|
||||
|
APPENDIX A SAMPLE CONSENT FORM
I, (patient) _________________________ hereby give permission to (hospital) to test my blood for presence of the ANTIBODY to the human T-Lymphotropic Virus type III (HTLV-III). I understand that this test is licensed by the Food and Drug Administration for the primary purpose of Blood Bank Screening and not as a diagnostic tool. This virus may well be the cause of the Acquired Immune Deficiency Syndrome (AIDS) and is associated with that disease. I understand that this test in itself is not diagnostic for AIDS, and that the meaning of a positive test is still under investigation. I understand that positive results from this test indicate the presence of ANTIBODIES in my blood which react with the HTLV-III antigen. Positive results do not conclusively indicate whether or not the virus is present in my blood, nor does a positive result mean that I have AIDS. I also understand that a positive result does not predict whether or not I will develop AIDS in the future. I understand that the test is capable of yielding false positive and false negative results and that such results can be effected by other factors including the presence of another virus in my system. I understand that a negative result from this test does not conclusively exclude the possibility of infection with HTLV-III virus. All positive test results will be confirmed by repeating the same test as a control for performance or laboratory error. The initial confirmation will not be performed by the Western Blot Method which is more accurate and may be recommended for subsequent confirmation. I understand that if this test result, in combination with other data, allows my physician to make a presumptive diagnosis of AIDS, my case must be reported to the Public Health Authorities, and be investigated by them. I understand that (hospital and/or doctor) will take precautions to protect the confidentiality of these ANTIBODY test results. There will be no disclosure to any unauthorized third party without my express written consent, as unwarranted disclosure may result in discrimination against me in areas of housing, employment and insurability. I understand that the results of this test will be recorded in my medical record. I further understand that because of the very nature of the medical record, confidentiality cannot be absolutely guaranteed. I further understand that the necessary or authorized release of this information, particularly of a positive result, could have undesirable personal, social, economic and psychological consequences to me for which the hospital and physician will have no liability. I understand that a waiver of the privilege of confidentiality and privacy of my medical records in order to gain insurance reimbursements means that the results of this test will be disclosed. After the test results are obtained, my physician will discuss these matters with me and, if necessary, refer me for appropriate medical, psychological and social consulting. I have been informed that HTLV-III infection may be transmitted and that if my test is positive, I will be given suggestions for precautions against transmitting this infection. However, in some cases, if I am at risk for this infection, I may still transmit the virus even if my test is negative. I have been given the opportunity to ask questions which have been answered to my satisfaction. I have read the above and have had the opportunity to discuss this information and my questions with (doctor) ________________________. I am aware of the test's limitations and the potential consequences of positive and negative test results. My signature indicates that I give my informed consent to have the HTLV-III screening test performed on a sample of my blood. __________________________________
|