcher cannot learn the identity of the person who the sample was obtained from.
• data obtained from another source (not directly from the patient or their records) that is either:
  • totally anonymous and unlinkable to the person who it was obtained from, or
  • is coded such that the researcher obtaining the datadoes not know who it belongs to, AND a confidentiality agreement assures the researcher cannot learn the identity of the person who the data was obtained from.

NOTE: research involving non-human subject tissue and/or data must still be submitted to the IRB for review.