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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Page 1
... ensure ethical design and implementation of research protocols is in need of structural reforms . These important findings and recommendations by the HHS In- spector General confirm and amplify testimony we heard in May 1997 , that the ...
... ensure ethical design and implementation of research protocols is in need of structural reforms . These important findings and recommendations by the HHS In- spector General confirm and amplify testimony we heard in May 1997 , that the ...
Page 12
... ensuring human - subject protections has not kept pace with these changes . Its shortcomings could become more apparent and significant in light of future developments . These include plans to increase the Federal investment in cancer ...
... ensuring human - subject protections has not kept pace with these changes . Its shortcomings could become more apparent and significant in light of future developments . These include plans to increase the Federal investment in cancer ...
Page 16
... ensure the equitable recruitment of subjects and , more importantly , ensure that subjects understand the distinction between research and treatment . Resources Subcommittee June 11 , 1998 2. IRBS Conduct Minimal Continuing Review of ...
... ensure the equitable recruitment of subjects and , more importantly , ensure that subjects understand the distinction between research and treatment . Resources Subcommittee June 11 , 1998 2. IRBS Conduct Minimal Continuing Review of ...
Page 25
... ensure the integrity of the consent process itself . In the current system , IRBs have no way of knowing whether those participating in research truly understand that they are research subjects , and that there may be risks associated ...
... ensure the integrity of the consent process itself . In the current system , IRBs have no way of knowing whether those participating in research truly understand that they are research subjects , and that there may be risks associated ...
Page 29
... ensure any risks subjects may incur are warranted in relation to the anticipated benefits , that informed consent documents clearly convey the risks and the true nature of research , advertisements are not misleading , and the selection ...
... ensure any risks subjects may incur are warranted in relation to the anticipated benefits , that informed consent documents clearly convey the risks and the true nature of research , advertisements are not misleading , and the selection ...
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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...