Common IRB Packages and Documents
All applications (except NHSR determinations) require, at minimum, an Application Form and the PI's CITI Core IRB Training Score Report.
Most applications require: Consent Materials, Recruitment Materials, and Study Instruments/Data Collection Tools.
Some applications require additional materials. See the accordion and tables below for these conditionally required documents. Every study is unique and may not always perfectly fit into a “typical” category. Determinations may only be made by designated IRB members.
Surveys, Interviews, and Public Observations
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Usually reviewed as Exempt Category 2. Examples include anonymous online surveys, interviews with adults, and observing public behaviors.
In addition to required application documents, these protocol packages typically include survey questions, interview protocols, or observation data collection forms.
Research on Normal Educational Practices
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Usually reviewed as Exempt Category 1. Examples include comparing teaching methods, curricula, or management techniques, and research on instructional strategies.
In addition to required application documents, these protocol packages typically include site/school permission and/or classroom materials.
Behavioral and Social Research
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If this research doesn't qualify for an exemption, it is usually reviewed as Expedited Category 7. Examples include sensitive online surveys, interviews with identifiable responses, and focus groups.
In addition to required application documents, these protocols typically include survey questions or interview/discussion guides.
Benign Behavioral Interventions
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Usually reviewed as Exempt Category 3. Examples include completing tasks under different conditions, tasks with different instructions, and responses to various stimuli.
In addition to required application documents, these protocols typically include intervention instructions and materials.
Non-Invasive Clinical Procedures
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Usually reviewed as Expedited Category 4. Examples include collecting height/weight, MRIs, ultrasounds, ECG, and moderate exercise testing.
In addition to required application documents, these protocols typically include procedure/device information and safety screenings.
Audio, Video, and Image Recordings
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Usually reviewed as Expedited Category 6. Examples include recorded interviews and photography.
In addition to required application documents, these protocols typically include recording procedures and interview guides.
Research That Will Always Require Full Board Review
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Greater than minimal risk to participants.
Investigational drugs and devices.
Significant interventions and procedures that don't qualify for exempt or expedited review.
Classified research.
Research involving minors, prisoners, and various other protected and vulnerable populations.
All other protocols that otherwise cannot be approved under exempt or expedited review procedures.
IRB FORMS, CHECKLISTS, AND TEMPLATES
Investigator Checklist for Preparing IRB Submissions
| Fillable IRB Forms | Documents to Prepare (if applicable) |
|---|---|
| IRB Human Subjects Study Application (Box) (Word) Coming Soon: WebTools e-Application NHSR Determination Form (Box) NEW! Please fill out if you would like to determine if your project qualifies as human subjects research. Research Team Form (Box) (up to 4 collaborators) Research Team Form (Box) (more than 4 collaborators) Waiver of Documentation of Informed Consent (Box) Removes signature requirement only. Common in online consent and sensitive research where a signature is the primary risk of breach of confidentiality. Waiver/Alteration of Informed Consent (Box) Removes or alters consent element(s). Common when research involves deception or observance of natural behaviors. Campus-Wide Survey Administration Request Form (Box) Required when surveying at least 10% of UIS population. This item will soon be migrating to the Office of Institutional Research & Effectiveness. Certificate of Translation Form (Box) Required for research that provides documents in a language besides English. HIPAA Compliance Form (Box) Mandated Reporter Form (PDF) | CITI Core IRB Training Report (required) Create an account with CITI Programs. After registering, affiliate your account with University of Illinois - Urbana Champaign before adding the course to your list. Additional CITI Training Report(s) Required for international research and research with vulnerable populations. Recruitment Materials Study Instruments/Data Collection Consent/Assent Document(s) Support Letters/Letters of Commitment Funding Notice/Contract Debriefing Statement Translated Documents Data Safety and Monitoring Plan |
Resources
The following e-presentation provides the basics for preparing a successful human subjects research protocol:
- Navigating the IRB Application (Box) (2024 PPT)
The EU General Data Protection Regulations or China's Personal Information Protection Law may apply to your research. Please consult the University of Illinois system GDPR Information Page and PIPL Information Page for more details. The Office of Research and Sponsored Programs will evaluate your protocol and provide advice.
This article describes the GDPR implications for secondary research, such as public clinical trial data.
External Resources
- Office for Human Research Protections
- Belmont Report
- Declaration of Helsinki
- Chastain, G., & Landrum, R.E. (1999). Protecting Human Subjects. Washington, DC: American Psychological Association.
- Sales, B.D., & Folkman, S. (2000). Ethics in Research with Human Participants. Washington, DC: American Psychological Association.
Additional Resources
Other resources to assist with research, grants and contracts, including workshops and tutorials, are available on the UIS Research Resources webpage.
