Guidance Documents
The following documents provide investigators with information that will be helpful for meeting the standards set by the Wright State IRB based upon the federal regulations for the protection of human subjects in research. Additional topics will be added on an ongoing basis.
Investigator Instructions
- How to Submit a New Study (PPSX)
- Investigator Initial Submission Guidance (DOCX)
- Faculty Advisor, Department Chair and Hospital Reviewer Guidance (DOCX)
- How to Submit Continuing Review, Amendment, Reportable Event, Study Closure, and Miscellaneous Forms (DOCX)
- How to Submit New and Continuing HUD Forms (PDF)
- How to Respond to a Request for Modifications/Tabled Letter (DOCX)
Researcher Credentialing Requirements
- IRB CV Requirements and Instructions
- Annual Investigator SFI Form Completion Guidance
- CITI Training Requirements & How to Enroll
Common Rule Update 2018
Brief Overview- Revised Common Rule Training for Investigators
- Guidelines for Implementing Revised Common Rule
Special Considerations
COVID-19 Safety Plan (DOCX)- Use of Deception in Research
- Research Involving the Department of Defense
- Research with FERPA Protected Educational Records
- Data Security Guidance for Human Subject Research
- Case Report Guidance
- Class Assignment Guidance
- Public Health Surveillance Guidance
- Umbrella Protocol Guidance
- Quality Improvement (QA/QI) Guidance
