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- What forms are required?
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- What happens after submission?
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For help with the IRB review process: |
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Phone: 317-274-8289 Email: resrisk@iupui.edu |
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New Research Submissions |
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What type of review is required?The type of review required for a study is initially determined by the investigator, but ultimately, the IRB decides the appropriate level of review. There are checklists and applications available to help you decide which type of review is applicable for your research. The checklists and applications are located in the Tool kit to the right. |
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Checklists:
 Exempt Research Checklist (v05/01/09) |
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 .rtf  .doc |
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| Expedited Research Checklist (v05/01/09) |
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| .rtf .doc |
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Once you have determined your type of review, you must submit the appropriate forms related to that review type. Also See 
What Forms are Required?
When you have completed all applicable forms, please submit them to the appropriate email address listed on the Where do I submit my forms? page.
Following is a list of the types of reviews, as well as a brief description of the types of review:
Exempt Review: *Research activities are exempt from regulations for the protection of human research subjects when they are considered minimal risk (i.e., the probability or 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, and the ONLY involvement of human subjects falls within one or more of the categories listed on the Exempt Research Checklist. Federal regulations mandate that someone other than the researcher determine whether research is exempt. Therefore, the Exempt Research Checklist and Application must be submitted to Research Compliance Administration for review.
Expedited Review: *Research activities that: (1) present no more than minimal privacy, psychological, and/or physical risk to human subjects, and (2) involve only procedures listed in one or more of the categories on the Expedited Research Checklist, may be reviewed by the IRB through an expedited review procedure. NOTE: The activities listed on the checklist should not be deemed to be of minimal risk simply because they are included on the list.
Full Board Review: *Any study involving greater than
minimal risk or involving human subjects from certain
vulnerable populations (e.g., prisoners) requires full board review -- that is, review by the full IRB, which meets monthly. Submissions must be received by the meeting deadline, typically two weeks before the meeting.
See Deadlines & Meeting Dates for details
Non-research student project: *If your activity does not involve research, but your activity is a student project that may place individuals at risk and involves a vulnerable population (i.e., children or adolescents, pregnant women and fetuses, prisoners, people who are mentally disabled or those with impaired decision-making capacity, or human in vitro fertilization), you will need to submit the Non-Research Student Project Application Form.
Non-human subjects research:
*Research involving data on Decedent PHI, a limited data set, de-identified health information, or coded private information or biological specimens may be eligible for review as Research Not Subject to FDA or Common Rule Definitions of Human Subjects Research. Refer to the Application in the Tool kit for additional information regarding this category.
*Note that these overviews are not exhaustive or definitive; they are meant to make quick review easy.
