Links
for the different Informed Consent form templates
are after the Informed Consent Tools.
Familiarizing
yourself with the first four tools will
greatly assist you with writing an Informed
Consent form that accurately informs
subjects about your research.
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.
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
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.
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.
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.
The Board changed our Informed Consent form templates on 02 May 2007. Investigators are required to use these consent forms in (when appropriate) new protocol submissions or continuing review after 12 PM on 25 May 2007. You do not have to use these new forms if you are simply revising your consent(s) - unless the IRB instructs you to do so.
With
HIPAA
Without
HIPAA
(not collecting, creating,
using, or disclosing any identifiable health
information)
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”.
Revised
08/02/2004 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").
Emergency Use Consent (if one not available from sponsor)
Please see the emergency use forms on the Forms page for more information (particularly the Emergency Use Checklist). This consent should be used if the sponsor does not provide a sample consent.
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.
Please
use the boilerplate language below if your research
includes any of these listed procedures. This language
has been previously reviewed and approved by the Board.
If the language does not accurately reflect how the
procedure will be performed in your study, please
be sure to inform the Board of any modifications to
the standardized text and justify the change.
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.
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.
Enrolling Children in Research 
