infographic of the IRB application information in the other column

IRB Document Checklist

  1. IRB Application
  2. Research Team Form - More than one investigator? Be sure to include your research team form!
  3. Consent Documents
    • Informed Consent/Assent Document(s)
    • Waiver of Documentation (signature) of Informed Consent
    • Waiver/Alteration of Informed Consent (elements)
  4. Recruitment Materials
    • Advertisement
    • Announcement
    • Flyers/Posters
    • Emails/Letters/Social Media Posts
  5. Study Instrument/Data Collection
    • Surveys/Questionnaires
    • Interview Questions, Focus Group Questions
    • Score Sheets/Assessment Instruments/Tests
    • Others
  6. CITI Reports - Core IRB for all UIS researchers. Each course must be passed with a minimum score of 80%. For external researchers, refer to their IRB policy for training requirements.
  7. Other Forms/Plans
    • Institutional Authorization Agreement for non-UIS researchers
    • Conflict of Interest Management Plan
    • Data Safety Monitoring Plan
    • International Research Checklist
    • Site Permission letter(s)


Fillable IRB FormsDocuments to Prepare (if applicable)
IRB Human Subjects Study Application (Word version)
IRB Human Subjects Study Application (Fillable PDF)
Coming Soon: WebTools e-Application

Research Team Form (up to 4 collaborators)
Research Team Form (more than 4 collaborators)

Waiver of Documentation of Informed Consent
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
Removes or alters consent element(s). Common when research involves deception or observance of natural behaviors.

Campus-Wide Survey Administration Request Form
Required when surveying at least 10% of UIS population.

Certificate of Translation Form
Required for research that provides documents in a language besides English.

HIPAA Compliance Form

Mandated Reporter Form
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

TemplatesChecklists AND GUIDELINES
General Informed Consent Form Template

English as a Second Language Consent Short Form

Institutional Authorization Agreement/Reliance Agreement Template

Conflict of Interest Management Plan
Elements of Informed Consent

International Research Checklist

Zoom Data Collection Guidance

Telephone Consent Guidance

Sample Reviewer Checklist
Post-approval forms
Annual Progress Report

Study Closure Form

Adverse Events Report Form

Unanticipated Problem Report Form

Protocol Amendment Form

Continuation Request (WebForm)


The following e-presentation provides the basics for preparing a successful human subjects research protocol:

The EU General Data Protection Regulations may apply to your research. Please consult the University of Illinois system GDPR 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

Additional Resources

Other resources to assist with research, grants and contracts, including workshops and tutorials, are available on the UIS Research Resources webpage.