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What is the Alpha-1 Research Registry?

The Alpha-1 Research Registry is a confidential database made up of individuals diagnosed with Alpha-1 Antitrypsin Deficiency (Alpha-1) and individuals identified as Alpha-1 carriers. The Registry was established to facilitate research initiatives and promote the development of improved treatments and a cure for Alpha-1. Located at the Alpha-1 Foundation, Miami, FL, the Registry employs procedures that ensure the most stringent confidentiality of participants. The Registry is under the direction of Jeanine D’Armiento, Chair of the Alpha-1 Foundation’s Board of Directors and is guided by an Advisory Committee comprised of leaders in the medical, ethical, scientific and Alpha communities. Individuals enrolled in the Registry have the ongoing opportunity to participate directly in clinical trials of new therapeutic approaches in addition to other research opportunities.

Who is eligible to enroll in the Registry?

  • Individuals of all ages who are diagnosed with Alpha-1 Antitrypsin Deficiency
  • Individuals identified as carriers of Alpha-1 Antitrypsin Deficiency
  • The Alpha-1 Research Registry is currently open to residents of the United States only. International individuals are not eligible to join at this time.

How do I enroll in the Registry?

Individuals interested in joining the Alpha-1 Research Registry can enroll in one of the following ways: via the Registry Portal or via hard copy

OPTION 1: Alpha-1 Research Registry Portal

To join the Alpha-1 Research Registry, visit the Registry Portal page by clicking on the following link: Research Registry Portal

STEP 1: Complete the Registration Form

  • All participants interested in joining the Alpha-1 Research Registry must complete a registration form.
  • If you are the parent or guardian who will be enrolling your child or minor in the Research Registry, please provide your contact information.

 

STEP 2: Read and Sign the Adult or Parental Informed Consent

  • Please read and review the informed
  • If you are the parent or guardian enrolling a child or minor in the Alpha-1 Research Registry, please provide your email address and provide your child or minor’s name.
  • You will have an opportunity to review your informed consent and response.
  • After you have reviewed your information, you will have the option of downloading and/or printing your informed consent and keeping a copy for your records. If you would like a copy of your fully signed informed consent please contact the Alpha-1 Foundation at 877-228-7321 ext. 252 or email at alpha1registry@alpha1.org.

STEP 3: Complete the Questionnaire

  • Answer all the questions to the best of your ability.
  • You will have the option to save your response and return to the questionnaire at any time if you are unable to complete the questionnaire in one sitting.
  • At the end of the questionnaire, you will have the option to download a copy of your completed questionnaire for your records.

STEP 4: Provide Medical Tests and Labs

  • We request that you provide up to 5 reports of each medical test and lab listed below. If you don’t have 5 reports for each test, we will accept whatever you can provide:
    • Pulmonary Function Test reports
    • Liver biopsy reports
    • Fibroscan reports
    • Lung and/or liver radiology imaging reports (reports from the scans or images, not the scans or images themselves)
    • Exercise test/6 minute walk test reports
    • Lab reports that include INR, GGT, total cholesterol, triglycerides, HDL and LDL.
  • You do not need to conduct any new tests. We request the reports from tests and labs already conducted
  • You can upload electronic copies, screenshots or pictures of your reports to the Portal.
  • You can also email or mail copies, screenshots or pictures of your reports to an Alpha-1 Registry Coordinator.
  • When applicable, you may submit your test and lab reports in-person to a Registry Coordinator.
  • Your reports will be securely uploaded into the Registry database by Alpha-1 Foundation Research Registry Coordinators.

 

There may be a fee when obtaining your medical tests and labs from your physician or healthcare organization.  The Alpha-1 Foundation will reimburse you up to and no more than $25 for the expense. The reimbursement will be made after you upload, email or mail the reports of your medical tests and labs. If you have any questions, please call the Alpha-1 Research Registry at 877-228-7321 ext. 252 or email at alpha1registry@alpha1.org.

OPTION 2: Request a Hard Copy Consent and Questionnaire

  • If you are unable to complete the informed consent and questionnaire through the patient portal and would like to request a hard copy of the informed consent or questionnaire, you can call the Alpha-1 Research Registry department at 1-877-228- 7321 ext. 252 or email at alpha1registry@alpha1.org

    • The Alpha-1 Foundation’s Registry staff will input the data you provided in the questionnaire into the Registry database.
    • After you have signed an informed consent and completed the questionnaire, you will be asked to provide up to 5 reports of each medical test and lab listed below. If you don’t have 5 reports for each test, we will accept whatever you can provide:
      • Pulmonary Function Test reports
      • Liver biopsy reports
      • Fibroscan reports
      • Lung and/or liver radiology imaging reports (reports from the scans or images, not the scans or images themselves)
      • Exercise test/6-minute walk test reports
      • Lab reports that include INR, GGT, total cholesterol, triglycerides, HDL and LDL.
    • You do not need to conduct any new tests. We request the reports from tests and labs already conducted
    • You can email or mail paper copies, screenshots or pictures of your reports to an Alpha-1 Registry Coordinator.

    Mail to:
    Alpha-1 Foundation
    Attn: Alpha-1 Research Registry
    3300 Ponce de Leon Boulevard,
    Coral Gables, FL 33134

     

    • Your reports will be securely uploaded into the Registry database by Alpha-1 Foundation Research Registry Coordinators.

    There may be a fee when obtaining your medical tests and labs from your physician or healthcare organization.  The Alpha-1 Foundation will reimburse you up to and no more than $25 for the expense. The reimbursement will be made after you upload, email or mail the reports of your medical tests and labs.

How to Obtain Your Medical Records

Requesting medical records can seem like a daunting or difficult task but it doesn’t have to be.

Under the Health Insurance Portability and Accountability Act (HIPAA),  every person has a right to access their medcail records, obtain copies of them, and request changes to them.

Below are a few basic steps you can take to obtain the reports from your medical tests and labs from your healthcare provider or facility for participation in the Alpha-1 Research Regstry.  ical records through your healthcare provider or healthcare facility.

Where do I Start?

The first thing to do is contact or visit the medical records department in your doctor’s office. In larger facilities this may be called a Health Information Management (HIM) department. Smaller  doctor’s offices may not have a  medical records or HIM department, so you may need to ask for the the administrative staff who will be able to release  your medical records.

Next, you will be required to complete a form enabling the authorization for disclosure of protected health information. Some healthcare facilities offer the authorization forms online to complete ahead of time. In addition, you can request your records be sent directly to the Alpha-1 Foundation via mail or email.  This option may speed up the request process and may be free of charge.

If you are having records sent directly to the Alpha-1 Foundation, you will need to provide a completed and signed authorization form to your provider and our contact listed below:

Alpha-1 Foundation

Attn: Research Registry,

3300 Ponce de Leon Blvd

Coral Gables, FL 33134

 

An incomplete or unsigned request will not be fulfilled.

Choose the Information you want from your Medical Records:

Medical records can contain a lot of information. Knowing exactly what information you want can help facility the medical records process. If you are unsure what documents you need, ask a medical professional for help to get the proper records.

Medical records can be requested in different formats; for example, you can request your records on a CD, DVD, USB flash drive, or sent securely via e-mail, or mail. Larger healthcare providers may have web based portals to enable individuals to directly access their medcail records.

Following are the reports of the medical tests and labs or medical records to submit as part of your participation in the Alpha-1 Research Registry:. We ask that you submit up to 5 of your most recent medical tests and lab reports.  If you don’t have 5 of any of the tests or lab reports, we will accept whatever you can provide.

  • Pulmonary Function Test reports
  • Liver biopsy reports
  • Fibroscan reports
  • Lung and/or liver radiology imaging reports (reports from the scans or images, not the scans or images themselves)
  • Exercise test/6 minute walk test reports
  • Lab reports that include INR, GGT, total cholesterol, triglycerides, HDL and LDL

You may upload screenshots, pictures or electronic copies of your reports to the Research Registry Portal https://is.gd/alpha1registry .  You may also email or mail paper copies, screenshots or pictures of your reports to an Alpha-1 Registry Coordinator.

Don’t Forget your Government Issued Photo ID:

Make sure to bring your valid government issued photo ID and all other required legal documents with you if you pick up your medical records in person. HIM professionals by law must deny requests where the individual cannot prove their identity or their right to access the records.

How Long Does it Take to Obtain Medical Records

According to HIPAA , providers have no more than 30 days to complete a record request. They are also allowed a single 30-day extension, but the facility must explain the cause of the delay. However, most facilities do not require that much time and many can fulfill a request in five to ten days.

Are There any Fees to Obtain Medical Records?

There may be fees for the cost of obtaining your medical records. The Alpha-1 Foundation will reimburse you up to, and no more than, $25 for obtaining your medcial records.

What if I am Requesting my Child’s Medical Records?

Parents have access to their childs medical records until the child turns 18. However, many states have laws in place where a healthcare provider can decided if a parent can access sensitive medical information within the child’s chart such as drug use or any form of abuse.

If your child or minor has consented to care and the consent of the parent is not required, the parent would not have acess to their child records. If the parent agrees that the minor and the health care provider may have a confidential relationship, the parent does not have rights to the child’s records. ( U.S. Department of Health and Human Services, 2013).

For example, parents no longer have access to a child’s mental health records when the child turns 15 or 16, depending on the state.

Research Registry Brochure

Frequently Asked Questions

Who will have access to my name? How confidential is this database?

Your questionnaire will go directly to the Registry Coordinating Center at the Alpha-1 Foundation. There is strict adherence to established confidentiality procedures that are intended to protect the identity of those who participate. The Registry is required to conceal a member’s identity and personal information from researchers and organizations unless consent is granted by the Registry member. The database is kept under tight security at all times. This means that it is password protected and inaccessible from the Internet. Also, all hard copies of personal information are kept under lock and key. Only the Registry staff at the Alpha-1 Foundation have access to a member’s personal information.

 

How can my participation help promote research?

One of the largest obstacles in Alpha-1 research is finding a sufficient number of volunteers to participate in studies. By establishing a database of thousands of people with Alpha-1 and promoting its use to the Alpha-1 research community, the Registry will allow new therapies and important research studies to be evaluated. Participation in research is voluntary and Registry members are always given the option to accept or decline research invitations.

 

The benefits of joining the Alpha-1 Research Registry:

  • Participate in clinical trials for new treatments.
  • Be part of survey studies to determine health care costs, environmental risks, and assist in collection of other specific data to advance scientific and medical knowledge about Alpha-1.
  • Access to experts in Alpha-1 clinical care.
  • Update Newsletter with information on latest research activities.

 

What should I do if I have already signed an informed consent?

Individuals who have signed an informed consent prior to February 2020, your hard copy informed consent is on file at the Alpha-1 Foundation. You will need to register online to the Registry Portal by clicking on the following link https://is.gd/alpha1registry to continue the process.

If I was enrolled in the registry at the Medical University of South Carolina, how does that affect my participation in the new Alpha-1 Research Registry at the Alpha-1 Foundation?

Even if you were enrolled in the Alpha-1 Registry at the Medical University of South Carolina, you will need to sign an informed consent to participate in the Alpha-1 Research Registry at the Alpha-1 Foundation. The Alpha-1 Research Registry is collecting more robust data that may be valuable to researchers and investigators.

For more information, please contact the Alpha-1 Research Registry at 877-228-7321 ext. 252 or alpha1registry@alpha1.org

The Alpha-1 Coded Testing (ACT) Study

The goal of the ACT Study is to provide free, confidential testing services and facilitate research on genetic testing. The test is administered through a research study which evaluates perceived risks and benefits of genetic testing. Anyone can ask to be tested. The ACT Study provides a way for family members of Alphas and others at risk to learn their Alpha-1 genotype. Enrollment into the study may end at any time. The ACT Study is sponsored by the Alpha-1 Foundation. For more information, alpha1lab@alphaone.ufl.edu call toll free 1-855-476-1227.

For more information about the Alpha-1 Research Registry, please contact the Alpha-1 Foundation at 877-228-7321 ext. 252 or alpha1registry@alpha1.org. 

International listing of Alpha-1 research studies

The U.S. National Institutes of Health (NIH) lists Alpha-1 research studies in the United States and around the world at ClinicalTrials.gov.

The NIH describes the Clinical Trials site:

ClinicalTrials.gov is a registry of federally and privately supported clinical trials conducted in the United States and around the world. ClinicalTrials.gov gives you information about a trial’s purpose, who may participate, locations, and phone numbers for more details. This information should be used in conjunction with advice from health care professionals.

You can find clinical trials for Alpha-1 by typing “Alpha-1 Antitrypsin Deficiency” into the search box. (You can just type “Alpha-1″ and get a lot of results — but many trials will appear that have nothing to do with Alpha-1 Antitrypsin Deficiency.)

Please note the important NIH caution if you should consider volunteering for one of these studies: “This information should be used in conjunction with advice from health care professionals.” It’s always a good idea for an Alpha to see a doctor who’s familiar with Alpha-1 and discuss the risks and benefits before joining a clinical trial.

Also keep in mind that many of these clinical trials will not be available in your area and that you may not qualify for them. If you are a member of the Alpha-1 Research Registry, that research is already done before you get a notice about a new trial.

For more information, please contact the Alpha-1 Research Registry at 877-228-7321 ext. 252 or alpha1registry@alpha1.org. Call or email us to receive a free subscription to the Alpha-1 Research Registry Research Update.

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