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IRB review? - Have you fulfilled the pre submission requirements?
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Contact us: Human Subjects
- For help with the
IRB review process:
- Phone: 812-855-3067
- Email: iub_hsc@indiana.edu
Getting Started |
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Does your study require IRB Review?The question of whether you need to submit is best answered by reviewing a checklist that has been constructed by the IUB Human Subjects Office. The checklist asks basic questions that help guide you in determining whether the IRB needs to review your activity. Refer to details within the 'Checklist for IRB Review' located in the Tool kit to the right. |  |
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The basic questions asked are: |
- Is it research?
If your activity involves a predetermined method and contributes to generalizable knowledge, it requires a research submission.
- Does your activity involve Human Subjects?
If your activity involves research and human subjects, your activity is subject to the Common Rule and requires a research submission.
- Does your activity involve deceased individuals?
If your activity involves research with one or more deceased individuals, it requires a research submission.
- Does your research involve the FDA?
If your activity involves one or more of the following test articles:
foods or dietary supplements that bear a nutrient content claim or a health claim, infant formulas, food and color additives, drugs for human use, medical devices for human use, biological products for human use, electronic products, and if the research involves using the test article with one or more participants the research is being done as part of an IND or IDE submission, the data may be submitted to the FDA, or the data may be held for inspection by the FDA. If your activity is subject to FDA regulations (as defined above), your activity requires a research submission.
- Is it a student project involving risk to human subjects?
Your activity does NOT involve research, BUT your activity is a student project that may place individuals at risk and involves a vulnerable population, please submit the 'Application for Non-Research Student Projects' form located on the Student Projects page.
The checklist can be found in the Tool kit section to the upper right. If you answer yes to any of the checklist components then you will need to submit to the IRB.
