University of Utah
ST. HELENA HOSPITAL
CONSENT TO BE IN A RESEARCH STUDY
Title: INTERNATIONAL REGISTRY ON SUSAC SYNDROME
Principal Investigator: Robert A. Egan, M.D.
INTRODUCTION
You have been invited to participate in this research study because you have been diagnosed with 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 document describes 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. Consider this information carefully and discuss it with the people you trust.
Why Is This Study Being Done?
It is unknown what causes Susac Syndrome. It is also unknown how to best treat this disorder. The purpose of this registry (also referred to as a study) is to collect clinical data on this syndrome in the hopes of potentially improving the care of patients diagnosed with Susac Syndrome.
A. STUDY DESCRIPTION
This study will collect clinical data from subjects diagnosed with Susac Syndrome worldwide. There is a single center in St. Helena, California that will be gathering the information in order to analyze and assess different patterns of treatment and interventions. Approximately 200 sets of patient records will be obtained.
What Will Happen If I Participate In This Study?
You will have no physical involvement in this study. The only procedure regarding this study refers to your medical records that will be sent to the study investigator, Dr. Egan, at St. Helena Hospital to enter into the Susac Syndrome Registry. Your doctor will pass on the results of your tests to the study investigator to see how you respond to your doctor’s treatment. Your medical records from your physician plus any diagnostic scans may be reviewed and recorded for future analysis.
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 and they will not be determined by any study protocol.
B. SIDE EFFECTS, RISKS, AND INCONVENIENCES
Are There Side Effects And Risks?
There are no known physical risks regarding participating in this study. There is a very low but theoretical risk that your patient data will be seen by others not associated with the research study. Dr. Egan has taken serious precautions to prevent this and your information will be kept on a computer with a secret password to prevent unauthorized viewing.
Is There A Risk Of Loss Of Confidentiality?
Any information obtained 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, identifying information collected from participation in this study may be disclosed to the Federal Office of Human Research and Protection, a study sponsor, St. Helena Hospital Institutional Review Board, and to designated persons assisting in 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 serving as a subject, you may contribute new information, which may benefit patients in the future.
D. FINANCIAL INFORMATION
Are There Any Costs For Taking Part In This Study?
There are no additional costs to you for participating in this study. The costs of any treatment for your disorder, including drugs, tests, hospital and study doctor charges, are based on fee for service with your own doctor and hospital. St. Helena Hospital will not bill you for any services.
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 you choose not to participate in this study, this will not affect your treatment from your treating physician. 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 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 eganr8@ .
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) at ludwigk1@.
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. VOLUNTARY PARTICIPATION
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 may leave the study at any time. No matter what decision you make, there will be no penalty to you and you will not lose any of your regular benefits. Leaving the study will not affect your usual medical care. You can still get your medical care from your doctor.
H. SIGNATURE
I have read all of the information given to me in this Consent document. The information in this document has been explained to me and I have had the opportunity to ask questions. My signature below indicates that I voluntarily agree to participate in the study described in this document.
________________________________________
Subject’s Name (printed)
________________________________________ ____________________
Subject’s Signature Date
To the best of my knowledge, the subject signing this consent 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.
________________________________________
Name of Person Obtaining Consent (printed)
________________________________________ ____________________
Signature of Person Obtaining Consent Date
Signed copies of this Consent form and the following HIPAA document will be given to you for your records.
ST. HELENA Hospital
Institutional Review Board
Patient Authorization for the Use and Disclosure
of Protected health Information for Research
|Participant’s Name | |
|Principal Investigator | Robert A. Egan MD |
|Investigator Address | 10 Woodland Rd, Lloyd Bldg, Ste 502, St. Helena, CA 94574 |
|Investigator Phone | 707 963-1882 |
|Study Title | International Registry on Susac Syndrome |
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. HELENA Hospital
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. HELENA Hospital 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. Helena Hospital participating in the research
A data safety monitoring board
Statistician for data analysis
Outside lab for specimen processing
Others (list all that apply)_________________________________________
ST. HELENA Hospital
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:
|Name |Name |
|Address |Address |
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.
|Participant name |Signature |Date |
| | | |
|If conservator or individual authorized to make health decisions on behalf of the participant, state relationship to participant: |
|____________________________ |
|Name |Signature |Date |
| | | |
................
................
In order to avoid copyright disputes, this page is only a partial summary.
To fulfill the demand for quickly locating and searching documents.
It is intelligent file search solution for home and business.
Related searches
- university of minnesota college of education
- university of minnesota school of social work
- wharton school of the university of pennsylvania
- cost of university of scranton
- state of utah division of finance
- university of minnesota school of education
- university of scranton cost of attendance
- university of south florida college of medicine
- state of utah medical license
- state of utah education
- university of minnesota masters of social work
- state of utah finance department