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 18
... ( OPRR ) and the Food and Drug Administration ( FDA ) have issued interpretations of Federal requirements in the forms of Dear Colleague letters and Information Sheets . However , from the perspective of the IRBs , some of these have ...
... ( OPRR ) and the Food and Drug Administration ( FDA ) have issued interpretations of Federal requirements in the forms of Dear Colleague letters and Information Sheets . However , from the perspective of the IRBs , some of these have ...
Page 20
... OPRR's oversight is limited almost entirely to an upfront assurance process . The assurance is a document stating an institution's commitment to adhere to Federal requirements and is considered by most IRB staff we spoke with to have ...
... OPRR's oversight is limited almost entirely to an upfront assurance process . The assurance is a document stating an institution's commitment to adhere to Federal requirements and is considered by most IRB staff we spoke with to have ...
Page 23
... OPRR and FDA . The thrust of our recommendations is for a more streamlined approach to providing human - subject protections , both at the local and Federal levels . At the same time , we call for a greater emphasis on accountability ...
... OPRR and FDA . The thrust of our recommendations is for a more streamlined approach to providing human - subject protections , both at the local and Federal levels . At the same time , we call for a greater emphasis on accountability ...
Page 24
... OPRR and FDA carry out their oversight responsibilities . We suggest reorienting the NIH / OPRR assurance process so that it rests essentially on an institutional attestation to conform to the IRB requirements set forth in Federal ...
... OPRR and FDA carry out their oversight responsibilities . We suggest reorienting the NIH / OPRR assurance process so that it rests essentially on an institutional attestation to conform to the IRB requirements set forth in Federal ...
Page 25
... OPRR incorporate into their oversight efforts specific lines of inquiry to determine how well IRBs are actually protecting human subjects . This would call for examining matters such as how the processes of recruiting , selecting , and ...
... OPRR incorporate into their oversight efforts specific lines of inquiry to determine how well IRBs are actually protecting human subjects . This would call for examining matters such as how the processes of recruiting , selecting , and ...
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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...