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North Florida/South Georgia Veterans Health System

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Human Research Protection Program (HRPP) Office

 **NOTE:  PLEASE ALWAYS REFER TO OUR WEBSITE FOR THE MOST CURRENT FORMS** 

ALL FORMS MUST BE TYPED, ELECTRONICALLY SIGNED (if required), and submitted via email to the HRPP staff. Your study IRB# should be noted in the subject  line of ALL emails to the HRPP office staff. This will ensure proper sorting, filing, and accountability of study materials. Do not scan documents together. Each form should be scanned & attached to the email  seperatley for better sorting.

New Study Submissions to the VA

All new studies must be submitted to the VA prior to submitting for IRB approval.  

Please provide (1) COMPLETE electronic copy of the VA forms, with signatures, to the HRPP Office via email:

Hattie Grant, Grants Administrator, 352-548-6000 ext. 4994 or
Lisa Campbell, HRPP Specialist, 352-548-6000 ext. 5310 

*** Navigate To:
 
New Study     Continuing Review    Revision     Closure      AE 

FORMS INDEX 
HRPP Coversheets and Forms for NEW Studies 
HRPP Coversheet  
Medical Center Support Form 
Page 18 (only for new PI’s) 
Abstract 
Protocol
Addendum V 
VA HIPPA Authorization (if consenting subjects)
Budget – All Funded Studies must provide a Budget.
One of the following is required for each person on the study:Scope of Practice, Clinical Privileges or Functional Statement 
Conflict of Interest  - This link will take you to Tech Transfers Model Agreements page.  The COI form is at the bottom of the page.  This form is needed with all New studies and with Continuing Reviews.   In the name of Study Title Field, please start with the IRB # and then type as much of the title as you can. 
VA Form – 10-9012 
VA Form – FDA 1572 
VA Form – 10-0403 
VA Form – 10-3203 

Data Management and Access Plan All new VA research proposals submitted to the IRB, IACUC, or RDC on or after January 1, 2016, regardless of funding status or funding source, must include a Data Management and Access Plan (DMAP). The plan must describe the conditions and mechanisms under which the publications and final data sets resulting from research will be shared with the public. IF your study is a VA funded study you will use the DMAP form below, BUT if you have a study that isn't VA funded but funded thru another goverment source besides the VA (that doesn't have it's own DMAP form) or if your study isn't funded at all you'll use the DMAP (unfunded) form below. 
Data Management and Access Plan FAQs 
Data Management and Access Plan Powerpoint 
Data Management and Access Plan Form 
Data Management and Access Plan Form(unfunded) 

Safety Evaluation: 
   This link will take you to the Safety Page.  Please include Safety Evaluation and Cover Sheet.
CPRS Information   
Definition of Engaged in Research 

Required Training
www.citiprogram.org -  VA Human Subjects Protection and Good Clinical Practices
**Please select Gainesville – 573 for the Institution.

HRPP Coversheets and Forms for CONTINUING REVIEWS
 HRPP Coversheet 
Abstract 
VA Annual Renewal/Closure (Expedited or Full Board Studies) 
VA Annual Renewal/Closure (Exempt or Non-Human Studies) 
Conflict of Interest - This link will take you to Tech Transfers Model Agreements page. The COI form is at the bottom of the page. This form is needed with all New studies and with Continuing Reviews  

HRPP Coversheets and Forms for CLOSURES 
HRPP Coversheet  
Abstract 
VA Annual Renewal/Closure (Expedited or Full Board Studies)  
VA Annual Renewal/Closure (Exempt or Non-Human Studies)  
HRPP Coversheets and Forms for REVISIONS 
HRPP Coversheet 
HRPP Coversheets and Forms for ADVERSE EVENTS or UNANTIPATED PROBLEMS 
HRPP Coversheet   

*** VA is committed to protecting your privacy -   please review our Privacy Policy.


In particular, please note that e-mail communication may not be secure against interception across the Internet.  Please do not include sensitive information such as medical records or financial information, drug prescriptions, or your social security number.

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 ***Conversion process of Legacy (paper) studies into myIRB***  

The Conversion of a Legacy (paper study) to myIRB is completed as a “new study”; therefore, you must complete this using the “new study” tab on this website.  Time is of the essence and this process should began per the  IRB’s instructions. Prior to beginning this process please contact the HRPP staff via email, and keep in mind the study must be pre-reviewed at the VA first by the HRPP office. Be advised that this process begans approximatley 60 days prior to your IRB continued review expiration. For further information/explanation please contact the IRB staff at (352) 273-9600.