Welcome to the University of Iowa Huntington's Disease Registry 2.0 webform.
Project title: Huntington's Disease Registry 2.0
Principal Investigator: Peggy Nopoulos, MD
Research Team Contact: Julie Koeppel
1-293 MEB
(319) 335-1611
This consent form describes the research study to help you decide if you want to participate. This form provides important information about what you will be asked to do during the study, about the risks and benefits of the study, and about your rights as a research subject.
- If you have any questions about or do not understand something in this form, you should ask the research team for more information.
- You should discuss your participation with anyone you choose such as family or friends.
- Do not agree to participate in this study unless the research team has answered your questions, and you decide that you want to be part of this study.
If you prefer to fill out a paper form, you may access a PDF version of the registry here, and mail to: Julie Koeppel; 1-293 MEB; 500 Newton Road, Iowa City, IA 52242.
WHAT IS THE PURPOSE OF THIS REGISTRY?
You are being invited to participate in a registry (list) of people interested in Huntington's disease (HD) research/clinical trials. 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. Peggy Nopoulos' HD research team and other researchers to contact individuals on the list who may fit a study's eligibility requirements.
HOW MANY PEOPLE WILL PARTICIPATE?
Approximately 2300 people will take part in this study at the University of Iowa.
HOW LONG WILL I BE IN THIS STUDY?
If you agree to take part in this study, you will be asked to complete an information sheet that will take approximately 15 minutes. Your involvement will last until you terminate your participation by contacting Dr. Peggy Nopoulos or one of her research assistants at 319-335-1611.
WHAT WILL HAPPEN DURING THIS STUDY?
On the following pages of this webform, there are some questions we would like you to answer. This information will help us identify in which research studies/clinical trials you may be able to participate. For some studies, we may need to contact you to ask about some protected health information. For example, we may need to know if you are currently participating in another research study/clinical trial. We may also need to know what medications you are currently taking and 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/clinical trials. 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 University of Iowa Health Care. 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 studies/clinical trials.
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 and 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 research study/clinical trial and invite him/her to participate. There is no obligation to take part in any future research study/clinical trail, and you may request to have your name removed from this registry at any time. Other members of your family may be invited to participate in this registry as well.
By participating in this registry, you will also receive information on HD support and updates. This list of names will only be used for understanding this disease and discovering ways of treating it.
To be a part of this 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, address, phone number, and email. 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. Completing this section is optional. All of this information will help the research team decide which research studies/clinical trials in which you are eligible. Information from this registry is stored on a password protected computer file accessible only to Dr. Peggy Nopoulos and her HD research team. Your medical records will never be accessed for the registry.
WHAT ARE THE RISKS OF BEING ON THIS REGISTRY?
You may experience the risk indicated below from being in this study. In addition to this, there may be other unknown risks, or risks that we did not anticipate, associated with being in this study.
With any registry, there is a risk to confidentiality of data. All information collected for this registry is stored on a password protected computer file accessible only to Dr. Nopoulos and her HD study team.
WHAT ARE THE BENEFITS OF THIS STUDY?
There is no personal benefit from participating in this registry. However, it is hoped that this registry will be of use to research studies/clinical trials that will benefit future HD families. These future studies may help us to better understand the disease and its progression and 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 IN THIS STUDY?
You will not have any costs for being on this registry.
WILL I BE PAID FOR PARTICIPATING?
You will not be paid for being In this registry.
WHO IS FUNDING THIS STUDY?
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 research study 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 IN THIS STUDY VOLUNTARY?
Taking part in this research 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 in this registry, or if you stop participating at any time, you won't 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 research registry itself, please contact: Dr. Peggy Nopoulos or one of her research assistants at (319) 335-1611. If you experience a research-related injury, please contact Julie Koeppel at (319) 335-1611.
If you have questions, concerns, or complaints about your rights as a research subject or about research related injury, please contact the Human Subjects Office, 105 Hardin Library for the Health Sciences, 600 Newton Road, The University of Iowa, Iowa City, Iowa, 52242-1098, (319) 335-6564, or e-mail irb@uiowa.edu. General information about being a research subject can be found by clicking "Info for Public" on the Human Subjects Office web site, http://hso.research.uiowa.edu/. To offer input about your experiences as a research subject or to speak to someone other than the research staff, call the Human Subjects Office at the number above.
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 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.