As you prepare your human subjects application, please take note of the following:
- All human subjects related documents are to be submitted through our online protocol management system, IRBNet.
- All forms noted above can be found within IRBNet; A copy of the IRB checklist (Item 2) can be downloaded using the following link: IRB Checklist
- As you review the application material on this page, you may encounter terms with which you are unfamiliar. As a first step, please check our glossary page for frequent terms and definitions.
- For further questions, please e-mail email@example.com.
- Application Form, including the following addendums as applicable
Addendum A: Research with minors
Addendum B: Research with prisoners
Addendum C: Research with pregnant women, fetuses, and neonates
Addendum D: FDA regulated drugs
Addendum E: FDA regulated device
Addendum F: Deception
Addendum G: Audio or videotape
Addendum H: Other potentially vulnerable populations
Addendum I: International study sites
Addendum J: Additional team members
- IRB Checklist – Checklist to assist with ensuring all necessary materials are included with IRB application.
- Existing data form – If you are conducting research on pre-existing data, please submit this form instead the application form noted above.
- Human Subjects Research Determination Form – If you are an experienced applicant, you may use this form for a self-evaluation or to obtain a letter from ORIA indicating that a project that is not research based on the federal definition or does not involve human subjects based on the federal definition. Instructions and definitions are included on the form.
Forms for Approved Projects
- Research Determination Form – this form can be used to assess the need for IRB review. If you would like an official determination from the ORIA, you must submit this form through IRBNet.
- Reportable New Information (Adverse Event Report Form)—Promptly fill out this form and submit it to ORIA if an unexpected problem has occurred that directly relates to your research activity. If the problem that has occurred was described in your consent form and the IRB protocol, unless the problem represents a magnitude or severity that was unanticipated and not described in these documents, you do not need to fill out this form.
- Amendment Form and Guidelines—If you make any changes to your project or find that there has been a change in the risk/benefit analysis, please fill out this form and submit it to ORIA for further review.
- Continuing Review Form—Please use this form to provide updates on your project to ORIA. Projects reviewed by the IRB (either expedited review or full board review) require annual review.
- Informed Consent Template—Use this form as a base for your own informed consent form.
- Assent Template —If you are doing research with minors, you may use this template as the base for your own assent form. Remember that an assent form should be written in an age appropriate way and give the minor-participant all relevant information about the study.