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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AAMC amphetamine approved assurance behavior Belmont Report benefits Biological Psychiatry biomedical Center Chairman Christopher Shays clinical research clinical trials Committee concerns conducted CONGRESS THE LIBRARY consent form continuing review disorders drug ELLIS ensure ethical evaluate Federal regulations fenfluramine fenfluramine study funded Government Reform GROB haloperidol Health and Human Human Services human subject protection human subjects research informed consent document informed consent process Institutional Review Boards investigators IRB members IRB process IRB review IRB system IRB's issues June 11 Kammen DP KUCINICH Levine LIBRARY OF CONGRESS MESLIN methylphenidate monitoring NBAC NIH-GRANT-NUMBER NIH/OPRR NIMH Office OIG's OPRR patients pharmaceutical population potential problems procedures protecting human subjects Protection from Research protection of human Psychiatric Institute question recommendations recruited Reform and Oversight regulatory require Research Risks research subjects response schizophrenia scientific serotonin SHAYS SNOWBARGER sponsors staff Thank Timothy Walsh Towns volunteer WALSH YESSIAN
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Page 45 - 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 46 - ... 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 46 - 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 44 - 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 47 - 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 144 - 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 5 - ... 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 45 - ... 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 42 - It is a local review, by individuals who are in the best position to know the resources of the institution, the capabilities and reputations of the investigators and staff, and the prevailing values and ethics of the community and likely subject population.