Statement of Informed Consent
The following statement must be read to all potential participants:
Purpose and Background
The Arizona Department of Health Services, together with the Centers for Disease Control and Prevention
(CDC), is doing a research study to learn more about people who are infected with the HIV virus and about the types of services they use and need. We are collecting this information so we can improve our programs to prevent other people from getting infected with the HIV virus and so we can improve the services for those who are already infected.
Procedures
If you choose to be in this research study, you will be asked questions about your medical history, use of medical and social services, sexual practices, drug and alcohol use, and your ability to work and manage your affairs. You must voluntarily decide if you want to be in the study. If you decide not to be in the study, your services will not be affected. You do not have to answer any question if you do not want to, and you may withdraw from the study at any time.
The interview will take about an hour to complete. The answers you give to the interview questions will not be identified as having come from you. You will be identified only by a code number on the interview form. All the information that you give us will be kept confidential in a locked file and will only be shared with members of the research staff. If additional information is needed, you may be contacted again by the interviewer. We will be sending information from your interview to the
CDC, but we will not send them any information that would identify you.
Some of the questions may make you feel uncomfortable or you may feel are too personal. If you do not wish to answer any questions, you do not have to do so.
Confidentiality
Your records will be kept confidential to the extent legally possible. To protect your privacy, your answers will be grouped with others so that no one will know how you answered the questions. We will be sending information from the study to the
CDC, but will not send them any information that would identify you. The confidentiality of information kept at the CDC is protected by federal law.
Costs and Benefits
There is no cost to you for participating in this study other than your time and effort.
There are no direct benefits to you from taking part in this study. However, the study may lead to a better understanding of the services available to people with the HIV virus and how to improve those services.
If you choose, your interviewer can give you information about practices to avoid HIV transmission. If you wish, you may also get information or referrals from the interviewer for medical and social services in your area.
Risks
The only risk to you is the possibility that the information you give us will not be kept confidential. This risk is very small because we have worked very hard to find ways to keep information you give us confidential. These ways were explained to you above. Since this study was begun in 1990, there has been no loss of confidentiality for any of the more than 23,000 patients who have been interviewed.
Voluntary Participation
Refusal to participate in this study will not involve any penalty or loss to you of benefits. You may stop the interview at any time.
Questions
If you have any questions about this study, please feel free to ask them either during the interview or call
Rick DeStephens at (602) 364-3614 or toll-free at (800) 334-1540. If you have questions about your rights as a participant in this study, you may call John
Livengood, MD at
(800) 447-4784, mailbox 639-7262. This is a toll free call.
Participant's Consent Statement
I agree to take part in the research study described here. I have read and understand the statement and I have had all my questions answered. I understand that my participation is completely voluntary.
Mark of Participant/Date
Signature of Interviewer |
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