| Forms
for Research Conducted at Shands/UF |
Last
Updated: |
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HIPAA
Authorization for enrolling
new subjects after 04/13/2003 (separate document
from the consent form)
05/09 note: remember
the following (1) when using the separate authorization
form to enroll subjects, the subject must also
sign an actively approved Informed Consent form;
(2) just because the separate HIPAA authorization
is approved does NOT mean you can simply add this
language to your Informed Consent form. If you
wish to change your regular consent into the Informed
Consent for with HIPAA language, you MUST submit
this as a revision (use a revision memo, provide
strike-out/underline of changes, plus clean copy,
etc).
02/17 note: information about the study sponsor
and the VA has been moved from question 5 to question
6. If you have previously downloaded and completed
the ICF, please make this change on your form.
Click
here to view a strike-out/underline which
shows the change. NOTE: you do not have to make
a strike-out/underline version showing this change.
03/01
note:
instructions for the form were corrected to reflect
the change made on 02/17. |
03/01/2003
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Informed
Consent Form with HIPAA Authorization elements
for studies that are:
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(1)
new, currently approved, or undergoing continuing
review, and |
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(2)
collect, create, use, or disclose
protected health information (PHI). If
your study does not include PHI use the
ICF without HIPAA on our IRB-01
Forms page. |
02/10
note: form previously had two questions
numbered 22. This has been corrected.
02/17 note: information about the study
sponsor and the VA has been moved from question
17 to question 18. If you have previously downloaded
and completed the ICF, please make this change
on your form. Click
here to view a strike-out/underline which
shows the change. NOTE: you do not have to make
a strike-out/underline version showing this
change.
02/21 note: click
here to see an example of appropriate answers
to the HIPAA questions. |
03/10/2004 |
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 Request
for Waiver of Authorization (UF/Shands
version)
for (1) new or existing projects with Waiver
of Documentation of Consent or full Waiver of
Informed Consent, or (2) all Exempt protocols
that collect/use/disclose PHI.
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04/16/2007 |
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Certificate
for Preparatory Research (UF/Shands
version) |
06/22/2007 |
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Certificate
for Research with Decedents Info (UF/Shands
version). |
06/22/2007 |
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Disclosure
Tracking Log: Research
For research that has obtained
a Waiver of HIPAA Authorization. |
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| Separate
Forms for Research Conducted at the VA |
Last
Updated: |
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Veterans
Administration Form 10-1086 with HIPAA
for studies that are:
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(1)
new, currently approved, or undergoing continuing
review, and |
| |
(2)
collect, create, use, or disclose
protected health information (PHI). If
your study does not include PHI you should
use the ICF without HIPAA on our IRB-01
Forms page. |
02/21
note: click
here to see an example of appropriate answers
to the HIPAA questions.
03/31
note: having problems with how the page
numbers print on the consent form? Click
here for info on how to fix page numbering
problems.
03/31
note: the automated features have been removed
due to the difficulties some PIs were experiencing.
Form content has not changed.
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03/10/2004 |
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Request
for Waiver of Authorization (VA
version)
for (1)
new or existing projects with Waiver of Documentation
of Consent or full Waiver of Informed Consent,
or (2) all Exempt protocols that collect/use/disclose
PHI.
|
05/09/2003 |
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Certificate
for Preparatory Research (VA
version) |
05/09/2003 |
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Certificate
for Research with Decedents Info (VA
version).
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05/09/2003 |
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HIPAA
authorization for enrolling new subjects after
04/13/2003 - The VA
does not require a special/different VA authorization.
If you receive IRB-01 approval to use a separate
authorization you may use it in conjunction with
your IRB approved VA Informed Consent formwithout
HIPAA language Veterans Administration Form
10-1086 . Therefore: you can submit a single
authorization and use it in conjunction with both
your UF and VA informed consent forms! |
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