IRB Document Checklist
- IRB Application
- Research Team Form - More than one investigator? Be sure to include your research team form!
- Consent Documents
- Informed Consent/Assent Document
- Waiver/Alteration of Informed Consent
- Recruitment Materials
- Advertisement
- Announcement
- Flyers/Posters
- Emails/Letters/Social Media Posts
- Study Instrument/Data Collection
- Surveys/Questionnaires
- Interview Questions, Focus Group Questions
- Score Sheets/Assessment Instruments/Tests
- Others
- CITI Certificates - For all the Researchers involved in the study
- Other Forms/Plans
- Conflict of interest management plan
- Data Safety Monitoring Plan
- International Research Form
- Site permission letter
Forms
To check boxes in the forms, please double click!
IRB Human Subjects Study Application (Word)
Adverse Events Form (fillable PDF)
Amendment Form (Fillable PDF)
Campus Survey Request Form (PDF)
Continuation Request Form (Webtools Form)
HIPAA Compliance Form (Word)
Mandated Reporter Form (PDF)
Request for Waiver or Alteration of informed Consent (Fillable PDF) Note: Use this form if waiving or altering required consent elements beyond the signature.
Research Team Form (fillable PDF)
Study Closure Form (Fillable PDF)
Unanticipated Problem Report Form (Word)
Waiver of Documentation of Informed Consent (Fillable PDF) Note: Use this form if only waiving the signature requirement.
Templates
Informed Consent Document (Word)
Institutional Authorization Agreement (Word)
Checklists
International Research (docx)
Resources
The following e-presentation provides the basics for preparing a successful human subjects research protocol:
- Navigating-the-IRB-2016 (pdf)
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
- 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.