Treatment (or Device) Name:
Treating Doctor:
_____________________________________________________
Introduction:
The Food and Drug Administration (FDA) has approved
humanitarian use of <<insert name of HUD>> to provide
treatment for people who have <<insert name of disease or
injury>>. A
Humanitarian Use Device (HUD) is a device used to diagnose or treat a disease
or condition that affects fewer than 4,000 people in the
You are eligible to get <<name of HUD>>
because you have <<name of disease or injury>> and you have
not improved with available treatments.
Procedures:
If you agree to the use of <<insert name of
HUD>>, you will
<<Describe the procedure chronologically using lay
language, short sentences, and short paragraphs. Include information about what
will be different if this treatment is used instead of standard/usual treatment.>>
Risks:
The HUD has not been proven
effective for this use.
<<Identify the risks of using
the HUD and any procedures required for its use. List risks in order of
relative probability (for example, “likely,” “possible,” or “50-50,” and
“unlikely.” In addition to physiological risks/discomforts, if appropriate, describe
psychological, social, and legal risks that might result. For example, address
the risk for the loss of confidentiality of sensitive information. >>
<<If the risk profile of the
HUD or any other procedure required for the use of the HUD is not well known, end with the
statement:>> There
may be side effects and discomforts that we do not yet know about.
Pregnancy: (if applicable)
The risks
of <<insert name of HUD>> to an
unborn child are unknown. Pregnant women
may not take part in this treatment program.
Pregnancy tests will be done on all women of child bearing potential
before beginning the treatment and every …xxx… The sponsor or your insurance
company (indicate which one) will pay for these pregnancy tests.
All women
of child bearing potential are required to use an acceptable method of
birth control in order to take part in this treatment program, such as
(identify the acceptable methods).
Men should avoid fathering a child while
participating in the treatment, and for (identify the appropriate time period)
after participating.
If you or
your partner becomes pregnant, please notify the treating doctor immediately.
Benefits:
<<State direct or possible benefit from the use of the
HUD. Describe the generalizable or societal benefits and use a sentence such
as:>> We hope
to learn (xxx) about <<insert name of HUD>>. (If applicable.)
Alternatives:
<<Describe any alternatives that should be considered
before deciding whether or not to use the HUD. If there are no alternatives,
state that an alternative is to not allow the use of the HUD. Avoid suggesting that participation is the
only way to obtain medical care. >>
You do not have to agree to the use of <<insert
name of HUD>>. If you do not agree, your care at the University of
Mississippi Medical Center will not be affected.
Costs:
You will be charged the usual and
customary charges for all costs related to this procedure, including (xxx).
Confidentiality:
Every
effort will be made to keep the information we learn about you private. Treating staff, the device manufacturer (if
applicable), the Food and Drug Administration (FDA), the Office for Human
Research Protections (OHRP) and the University of Mississippi Medical Center’s
Institutional Review Board (IRB) and Office of Compliance may review the treatment
records. (only insert the following if
applicable to the use of this device) If
the manufacturer shares this information with others the information is no
longer covered by the federal privacy regulations. If device results are published your name
will not be used. Data may be submitted
to regulatory agencies in other countries but you will not be identified.
Protected Health Information:
Protected
health information is any personal health information through which you can be
identified. (If protected health information will not be collected for any
purpose beyond treatment of the patient the rest of the paragraph should read: Information about your treatment will be
collected and put in your medical records but it will not be shared with anyone.) (If
protected health information will be collected for any reporting purposes or
purposes other than treatment, the rest of the paragraph should be:) The
data collected during your treatment includes: (specifically describe the
phi that will be collected here, for example, name, date of birth, address,
social security number). The
information may be shared with the device manufacturer and the Food and Drug
Administration. A decision to receive
this treatment means that you agree to the use and sharing of your health
information as described. The
information collected will be kept (indefinitely/until the treatment is
complete/until the device is approved/ or insert an expiration date or describe
an event upon which the authorization will expire).
You will
be given a copy of this consent document (to take home and review) or (for
your records) or (if you agree to participate in this treatment) or (after it
has been signed), whichever is appropriate. If you do not sign this consent
document you will not receive the treatment/device.
Questions:
If you have questions about this treatment or need
to report any problems, side effects, or injuries, please call . . . at . .
. After hours and on weekends please
call . . .
You may discuss your rights regarding
this treatment/device with the Chairman of the University of Mississippi
Medical Center’s Institutional Review Board,
Statement of
Participation
(NOTE TO INVESTIGATOR: The treating
physician is responsible for ensuring all patients agreeing to the treatment
have given legally effective informed consent and/or assent. )
I have been told about this (experimental treatment or device),
and the possible risks and benefits. I
agree to receive this (treatment or device), to follow instructions, and to
report any side effects to my treating doctor.
My agreement is voluntary.
By signing this form I am not giving up any legal rights (I, my
child, or insert the printed name of the participant, whichever is appropriate)
may have.
________________________________
Patient’s Printed Name
________________________________
Signature of Patient
________________________________
Printed Name of Person Obtaining
Informed Consent
________________________________
________________________________
I acknowledge that the patient
identified above has agreed to treatment with this device with properly
obtained informed consent.
________________________________
Signature of Treating Doctor
________________________________