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 9
... too alarmist . And it was our feeling that it would be bet- ter to concentrate our discussions on what should be done about the problem than on the particular language that was used in the title . So we were more than happy to change 9.
... too alarmist . And it was our feeling that it would be bet- ter to concentrate our discussions on what should be done about the problem than on the particular language that was used in the title . So we were more than happy to change 9.
Page 10
... particular problems that led us to do the broader study that is the subject of our hearing today . The things we found there are just not supposed to happen . So we thought well let us take a look then at the system under which that did ...
... particular problems that led us to do the broader study that is the subject of our hearing today . The things we found there are just not supposed to happen . So we thought well let us take a look then at the system under which that did ...
Page 31
... particular , how IRBS assess the risks of non - physical harms , such as dignitary or psychosocial harms resulting from discrimination or stigmatization . We expect this report to be available in the late spring , or early summer , and ...
... particular , how IRBS assess the risks of non - physical harms , such as dignitary or psychosocial harms resulting from discrimination or stigmatization . We expect this report to be available in the late spring , or early summer , and ...
Page 34
... particular protections in regulation . Second , given the importance for scientific and medical progress on diseases such as schizophrenia and Alzheimer's , some of these individuals are vulnerable to discrimination because they lack ...
... particular protections in regulation . Second , given the importance for scientific and medical progress on diseases such as schizophrenia and Alzheimer's , some of these individuals are vulnerable to discrimination because they lack ...
Page 35
... particular . One of these focuses on international research , specifically the rules that ought to apply when the United States conducts or supports research in other countries . The other project is a comprehensive assessment of the ...
... particular . One of these focuses on international research , specifically the rules that ought to apply when the United States conducts or supports research in other countries . The other project is a comprehensive assessment of the ...
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amphetamine approved asked assurance BARRETT behavior Belmont Report benefits Biological Psychiatry biomedical Center Chairman Christopher Shays clinical research clinical trials Committee concerns conducted consent form continuing review disorders drug ELLIS ensure ethical evaluate Federal regulations Fen-Phen fenfluramine fenfluramine study funded Government Reform GROB haloperidol Health and Human HIMA 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 MESLIN methylphenidate monitoring NBAC NIH-GRANT-NUMBER NIH/OPRR NIMH Nuremberg Code Office OIG's OPRR patients pharmaceutical population potential problems procedures Protection from Research protection of human Psychiatric Institute Psychopharmacology question recommendations recruited Reform and Oversight regulatory require research protocols Research Risks research subjects response schizophrenia scientific serotonin SHAYS SNOWBARGER sponsors staff Thank Timothy Walsh Towns understand volunteer WALSH YESSIAN
Popular passages
Page 44 - ... 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 43 - 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...
Page 44 - 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 42 - 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 45 - 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 123 - 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 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 4 - ... 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 43 - ... a description of the procedures to be followed, and identification of any procedures which are experimental; (2) A description of any reasonably foreseeable risks or discomforts to the subject...
Page 40 - Ideally, 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.