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Human Subjects Division (HSD)

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Apply for Review

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Is your study exempt from IRB review? Or does it require expedited or full board review?

While the researcher initially decides which form to use, the appropriate level of review is ultimately determined by HSD and the IRB, based on federal regulations.

 

Not Human Subjects

The UW Human Subjects Division has several forms to help guide you in the decision making process regarding whether or not your research includes human subjects, as well as a Standard Operating Procedure (SOP) document called Human Subjects Research.

Forms:

 

Exempt

There are six federally-defined categories of research that qualify for exempt status. HSD determines whether the research activity qualifies for exempt status.  Although "exempt" means that the research is not subject to IRB review, investigators still have the responsibility to conduct their research ethically.

Form:

 

Expedited/Minimal Risk

Expedited Review is a review process defined by the federal regulations. It allows a research study to be reviewed by the IRB committee chair, or by one or more review members designated by the chair rather than the full convened IRB.  In addition to meeting the regulatory definition of Minimal Risk, all procedures must fall into one or more of the research categories in this regulatory list: http://www.hhs.gov/ohrp/policy/expedited98.html . If the procedures do not fit into a category in this list, the study cannot receive expedited review even if it is not more than minimal risk.

As defined by the federal regulations, 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.

Despite its name, expedited review is not necessarily quicker than review by a full IRB committee. The key to an efficient review is a complete and accurate application.

Form and Instructions:

 

Full Board/Committee (Convened IRB):

Research with human subjects that doesn't qualify for an Exempt determination or Expedited/Minimal Risk review is assigned to a full board.  The UW has seven IRBs; some review biomedical research and some behavioral research.  Each committee usually meets twice per month.

Form and Instructions:

 

Use of Identifiable Biological Specimens/Data (formerly Medical Records Review)

The use of identifiable data and or specimens including: medical records; protected health information (PHI); employment data; study records; pathology specimens; or data and/or specimens from a repository requires IRB review. Use this form if your study involves the retrospective or prospective review of data and does not involve directly interacting with the research subjects. Due to the complex relationship between the Health Insurance Portability and Accountability Act (HIPAA) and medical records or protected health information (PHI), HSD has developed a helpful decision tree regarding when a waiver of consent must also be obtained.

Forms and Topics:

Change Notes

  • Noted 11/30/2012 @ 09:34am
    Updated with new references to Use of Identifiable Biological Specimens/Data form.
    - sherrye
  • Noted 05/31/2012 @ 12:38pm
    Keyword newly added.
    - sherrye