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Alphabetical listing of IRB forms Informed Consent forms
Standardized Text for IRB Forms Form FAQs


Informed Consent form templates frequently need to change for a variety of reasons. Investigators are required to use these the newest versions of consent forms whenever you submit (a) a new protocol (if you need to obtain consent), or (b) continuing review (if enrollment continues or re-consent is necessary). You do not have to use the newest templates when revising previously approved consent(s) unless the IRB specifically instructs you to do so.

This page is divided into the following sections. Click on the link to jump to a different sections:

Consent is a process that starts at recruitment, continues through participation, and may extend to the end of the study

Informed Consent Forms with HIPAA

Informed Consent Forms no HIPAA

When subjects can't speak or read English

When a child subject turns 18 years old

Informed Consent Tools

  Informed Consent Forms WITH HIPAA: ICF + Instructions! (read only) Last Updated:
  Full consent: UF/Shands + HIPAA
What's different?
Full UF/Shands ICF + HIPAA+ instructions

10/19/2011

  Full consent: VA for all NEW STUDIES with HIPAA*
What's different?
Full VA ICF + HIPAA + instructions 10/19/2011
  Full consent: VA + HIPAA - for studies originally approved before 3/31/2011
For use on continuing review or revisions of older studies ONLY.
What's different?
  10/19/2011
  Short ICF: Follow-up Data on Child Subjects Who Turn 18 Children who turn 18 ICF + instructions 11/20/2010
  Short ICF: Tissue/Data Banks conducted at UF/Shands
Absolutely no research being conducted - only banking of tissue/data
Tissue/Data Bank ICF + instructions 04/15/2013
 
  Alternate Signature Sections for ICFs WITH HIPAA  
  Adult + Child - no assent (HIPAA version) 01/26/2011
  Adult + Child + assent (HIPAA version) 01/26/2011
  Adult + Child + 2 Parents - no assent (HIPAA version) 10/05/2011
  Adult + Child + 2 Parents + assent (HIPAA version) 10/05/2011
  Child only - no assent (HIPAA version) 01/26/2011
  Child only + assent (HIPAA version) 01/26/2011
  Tissue Consent Adult + Child + assent (HIPAA version) 01/26/2011
     
  Informed Consent Forms (no HIPAA) ICF + Instructions! (read only) Last Updated:
 

Full consent: UF/Shands without HIPAA
What's different?

Full UF/Shands ICF + instructions

10/19/2011

  Full consent: VA template without HIPAA
What's different?
Full VA ICF + instructions 10/19/2011
  Short form for subjects who can't speak/read English   11/20/2010
  Emergency Use (if no sponsor template)   12/15/2006
  Alternate Signature Sections for ICFs (no HIPAA)  
  Adult + Child - no assent (no HIPAA) 01/28/2011
  Adult + Child + assent (no HIPAA) 01/28/2011
  Adult + Child + 2 Parents - no assent (no HIPAA) 10/05/2011
  Adult + Child + 2 Parents + assent (no HIPAA) 10/05/2011
  Child only - no assent (no HIPAA) 01/28/2011
  Child only + assent (no HIPAA) 01/28/2011

 

 

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. Per our position paper, the translator should sign the full Informed Consent 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. You should review our Kids to Adults: reconsenting flow chart and Kids to Adults: reconsenting FAQ.

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
Q.14 Cost Template
---see what's new with track changes.
Instructions and sample language for filling out question 14 on our full Informed Consent form (with or without HIPAA).
Q.16 Injury Cost Template
---see what's new with track chagnes.
Instructions and sample language for filling out question 16 on our full Informed Consent form (with or without HIPAA).
   
 

  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 (Word 2003 version) (Word 2007 version) since July 2002.

 

 

 
     
 
 
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10/19/2011 12:06 PM


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