Study# xx-xxxx version 00/00/0000 NYU SoM IRB HRPP Institutional Review Board Human Research Protection Program 1 Park Avenue | 6th Floor | New York, NY 10016 http://irb.med.nyu.edu NEW YORK STATE DEPARTMENT OF HEALTH Informed Consent to Perform an HIV Test and Release HIV Information Form 1. Testing for HIV Infection/Testing Methods: There are a number of tests that can be done to show if you are infected with HIV, the virus that causes AIDS. Your provider or counselor can provide specific information on these tests. These tests involve collecting and testing blood, urine or oral fluid. The most common test for HIV is the anti-body test. The HIV antibody test is a blood test. The test shows if you have antibodies to the virus that causes AIDS. A sample of your blood will be taken from your arm with a needle. If the first test shows that you have antibodies, a different test will then be done on the same blood sample to make sure the first test was right. A positive test result means that you have been exposed to the virus and are infected. It does not mean that you have AIDS or that you will become sick with AIDS in the future. A negative test means that you are probably not infected with the virus. It takes the body time to produce HIV antibodies. If you have been exposed to HIV recently, you need to be retested in several months to make sure you are not infected. Your doctor or counselor will explain this to you. 2. Meaning of HIV Test Results? A negative test result on the HIV antibody test most likely means that you are not infected with HIV, but it may not show recent infection. If you think you have been exposed to HIV, you should take the test again three months after the last possible exposure. A positive result on the test means that you are infected with HIV and can infect others. Sometimes the HIV antibody test result is not clearly positive or negative, or may be a preliminary result. Your provider or counselor will explain this result, and may ask that you give you consent for further testing. 3. What are the benefits of taking the test? If you test negative: you can learn how to protect yourself from getting infected with the virus in the future. Ask your doctor or counselor how. If you test positive: You can learn how to avoid giving the virus to others. Knowing that you are infected is important for your health. Your doctor can care for you better. If you are a woman or man who is thinking of having a child, you can learn about the risk of passing the virus to your baby. If you are a woman who is already pregnant, your doctor can provide information on the full range of options and services available to you. 4. Confidentiality of HIV Information: If you take the HIV antibody test your test results are confidential. Under New York State Law, confidential HIV information can only be given to people you allow to have it by giving your written approval, or to people who need to know your HIV status in order to provide medial care and services, including: medical care providers; persons involved with foster care or adoption; parents and guardians who consent to care of minors; jail, prison, probation and parole employees; emergency response workers and other workers in hospitals, other regulated settings or medical offices, who are exposed to blood/body fluids in the course of their employment; and organizations that review the services you receive. The law also allows you HIV information to be released under limited circumstances: by special court order; to public health officials as required by law; and to insurers if necessary to pay for care and treatment. 1 of 5 Study# xx-xxxx version 00/00/0000 NYU SoM IRB HRPP 5. Reporting Requirements: Your name will be reported to the health department if you have a confirmed positive HIV antibody test result received through a confidential test, other HIV related test results, a diagnosis of AIDS, or if you have chosen to attach your name to a positive test result at an anonymous site. The health department will use this information to track the epidemic and to better plan prevention, health care and other services. 6. Notifying Partners: If you test positive, your provider will talk with you about the importance and benefits of notifying your partners of their possible exposure to HIV. It is important that your partners know they may have been exposed to HIV so they can find out whether they are infected and benefit from early diagnosis and treatment. Your provider may ask you to provide the names of your partners, and whether it is safe for you if they are notified. If you have been in an abusive relationship with on of these partners; it is important to share information with your provider. For information regarding services related to domestic violence, call 1-800-942-6906. Under state law, you provider is required to report to the health department the names of any of your partners (present and past sexual partners, including spouses, and needle sharing partners whom they know). Several options are available to assist you and your provider in notifying partners. If you or your provider does not have a plan to notify you partners, the Health Department may notify them without revealing your identity. If this notification presents risk of harm to you, the Health Department may defer the notification for a period of time sufficient to allow you to access domestic violence prevention services. If you do not name any partners to your provider or if a need exists to confirm information about your partners, the health department may contact you to request your cooperation in this process. 7. Voluntary Testing: Taking an HIV antibody test is voluntary. You do not have to take the test. If you do not wish anyone to know your test results or even that you have been tested, you can go to an anonymous test site. This is a place where you can receive counseling and the HIV test without giving your name or address. You can find the nearest anonymous test site by calling the AIDS hotline at 1-800-541-2437. 8. Confidentiality of Test Results If you feel your confidentiality has been broken, or for more information about HIV confidentiality, call the New York State Department of Health HIV Confidentiality Hotline at 1-800-962-5065. Any health or social service provider who illegally tells anyone about your HIV information may be punished by a fine of up to $5000 and jail term of up to one year. The law also protects you from HIV related discrimination in housing, employment, health care or other services. For more information, call the New York State Division of Human Rights at 1-800-523-2437. If you take the HIV antibody test, your test results are confidential. Under the New York State Law, confidential HIV related information can only be given to people you allow to have it by signing a release form, or the persons listed below on this form.** 9. Risks Involved with Disclosure and Sources of Help If you test positive, you should be careful about telling others what your test showed. Some HIV positive people have been discriminated against by employers, landlords and others. If you experience discrimination because of release of HIV related information you may contact the New York State Division of Human Rights at (212) 870-8624 or the New York City Commission of Human Rights at (212) 566-5493. These agencies are responsible for protecting your rights. 10. For More Information 2 of 5 Study# xx-xxxx version 00/00/0000 NYU SoM IRB HRPP If you have further questions about informed consent to HIV antibody testing, you may contact the New York State Department of Health at (518) 486-1595. * Human Immunodeficiency Virus that causes AIDS. See below for a list of persons who can receive HIV related information. ** My questions about the HIV test have been answered. I agree to take the HIV antibody test. Signature of person who will be tested Signature of person authorized to consent for person to be tested Date Date Name of person who will be tested (please Print) Name of person authorized to consent (Please Print) I have explained the means by which the HIV antibody test is done, the meaning of the results and the possible consequences of disclosing of the test results to the individual above, and have answered any questions she/he had about the test. Name: 11. Under New York State Law. HIV related information is confidential and may only be given: a. To you (or a person authorized by law who consented to the test for you): b. To anyone whom you have specifically authorized to receive such information by signing a written release: c. To a health care facility (such as a hospital, blood bank, or clinical laboratory) or a health care provider (such as a physician, nurse, or mental counselor) providing care to you or your child, and anyone working for such a facility or provider who reasonably needs the information to supervise, monitor, or administer a health service; d. To a person who your doctor believes is at a significant risk for HIV infection, if you do not notify that person after being counseled to do so; e. To committee or organization responsible for reviewing or monitoring a health facility. f. To a federal, state, county, or local health officer when the state or federal law requires disclosure; g. To government agency, when the agency needs the information to supervise, monitor or administer a health or social service; h. To an authorized foster care or adoption agency; 3 of 5 Study# xx-xxxx version 00/00/0000 i. To insurance companies and other third party payers such as Medicaid if necessary for the payment of services to you; NYU SoM IRB HRPP j. To any person to whom a court orders disclosure under limited circumstances set forth by law. Except in an emergency situation, advance notice and an opportunity to oppose the release of such information would be given to you; k. To the Division of Parole, the Division of Probation, the Commission of Correction, or a medical director of a local correctional facility, as permitted by HIV confidentiality regulations of such organization. I. By a physician to the person, who consents for your health care (parent, guardian, etc.) if disclosure is necessary to provide timely care for you, and you have been counseled regarding the need for disclosure. A physician may not disclose such information if it is against your best interest to do so. 12. SPECIAL CONDITIONS You can ask your doctor if HIV related information about you has been released to anyone listed above. Despite the fact that New York State Law provides that certain persons or agencies may receive confidential HIV information without you specific consent, the researchers conducting this study and NYU Medical Center will not release confidential HIV information derived from this research study except as follows: 1) to persons whom you specifically authorize in writing to receive it 2) to parties to whom disclosure is compelled by court order; and 3) if the confidential HIV information is obtained in a treatment setting it may become part of your confidential medical record, in which case, it will be maintained as confidential in accordance with laws for the confidentiality' of patient medical records as stated above. (HIV = Human Immunodeficiency Virus) New York State Department of Health AIDS Institute 13. Authorization for Release of Confidential HIV* Related Information. Confidential HIV Related Information is any information indicating that a person had a HIV related test, or has HIV infection, HIV related illness or AIDS, or any information which could indicate that a person has been potentially exposed to HIV. Under the New York State Law, except for certain people, confidential HIV related information can only be given to persons you allow to have it by signing a release. You can ask for a list of people who can be given confidential HIV related information without a release form, Despite the fact that New York State Law provides that certain persons or agencies may receive confidential HIV information without your specific consent, the researchers conducting this study and NYUMC will not release confidential HIV information derived from this research study except as follows: 1) To persons whom you specifically authorize in writing to receive it. 2) To parties to whom disclosure is compelled by court order, and 3) if the confidential HIV information is obtained in a treatment setting, it may become part of your confidential medical record, in which case, it will be maintained as confidential in accordance with laws for the confidentiality of patient medical records as stated above. If you sign this form, HIV related information can be given to the people listed on this form, and for the reason(s) listed on the form. Any confidential information disclosed to the persons named below will be marked confidential and will bear a warning that the information may not be further disclosed. If you experience discrimination because of release of HIV related information, you may contact the New York State Division of Human Rights at (212) 870-8624 or the New York City Commission of Human Rights at (212) 566-5493. These agencies are responsible for protecting your rights. Name and address of facility/provider obtaining release: 4 of 5 Study# xx-xxxx version 00/00/0000 NYU SoM IRB HRPP Name of person whose HIV related information will be released: Name and address of person signing this form: (if other than above): Relationship to person whose HIV information will be released: Name and address of person who will be given HIV related information: Reason for release of HIV related information: Validation of research results by research sponsor and/or FDA Delivery to a cooperating researcher Other—Specify Time during which release is authorized: From: To: My questions about this form have been answered. I know that I do not have to allow release of HIV related information, and that I can change my mind at any time. Signature Date 5 of 5