Alpha-1 Coded Testing (ACT) Study Questionnaire

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Thank you for your interest in the ACT study. If you are interested in participating, please read the following 4 page consent form that will have an electronic signature at the end. Following the consent, a questionnaire must be answered completely. At completion of the consent and questionnaire, the Alpha-1 test kit will be mailed to you. If you have any questions about either the consent form or the questionnaire, please call us toll-free at 1-877-886-2383, or email us at alphaone@musc.edu.

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Medical University of South Carolina
Electronic Consent to Be A Research Subject
And HIPAA Authorization

Title: Alpha-1 Coded Testing Study
Principal Investigator: Charlie Strange, MD

If participants include those under 18 years of age: 1) The subject's parent or legal guardian will be present when the informed consent form is provided. 2) The subject will be able to participate only if the parent or legal guardian provides permission and the adolescent (age 12-17) provides his/her assent. 3) In statements below, the word "you" refers to your child or adolescent who is being asked to participate in the study.

A. PURPOSE AND BACKGROUND
You have been identified because of your interest in obtaining a blood test for a protein called alpha-1 antitrypsin (Alpha-1). This document explains a way to receive that blood test through a research study designed to evaluate your thoughts and feelings about taking a blood test for a genetic disorder.

B. PROCEDURES
This study contains the following parts:

1. You should read, sign, and date this consent form if you agree to participate. Consent for minors less than 18 years of age should be from a legal guardian and also have the child's assent by signature if he or she is of age to understand why testing is being done. Once your consent and questionnaire (see #2 below) have been returned to us electronically, you will receive your Alpha-1 test kit in the mail.

2. Read and fill in the questionnaire. To receive your Alpha-1 test kit, you must submit a completed research questionnaire.

3. Obtain your blood sample by following the instructions in the test kit. You will receive a blood test kit that contains instructions for obtaining drops of blood, which will be collected on a piece of filter paper. The blood will be mailed to the Medical University of South Carolina (MUSC) where the sample will be coded with a research number and transferred to GeneAidyx LLC, Alpha-1 Antitrypsin Genetics Laboratory (GeneAidyx) in Alachua, Florida to test for Alpha-1. Results will be returned to MUSC. MUSC will link the coded research number with your address and mail you results of the test.

4. Mail the blood sample in the provided postage paid mailer.

5. By submitting this test, you also agree to receive future questionnaires that could arrive electronically or by mail at any time in the future. You also agree that ACT study staff can contact you for an updated email address, should your current email address become invalid.

6. If your finger stick test results suggest the possibility of a rare allele, a follow-up blood tube test by needle stick will be recommended since this is an important diagnosis. In this event, you may request venipuncture tubes from the University of Florida DNA and Tissue Bank with a return address to Florida with results mailed to the participant and faxed to the ACT study.

C. DURATION
Your participation in the Alpha Coded Testing Study will be for life. Alpha-1 test results should arrive within 6 weeks of mailing.

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