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Human Subjects Division (HSD)

Quick Tips from HSD

Exempt?

Apr 13, 2012 at 12:00am

Exempt is another one of those terms that has a different meaning in connection with human subjects research than you might expect. (Recall how "expedited" doesn't mean quicker in the IRB world.)

It is often thought that "exempt" means that the research activity does not involve human subjects. This is not the case. Exempt, in regulatory speak, means that the activity involves human subjects, however, because it is no more than minimal risk and fits into one or more of the six specific categories of research defined by the federal Office of Human Research Protections or OHRP (affectionately pronounced "O-Harp") it is "exempt from the regulations." An exempt determination is a specific determination that is made only by the Human Subjects Division (HSD). Take a look at either the regulations themselves, or HSD's well written and easy to read Exempt Status Request Guidance document to learn more about the six categories.

While you're reading that guidance, Quick Tips is going to consult the Exempt Magic Eight Ball to clear up some misconceptions about Exempt Research:

eight ballCan I use deception in Exempt research, as long as the risk is minimal and I debrief the participants afterwards?

"My reply is no." Deception studies that intentionally provide misleading or false information are not eligible for Exempt status. One example: Participants complete a quiz and are falsely told that they did poorly, regardless of performance.This is no longer true, see HSD's revised SOP Exempt Determination for details on how projects that involve deception can be eligible for exempt status

eight ballDoes a determination of "Exempt" mean that I have IRB approval?

"Outlook not so good." Exemption is a determination by the staff of HSD that the research is exempt from review by the IRB. However, keep in mind that researchers still have a responsibility to protect the rights and welfare of their subjects, and are expected to conduct their research in accordance with ethical principles, as well as state and local institutional policy.

eight ballExempt means it's not Human Subjects Research, right?

"My sources say no." If a research project involves humans (see the definition of a human subject on the HSD website) it is still human subjects research, even if it is minimal risk, and falls under one of the six categories of exemption.

eight ballI've heard that I can determine whether my research is exempt.

"Don't count on it." The staff of the Human Subjects Division are the only individuals authorized at the UW to determine whether the research activity is exempt from federal regulations. The UW applies the federal regulations and guidance about exemption to all human subjects research, regardless of funding, or funding source.

eight ballSo, if my research is "exempt," I don't have to do anything?

"Very doubtful." You must complete the form "Initial Application: Exempt Status Request" either in Word or PDF. Then, send it to the HSD office to request a determination of "Exempt." Think of "Exempt" as a status that is determined by HSD, according to the specific federal regulations governing human subjects protections. The everyday usage of the word exempt does not really apply.

Hmm, the Exempt Magic Eight Ball is on a negative streak today. Let's refrain from asking it about the lottery.