Abstract: - Research Affairs



Abstract Template for Expedited or Exempt IRB Applications

1. Study title:

2. Purpose:

“The purpose of this investigator-initiated/industry-initiated (pick one) study is…”

List all reasons for conducting the study.

3. The procedures include:

Will data be collected from medical records? Will subjects fill out surveys/questionnaires? Will subjects be randomized? Are there multiple arms to the study? Will the study use a placebo? (This is only a partial list)

4. “Subjects will be… (Choose from IRB application VI B – classification of subjects - for example: male, female, adults, children, etc…).

5. “Subjects will be between ____ and ____ years of age.”

6. “In total, subject participation will last approximately ____ (e.g. 2 months/years).”

7. “Subjects will be recruited ____.” (Insert where and how)

8. “Consent will take place ____.” (Insert where and by whom)

9. If Multi-center:

“____ subjects will be recruited at ____ sites, with ____ at LLU.”

10. If Single center or investigator-initiated:

“____ subjects will participate in the study.”

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➢ Fill in the following abstract template in lay terms (in 200 words or less).

➢ Email the abstract in Microsoft Word to the Office of Sponsored Research (to IRB@llu.edu) when you submit hard copies of your application to OSR.

Note: Use provided boilerplate (shown in quotations) and spell out all abbreviations

the first time they are used.

Updated on: 6/9/2008

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