Human Studies Forms

Amendments Forms

1. Recruitment plan- change
2. Request for Amendment to Recruitment Plan
3. Request for Amendment

Application Forms: Note * = required for all applications

1. Application For Miami VA Research Project (Front Page)*
2. Application For New Human Research Study
3. Project Data Sheet*
4. Report of Research Staff*
5. Location of Research*
6. Disclose of Financial Interest*
7. Admission of Non-Veteran Patients
8. Biohazard/Chemical Hazard Information Involving Research
9. Disclosure of Available Funds
10. Informed Consent_Blank
11. Informed Consent_Surrogate
12. Informed Consent_Blank (Spanish)
13. Informed Consent_Example
14. Informed Consent Preparation Checklist
15. Investigational Drug Information Record_10-9012
16. Request for Exempt Review
17. Request for Expedited Review of New Application
18. Request for Waiver from the Requirement to Submit an IND Application to the FDA
19. Resident Scholarly
20. Scope of Practice for Research Staff
21. Request for Waiver or Alteration of IC- HIPPA Authorization
22. Waiver of Document of IC

Continuing Review Forms

1. Request for Continued Approval or Closure of Project Involving Human Subjects
2. Report of Research Staff Members

General Forms

1. Conflict on Interest – Meeting Signature Form

Guidance Documents

1. Guidelines for Subject Recruitment in Research Studies
2. Guidelines for Submitting a Research Application
3. Informed Consent Preparation Checklist
4. PI Manual

Reviewer Forms

1. Conflict of Interest Reviewer Form
2. Continuing Review – IRB Reviewer Worksheet
3. Human Subject Research Determination Form
4. Human Subjects Research Exemption Determination Form – FDA
5. Human Subjects Research Exemption Determination Form – NON-FDA
6. IRB Reviewer Checklist – Initial Review
7. Unanticipated Problems Involving Risk to Subjects or Others Primary Reviewer Form

Unanticipated Problems forms

1. Tracking Log for Non Reportable Events
2. Unanticipated Problems form