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 |
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Page 2
... participating in medical research . Without informed consent , no veteran can properly be a research subject . The concerns about informed consent go straight back to the awful things the Nazis did to people during the holocaust , and ...
... participating in medical research . Without informed consent , no veteran can properly be a research subject . The concerns about informed consent go straight back to the awful things the Nazis did to people during the holocaust , and ...
Page 4
... participate in medical research programs that offer them the most advanced treatment available . But if informed con- sent requirements for veteran patients are not respected , and re- searchers are not held accountable for their ...
... participate in medical research programs that offer them the most advanced treatment available . But if informed con- sent requirements for veteran patients are not respected , and re- searchers are not held accountable for their ...
Page 7
... participating that might be beneficial to subjects . We essentially confirmed those allegations for a number of studies conducted at the Bronx VA , and required the Bronx VA and Mt. Sinai to institute corrective actions , not only in ...
... participating that might be beneficial to subjects . We essentially confirmed those allegations for a number of studies conducted at the Bronx VA , and required the Bronx VA and Mt. Sinai to institute corrective actions , not only in ...
Page 11
... participate if she or he does not want to participate . For vulnerable populations , such as elderly people , institutional review boards need to make sure there are special protections in place to ensure that subjects understand , and ...
... participate if she or he does not want to participate . For vulnerable populations , such as elderly people , institutional review boards need to make sure there are special protections in place to ensure that subjects understand , and ...
Page 14
... participate . We recommend that there be wait- ing periods between the time that the subject is approached about participating in research until the subject actually provides con- sent , so that the perspective subject has time to think ...
... participate . We recommend that there be wait- ing periods between the time that the subject is approached about participating in research until the subject actually provides con- sent , so that the perspective subject has time to think ...
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Common terms and phrases
action appropriate approved BUYER cardiology Chairman Chief of Staff Common Rule compliance conducted Cooperative Studies Program costs CRDO CSEC CSP study CSP/VA Headquarters CSPCC CSPCRPCC Data Monitoring Board Department of Veterans doctor drug ERIN MORIARTY ethical EVERETT facility Federal FEUSSNER Footage funding GLAHS Health hospital human research Human Rights Committee Human Studies informed consent Institutional Review Board issues KIZER March 22 medical research meeting MORIARTY NBAC NORMAN October 30 Office OPRR oversight PANDOL participating medical centers patients planning Principal Proponent problems procedures proposed Protection of Human protocol psychiatric PUGLISI R&D Committee recommendations regulations Research and Development research involving research program research project research subjects responsible risk Sager SANTANA schizophrenia Shalmah Shamoo SNYDER specific SPENCER Study Biostatistician Study Chairperson Study CRP Subcommittee Thank treatment UCLA VA Medical Center VAMC Veterans Affairs Voiceover West Los Angeles
Popular passages
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.