UW – Health Sciences IRB

UW-Madison IRBs permit the application of 6 exemption categories, and apply these categories only to studies determined to be no more than minimal risk. The Exemption Category Tool is designed to help investigators determine if their project is eligible for review under exemption, and may be helpful for new investigators.

Secondary use of SHOW data most often falls into the following exemption category:

Category 4: Secondary research uses of identifiable private information or identifiable biospecimens.

The data collected by the SHOW team spans a wide range of topics, and combinations of data (for example, rare demographic and health history responses) and unique responses may make individual respondents identifiable. SHOW data is not a pre-approved secondary, or de-identified publicly available dataset.

Importantly, if an investigator believes his or her research falls into one of these exemption categories, he or she must still submit an application (via ARROW/Application Review for Research Oversight at Wisconsin) to an IRB. Only an IRB can determine whether the research is exempt from full review.

Selections to begin an application for IRB Exemption Determination:

· IRB Application

· Non-Protocol-Based Application

As part of the application, you will be asked basic study information including, but not limited to:

· Title, Principal Investigator

· Points of contact and study team personnel

· Funding, conflicts of interest, intellectual property

· Study Procedures

· Research design and procedures (similar to what would be included in a study abstract)

· Risk and benefits

Exempt determinations are made on a rolling basis, typically within 7-10 days. Once you receive notice that your application was approved, please share the following documents with SHOW staff:

· Approval letter

· PDF version of your application