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 211
... CSEC Review Process 3 . CSEC Recommendations E. Review by Participating Medical Centers IV . INITIATING A CSP COOPERATIVE STUDY A. B. C. Study Chairperson Selecting the Participating VA Medical Centers Forms Approval and Printing D. The ...
... CSEC Review Process 3 . CSEC Recommendations E. Review by Participating Medical Centers IV . INITIATING A CSP COOPERATIVE STUDY A. B. C. Study Chairperson Selecting the Participating VA Medical Centers Forms Approval and Printing D. The ...
Side 212
... CSEC Reviews of Ongoing Studies P. Periodic Reports . 1 . Research and Development Information System ( RDIS ) 2 . Annual Progress Report to FDA 28 28 29 29 30 30 30 K. Replacement of a PI or Study Chairperson During the Course of a ...
... CSEC Reviews of Ongoing Studies P. Periodic Reports . 1 . Research and Development Information System ( RDIS ) 2 . Annual Progress Report to FDA 28 28 29 29 30 30 30 K. Replacement of a PI or Study Chairperson During the Course of a ...
Side 217
... ( CSEC ) . Cooperative Studies Program Coordinating Center ( CSPCC ) During the planning phase , the CSPCC , represented primarily by the Study Biostatistician , will : Help select members of the Planning Committee . • Provide logistical ...
... ( CSEC ) . Cooperative Studies Program Coordinating Center ( CSPCC ) During the planning phase , the CSPCC , represented primarily by the Study Biostatistician , will : Help select members of the Planning Committee . • Provide logistical ...
Side 220
... CSEC review . It is important that these negotiations be completed prior to CSEC review so that the start of the study will not be delayed once funding is approved . Industry representatives may participate in planning meetings , since ...
... CSEC review . It is important that these negotiations be completed prior to CSEC review so that the start of the study will not be delayed once funding is approved . Industry representatives may participate in planning meetings , since ...
Side 221
... CSEC review . To facilitate review , the proposal will be assembled in two volumes . The first volume contains the study protocol , study budget material , selected human rights documents and CVs of the Principal Proponent ( s ) , Study ...
... CSEC review . To facilitate review , the proposal will be assembled in two volumes . The first volume contains the study protocol , study budget material , selected human rights documents and CVs of the Principal Proponent ( s ) , Study ...
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Vanlige uttrykk og setninger
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.