Informed Consent Forms
Informed Consent Form templates frequently need to change for a variety of reasons. Investigators are required to use 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.
The IRB provides standardized template language for special situations that should be included in Informed Consent Forms, please see the following link for specific standardized text: Standardized Text for Informed Consent Forms
Note: Informed Consent is more that just a form – it is an on-going process that starts as early as recruitment, continues throughout the person’s participation in the research, and may extend until the completion of the research.
Informed Consent Forms WITH HIPAA
- Full consent: UF/Shands + HIPAA (Last Revision: 03/01/24)
- Full consent: VA for all NEW STUDIES (Last Revision: 08/13/21)
- Brief ICF: UF/Shands + HIPAA (Last Revision: 02/02/22)
- Contact registry only ICF (Last Revision 02/02/22)
- Tissue/Data Bank ICF (banks conducted at UF/Shands) (Last Revision: 02/02/22) To be used when absolutely no research is being conducted, only banking of tissue/data
- OneFlorida Short Consent Form – CORE (Last Revision: 02/02/22)
- Core Consent (Last Revision 02/02/22) To be used as the main consent for a multi-center study, the consent includes HIPAA language. This consent is un-editable by the participating site(s) and references the local addendum.
- Tissue/Data Bank addendum (sIRB studies) (Last Revision 03/14/22) To be used by sIRB studies that intend to bank tissue/data.
- Brief Core Consent (Last Revision 02/02/22) To be used as the main consent for a multi-center study, the consent includes HIPAA language. This consent is un-editable by the participating site(s) and references the local addendum.
- Local Addendum (Last Revision 03/01/24) For use in conjunction with the Core Consent. The local addendum allows each participating institution to enter specific local language and add their institutional logo at the top. NOTE: UF Investigators will need to use the sIRB Local addendum for the UF site as well.
- Halifax ICF (Last Revision 03/01/24)
Alternate Signature Sections for ICFs WITH HIPAA
- Adult + Child – no assent (HIPAA version)(Last Revision: 01/26/11)
- Adult + Child + assent (HIPAA version) (Last Revision: 12/16/22)
- Adult + Child + 2 Parents – no assent (HIPAA version) (Last Revision: 10/05/11)
- Adult + Child + 2 Parents + assent (HIPAA version) (Last Revision: 12/16/22)
- Child only – no assent (HIPAA version) (Last Revision: 01/26/11)
- Child only + assent (HIPAA version) (Last Revision: 12/16/22)
- Tissue Consent Adult + Child + assent (HIPAA version) (Last Revision: 12/16/22)
- Witness – Subject with Physical Limitations (Last Revision: 10/01/15)
- Witnesses – Post-Mortem Tissue and Organ Donation (Last Revision: 12/11/20)
Informed Consent Forms WITHOUT HIPAA
- Full consent: UF/Shands without HIPAA (Last Revision: 03/01/24)
- Full consent: VA template without HIPAA (Last Revision: 08/13/2021)
- Brief ICF: UF/Shands without HIPAA (Last Revision 02/02/22)
Alternate Signature Sections for ICFs WITHOUT HIPAA
- Adult + Child – no assent (no HIPAA) (Last Revision: 01/28/11)
- Adult + Child + assent (no HIPAA) (Last Revision: 08/16/22)
- Adult + Child + 2 Parents – no assent (no HIPAA) (Last Revision: 10/05/11)
- Adult + Child + 2 Parents + assent (no HIPAA) (Last Revision: 08/16/22)
- Child only – no assent (no HIPAA) (Last Revision: 01/28/11)
For Currently Approved Federally Funded and VA Studies ONLY - Conversion Consent
- Conversion Consent with HIPAA UF/Shands (Last Revision:10/01/18) For use with Federally Funded studies ONLY. Use this template to revise consent form to comply with Updated Common Rule
- VA Conversion Consent Form (Last Revision: 10/01/18) Use this template to revise consent form to comply with Updated Common Rule
- separate VA HIPAA Authorization (required)
- sIRB Core Consent for Conversion (Last Revision: 10/02/18) For use with Federally Funded studies ONLY. Use this template to revise consent form to comply with Updated Common Rule
For Baptist (Wolfson Children's Hospital)
- Wolfson site only ICF (Last Revision: 03/01/24)
- Local addendum (UF JAX) (Last Revision: 03/01/24)
- Local addendum (Wolfson) (Last Revision: 02/02/22)
- Banking ICF (Wolfson) (Last Revision: 02/02/22)
Additional Consent Options
Visit the “Special Situations” page for information on when to use these
- Certified Spanish Translation
- Certified Hindi Translation
- Certified Arabic Translation
- Certified Cambodian Translation
- Certified Portuguese Translation
- English version
- Child to Adult Consent(Last Revision: 02/21/11) For children who turn 18, whose study involvement is limited only to post-study intervention long term follow-up
- HIV Testing for Research Purposes
- Emergent Use (if no sponsor template)(Last Revision: 12/08/16)