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 4

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Page 169 - 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 169 - ... 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 171 - 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 347 - INPATIENT HOSPITAL SERVICES, OUTPATIENT HOSPITAL SERVICES, RURAL HEALTH CLINIC SERVICES, OTHER LABORATORY AND RADIOLOGY SERVICES, SKILLED NURSING FACILITY (SNF) SERVICES...
Page 163 - 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 171 - 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 - AIDS or one of its signs and symptoms; 2) males who have had sex with more than one male since 1979, and males whose sexual partner has had sex with more than one male since 1979; 3) past or present abusers of intravenous drugs; 4) Haitians who entered the (JSA after 1977; 5) hemophiliacs; and 6) sexual partners of persons in these groups.
Page 21 - ... extremely sensitive to the gravity of the AIDS problem and has expedited all requests for the study of experimental agents for this condition. The FDA has met on one or more occasions with every manufacturer who has expressed an interest in submitting an IND for the use of a product in AIDS or AIDS-related complex to discuss the procedures for filing an IND. In these meetings with company officials, FDA scientists have discussed the information necessary to submit for inclusion in the IND request....
Page 157 - Consistent with the recommendations of the American Red Cross, the American Association of Blood Banks, the Council of Community Blood Centers, the...
Page 34 - Based upon the observations of PHS scientists in early 1982 that IL-2, a T cell derived protein was capable of enhancing the killer cell activity of lymphocytes from AIDS patients, Phase I clinical trials of this compound were Initiated in June, 1982. Initial trials employed low doses of crudely prepared materials while the current trials utilize highly purified recombinant proteins. Preliminary results indicate that this drug can enhance the lymphocyte count and cause a minor reduction 1n Kaposl's...

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