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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 operates under the direction of the Alpha-1 Foundation 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 and individuals identified as carriers of Alpha-1 Antitrypsin Deficiency are encouraged to enroll in the Alpha-1 Research Registry.

How do I enroll in the Registry?

Simply sign the informed consent and complete the Contact Information Form contained in one the following links. We are using DocuSign as the mechanism to sign informed consents online. DocuSign is a HIPAA compliant partner.

STEP 1: Instructions for signing the informed consent and completing the Contact Information Form:

Click on one of the following links:

Subjects who are 18 years or older: Adult Informed Consent

Parental Consent for subjects who are less than 18 years old: Informed Consent

  1. You will be prompted to provide your name and email address. Enter each and click Begin Signing.
  2. You will be prompted to verify your email address. Check your email account for an email from DocuSign containing a validation code. Copy the validation code and go back to the screen that asked for the validation code. Enter the validation code and click Validate
  3. After your email is validated, you will be brought to the informed consent.
  4. Read the electronic record and signature disclosure policy contained in the link. If you agree, check the box that you agree to use electronic records and signatures and click Continue.
  5. Read the informed consent.
  6. If you agree to participate in the Alpha-1 Research Registry, answer the questions on pages 9 and 10 by clicking the appropriate checkboxes.
  7. Click on the Sign sticky on page 10. A computer generated signature will be created for you. Click Adopt and Sign.
  8. Complete the Alpha-1 Research Registry Contact Information Form on page 11.
  9. After you have answered the questions on pages 9 and 10, signed the informed consent and completed the Contact Information Form, click Finish at the bottom of the webpage.
  10. You will be prompted with the option of printing or downloading the partially signed informed consent.
  11. The Alpha-1 Foundation Research Registry staff will receive a copy of the partially signed consent. The Foundation’s Registry staff will sign the informed consent and a fully signed copy of your informed consent will be emailed to you.
  12. You are now a participant in the Alpha-1 Research Registry! The next step is to complete the Alpha-1 Research Registry Questionnaire.

If you have any questions, please call the Alpha-1 Research Registry at 877-228-7321 ext 327 or email at alpha1registry@alpha1.org.

STEP 2: Complete the Alpha-1 Research Registry Questionnaire

Instructions for completing the Alpha-1 Research Registry questionnaire:

  1. Click the following link: Alpha-1 Research Registry Questionnaire
  2. Print the questionnaire and answer all of the questions.
  3. Mail the completed questionnaire to the following address:

Alpha-1 Research Registry
c/o Alpha-1 Foundation
Attn: Registry Staff
3300 Ponce de Leon Boulevard
Coral Gables, FL 33134

The Alpha-1 Foundation’s Registry staff will input the data you provided in the questionnaire into the Registry database.

If you have any questions, please call the Alpha-1 Research Registry at 877-228-7321 ext 327 or email at alpha1registry@alpha1.org.

STEP 3: Submit the results of medical tests and followup communications

Following the submission of the completed questionnaire, the Alpha-1 Foundation Registry staff will contact you to provide the 5 most recent pulmonary function testing results, radiology imaging CD and reports, exercise test/6-minute walk test results Additionally, you will be asked to provide the results from liver tests, including a pathology report, fibroscan results, and lab reports. You also may be contacted every 1-2 years after the baseline visit to determine if you have any updated medical information. During these follow up communications, you may be informed of future research studies for which you may qualify for.

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.

For more information, please contact the Alpha-1 Research Registry at 877-228-7321 ext 327 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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What is a clinical trial?

Clinical trials are research studies performed on human subjects. Studies conducted on animals, in test tubes, or using various other laboratory techniques are often called basic research. Clinical trials may include studies to evaluate the course of a disease, its cause or treatment.

Testing of new drugs or therapies is often the most visible and tantalizing type of clinical trial. In the U.S., clinical trials that evaluate a new drug or pharmaceutical therapy fall under very strict regulation by the Food and Drug Administration (FDA). The FDA decides whether the studies performed show that a drug is effective enough and safe enough to warrant broad distribution of the drug to patients.

There are many Alpha-1 clinical trials going on that do not involve the testing of new drugs or therapies, many supported by the Alpha-1 Foundation.

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, email gettested@alpha1.org or call toll free, 877-228-7321 ext 245.

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.