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Does your project require IRB review?

Determining whether or not a project meets the federal definition of human subjects research is a two-step process. The information below will help assess whether a project requires IRB review.

1. Is your project considered research?

Does your project meet the federal definitions of research described below? If not, it may not need to be reviewed by the HSC. See below for examples of projects that are usually Not human subjects research.

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

Systematic investigation means a study or examination involving a methodical procedure or plan.

Generalizable knowledge means conclusions, facts, or principles derived from particulars (individual subjects, medical records, etc.) that are applicable to or affect a whole category (members of a class, kind, or group, a field of knowledge, etc.) and are intended for dissemination in the public domain, typically through publication.

 

2. Does your research involve human subjects?

If you answered “yes” to whether your project is considered research, does your project meet the federal definition of a “human subject”?

Human Subject means a living individual about whom an investigator conducting research obtains: (1) data through intervention or interaction with the individual or (2) identifiable private information.

Intervention includes both physical procedures by which data are gathered (e.g., 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 (e.g., a medical or school record). In order to meet the above definition, private information must be individually identifiable (i.e., the identity of the subject is known or may readily be ascertained by the investigator or associated with the information) in order for the investigation to constitute research involving human subjects. In general, private information is considered to be to be individually identifiable when it can be linked to specific individuals by the investigator(s) either directly or indirectly through coding systems, or when characteristics of the information obtained are such that by their nature a reasonably knowledgeable person could ascertain the identities of individuals.

If you think your project does not require review and you require documentation for your records, then submit this form to the HSC for a formal determination.

 

Activities that may Not be considered human subjects research

Below are examples of activities that are typically NOT human subjects research:

 


 

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