Suspension of Medical Research at West Los Angeles and Sepulveda VA Medical Facilities and Informed Consent and Patient Safety in VA Medical Research: Joint Hearing Before the Subcommittee on Oversight and Investigations and Subcommittee on Health of the Committee on Veterans' Affairs, House of Representatives, One Hundred Sixth Congress, First Session, April 21, 1999
United States. Congress. House. Committee on Veterans' Affairs. Subcommittee on Oversight and Investigations
U.S. Government Printing Office, 2000 - 253 sider
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action activities additional administrative agencies animal appropriate approved associated Assurance authority benefit Board Chairman changes Chief clinical Committee Common Rule completed concerns conducted considered continue Cooperative Studies copy correct costs CRDO CSEC CSPCC Department Development Director doctor documents drug ensure ethical EVERETT experiments facilities Federal final Footage funding GLAHS going Headquarters Health hospital human research human subjects identified important individual informed consent institutions interest investigators involving issues March Medical Center meeting Monitoring MORIARTY NORMAN Office OPRR oversight participating patients performance person planning present Principal problems procedures proposed protection protocol PUGLISI question receive recommendations records regulations representative request responsible Review Board risk specific staff statement Study Chairperson Subcommittee Thank treatment understand University veterans Voiceover West Los Angeles
Side 98 - A statement that the study Involves research, an explanation of the purposes of the research and the expected duration of the subject's participation, a description of the procedures to be followed, and identification of any procedures which are experimental...
Side 203 - ... responses outside the research could reasonably place the subjects at risk of criminal or civil liability or be damaging to the subjects' financial standing, employability, or reputation.
Side 195 - That the research presents no more than minimal risk of harm to subjects and involves no procedures for which written consent is normally required outside of the research context.
Side 99 - A statement describing the extent, if any, to which confidentiality of records identifying the subject will be maintained; (6) For research involving more than minimal risk, an explanation as to whether any compensation and an explanation as to whether any medical treatments are available if injury occurs and, if so, what they consist of, or where further information may be obtained; (7) An explanation of whom to contact for answers to pertinent questions about the research and research subjects'...
Side 195 - ... short form. (c) 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.
Side 203 - ... specimens, if these sources are publicly available or if the information is recorded by the investigator in such a manner that subjects cannot be identified, directly or through identifiers linked to the subjects.
Side 209 - Nothing in these regulations is intended to limit the authority of a physician to provide emergency medical care, to the extent the physician is permitted to do so under applicable federal, state, or local law.
Side 96 - Department of Agriculture Department of Commerce Department of Defense Department of Education Department of Energy Department of Health and Human Services...