CONSENT FOR USE OF A HUMANITARIAN DEVICE

 

The University of Mississippi Medical Center

 

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 United States each year.  The FDA approves the use of humanitarian use devices based on information that the device does not present an unreasonable risk of illness or injury to the patient and the potential benefit to the patient’s health outweighs the risk of its use. 

 

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, 2500 North State Street, Jackson, Mississippi  39216; telephone, 601 984-2815; facsimile, 601 984-2961.  The Institutional Review Board is a group of people not involved with this treatment/device who have reviewed the treatment to protect your rights.

 


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

 

 

________________________________

Signature of Person Obtaining Informed Consent

 

 

________________________________

Date

 

 

I acknowledge that the patient identified above has agreed to treatment with this device with properly obtained informed consent.

 

________________________________

Signature of Treating Doctor

 

________________________________

Date