IRB-01 Forms

myIRB: submit new studies electronically. Click here to learn more.

Do you want your submission reviewed FASTER?

Please read and follow the important directions below. Failure to comply with these directions will likely increase the amount of time it takes to process, review, and approve your research. Please contact us (call (352) 273-9600 or e-mail ufirb-l@lists.ufl.edu) if you ever have any questions, concerns, or suggestions. Once you are familiar with our requirements use the links above to obtain the forms you need to submit to IRB-01.

You must download and use the most current forms.
IRB-01 continuously assesses our compliance with the current interpretation and implementation of existing and new regulations, laws, guidance, as well as federal citations of other institutions in order to insure optimal protection of those involved in research.

2.	All paperwork must be typed. Our Board reviews approximately 10,000 submissions a year. Handwriting is usually difficult to read, thereby making the reviewer's job more difficult and time consuming. At their behest, the IRB-01 office will not accept forms that are not typed.

All submissions must be signed by the Principal Investigator.
The PI is responsible for the conduct of the study and this helps insure the PI is aware of the status of the study. Co-PI or Sub-I signatures are not sufficient unless a temporary transfer of responsibility is obtained previously. Click here for more info.

4.	You must include copies of all pertinent, supporting documents Such as the protocol, grant, investigator brochure, advertisements, patient/subject questionnaires/surveys, data collection forms, etc.

Once you have a completed submission with original signatures, you must also make and submit an additional 1 to 3 photocopies of the entire submission
Why extra copies? The original stays in the IRB office and the remaining copies are distributed to the different parties involved in the review process. Requiring the PI to provide copies expedites our ability to distribute these materials to the pertinent parties. Keeping this in mind, please sort your paperwork into separate copies of the submission so we can distribute one copy to each of the separate reviewers. Paperwork will be returned to you if it does not include the appropriate number of copies. How many copies do you need? Each form indicates how many are needed, or you can print a list by clicking here.

Changes to previously reviewed paperwork must include (a) the changes tracked by underlining any information to be added to the paperwork (insertions) and striking-out any information to be removed (deletions), along with (b) a clean final copy with the changes executed.
Tracked changes greatly assist reviewers with identifying and understanding what you wish to change in your paperwork. The clean copies then serve as the final document once approved. Microsoft Word automatically tracks insertions and deletions. We offer instructions on how to first unlock our forms and then how to use the Microsoft Word track changes feature. Lastly, be sure to also include the appropriate IRB form to identify why your changing your paperwork: (a) the Revision Form should be used when you are initiating a change to your paperwork, (b) Explicit Change Form should be used when responding to the IRB's request for Explicit Changes, or (c) Tabled Response Form should be used when responding to a Full Board Tabled letter. The later two forms help us appropriately route your response and insure proper processing of the submission, thereby helping us process your submission faster. Please be sure to read the instructions on each of these forms.

Before submitting any forms to IRB-01 you should be intimately familiar with all of our requirements.
Please visit our Instructions for IRB-01 Forms page and our Submitting Paperwork to IRB-01 page before submitting any paperwork. Some forms (e.g. the Informed Consent form) have their own specific instructions. Important information is also discussed in our Policies & Procedures, Position Papers,and other topics as listed in the gray navigation bar on the left of this page. You are required to be familiar with any pertinent information prior to submitting these forms.

Attach a separate coverletter if you need to provide additional information.
The purpose of our forms is to give the IRB the information it needs to protect subjects and thereupon approve your research. Unfortunately it is difficult to design forms that accurately address the many different kinds of studies performed at our institution. If a form doesn't fit your research fill it out to the best of your ability and attach a coverletter that provides additional information and/or clarification. The more information you can give the IRB, the easier it is to evaluate your study!

Upon submission your paperwork must be complete, correct, and meet our Acceptability Standards.
The Board does not wish to review submissions that are incomplete, poorly prepared, or fail to comply with pertinent requirements. You can help us process, review, and approve your submission faster by insuring your paperwork is complete, properly prepared, and complies with all requirements. Click here for more information. Please note that your paperwork will not be forwarded for review if it is not complete and correct. This is particularly important for paperwork that must be reviewed at a Full Board meeting because it may result in your paperwork being reviewed at a meeting later than you originally expected. Please coordinate with the IRB Office BEFORE our Full Board Meeting Deadline in order to insure that your paperwork is appropriate and acceptable.

10.	Enrolling Children: There are special considerations when involving children in research. Please be sure to review these new forms, tools, and instructions.