1.
FLYING OBJECT CLAUSE; must
be added to the consent form under RISK factors (May
use a variation)
"The known risks associated with this study
are minimal. The greatest risk is a metallic object
flying through the air toward the magnet and hitting
you. To reduce this risk we require that all people
involved with the study remove all metal from their
clothing and all metal objects from their pockets.
No metal objects are allowed to be brought into the
magnet room at any time. In addition, once you are
in the magnet, the door to the room will be closed
so that no one inadvertently walks into the magnet".
2.COILS
AND SOFTWARE EXPERIMENTAL DEVICE STATEMENT
:
Non-FDA
approved devices can only be used following designation
as non-signficant risk by the IRB and approval by
CAMRIS. Coils and Pulse sequences must be approved
according to revelant CAMRIS policies. There must
be reference in the protocol and consent forms to
non significant risk investigational devices.
"some
of the pulse sequences and/or RF coils are not FDA
approved by are consdiered non-significant risk investigational
devices"
Devices
( Coils and sequences) to be used for applications
which exceed the FDA's guidelines must be under an
IDE from the FDA as well as having approval from the
IRB and CAMRIS.
For
new PRODUCT (SIEMENS) pulse sequences and/or coils
that become available, you may pursue them without
any changes in your protocol or consent forms.
3)
TO GAD OR NOT TO GAD:
First, Investigators to decide if subjects can or
can not participate their MRI study if they cannot
receive gadolinium due to moderate to severe renal
disease ( creatinine clearance level of less than
30)
CONSENTS
a) If the investigator decides that such subjects
cannot participate in the MRI study unless they can
also receive contrast then you need to modify your
consent by adding "moderate to severe renal
disease" under the EXCLUSION criteria.
b)
If the investigator decides that such subjects are
still eligible to participate but only for the noncontrast
MR portion of the study, then you need to modify your
consent under RISKS to reflect that those with moderate
to severe renal disease will not undergo the dynamic
portion of the study.
"subjects
with known moderate to severe renal disease will not
undergo the contrast portion of this study"
STUDY
PROTOCOLS
a) If the investigator decides that such subjects
cannot participate in the MRI study unless they can
also receive contrast then you need to modify your
study protocol by adding "moderate to severe
renal disease" under the EXCLUSION criteria.
b)
If the investigator decides that such subjects are
still eligible to participate but only for the noncontrast
MR portion of the study, then you need to modify your
study protocol under RISKS to reflect that those with
moderate to severe renal disease will not undergo
the dynamic portion of the study. ( but
with a little more detail)
In
light of recent reports of a possible risk of nephrogenic
systemic fibrosis (NSF, also referred to as nephrogenic
fibrosing dermopathy or NFD) occurring following administration
of a Gadolinium-based contrast agent, subjects with
known moderate to severe renal disease will not undergo
the dynamic portion of this study"
4).
PREGNANCY CLAUSES:
templates for use in consents and study protocols
a)
"There are no known risks of MRI on pregnant
women or a fetus.Therefore routine, non-contrast,
imaging protocols at 1.5T and 3T scanners need not
exclude pregnant women if there is any possibility
that they may benefit from this research. However,
these women should be informed that there is a possibility
of a yet undiscovered pregnancy related risk and a
urine pregnancy test could be made available to them
to help them make an informed decision whether or
not to participate".
b)
"Although there are no known risks of MRI
on pregnant women or a fetus, there is a possibility
of yet undiscovered pregnancy related risks. Since
there is no direct benefit from participating in this
protocol for a pregnant woman, we will exclude pregnant
women. A
negative urine pregnancy test will be mandated before
a woman of child-bearing potential can participate
in this study".
c)
"Gadolinium-based IV contrast agents are not
approved in pregnant women and they are to be excluded
from trials using such. A negative urine pregnancy
test will be mandated before house stock agents can
be administered to any woman of child bearing potential."
5)
TARGETED ENROLLMENTS:
The number of subjects to be recruited as part of
the study needs to be stated in both the consent and
in the study protocol.
The number of MRI's each subject will undergo for
research purposes needs to be stated in both the consent
and in the study protocol.
The length of time each subject is to be in the study
needs to be stated in both the consent and the study
protocol.
A
few additional consent guidelines
METALLIC FOREIGN BODIES RISK STATEMENT;
Because the magnetic field of the MRI scanner attracts
metal, these studies will not be performed on anyone
with a pacemaker or any non-removable metallic foreign
objects in their body. If you have any such object
on your body, you will not receive the scan.
MAGNETIC FIELDS HEALTH RISK STATEMENT;
There are no known health risk associated with
exposure to magnetic fields during an MRI. There are
minimal risks from the loud noise associated with
the MRI scanner and from the discomfort of lying on
a hard surface. We shall provide you with protective
earplugs as necessary and make every attempt to ensure
your comfort with blankets, etc during their time
in the scanner
3T STANDARD CLINICAL STATEMENT;Since
the Siemen's 3T is considered a "standard Clinical
scanner", this does not need to be added as such
on the consent form. However, if you want, you may
state that this study is being performed on a "standard
clinical scanner operating at 3 Tesla"
1.5T
AND/OR 3T STATEMENT:
If your consent form currently states that the study
is being done on a 1.5 Tesla Scanner, you cannot use
the 3 Tesla scanner unless you modify the consent.
However, if your consent form states this study is
being done on a "Magnetic Resonance Scanner,
" (nonspecific) then you can use either.
IV CONTRAST RISKS & PROCEDURES STATEMENTS
Updated
IV Contrast RISK statement
"There is a risk that multiple needle-sticks
will be necessary in order to ensure proper placement
of the Intravenous line. There is a small risk of
infection at the site the catheter is placed or there
may be a small amount of pain or bruising associated
with the placement of the Intravenous catheter. The
FDA approves the Imaging agent ( Gadolinium) given
for this research project for use with human participants
and does not recognize any major risks asociated with
its use. Some patients ( less than 3%) may experience
mild nausea and/or headache after the injection: however
these side effects usually resolve themselves without
need for treatment. There is a very low risk of allergic
reaction ( less than 1% including a reaction at the
injection site, hives and/or difficulty breathing)
to gadolinium.
Updated
IV Contrast procedure statement
: "A small catheter will be placed into a
vein in your forearm before your MRI. The Intravenous
line will be used for the injection of Gadolinium"
INCIDENTAL
FINDINGS STATEMENT
“There
is also a risk that during the course of this study*,
an unexpected abnormality may be observed in your
MRI scans, even though the scans are not intended
for diagnostic purposes. These abnormalities are termed
“incidental findings.” Most incidental findings
have no significant health consequences, but in a
small percentage of cases further evaluation or treatment
may be indicated. If an incidental finding is noted
in your image data, you will be notified of it and
given a written report describing it. It will then
be up to you to pursue it with your physician. Although
study personnel may be able to provide some advice,
the decision of whether and how to pursue an incidental
finding can only be made by your physician who has
knowledge of your medical history”.
*(
this includes the data analysis portion, not just
the scanning portion as an abnormality would probably
not be noticed at the console)
updated
8-4-08 ak
