Huntington's Disease Registry
Welcome to the University of Iowa Huntington's Disease Registry webform.
Project title: Huntington's Disease Registry
Principal Investigator: Jane Paulsen, PhD
Research Team Contact: Julie Koeppel
This form provides important information about what you will be asked to do while on the registry, about the risks and benefits of the registry, and about your rights as a research participant. You will also be asked a set of preliminary questions to determine if signing up via the web is appropriate. If it is determined that another method of signing up for the Reigstry is more appropriate, you will be directed to contact our HD Center for additional information on how to participate in our registry.
- If you have questions about or do not understand something in this form, you should ask the research team for more information at firstname.lastname@example.org, or (319) 335-1611 or (319)-384-4912.
- You should discuss your participation with anyone you choose, such as family or friends.
- Do not submit this form unless the study research team has answered your questions and you decide that you want to be part of this registry.
- Please only submit this form in order to add your name to the registry. Please do not fill out the form for someone else.
- Do not submit this form if you are under 18 years of age. Please have a parent or guardian contact us for more information at email@example.com, or (319) 335-1611 or (319)-384-4912.
- If you prefer to fill out a paper form, you may access a PDF version of the registry here, and mail to: Jane S. Paulsen; 1-305 MEB; Iowa City, IA, 52242.
You are being invited to participate in a registry (list) of people interested in Huntington's disease (HD) research. It may be that you have a family member or other loved one with HD, or that you may have or are at-risk for HD. If you agree to participate in the registry, your name will be added to a list of people who will be invited to participate in future research studies on Huntington's disease.
The purpose of this registry is to allow Dr. Jane Paulsen's HD research team to contact individuals on the list who may fit a study's eligibility requirements. On the following pages of this webform, there are some questions we would like you to answer. These answers will help us identify in which research studies you may be able to participate. However, for some studies, we may need to call you to ask about some current protected health information. For example, we may need to know if you are currently participating in a research study, or if you have previously participated in a research study at our HD Center of Excellence. We may also need to know what medications you are currently taking, or whether you have experienced any recent outpatient or inpatient medical events (e.g., surgeries, hospitalizations, etc.). Answering these questions helps us determine your eligibility for our research studies. None of the information you provide us will be used to provide you with clinical care. We will not be creating any medical record or adding any information to an existing medical record for you at the University of Iowa Hospitals and Clinics. Rather, as part of your participation in this registry, the information you provide us is used only to check for your eligibility to participate in our research.
We would also like to keep a written summary of any interaction we have with you while you participate in this registry. For example, if we mail you information, we would like to record the date and type of information we sent you. If we have a phone conversation with you, we would like to record a written summary of the conversation. These summaries help our staff track your requests for information to ensure our communication with you is efficient. All information you provide us will be kept on a password protected website which is housed on a secure server that is only accessible to members of our research team.
If an individual meets the requirements for a study, we will send information on the study and invite him/her to participate. There is no obligation to take part in any future research, and you may request to have your name removed from this contact list at any time. Other members of your family are invited to participate in this registry as well.
By participating in this registry, you will also receive information on local support groups and newsletters letting you know what is happening in HD research. This list of names will only be used for Huntington's disease research and communication. With this registry, we hope to increase the understanding of this disease and discover ways of treating it.
To be on the registry, please complete the following pages of this webform. In order to send you information and contact you about study involvement, please complete the section titled "Contact information" with your name, phone number, address, and email (if applicable). Additionally, we would like your date of birth, handedness, and years of education. The section titled "Medical information" includes information on your HD gene status, and completing this section is optional. All of this information will help the research team decide for which studies you are eligible. Information from this registry is stored on a password-protected computer file accessible only to Dr. Jane Paulsen and her HD research team. Your medical records will never be accessed for the registry.
HOW MANY PEOPLE WILL PARTICIPATE?
Approximately 2100 people will take part in this study at the University of Iowa.
WHO IS ELIGIBLE TO PARTICIPATE IN THIS REGISTRY?
All individuals interested in Huntington's disease (HD) research are eligible to participate in this registry. It may be that you have a family member or other loved one with HD or that you yourself may have or be at-risk for HD.
HOW LONG WILL I BE ON THIS REGISTRY?
If you agree to take part in this registry, your involvement will last until you terminate your participation by calling Dr. Jane S. Paulsen or one of her research assistants at (319)-384-4912.
WHAT ARE THE RISKS OF BEING ON THIS REGISTRY?
As with any registry, there is a risk to confidentiality. Information we gather will remain confidential unless otherwise governed by law. All information collected for this registry is stored on a password-protected computer file accessible only to Dr. Jane Paulsen and her HD research team.
ARE THERE ANY UNFORSEEN RISKS?
In addition to the risks described below, there may be unknown risks, or risks that we did not anticipate, associated with being on this registry.
WHAT ARE THE BENEFITS OF BEING ON THIS REGISTRY?
There may be no personal benefit from participating in this registry. However, it is hoped that this registry will be of use to research studies that will benefit future Huntington's disease families. It will help us to better understand the disease and its progression, and it will hopefully provide a greater chance of understanding and eventually curing the disease. It may also lead to a better understanding of this disease for you and your family.
WILL IT COST ME ANYTHING TO BE ON THIS REGISTRY?
You will not have any costs for being on this registry.
WILL I BE PAID FOR PARTICIPATING?
You will not be paid for being on this registry.
WHO IS FUNDING THE REGISTRY?
The University of Iowa and the research team are receiving no payments from other agencies, organizations, or companies to keep this registry.
WHAT ABOUT CONFIDENTIALITY?
We will keep your participation in this registry confidential to the extent permitted by law. However, it is possible that other people may become aware of your participation in the registry. For example, federal government regulatory agencies, people who use the registry, auditing departments of the University of Iowa, and the University of Iowa Institutional Review Board (a committee that reviews and approves research studies) may inspect and copy records pertaining to this research. Some of these records could contain information that personally identifies you.
To protect your confidentiality, we will keep your information in locked filing cabinets and storage areas, and use password-protected computer files.
IS BEING ON THE REGISTRY VOLUNTARY?
Taking part in the registry study is completely voluntary. You may choose not to take part at all. If you decide to be in this registry, you may stop participating at any time. If you decide not to be on the registry, or if you stop participating at any time, you will not be penalized or lose any benefits for which you otherwise qualify.
WHAT IF I HAVE QUESTIONS?
We encourage you to ask questions. If you have any questions about the registry itself, please contact: Dr. Jane S. Paulsen or one of her research assistants at (319) 335-1611 or (319) 384-4912.
If you have questions, concerns or complaints about your rights as a research participant or about research related injury, please contact the Human Subjects Office, The University of Iowa, Hardin Library for the Health Sciences, 600 Newton Road, Office 105, Iowa City, Iowa, 52242, (319) 335-6564, or e-mail firstname.lastname@example.org. General information about being a research participant can be found by clicking "Info for Public" on the Human Subjects Office web site, http://research.uiowa.edu/hso
This Informed Consent webform is not a contract. It is a written explanation of what will happen during the study if you decide to participate. You are not waiving any legal rights by signing up using this Informed Consent webform. Your e-signature below indicates that this research study has been explained to you, that your questions have been answered, and that you agree to take part in this study. You will be offered a PDF copy of this form at the end of this webform should you wish to keep it.
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