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. Checklist for Reviewing Privacy Confidentiality and Information Security in Research
4. Project Data Sheet*
5. Report of Research Staff*
6. Location of Research*
7. Disclose of Financial Interest*
8. Admission of Non-Veteran Patients
9. Biohazard/Chemical Hazard Information Involving Research
10. Biological Sample Not Stored Statement
11. Disclosure of Available Funds
12. Informed Consent_Blank
13. Informed Consent_Surrogate
14. Informed Consent_Blank (Spanish)
15. Informed Consent_Example
16. Informed Consent Preparation Checklist
17. Investigational Drug Information Record
18. Request for Exempt Review
19. Request for Expedited Review of New Application
20. Request for Waiver from the Requirement to Submit an IND Application to the FDA
21. Request for Access to Health Information for Research
22. Resident Scholarly
23. Scope of Practice for Research Staff
24. Scope of Practice for Principal Investigator
25. Request for Waiver or Alteration of IC- HIPPA Authorization
26. Waiver of Documentation of Informed Consent
27. Waiver of Informed Consent - HIPPA Authorization
28. Revocation of Authorization Form
29. FDA-1572_Statement_Exp
30. HIPAA authorization / Revocation form
31. VA Privacy Notice
32. vha-10-3203-consen for voice-picture
33. Required for all Applications

Continuing Review Forms

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

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
5. IRB Standard Operating Procedures

Reviewer Forms

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

Unanticipated Problems forms

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