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]

 Miami VA Science/Lab Safety

Radioactive Materials

All Research Projects which include the use of radioisotopes require an Application for the Use of Radioactive Materials to be completed and submitted along with the Research Protocol.  

Please note that all purchase orders for radioactive materials must be signed and recorded by the Radiation Safety Officer (Dr. Russell Isaacks) or Alternate Radiation Safety Officer to assure NRC license compliance and possession limits.  Transfer of Radioactive materials between the VAMC and other institutions is prohibited except where both are licensed for the same material.  All transfers must be made between Radiation Safety Officers for recording into the records.  Please direct questions regarding the order of radioisotopes to Ines Robles or Dr. Isaacks. All Principal Investigators and technicians handling radioactive materials must attend at least one radioisotope training session each year.  

Radioactive Materials Application Form Aug 1997 ms word icon (Link)

 

Biohazard/Chemical Hazard Information Involving Research

Virtually all studies, even clinical studies, in which bodily fluids (blood, urine, etc.) or tissues are collected require the completion and submission of a Biohazard Information Form.  Additionally, a laboratory-specific Chemical and Biosafety Plan may be required, as determined by the Chemical Hygiene & Biosafety Committee.

Biohazard/Chemical Hazard Information Forms for Research (Click Here for Forms)

 

                          

Infection Control Policy & Exposure Control Plan for Bloodborne Pathogens

The first section of this manual describes the Research Service infection control policy and procedures.  The second section describes the Research Service bloodborne pathogens exposure control plan in accordance with OSHA requirements. The appendix contains the OSHA regulations.

Infection Control Policy & Exposure Control Plan for Research adobe pdf icon (Link)



Appendix  (OSHA Regulations) adobe pdf icon (Link)