Children S Hospital of Wisconsin

Children’s Hospital Of Wisconsin

Informed Consent – Individual Patient Expanded Access IND

Banking template –Draft Version: June 24, 2016
Single Patient Use of: <Enter Investigational Drug Name>

Children’s Hospital of Wisconsin

INFORMED CONSENTFORM

Single Patient Use – Expanded Access IND

This template is for Individual Patient Expanded Access IND: Use of an investigational drug outside of a clinical trial to diagnose, monitor, or treat a single patient as per 21 CFR 312.305 and 21 CFR 312.310.

Instructions:

This is a template only. Please remove any of the bullets after including the appropriate information and fill in sections bracketed with > with the appropriate information pertaining to the patient and the investigational drug being used.

· The language used throughout the consent form should be written at a 6th to 8th grade reading level. Most word processing programs allow you to check the reading level.

· Lay language should be used throughout the consent form.

· Avoid use of medical/technical terms and symbols (such as <).

· Acronyms (i.e. NIH), should be spelled out the first time they are used (i.e. National Institutes of Health

· Add page numbers and version numbers

· Logos other than CHW and MCW are not to be included in the consent form

Name of Patient: ______

Single Patient Use of Insert Investigational Drug Name

Treating Physicianr

Emergency Contact <Insert 24 hour emergency contact number

When the word “you” appears in this consent form, it refers to you or your son or daughter; “we” means the doctors and other staff.

You are being offered the opportunity to decide to receive <investigational drug>, which is a drug that <insert either current approval status by the FDA for another condition or provide a patient appropriate explanation of what the investigational drug is intended to do>.

This drug is not approved for <indicate what condition the patient has>, as such, this drug may or may not be effective in the treatment of your disease.

A. WHY IS <INSERT NAME OF THE INVESTIGATIONAL DRUG> BEING OFFERED?

It is the opinion of your treating physician(s) that <investigational drug> is the best option for your clinical care, as <insert language that describes why this investigational drug is the best option for the patient>.

B. HOW LONG WILL I TAKE <INVESTIGATIONAL DRUG>?

The total duration of treatment will depend on the clinical response of your disease.

· Or incorporate a specific schedule for the receipt of the investigational drug, if one is known

C. WHAT IS INVOLVED IN THIS TREATMENT?

You will receive <investigational drug> in <location of receipt of the investigational drug, i.e. clinic/infusion suite/etc.>. You are asked to take a <insert appropriate dose> dose <insert dosing schedule, i.e. once per day>.

· Be sure to include any other drugs that are taken in combination with investigational drug if appropriate

· Provide information pertaining to any safety or other assessments needed during the time that the patient receives the investigational drug

D. WHAT ARE THE POSSIBLE RISKS OR DISCOMFORTS?

LIKELY:

· Provide appropriate risk listing

LESS LIKELY:

· Provide appropriate risk listing

RARE, BUT SERIOUS:

· Provide appropriate risk listing

Reproductive risks: Because of the effects of this drug/device, there could be serious harm to unborn children or children who are breast-feeding. You are asked to use a medically accepted method of birth control such as condoms is you engage in sex while you are receiving this investigational drug. If your partner does become pregnant while you are taking this medication, you must tell the investigator and consult an obstetrician or maternal-fetal specialist.

· Do not include reproductive risk information if it does not pertain to the patient being offered the investigational drug or limit the information as appropriate

Unknown Side Effects: There may also be other unknown side effects that could harm you while you are taking <insert name of investigational drug>, or after you have finished taking it. We cannot predict what these side effects may be, which is why it is so important for you to report any side effects you experience to your physician. There is always the possibility that you will have a reaction that, if not treated properly, could be life-threatening.

E. WHAT ARE THE POSSIBLE BENEFITS OF THE TAKING <INSERT THE INVESTIGATIONAL DRUG>?

You may not receive any benefit from taking <investigational drug>.

F. WHAT IF NEW INFORMATION BECOMES AVAILABLE?

While you are taking < insert name of the investigational drug>, we may find more information that could be important to you. This includes information that, once learned, might cause you to change your mind about taking the drug. We will notify you as soon as possible if such information becomes available.

G. WHAT OTHER CHOICES DO I HAVE IF I DO NOT RECEIVE THIS MEDICATION?

It is the opinion of your treating physician(s) that there are no other satisfactory alternatives available to you. You always have the option of deciding not to seek treatment or other care for comfort; you can discuss these options with your physician.

H. WILL I HAVE TO PAY FOR ANYTHING?

You and/or your health insurance may be billed for the costs of medical care while you are receiving < insert the investigational drug>, if these expenses would have happened even if you were not receiving the drug, or if your insurance agrees in advance to pay.

· Include information about whether the drug company supplying the drug will be covering the cost of the drug, if applicable

I. WHAT HAPPENS IF I AM INJURED?

We will offer you the care needed to treat injuries directly resulting from taking the investigational drug. We may bill your insurance company or other third parties, if appropriate, for the costs of the care you get for the injury, but you may also be responsible for some of them.

There are no plans for the Children’s Hospital of Wisconsin to pay you or give you other compensation for the injury. You do not give up your legal rights by signing this form.

If you think you have been injured as a result of taking the investigational drug, tell your physician as soon as possible. The physician’s name and phone number are listed in this form at the top.

J. WHEN WILL MY PARTICIPATION BE OVER?

Your participation will last until <insert appropriate language based on investigational drug being used>.

If you decide to receive the investigational drug, you are free to stop taking it any time. Please inform your physician if you choose to do this, so appropriate follow-up to your decision can occur.

L. WHO CAN SEE OR USE MY INFORMATION? HOW WILL MY PERSONAL

INFORMATION BE PROTECTED?

We will do our best to make sure that the personal information in your medical record will be kept private. However, we cannot guarantee total privacy. Your personal information may be given out if required by law. If your information is published or presented at scientific meetings, your name and other personal information will not be used. Some organizations that may inspect and/or copy your records include groups such as:

List relevant agencies like

· Food and Drug Administration

· The Drug Manufacturer

· Institutional Review Board of Children’s Hospital of Wisconsin.

· The Medical College of Wisconsin

· Children’s Hospital of Wisconsin

· Other persons or entities as appropriate

M. WHO CAN I CALL WITH QUESTIONS, COMPLAINTS, OR IF I AM CONCERNED

ABOUT MY RIGHTS?

If you have questions, concerns or complaints while you are taking the investigational drug or if you have any questions about your rights, you should speak with the treating physician listed on page one of this form.

If you have any questions about your rights or any concerns or complaints, please contact the Children’s Hospital of Wisconsin Institutional Review Board (a group of people who review research to protect your rights) at 414-337-7705.

CONSENT TO TREATMENT

When you sign this form, you are agreeing to take <investigational drug> for your <patient condition>. This means that you have read this form, your questions have been answered, and you have decided to receive the drug. Your signature also means that you are permitting the Children’s Hospital of Wisconsin to use your personal health information collected about you within our institution. You are also allowing the Children’s Hospital of Wisconsin to disclose that personal health information to any appropriate outside organizations or people.

IMPORTANT: You will receive a signed and dated copy of this consent form. Please keep it where you can find it easily. It will help you remember what we discussed today.

Name of Person Obtaining Consent please print / Signature of Person Obtaining Consent / Date/Time
Patient’s Name please print / Patient’s Signature (if subject has reached age of majority) / Date/Time
Name of Legally Authorized Representative (if applicable)
please print / Signature of Legally Authorized Representative / Date/Time
Name of Parent or Legal Guardian #1 please print / Parent or Legal Guardian #1 Signature / Date/Time
Name of Parent or Legal Guardian #2 please print / Parent or Legal Guardian #2 Signature / Date/Time

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Version: <Enter Version #>