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Human Subjects Division (HSD)

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Does Your Research Involve Human Subjects

Human Subject?

Will your research involve "a living individual about whom an investigator conducting research obtains:

  1. data through intervention or interaction with the individual, or
  2. identifiable private information"?

If "yes," then you will likely need IRB review. See the federal definitions of Human Subjects below.

 

Specimens or Data from a Human Subject?

If your research involves only the use of non-identifiable biological specimens and/or data, and you need a formal determination from our office that your research does not involve human subjects, please fill out the APPLICATION: Specimen or Data Use, Non-Identifiable (and self-determination).

Other Resources

The documents below offer more options for determining if your research involves human subjects under the federal definitions:

 

Definition 1. This definition is for all projects.

A human subject is a living individual about whom an investigator (whether professional or student) conducting research obtains (1) data through intervention or interaction with the individual or (2) identifiable private information.

 

Living: means that the subject is alive at the time of the research, according to applicable local and national regulations.
About whom: means the data or information relates to the person. Asking individuals what they think about something is almost always about the person.
Intervention: includes both physical procedures by which data are gathered, 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.
Identifiable: the identity of the subject is or may readily be ascertained by the investigator or associated with the information.
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).

 

Definition 2. This definition is for all projects involving the use of a drug, device, or other item that is regulated by the Food and Drug Administration.

A human subject is a living individual who participates in a research investigation, as (a) a recipient of an item regulated by the FDA (b)as a control; or (c) on whose specimen an investigational device is used. 

Items regulated by the FDA include: any drug (including biological products) for human use, medical device for human use, human food additives, color additives, and electronic products intended for clinical use by or with humans.

 

Is IRB review required when the human subjects are people who are dead?

Yes, but only as required by Washington State law in the following circumstances:

  1. The research involves the research use of individually-identifiable records from the UW and certain other state agencies, without the consent or authorization of the individuals (whether living or dead).
  2. The research involves the research use of individually-identifiable health care information collected from patients in Washington State, without the consent or authorization of the individuals (whether living or dead).

 

Next Steps

Now that you know you are working with human subjects, what do you do? Continue on...

Change Notes

  • Noted 05/31/2012 @ 12:10pm
    Keyword newly added.
    - sherrye