For a project or study to be considered Human Subjects Research, please consider the following:

Determination of Research Activity

Research Definition

The activity meets the definition of "research", which is a systematic investigation, including research development, testing, and evaluation, designed to develop or contribute to generalizable knowledge.

Systematic Investigation

The activity involves planned data collection (quantitative or qualitative) and data analysis to answer a specific question. 

Generalizable Knowledge

The activity is designed so that findings are intended to generate or contribute to generalizable knowledge. This includes drawing general conclusions that may apply beyond the specific participants, program, or setting; informing theory, policy, or practice; or contributing to publications or presentations for a broad scholarly or public audience. 

Determination of Human Subjects Involvement

Involvement of Human Subjects

The research involves human subjects, defined as living individuals from whom an investigator obtains data or biospecimens.

Intervention or Interaction

The research involves the prospective collection of information or biospecimens through:

• Intervention (e.g. physical procesures or manipulation of the individual or their environment)
• Interaction (e.g. communication or interpersonal contact, including electronic interaction)

Use of Private Information or Biospecimens

The research involves obtaining, using, studying, analyzing, or generating identifiable private information or identifiable biospecimens.

• Private information refers to information provided for specific purposes that individuals reasonably expect will not be made public (e.g., medical or psychological data), or information about behavior in contexts where individuals expect no observation or record. 
• Identifiable private information or biospecimens refers to data or specimens where the identity of the subject is or can be readibly be ascertained by the investigator or linked to the information. 

If you have any questions, please contact the IRB office.