WHAT IS A REGISTRY AND WHAT IS ITS PURPOSE?
- A registry is a research tool that collects information on the health of individuals with a particular disease over time. This information is then used to improve resources available and quality of care for patients. The Association of Migraine Disorders (AMD) has established the Headache, Ear, Auditory, Dizziness, Sinus (HEADS) Registry to study chronic head and neck conditions.
WHY SHOULD I PARTICIPATE?
- You will help improve the understanding of these common symptoms. The information that you provide may help you understand your own condition, but it is the strength of collecting information from many participants and family members that has the potential to provide researchers with knowledge that should improve the future health of your family and others. This registry will gather information about the alternative causes of common ear and facial symptoms to help improve their diagnosis and treatment.
HOW IT WORKS?
- You will be asked to answer questions about your health history and patient experience through a secure online portal. Importantly, this registry will ask you to update your experiences annually or biannually over years. Along the way, we will be sharing our findings with you.
WHAT RESEARCH MIGHT BE DONE?
- The goal of the registry and its council of researchers is to analyze, then draw conclusions from the information that is provided by the registrants and finally publish those findings. Other researchers will have the opportunity to request access to the registry information, but this is strictly controlled through an approval process to protect patient privacy. Common uses of registry data include: studying the relationships between different symptoms, identifying treatments that are either effective or not for specific symptoms, and developing new standards of care. Researchers may also request new studies to look at potential diagnostic tests or tools and innovative treatments. These requests will be vigorously screened for their value. Registry members would be invited to participate in any additional studies and given the option to either decline or sign a separate consent in which the details of those studies would be explained.
WHY WOULD I WANT TO PARTICIPATE IN SUPPLEMENTARY RESEARCH STUDIES?
- As a participant in the HEADS Registry, you are providing valuable information about symptoms that are rarely studied. There are scientists who have many other questions about headache, sinus, vestibular or auditory symptoms and conditions that cannot be answered with information collected in the annual HEADS Registry survey. With your interest and consent along with that of other members of this registry, those researchers will be able to find a large group of people with the specific symptoms and life experiences they wish to study. This will provide the potential to make more improvements to the diagnosis and care of individuals with these symptoms and conditions.
WHO CAN PARTICIPATE?
- The registry is looking for participants with the following symptoms.
• Ear pressure
• Sudden hearing loss
• Facial pain or pressure
To understand these conditions thoroughly, this registry wants to include people from a wide range of backgrounds. The only restrictions are that you must be 18 years of age or older (or 19 years of age or older if you are living in Nebraska or Alabama) and living in the United States. Enrollment is voluntary, confidential, and free of charge. You can withdraw at any time.
WILL MY INFORMATION BE SECURE?
- Absolutely. Your information will be given a coded number. Scientists and other stakeholders studying migraine, headache, sinus, vestibular, and auditory disorders may approach the registry to ask for access. If granted they will be able to obtain data for use in expanding their research studies, but they will not be able to access your identifying information. If you are eligible for a clinical trial, the Association of Migraine Disorders team will reach out to you directly to ask for your permission. Many security measures are in place to ensure your information is only used in ways that you have agreed to, and that identifying information can never be released without consent.
HOW DO I REGISTER?
- If you would like to participate in the registry, you will need to register and provide your consent. Please create an account by registering at www.headsregistry.lumiio.com and fill out and sign the consent form. If you have any questions, please contact us at email@example.com.
ARE MY RIGHTS AS A RESEARCH PARTICIPANT PROTECTED?
- This study has been reviewed and approved by Advarra, and Institutional Review Board (IRB). An IRB is an independent committee established to help protect the rights of research participants. If you have any questions about your rights as a research participant, please contact:
Study Subject Adviser
6100 Merriweather Dr., Suite 600
Columbia, MD 21044
or Call toll free: 877-992-4724
or by Email: firstname.lastname@example.org