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
... result , the 25 - year - old system of review and oversight intended to ensure ethical design and implementation of research protocols is in need of structural reforms . These important findings and recommendations by the HHS In ...
... result , the 25 - year - old system of review and oversight intended to ensure ethical design and implementation of research protocols is in need of structural reforms . These important findings and recommendations by the HHS In ...
Page 3
... result of some compelling witnesses ' testimony , that a real problem exists within the scientific community in providing meaningful protections to clinical trial subjects . Several problems were discussed in the context of clinical ...
... result of some compelling witnesses ' testimony , that a real problem exists within the scientific community in providing meaningful protections to clinical trial subjects . Several problems were discussed in the context of clinical ...
Page 12
... describe the results of our recent work . Our total effort reveals a brittle system Human Resources Subcommittee June 11 , 1998 and even a few cracks . I call these to House Government Reform and Oversight Committee Page 1 12.
... describe the results of our recent work . Our total effort reveals a brittle system Human Resources Subcommittee June 11 , 1998 and even a few cracks . I call these to House Government Reform and Oversight Committee Page 1 12.
Page 20
... results - focused inquires we have found of IRB performance , resulting in strong recommendations to the IRBs . But because of resource shortages , they are infrequent . Between April 1997 and May 1998 , OPRR conducted only one for ...
... results - focused inquires we have found of IRB performance , resulting in strong recommendations to the IRBs . But because of resource shortages , they are infrequent . Between April 1997 and May 1998 , OPRR conducted only one for ...
Page 23
... results . Our recommendations include a number of actions , many of which , in the near - term , could help to address the vulnerabilities in the system . These are , among others : Grant IRBs Greater Flexibility but Hold them More ...
... results . Our recommendations include a number of actions , many of which , in the near - term , could help to address the vulnerabilities in the system . These are , among others : Grant IRBs Greater Flexibility but Hold them More ...
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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.