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5. How do I know whether I must submit an IRB application? The following four decision questions should help you determine whether you need to submit and application to the IRB. 1. Is the proposed activity research?

Research is a systematic investigation designed to develop or contribute to generalizable knowledge.
Generalizable knowledge means that the information derived from the investigation will be applicable to other cases.
Systematic investigation means that the information will be arranged such that conclusions can be drawn and others can review those conclusions.

Answer:

No – Stop, your investigation does not need IRB approval

YES – Go to question 2

2. Does the research involve human participants? This means that the person is alive and the information pertaining to that person will be obtained though

Intervention (e.g., taking a saliva sample, manipulating the participant’s environment or setting)
Interaction (e.g., an interview, survey, or other interpersonal contact)
A private/confidential source (e.g., medical, governmental, school, business records). 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. Also, private information is that 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 participant is or may readily be ascertained by the investigator or associated with the information) in order for it to constitute research involving human participants.

Note: Information collected about deceased individuals or from commercial or public repositories or registries does not need IRB approval.

Answer:

No – Stop, your investigation does not need IRB approval

Yes – Go to question 3

3. Does the research meet the criteria for exemption? (See Categories of Exemption) There are six categories of exemption. All follow the general rationale that the research exposes participants only to the same small physical, social, and psychological risks that they take in living every day.
Answer:

Yes – Submit a claim of exemption (See Claim of Exemption). Investigators do not have the authority to determine whether their research involving humans is exempt from full review. Although research that involves only minimal risk is sometimes exempt from full review, it is never exempt from peer review.

No – Go to question 4

4. Does the research meet the criteria of minimal risk?(See Categories for Expedited Review) Minimal risk means that the probability and magnitude of harm or discomfort anticipated in the research are not greater in and of themselves than those ordinarily encountered in daily life or during the performance of routine physical or psychological examinations or tests.
Answer:

Yes – Submit a request for expedited review

No – Submit information for full IRB review