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, 1999U.S. Government Printing Office, 2000 - 253 sider |
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Side 8
... going to have a second round for the members . At this time , I will ask Chairman Stearns for his questions . Mr. STEARNS . Thank you , Mr. Chairman . Dr. Ellis , how long have you been in your present position ? Mr. ELLIS . Six and a ...
... going to have a second round for the members . At this time , I will ask Chairman Stearns for his questions . Mr. STEARNS . Thank you , Mr. Chairman . Dr. Ellis , how long have you been in your present position ? Mr. ELLIS . Six and a ...
Side 11
... going to be done , and what the risks are . Ms. BROWN . Let me just ask you , is OPRR adequately funded , staffed ? Mr. PUGLISI . OPRR oversees research at approximately 4,000 in- stitutions . We have our human subject staff of ...
... going to be done , and what the risks are . Ms. BROWN . Let me just ask you , is OPRR adequately funded , staffed ? Mr. PUGLISI . OPRR oversees research at approximately 4,000 in- stitutions . We have our human subject staff of ...
Side 12
... going on at any time . It is not amazing that you begin an investiga- tion in 1993 , and in 1998 you finally reach a conclusion . Five years from the moment in which - to use your words , Dr. Ellis - you found a serious situation , a ...
... going on at any time . It is not amazing that you begin an investiga- tion in 1993 , and in 1998 you finally reach a conclusion . Five years from the moment in which - to use your words , Dr. Ellis - you found a serious situation , a ...
Side 13
... going to cut 7,500 em- ployees . This particular veteran - this is just one example - I don't know how they are going to have anybody for institutional review boards , they don't have people to feed the patients . Their goal , Mr ...
... going to cut 7,500 em- ployees . This particular veteran - this is just one example - I don't know how they are going to have anybody for institutional review boards , they don't have people to feed the patients . Their goal , Mr ...
Side 16
... going , to the benefit of what institutions ? Do you know that yet ? Mr. PUGLISI / ELLIS . No , sir . Mr. BUYER . When will you be able to inform us of that ? Mr. PUGLISI . The cardiac research that has been in the media has not , up to ...
... going , to the benefit of what institutions ? Do you know that yet ? Mr. PUGLISI / ELLIS . No , sir . Mr. BUYER . When will you be able to inform us of that ? Mr. PUGLISI . The cardiac research that has been in the media has not , up to ...
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appropriate approved Chairman Chief of Staff Common Rule compliance conducted CONGRESS THE LIBRARY Cooperative Studies Program CRDO CSEC CSP study 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 human subjects informed consent Institutional Review Board issues KIZER medical research meeting MORIARTY NBAC NORMAN October 30 Office OPRR oversight PANDOL participating medical centers patients planning post-traumatic stress disorder Principal Proponent problems procedures proposed Protection of Human protocol psychiatric PUGLISI R&D Committee radioactive recommendations regulations Research and Development research involving research program research subjects responsible risk Sager SANTANA schizophrenia Sepulveda 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
Populære avsnitt
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 209 - The research involves no more than minimal risk to the subjects; (2) The waiver or alteration will not Adversely affect the rights and welfare of the subjects; (3) The research could not practicably be carried out without the waiver or alteration...
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...
Side 191 - 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.