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Unsure if your research activity needs to be submitted to the IRB? Click here for OHRP's Human Subject Regualtions Decision charts

www.hhs.gov/ohrp/humansubjects/ guidance/decisioncharts.htm

INVESTIGATOR FORMS > Outline of Research Study

Outline of Research Study

The Outline of Research Study should include enough information in the background and methods sections to permit a physician (perhaps one not in your field) to understand the rationale and conduct of the study. The information in the study outline should be sufficient to support the information provided in the informed consent form. Submitting copies of protocols prepared by study sponsors in lieu of the IRB study outline format is NOT ACCEPTABLE. Please edit Header A & Footer A to conform to your study.

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