AIDS Issues: Hearings Before the Subcommittee on Health and the Environment of the Committee on Energy and Commerce, House of Representatives, Ninety-ninth Congress, First Session, on Research and Treatment for Acquired Immune Deficiency Syndrome, July 22, 1985; Protection of Confidentiality of Records of Research Subjects and Blood Donors, July 29, 1985; Cost of AIDS Care and who is Going to Pay, November 1, 1985, Volume 4U.S. Government Printing Office, 1985 - 357 pages |
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Page 137
... Plasma for Antibodies to HTLV - III TO : All Registered Blood Establishments The Food and Drug Administration ( FDA ) ... source . IT IS IMPORTANT FOR DONORS TO UNDERSTAND THAT ALTHOUGH THE TEST IS BEING INTRODUCED TO MAKE BLOOD PRODUCTS AND ...
... Plasma for Antibodies to HTLV - III TO : All Registered Blood Establishments The Food and Drug Administration ( FDA ) ... source . IT IS IMPORTANT FOR DONORS TO UNDERSTAND THAT ALTHOUGH THE TEST IS BEING INTRODUCED TO MAKE BLOOD PRODUCTS AND ...
Page 142
... plasma collecting facility must maintain written records of all test results . The written record must be available before any product distribution occurs except for Source Leukocytes or in emergency situations when the blood product is ...
... plasma collecting facility must maintain written records of all test results . The written record must be available before any product distribution occurs except for Source Leukocytes or in emergency situations when the blood product is ...
Page 143
... Source Plasma , Recovered Human Plasma and other products intended only for further manufacture . An acceptable container statement is " Non - reactive by serologic test for HTLV - III " or " Non - reactive when tested for HBsAg and ...
... Source Plasma , Recovered Human Plasma and other products intended only for further manufacture . An acceptable container statement is " Non - reactive by serologic test for HTLV - III " or " Non - reactive when tested for HBsAg and ...
Page 156
... Source Plasma and all Licensed Manufacturers of Plasma Derivatives On 24 March 1983 , we issued recommendations to decrease the risk of transmitting the Acquired Immunodeficiency Syndrome ( AIDS ) from blood and plasma donors . Recently ...
... Source Plasma and all Licensed Manufacturers of Plasma Derivatives On 24 March 1983 , we issued recommendations to decrease the risk of transmitting the Acquired Immunodeficiency Syndrome ( AIDS ) from blood and plasma donors . Recently ...
Page 157
... PLASMA DERIVATIVES : 1. Educational materials should be provided to inform donors that at this time the following individuals should refrain from donating blood or plasma . 2 . A. B. C. D. E. Anyone who has AIDS or ... Source Plasma : 157.
... PLASMA DERIVATIVES : 1. Educational materials should be provided to inform donors that at this time the following individuals should refrain from donating blood or plasma . 2 . A. B. C. D. E. Anyone who has AIDS or ... Source Plasma : 157.
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Common terms and phrases
additional AIDS epidemic AIDS patients AIDS victims AIDS virus American antibody test antiviral agents Association Belle Glade blood and plasma blood banks blood or plasma blood products Blue Cross cells Chairman clinical confidentiality cost coverage DANNEMEYER diagnosis disability disclosure donate blood drug eligible ELISA employers estimated evaluation facilities factor IX factor VIII Federal funding Glades General Hospital health insurance hemophilia hospital HTLV-III antibody HTLV-III virus immune globulin increased risk individuals infected Kaposi's sarcoma LEHNHARD lymphadenopathy Medicaid Medicare million NIELSON Office of Biologics patients with AIDS percent persons plasma plasma collection plasma derivatives plasmapheresis positive potential present problem procedures programs protect Public Health Service questions reactive retrovirus risk groups SCHEUER screening sexual Source Plasma specific studies Subcommittee suramin Syndrome AIDS test results therapy tion transfusion trials viral WACHS WAXMAN Western blot York City
Popular passages
Page 171 - Records of the identity, diagnosis, prognosis, or treatment of any patient which are maintained in connection with the performance of any drug abuse prevention function...
Page 171 - ... conducted, regulated, or directly or indirectly assisted by any department or agency of the United States shall, except as provided in subsection (c), be confidential and be disclosed only for the purposes and under the circumstances expressly authorized under subsection (b) of this section.
Page 166 - An IRB may waive the requirement for the investigator to obtain a signed consent form for some or all subjects if it finds either: (1) That the only record linking the subject and the research would be the consent document and the principal risk would be potential harm resulting from a breach of confidentiality. Each subject will be asked whether the subject wants documentation linking the subject with...
Page 159 - Consistent with the recommendations of the American Red Cross, the American Association of Blood Banks, the Council of Community Blood Centers, the...
Page 165 - A disclosure of appropriate alternative procedures or courses of treatment, if any, that might be advantageous to the subject; (5) A statement describing the extent, if any, to which confidentiality of records identifying the subject will be maintained...
Page 166 - When appropriate, the research plan makes adequate provision for monitoring the data collected to ensure the safety of subjects. (7) When appropriate, there are adequate provisions to protect the privacy of subjects and to maintain the confidentiality of data.
Page 155 - DEPARTMENT OF HEALTH & HUMAN SERVICES Public Health Service Food and Drug Administration Rockville...
Page 178 - In addition, three major organizations dedicated to the development of high standards of donor protection and blood transfusion therapy — the American Association of Blood Banks, the American Red Cross, and the Council of Community Blood Centers...
Page 223 - The White House 1600 Pennsylvania Avenue NW Washington, DC 20500 Dear Mr. President: I am...
Page 150 - HTLV-III antibody should be offered to persons who may have been infected as a result of their contact with seropositive individuals (eg, sexual partners, persons with whom needles have been shared, infants born to seropositive mothers).