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ALPHA-1 FOUNDATION

Registry Questionnaire

(HR #9059) Research Questionnaire
CONSENT TO PARTICIPATE IN THE ALPHA-1 RESEARCH REGISTRY


PURPOSE
We invite you to join the Alpha-1 Research Registry, a program of the Alpha-1 Foundation. The purpose of the research database is to identify a group of people who are interested in receiving information about research studies focused on Alpha-1 Antitrypsin Deficiency and possibly participating in these research studies.
Before you do, we want you to know that:
1. Your participation is entirely voluntary.
2. If you choose to join the research registry now, you may withdraw at any time for any reason.
3. You may receive no benefit from taking part in the research registry. The only benefit that can be reasonably expected, at this time, is that research using information from the research registry may give us knowledge that may help persons with Alpha-1Antitrypsin (AAT) Deficiency (or Alpha-1) in the future.


CONFIDENTIALITY
No information about research registry participants will be given to the Alpha-1 Foundation or directly to any researcher(s). Only the contractor managing the database (the Data Management Center, located at the Medical University of South Carolina) and university/Federal auditors required by law can have access to confidential personal information. It will be up to you to choose whether or not to contact any researcher(s) seeking to recruit research volunteers from among participants in the Alpha-1 Research Registry.
To help us protect your privacy, we have obtained a Certificate of Confidentiality from the National Institutes of Health. With this Certificate, the researchers cannot be forced to disclose information that may identify you, even by a court subpoena, in any federal, state, or local civil, criminal, administrative, legislative, or other proceedings. The Certificate cannot be used to resist a demand for information from personnel of the United States Government that is used for auditing or evaluation of Federally funded projects. You should understand that a Certificate of Confidentiality does not prevent you or a member of your family from voluntarily releasing information about yourself or your involvement in this research. If an insurer, employer, or other person obtains your written consent to receive research information, then the researchers may not use the Certificate to withhold that information. The Certificate of Confidentiality does not prevent the researchers from disclosing voluntarily, without your consent, information that would identify you as a participant in the research project if the researchers hear something that would immediately endanger you, your child, or others.


RISKS AND INCONVENIENCES
Risks
The physical risks of participating in this Research Registry are anticipated to be minimal. All that is required is the time to fill out this survey. The risks that require more serious consideration relate to keeping your name in a database connected to your personal health information.
Although every reasonable effort will be made to keep your information confidential, there can be no guarantees that errors in protecting this information will not be made. If it became known that you have Alpha1-Antitrypsin (AAT) Deficiency, there may be risks to you related to your employment, or health or life insurance. Insurers have been known to cancel insurance policies of persons who they found out had a genetic disorder.
Inconveniences
The burdens associated with participation in the Research Registry are:
1. Being contacted by the Alpha-1 Research Registry about your willingness to participate in research projects approved by the Medical And Scientific Advisory Committee of the Alpha-1 Foundation.
2. Being sent additional survey questionnaires and follow-up surveys on a continuing basis.


HIPAA AUTHORIZATION HR #9059
HIPAA is a federal law that requires the protection of health information that can identify you. Protected Health Information includes information that pertains to your past, present or future physical and mental health conditions or the provision of health care. You have to authorize the use of this information for any purpose.
As you know, you are sharing this Protected Health Information to participate in the activities of the Alpha-1 Research Registry as described to you in the application. The information you share on the Registry questionnaire and when you update the questionnaire is the Protected Health Information the Registry staff will use. The health information you have shared will not be disclosed to any one other than Dr. Charlie Strange and the Registry staff; they agree to protect your health information by using it only as permitted by you and as directed by state and federal law. Federal law does require that the MUSC Institutional Review Board and the federal Office of Human Research Protection be given access to any research data as required to protect research participants.
If you do not wish to authorize the use of your Protected Health Information, you will not be able to continue to participate in the Alpha-1 Research Registry. If you authorize the use of your Protected Health Information, you can change your mind at a later time. Protected Health Information that has already been used cannot be withdrawn. If you want to withdraw your authorization, you must do so in writing to the investigator at the following address:


Dr. Charlie Strange
Medical University of South Carolina
Division of Pulmonary and Critical Care Medicine
Allergy and Clinical Immunology
96 Jonathan Lucas Street, Suite 812-CSB
PO Box 250630 · Charleston, SC 29425


When you sign the consent to be a member of the Registry, you are also authorizing Dr. Charlie Strange and the registry staff to use the information you have shared for the purposes of the Registry. There is no expiration date for this authorization. You may copy the information on this form and all forms you complete for the registry.
If you have questions or concerns about your privacy rights, you should contact MUSC's Privacy Officer at (843) 792-0021. MUSC's Privacy Notice can be found @ http://research.musc.edu/hipaa/final%20Notice.PDF
If you have any questions about your rights as a participant in the Alpha-1 Research Registry, contact the Institutional Review Board for Human Research, Medical University of South Carolina, (843/792-4148). If you have questions related to harm suffered as a result of your participation, contact Dr. Charlie Strange, (843/792-0260).

By my signature below I agree to participate in the Alpha-1 Research Registry.
Signature: _____________________________________________
Date: ____/_____/____
Signature of Legal Guardian: _______________________________
(If participant is under 18 years of age)
Date:____/_____/____
Minor Participation: Minors enrolled in the Research Registry must reenroll upon turning 18 years of age by filling out a new questionnaire and signing the consent form. Minors who choose not to renew their membership upon turning eighteen will no longer be enrolled in the Research Registry.
Please mail when completed to:

ALPHA-1 RESEARCH REGISTRY
c/o Medical University of South Carolina
Division of Pulmonary and Critical Care Medicine
Allergy & Clinical Immunology
96 Jonathan Lucas St., Suite 812-CSB
PO Box 250623, Charleston, SC 29425
Toll Free Phone: 1-877-886-2383
Regular Phone: 1-843-792-0260
Fax: 1-843-792-0297
Email: alphaone@musc.edu

_________________________________________________________________________________________________________________________

PATIENT INFORMATION

Patient name and address

• Name: Last, First, MI

• Address: Street, Apt.#

• City, State, Zip, Country

• Soc. Sec. #

• Phone: Area Code ( ) - - •

Do you have a physician who cares for your Alpha1-Deficiency? Yes No

Who is your current physician?

• Name: Last, First, MI

• Address: Street, Suite #

• City, State, Zip, Country

• Phone: Area Code ( ) - -

_________________________________________________________________________________________________________________________

DEMOGRAPHICS

1. What is your date of birth? Month Day Year

2. What is your gender? Male Female

3. Race/Ethnicity (Circle all that apply)? Native American/American Indian, African American, Hispanic, White/Caucasian, Asian, Other

4. Are you currently employed? Yes No

5. Please identify your smoking behavior: Nonsmoker (Less than 100 cigarettes in whole life), Ex-Smoker, Smoker

• At what age did you start smoking?

• At what age did you stop smoking?

• How many cigarettes did you smoke per day?

• (For Smoker) At what age did you start smoking?

• Current Use: How many cigarettes do you smoke per day?

6. Please identify your alcohol use: No alcohol, Ex-alcohol consumer, Currently consume alcohol

• At what age did you start drinking?

• At what age did you stop drinking?

• Current use: (Occasional) (1-3 drinks/wk.) (4-15 drinks/wk.) (16+ drinks/wk.)

_________________________________________________________________________________________________________________________

ALPHA 1 DIAGNOSTIC INFORMATION

7. Have you been diagnosed with AAT Deficiency? Yes No

8. What is your phenotype? ZZ , MZ, SZ, Don’t know or unsure

Other: (Please Specify)

9. What was your most recent alpha-1 antitrypsin level? (microM) - or - (mg/dl) I don't know

10. How old were you when you were diagnosed with AAT Deficiency?

11. Have you ever had pulmonary function (breathing) tests? Yes No I don't know

• If yes, date of most recent FEV1: Month Day Year or - I don’t know

12. What was your percent predicted FEV1? Less than 30%, 30-50%,

50-80%, More than 80%, - or - I don’t know

• What was your last FEV1 in liters?

13. Do you currently have elevated liver function or elevated liver enzyme levels? Yes No Unknown

14. Please mark any of the following diseases/conditions that you have been diagnosed with:

Chronic liver disease, Chronic lung disease, Emphysema, Jaundice, Cirrhosis

Bronchitis, Asthma, Hepatitis, Panniculitis

_________________________________________________________________________________________________________________________

TREATMENT

15. Are you currently receiving Prolastin or another AAT replacement therapy? I have never received AAT Replacement; I am currently receiving AAT replacement; I am NOT currently receiving AAT replacement, but have in the past.

16. Have you ever had a liver transplant? Yes No

17. Have you ever had a lung transplant? Yes No

18. Have you ever had a lung volume reduction? Yes No

_________________________________________________________________________________________________________________________

PREVIOUS REGISTRY ENROLLMENT AND FUTURE SURVEYS

19. Did you participate in the National Institutes of Health, National Heart Lung and

Blood Institute (NIH-NHLBI) Alpha One Registry in the period from 1989-1995? Yes No

20. Do you own a computer? Yes No

21. Would you be interested in responding to future surveys over the Internet or the World Wide Web? Yes No

22. If you answered “yes” to the previous question, what is your email address?

Final Check:

• I have signed and dated the consent form on the front of the application.

• I have filled the application out in full to the best of my knowledge.

If you have family members who have AAT Deficiency of the carrier phenotype and would like to join the Research Registry please encourage them to contact the Alpha-1 Research Registry at our toll free number, 1-877-886-2383, or by email at alphaone@musc.edu. We will be happy to assist them.

 
 
 

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