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).
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”.
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").
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.
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
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.
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.
