Institutional Review Boards, a System in Jeopardy: Hearing Before the Subcommittee on Human Resources of the Committee on Government Reform and Oversight, House of Representatives, One Hundred Fifth Congress, Second Session, June 11, 1998 |
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... SHAYS , Connecticut CHRISTOPHER COX , California ILEANA ROS - LEHTINEN , Florida JOHN M. MCHUGH , New York ' STEPHEN HORN , California JOHN L. MICA , Florida THOMAS M. DAVIS , Virginia DAVID M. MCINTOSH , Indiana MARK E. SOUDER ...
... SHAYS , Connecticut CHRISTOPHER COX , California ILEANA ROS - LEHTINEN , Florida JOHN M. MCHUGH , New York ' STEPHEN HORN , California JOHN L. MICA , Florida THOMAS M. DAVIS , Virginia DAVID M. MCINTOSH , Indiana MARK E. SOUDER ...
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... Shays , Hon . Christopher , a Representative in Congress from the State of Connecticut , information concerning IRBS Spilker , Bert , Ph.D. , M.D. , senior vice president , Scientific and Regu- latory Affairs , Pharmaceutical Research ...
... Shays , Hon . Christopher , a Representative in Congress from the State of Connecticut , information concerning IRBS Spilker , Bert , Ph.D. , M.D. , senior vice president , Scientific and Regu- latory Affairs , Pharmaceutical Research ...
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... Shays ( chairman of the subcommittee ) presiding . Present : Representatives Shays , Snowbarger , Pappas , Burton , Towns , Barrett , and Kucinich . Staff present : Lawrence J. Halloran , staff director and counsel ; Anne Marie Finley ...
... Shays ( chairman of the subcommittee ) presiding . Present : Representatives Shays , Snowbarger , Pappas , Burton , Towns , Barrett , and Kucinich . Staff present : Lawrence J. Halloran , staff director and counsel ; Anne Marie Finley ...
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... SHAYS . I thank the chairman of the full committee , and as- sure him that this will not be our only hearing and that we will have the FDA , HHS , and NIH here . Thank you very much . At this time , the Chair would recognize the ranking ...
... SHAYS . I thank the chairman of the full committee , and as- sure him that this will not be our only hearing and that we will have the FDA , HHS , and NIH here . Thank you very much . At this time , the Chair would recognize the ranking ...
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... SHAYS . I thank the gentleman . Mr. Pappas , do you have an opening statement ? Mr. PAPPAS . No , Mr. Chairman . Mr. SHAYS . Let me just get some housekeeping out of the way and ask unanimous consent that all members of the subcommittee ...
... SHAYS . I thank the gentleman . Mr. Pappas , do you have an opening statement ? Mr. PAPPAS . No , Mr. Chairman . Mr. SHAYS . Let me just get some housekeeping out of the way and ask unanimous consent that all members of the subcommittee ...
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Common terms and phrases
agencies approved assurance behavior Belmont Report benefits Biological Psychiatry biomedical Center Chairman Christopher Shays clinical research clinical trials Committee concerns conducted consent form continuing review Department of Health disorders drug ELLIS ensure ethical evaluate Federal regulations fenfluramine fenfluramine study funds Gary Ellis Government Reform GROB haloperidol Health and Human HIMA Human Services human subject protection human subjects research informed consent document informed consent process Inspector Institutional Review Boards IRB members IRB review IRB system IRB's issues June 11 Kammen DP Levine Meslin methylphenidate monitoring NBAC NIH-GRANT-NUMBER NIH/OPRR NIMH Office OIG's OPRR patients pharmaceutical population potential problems procedures Protection from Research protection of human Psychiatric Institute question recommendations regulatory research involving research protocols Research Risks research subjects response rights and welfare schizophrenia serotonin SHAYS SNOWBARGER sponsors staff Subcommittee system of protection Thank Timothy Walsh Towns understand volunteer WALSH YESSIAN
Popular passages
Page 46 - A description of any benefits to the subject or to others which may reasonably be expected from the research; §27.114 §27.116 (4) A disclosure of appropriate alternative procedures or courses of treatment, if any, that might be advantageous to the subject; (5) A statement describing the extent, if any, to which confidentiality of records identifying the subject will be maintained...
Page 47 - ... 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' rights, and whom to contact in the event of a research-related injury to the subject 8.
Page 47 - 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 45 - When some or all of the subjects are likely to be vulnerable to coercion or undue influence, such as children, prisoners, pregnant women, mentally disabled persons, or economically or educationally disadvantaged persons, additional safeguards have been included in the study to protect the rights and welfare of these subjects.
Page 48 - Department of Agriculture Department of Commerce Department of Defense Department of Education Department of Energy Department of Health and Human Services Department of Housing and Urban Development...
Page 110 - New imaging techniques, such as positron emission tomography (PET) and functional magnetic resonance imaging (fMRI), promise advances in our ability to identify regions of the brain associated with cognitive and affective disorders.
Page 131 - This meeting is adjourned. [Whereupon, at 3:35 pm, the subcommittee was adjourned, to reconvene at the call of the Chair.] [Additional information submitted for the hearing record follows:] EXECUTIVE OFFICE OF THE PRESIDENT OFFICE OF MANAGEMENT AND BUDGET WASHINGTON.
Page 6 - ... opening statement in the record, and that the record remain open for 3 days for that purpose. Without objection, so ordered. I ask further unanimous consent that all witnesses be permitted to include their written statements in the record.
Page 46 - ... are experimental. (2) A description of any reasonably foreseeable risks or discomforts to the subject. (3) A description of any benefits to the subject or to others which may reasonably be expected from the research. (4) A disclosure of appropriate alternative procedures or courses of treatment, if any, that might be advantageous to the subject. (5) A statement describing the extent, if any, to which confidentiality of records identifying the subject will be maintained and that notes the possibility...
Page 143 - The intervention or procedure is likely to yield generalizable knowledge about the subjects' disorder or condition which is of vital importance for the understanding or amelioration of the subjects...