RESEARCH STUDY ASSENT for Subjects Under the Age of 18 Years

ST. HELENA HOSPITAL

RESEARCH STUDY ASSENT for subjects under the age of 18 years

Title: INTERNATIONAL REGISTRY ON SUSAC SYNDROME

Principal Investigator: Robert A. Egan, M.D.

INTRODUCTION

You have been asked to participate in this research study because you have a rare disorder called Susac Syndrome. This disorder can cause vision loss, stroke-like episodes, and hearing loss. Many patients have headaches. Tests such as MRI scans of the brain are often abnormal as well as pictures of the back of your eyes.

This formdescribes the important points to being in this study. Before you agree to participate in this research study, it is important that you read all of the information. Read and think throughthis information carefully and discuss it with the people you trust.

Why Is This Study Being Done?

It is not knownwhat causes Susac Syndrome. It is also not known how to best treat this disorder. The purpose of this registry (also referred to as a study) is to collect medicalinformation on this syndrome so that we may hopefully improve the care of patients diagnosed with Susac Syndrome.

A. STUDY DESCRIPTION

This study will collect medical information from participants diagnosed with Susac Syndrome worldwide. There is a single center in St. Helena, California that will be gathering the information in order to study different types of treatment by doctors taking care of patients with Susac Syndrome everywhere in the world. Approximately 200 sets of patient records will be studied.

What Will Happen If I Participate In This Study?

You will not be medically treated in this study. The only procedure inthis study is to sendyour medical records to the study investigator, Dr. Egan, at St. Helena Hospitalso that he can enter information into the Susac Syndrome Registry. Your doctor will send the results of your tests to the study investigator to see how you respond to your doctor’s treatment. We will look at your medical records from your doctor plus anyof your medicalscans.

You will continue to be a patient of your regular doctor. Your own doctor will schedule any follow up visits that he or she feels are medically necessary. This study will not ask you to make any extra visits to your doctor.

B. SIDE EFFECTS, RISKS, AND INCONVENIENCES

Are There Side Effects And Risks?

There are no known physical risks byparticipating in this study. You will not be asked to take any special tests in this research study. There is a very low risk that your patient informationwill be seen by others who are not involved with the research study. Dr. Egan will be very careful about protecting your medical information and it will be kept on a computer with a secret password to prevent someone else from seeing it.

Is There A Risk Of Loss Of Confidentiality?

Any information from this research, which could identify you, must be kept confidential according to California, United States, and International law. We will do our best to make sure that the personal information in your medical record will be kept private. However, it could happen that groups of people who care about protecting you in research might get information that identifies you.These groups may be theFederal Office of Human Research and Protection, a study sponsor, St. Helena Hospital Institutional Review Board, and other persons helpingin conducting this study.

If information from this study is published or presented at meetings, you will not be identified.

C. POSSIBLE BENEFITS:

Are There Benefits To Participating In This Study?

You may or may not personally benefit from participating in this study. However, by being a research subject, you may help other children and adults who have this disorder in the future.

D. FINANCIAL INFORMATION

Are There Any Costs For Taking Part In This Study?

There are no extra costs to you or your family for participating in this study.

Will I Be Paid To Take Part In This Study?

You will not be paid for taking part in this study.

E. STUDY ALTERNATIVES:

Do I Have Other Options to Participating In This Study?

You do not have to participate in this study to receive treatment for your condition. If youchoose not to participate in this study, your doctor will still treat you. You may also change your mind and cancel your participation in this study at any time.

F. QUESTIONS?

Who Can Answer My Questions About This Study?

You and your parents can talk to your doctor about any questions or concerns you have about this study. If you have other questions about this study, you may call the study investigator, Robert A. Egan MD at (707) 963-1882 or e-mail at .

For questions about your rights while taking part in this study, contact the St. Helena Hospital Institutional Review Board (a group of people who review the research to protect your rights) .

A description of this clinical trial will be available on , as required by U.S. Law. This web site will not include information that can identify you. At most, the web site will include a summary of the results. You can search this web site at any time.

G. VOLUNTARYPARTICIPATION

Is Participation Voluntary And Can I Withdraw From This Study?

Taking part in this study is your choice. You may choose either to take part or not to take part in the study. If you decide to take part in this study, you can stillchange your mind at any time. No matter what decision you make, you can still get your medical care from your doctor.

H. SIGNATURE

I have read all of the information on these pages or it has been read to me. The information has also been explained to me and I have had the chanceto ask questions. I know that being in the research is up to me. No one will be upset if I don’t sign the paper or if I change my mind later. By signing this paper, I am stating that I want to be in the research.

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Printed Name of Child/Adolescent Age

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Signature of Child/Adolescent Date

I have the option of having my child or teen join a research study and I agree with the decision of my child to participate.

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Printed Name of Parent/Guardian

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Signature of Parent/Guardian Date

To the best of my knowledge, the subject signing this assent form has had the study fully and carefully explained by me and the subject has been given the opportunity to ask questions regarding his/her participation in this research study.

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Printed Name of Person Obtaining Assent

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Signature of Person Obtaining Assent Date

Signed copies of this Assent form and the following HIPAA documentwill be given to you and your parents for your records.

ST. HELENA Hospital

Institutional Review Board

Patient Authorization for the Use and Disclosure

of Protected health Information for Research

Authorization Expiration Date:

Protected Health Information (PHI) is any health information including medical records, mental health records, billing records, survey data, and demographic data that is identified to you. By signing below, you are authorizing the Principal Investigator and the research team participating in the research to collect, store, use, and disclose the PHI described below. You are also authorizing the Principal Investigator and the research team to request copies of your previous medical and/or billing records from the providers listed.

The main reason to share this information is to be able to conduct the research as described earlier in the research consent form. Information is also shared to report adverse events or situations that may help prevent other individuals at risk. Other reasons include treatment, payment, or health care operations.

Your authorization is required for participation in this research study. You may revoke your authorization at any time by sending a written notification to the Principal Investigator at the address above. We will discontinue collecting, using or disclosing your information except as required to maintain the integrity of the research study or as required by law. For example, we may need to use your information to document why you have withdrawn from the study, for compliance reporting purposes, or to report adverse events.

ST. HELENAHospital

Institutional Review Board

Patient Authorization for the Use and Disclosure

of Protected Health Information for Research

During the research study, your research team will look at the following health information pertaining to your medical history, mental or physical condition and treatment received. These records may include (check all that apply):

Billing records for health care services

Medical records

Lab, pathology and/or radiology results

Mental health records

Previous research records

Questionnaires and interviews

Other (specify):

Your research team may disclose your PHI to the individuals or organizations

below for data collection, safety, compliance, and for study oversight:

ST. HELENAHospital Institutional Review Board

Study sponsor ______

Contract research organization: ______

The Office for Human Research Protections (OHRP) in the U.S. Department of Health and Human Services (DHHS)

The Food and Drug Administration (FDA) and perhaps similar regulatory agencies in other countries.

Other federal and state agencies that have authority over the research project or other governmental offices as required by law

National Institutes of Health

Other medical centers/institutions outside of St. HelenaHospital participating in the research

A data safety monitoring board

Statistician for data analysis

Outside lab for specimen processing

Others (list all that apply)______

ST. HELENAHospital

Institutional Review Board

Patient Authorization for the Use and Disclosure

of Protected Health Information for Research

During the study, we may request copies of your PHI from the following sources:

Providers are required by State and Federal laws to protect your information. California law prohibits the recipient from making further disclosure of your health information unless the recipient obtains another authorization from you or unless the disclosure is required or permitted by law. This protection does not extend to recipients outside the state of California. There is always the possibility that your information could be disclosed to a party that is not required to protect its confidentiality. Your identity will not be revealed in any publication that may result from this study.

You have the right to choose not to sign this form. However, if you decide not to sign, you cannot participate in the research study. Refusing to sign will not prejudice your future medical treatment at this institution.

Participant’s Statement:

I acknowledge that I have the right to review and/or copy records of my personal health information kept by this institution. However, I do not have the right to review and/or copy records kept the study sponsor or other researchers associated with the research study

I hereby authorize the Principal Investigator listed above and the research team to use and disclose my protected health information as described herein.

Version: 9/2011

Page 1 of 7SHH IRB Approved to May 19, 2011