Miami VA Human Studies Forms

Amendments Forms

  1. Recruitment plan- change
  2. Request for Amendment
  3. Report of Research Staff Members & Delegation of Authorities

Application Forms: 
Note * = off-site waiver request

Investigator Pre-submission Checklist*
(Note: Your are required to complete and submit this pre-submission checklist along with your proposal)

  1. Application For Miami VA Research Project (Front Page)*
  2. Application For New Human Research Study (version: 10-26-2016)
  3. MVAHCS Privacy and Data Security Plan
  4. Project Data Sheet*
  5. Financial Conflict of Interest Form
  6. Biohazard/Chemical Hazard Information (Once Redirected, Select Form)
  7. Biological Sample Not Stored Statement
  8. Disclosure of Available Funds
  9. Informed Consent_Blank
  10. Informed Consent_Blank (Spanish)
  11. Informed Consent_Surrogate
  12. Informed Consent_Example
  13. Informed Consent Preparation Checklist
  14. Investigational Drug Information Record
  15. Request for Exemption Review for Human Research Oversight - 9-24-2016
  16. Request for Expedited Review of New Application
  17. Request for Waiver from the Requirement to Submit an IND Application to the FDA
  18. Request for Access to Health Information for Research
  19. Waiver of Documentation of Informed Consent
  20. Request for Waiver of Authorization and waiver of Informed Consent - 3-22-2016
  21. FDA Statement of Investigator 1572
  22. Authorization for Use & Release of Individually Identifiable Health Information - 9/2015
  23. Revocation of Authorization for Use & Release of Individual Identifiable Health Information - 9/2015
  24. VA Privacy Notice
  25. vha-10-3203-consen for voice-picture

Continuing Review Forms

  1. Continuing Review (version 5-8-2015)
  2. Tracking Log for Reportable and Non-Reportable Events
  3. Financial Conflict of Interest Form 

Request for Study Closure

  1. Study Closure Form
  2. Tracking Log for Reportable and Non-Reportable Events
  3. Project Data Sheet

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. IRB Standard Operating Procedures (version 10-11-2016)
  5. De-Identification of Data
  6. Guidance on Collecting Data on Pregnancy and Outcomes of Pregnancy from VA Research Subjects and Pregnant Partners of VA Research Subjects for Safety Monitoring
  7. Belmont Report

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

Reporting Requirement Forms to the IRB

  1. Tracking Log for Reportable and Non-Reportable Events
  2. Report of Protocol Deviation, Protocol Violation or Apparent Research Non-Compliance [NEW]
  3. Report of U-SAE, U-ADE or UAP [NEW]