Institutional Review Board

The DeSales IRB Committee has the responsibility and full capabilities to review and monitor biomedical and socio-behavioral research that involves human subjects in which DeSales is engaged before the involvement of human subjects may begin.

It is established to provide ethical review of research, and to assure that the rights and welfare of the human subjects are adequately protected in research and federal regulations are followed. Members include researchers, non-researchers and one member of the local community.

Does My Research Require IRB Review?

IRB Review

IRB Review

Investigators are responsible for determining whether an activity requires IRB review. The DeSales IRB provides ethical oversight to all activities that meet the criteria of "research involving a human subject", meaning that any activity meeting both of the following definitions requires IRB review.


IRB Review Illustration 

If an activity does not meet the research criterion, no IRB review is required. Similarly, if an activity is research, but it does not involve human subjects as defined above, the research does not require IRB review. 


Research is a systematic investigation, including research development, testing, and evaluation, designed to develop or contribute to generalizable knowledge. Activities that meet this definition constitute research even if they are a component of a larger non-research activity (e.g., instruction, demonstration).

Systematic investigation involves a predetermined system, method or plan for studying a specific topic, answering a specific question, testing a specific hypothesis, or developing theory. A systematic approach includes the collection of information and/or biospecimens, and analysis, either quantitative or qualitative.

Generalizable knowledge is information that is collected or gathered to draw general conclusions; inform policy; inform professional knowledge in a discipline; or generalize outcomes beyond the specific group, entity, or institution (i.e., to elaborate, to be an important factor in identifying or expanding truths, facts, information that are universally applicable). 

Examples of activities that generally do NOT meet the research definition:

  • Student projects conducted for a credit class assignment where there is no intent to contribute to knowledge in the field of study or present the data outside of the classroom.  However, faculty or staff who wish to assess students and use data for publication need IRB approval.

  • Medical case studies involving no more than two patients are not considered systematic investigations and there is no intent to publish.

  • Quality improvement activities where the data will only be used internally and there is no intent to publish or present the outcome. 


A human subject is a living individual about whom an investigator conducting research obtains data through an intervention or interaction with the individual or identifiable private information.

Intervention includes both physical procedures by which data are gathered (e.g., drawing blood) 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, including forms such as face to face surveys, web questionnaires, etc. 

Intervention includes both physical procedures by which data are gathered (e.g., drawing blood) and manipulations of the subject or the subject's environment that are performed for research purposes.

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 publi

c (e.g., medical record information). Since the definition of a human subject is a "living" individual, research involving autopsy materials, cadavers, and cadaveric materials is not considered human subjects research and is not reviewed by the IRB.

Examples of activities that generally do NOT involve human subjects:

  • Research only using data about deceased individuals; however, research using Protected Health Information about decedents does require submission of a Research with Decedents form.

  • Data that are obtained by the investigator in a completely de-identified state when the investigator will have no access to the ability to re-identify individuals.

If still in doubt about whether an activity requires IRB review, please submit information about the activity to the DeSales IRB Committee explaining how the activity meets the definitions above.  Once you have determined that IRB review is required, the next step is to assess what type of review is required: Exempt, Expedited, or Full Board.