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 - Informed consent (Medical law) - 253 pages
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action activities additional administrative Affairs agencies animal appropriate approved associated Assurance authority benefit Chairman changes Chief clinical Committee Common Rule completed compliance concerns conducted considered continue Cooperative Studies correct costs CSPCC Department Development Director disorders doctor documents drug ensure ethical EVERETT experiments facilities fact Federal Footage funding GLAHS going 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 participation patients performance person planning problems procedures proposed protection protocol PUGLISI question received recommendations record regulations representative request research involving responsible result risk safety specific SPENCER staff statement Subcommittee suspension Thank treatment understand University veterans Voiceover West Los Angeles
Page 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...
Page 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'...
Page 205 - ... 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.
Page 197 - ... 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.
Page 205 - ... 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.
Page 210 - The consequences of a subject's decision to withdraw from the research and procedures for orderly termination of participation by the subject...
Page 96 - Department of Agriculture Department of Commerce Department of Defense Department of Education Department of Energy Department of Health and Human Services...
Page 193 - The IRB should not consider possible longrange effects of applying knowledge gained in the research (for example, the possible effects of the research on public policy) as among those research risks that fall within the purview of its responsibility.
Page 210 - A statement that the particular treatment or procedure may involve risks to the subject (or to the embryo or fetus, if the subject is or may become pregnant) which are currently unforeseeable.
Page 98 - An IRB shall conduct continuing review of research covered by this policy at intervals appropriate to the degree of risk, but not less than once per year, and shall have authority to observe or have a third party observe the consent process and the research.