From WikiAdvocacy

What is the FARA Patient Registry?

The purpose of the patient registry is to collect basic information on individuals with Friedreich’s Ataxia (FA) and to share this information with scientists and companies who will be recruiting patients for FA clinical trials.

Participation in this registry does not guarantee that you will qualify for a clinical trial. Each clinical trial will have unique inclusion and exclusion criteria that the researchers will have to follow.

Participation in this registry does not mean that you are committed to participate in any clinical trial. This registry is simply a way for you to submit your name and contact information to researchers who will be conducting clinical research trials. Once you learn more about a specific clinical trial, you can make a decision about participation.

Recruitment for clinical trials can often take a long period of time, especially for a rare disease like FA. This is one way FARA is trying to facilitate and expedite clinical trials and to get us all closer to FA treatment and an eventual cure.

Who can participate?

This registry is for individuals diagnosed with FA. If you are less than 18 years of age, a parent or guardian consent is required. When you begin the registry process if the individual with FA has a date of birth that is consistent with an age less than 18 you will be prompted to provide parent/guardian information.

If you have another type of ataxia (e.g. spinocerebellar ataxia), there is another patient registry organized through the Cooperative Ataxia Group and Emory University that is more appropriate for you. <http://www.cooperative-ataxia-group.org> This patient registry is also interested in individuals with FA so we encourage you to consider participation in their registry. The Web site address is also located on the registry homepage and at the bottom of each page.

What is the registry process?

You will be asked to provide your contact information (name, address, phone number, etc.), clinical information (age of onset, disability status, if you have diabetes), and information about FA genetic test results. You will also be asked to complete this information as you go through a series of Web pages. There are helpful tips that “pop up” over each field title and a help link at the bottom of every page.

Also, at the beginning of the registry process you will be asked to review an informed consent document. The purpose of this consent is to describe the purpose, risks, and benefits of this registry so that all individuals can make an informed choice about their participation. If you choose to decline the informed consent then you will be taken back to the main page and all information you have entered will be deleted. You must accept the terms of the informed consent to participate.

When you have completed entering the required information, you will be directed to a summary screen, that you can review, print and submit. Once your information is submitted, a FARA registry coordinator will review it and may contact you if there are questions about your information.

It is important that the patient registry contain accurate information therefore you will be receiving an email reminder to review and confirm your information on a yearly basis.

What will the information be used for?

All information submitted and stored in the patient registry can be shared with researchers, scientists, pharmaceutical companies or other third parties who are recruiting individuals with FA to participate in clinical research studies or trials. All researchers who would like to request registry data will fill out an application to FARA. A review committee has been established to review all requests to ensure that information is only shared with qualified FA researchers. We will not release your personal information to anyone not affiliated with FARA or FA clinical research studies.

I have previously sent my name and contact information to FARA from the website – how is this different? If you have previously sent your name and contact information to FARA from link on the FARA homepage this means that you are on the FARA mail and email list. This is used only for FARA communications.

The information collected in the patient registry contains more questions about your FA medical history and this information will be shared with qualified FA researchers.

What are the risks associated with participating in the registry?

You are being asked to share your personal information and allowing FARA to release this information to third parties. FARA will review all requests for information from the patient registry and will only provide information to individuals or companies who are conducting FA clinical research studies. FARA will also request that third parties who receive information from the patient registry keep the information confidential and secure.

What are the benefits of participating in the registry?

You will be helping to facilitate the recruitment process for FA clinical trials. This registry is a means to possibly connect you or your child to the individuals conducting these trials.

Will my information be kept confidential?

When you submit your information to the patient registry, it will be stored and maintained in a database on a secure, password protected computer. Only the FARA registry coordinators and administrator will have access to the database. Third parties will not be given direct access to the database. Requested data will be extracted from the database and then sent to third parties.

Is participation in this database voluntary?

Your participation in the FARA patient registry is completely voluntary. Your participation in the registry will not impact your participation in other FARA activities, programs or projects.

How do I withdraw my name from the Registry?

You can withdraw your name and personal information from the FARA patient registry at any time. This can be done through a written communication to a FARA registry coordinator (email address and contact information provided at the homepage of the FARA patient registry, see “contact us” or “feedback”).