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Form Links
Alphabetical listing Forms for NEW studies
Informed Consent Forms Forms for PREVIOUSLY REVIEWED Studies
Introductory Questionnaire Forms Standardized Text for IRB Forms
HIPAA forms Form FAQs


The Board changed our Informed Consent form templates on 02 May 2007. Investigators are required to use these consent forms in new protocol submissions (when appropriate) or continuing review (if enrollment continues or re-consent is necessary) after 12 PM on 25 May 2007. You do not have to use these new forms if you are simply revising your previously approved consent(s) (unless the IRB specifically instructs you to do so).
  Informed Consent Form type: Last Updated:
  Emergency Use (if no sponsor template) 12/15/2006
new

Full consent, UF/Shands template, with HIPAA

06/12/2008

 

Full consent, UF/Shands template, without HIPAA

05/16/2007

new Full consent, VA 10-1086 template, with HIPAA 06/12/2008
  Full consent, VA 10-1086 template, without HIPAA 05/16/2007
  Short form for follow-up data on "Kids to Adults" 01/09/2007
  Short form for subjects who can't speak/read English 08/02/2004
  Short form Tissue/Data Banks conducted at UF/Shands Absolutely no research being conducted - only banking of tissue/data 03/10/2004
  Veterans Administration Form 10-1086 (blank)  
NOTE (05/2007): Our current versions of the Informed Consent forms utilize HIDDEN TEXT. Please be sure to turn this feature on when completing the forms. HIDDEN TEXT will display on your computer screen but will not print out.   “Hidden Text” will be displayed highlighted yellow, italics, and underlined.  Go to the “Tools” menu, “Options”, on the “View” tab make sure “Hidden Text” has a check mark, and click “OK”.

note 2note 3


When subjects cannot speak or read English

If your study does not specifically target subjects who cannot speak or read English, regulations permit the use of a "Short Form" to be used along with (a) an approved Informed Consent form and (b) a translator (or third party outside the research team who reads the English version to the potential subject).

Please read our position paper on the use of this form. This form has been reviewed and approved by the IRB and may be used by any investigator without prior approval for your specific study IF your study does not specifically target subjects who cannot speak or read English (in which case your full consent must be translated by a qualfied person and submitted to the IRB for approval). If your study targets English speaking subjects and you happen to have a subject who cannot read or speak English present for enrollment, download the appropriate form below, have a translator read the form to the subject and obtain appropriate signatures. The translator must also translate your "full sized" normal consent(s), and if the subject agrees to participate obtain signatures as usual (note, the translator does not have to sign the regular consent, just the "short form").

Certified Spanish Translation
Certified Hindi Translation
English version

 

Kids to Adults: shortened follow-up consent

If a minor is enrolled in a research study and during the course of their participation becomes an adult (or becomes capable of consenting for another reason, such as being emancipated by the courts, becoming married, etc), you will need to seek consent directly from that subject in order to continue their participation (note, consent was previously obtained from a parent, legal guardian, etc). The specialized Informed Consent form contained here is a shortened version for the purposes of obtaining reconsent for subjects whose study involvement is limited to post-study intervention long term follow-up. If study interventions continue you need to use a copy of your regular IRB approved ICF. Please note that if you need to use this shortened follow-up ICF you must submit it to the IRB for approval before being used.

 

Familiarizing yourself with the first four tools will greatly assist you with writing an Informed Consent form that accurately informs subjects about your research.


Informed Consent Instructions

These instructions are an invaluable tool and provide: (1) specific instructions on how to complete the form, (2) an explanation of what the IRB is looking for, (3) federal regulations governing ICFs (why certain things must be in consents), and (4) information about additional elements that may be needed in your ICF.
A bulleted list providing all of the federally mandated elements for consent forms. Investigators are encouraged to use this checklist to insure your consent is approvable and to include it with any submission that includes a new or revised ICF.
Federal regulations stipulate that the language of the consent form needs to be understandable. Please refer to this glossary for IRB approved alternatives to some of the most common scientific and medical terms.
The IRB provides pre-approved boilerplate language for certain research procedures (blood draws, subjects who are employees, MRIs, placebo, randomization, pregnancy risks, tissue storage, subjects who are students, and videotaping subjects
Documenting that Informed Consent occurred Good Clinical Practice guidelines recommends using a Medical Record Note or Research Record Note to document the steps you took to obtain informed consent from the participants in your research. This can be very helpful during any audits of your research by further demonstrating that informed consent was obtained, particularly if there are any irregularities in or absence of a particular consent form.
Enrolling Children in Research
  1. Worksheet for involving Children
  2. Signature Criteria for Minor Subjects (children)
  3. Kids to Adults: reconsenting flow chart
  4. Kids to Adults: reconsenting FAQ
  5. Kids to Adults: special Informed Consent form for follow up
 

  1. 03/31/03 note: having problems with how the page numbers print on the consent form? Click here for info on how to fix page numbering problems.
  2. Do you need to revise your Informed Consent form? Once you have submitted your Informed Consent form to the IRB you must submit any changes to the form before using it. In order to facilitate more accurate as well as faster review, the IRB requires you to track all of the changes by underlining all insertions and striking out all deletions. Microsoft Word will do this for you automatically and the IRB has provided instructions on how to have Word track changes since July 2002.

 

 

 
     
 
 
Copyright 2007
Updated: 06/12/2008 9:40 AM

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