Is Your Research Exempt?

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We expect few exemptions for human subjects at NIAID, so how can you decide if one applies to you?

Since the Office for Human Research Protections clarified what it considers to be human subjects research, the six human subjects exemptions rarely apply to NIAID.

Almost all research at NIAID is either "human subjects" or "not human subjects."

What is human subjects research? You are conducting human subjects research if you obtain data by intervening or interacting with a living person or if you obtain individually identifiable private information about a living person. Click on the glossary links in blue for definitions.

If your research is not considered to be human subjects, you won't need to address human subjects reporting requirements.

If you've looked through NIH and NIAID guidance and still think your research may be exempt, contact your program or project officer.

To learn more about exemptions, read the following:

• Electronic applications. Section 2, Scenario C, under Part II, Supplemental Instructions for Preparing the Human Subjects Section of the Research Plan, in the Grant Application Guide for your Grant Application Package.
• Paper applications. Section 2, Scenario C, under Part II, Supplemental Instructions for Preparing the Protection of Human Subjects Section of the Research Plan, in the PHS 398.

For additional information about human subjects research and exemptions, see NIAID's:

• Are You Conducting Human Subjects Research? tutorial page.
• Human Subjects Questions and Answers.
• Private Information or Biological Specimens in Human Subjects Research Questions and Answers.

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