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 7
... addition , this physician will assess : presence of prenatal / perinatal factors which may exert effects upon the central nervous system abnormal development history by use of the Denver Developmental Screening Test evidence of organic ...
... addition , this physician will assess : presence of prenatal / perinatal factors which may exert effects upon the central nervous system abnormal development history by use of the Denver Developmental Screening Test evidence of organic ...
Page 8
... additional concerns were raised and after these are addressed , approval will be given . Please send 2 copies of the revised material . 1. Delete Mt. Sinai as a site from the IRB Protocol Summary Form face sheet . 2. Approval of the MRI ...
... additional concerns were raised and after these are addressed , approval will be given . Please send 2 copies of the revised material . 1. Delete Mt. Sinai as a site from the IRB Protocol Summary Form face sheet . 2. Approval of the MRI ...
Page 14
... additional site visits accompanying FDA inspectors ; a survey on the electronic e - mail forum for those associated with IRBs ; and the systematic gathering of data from representatives of about 75 IRBS . IRB Role : Trust but Verify The ...
... additional site visits accompanying FDA inspectors ; a survey on the electronic e - mail forum for those associated with IRBs ; and the systematic gathering of data from representatives of about 75 IRBS . IRB Role : Trust but Verify The ...
Page 17
... addition , although many IRBs would like to , few oversee the consent process or solicit feedback from subjects . Research investigators are relied upon to provide timely , accurate reports to the IRB . Several IRB members we spoke with ...
... addition , although many IRBs would like to , few oversee the consent process or solicit feedback from subjects . Research investigators are relied upon to provide timely , accurate reports to the IRB . Several IRB members we spoke with ...
Page 28
... additional responsibilities . We cannot afford to wait any longer to act . It is time for reform . Thank you for the opportunity to testify on this most important topic . At this time , I would be happy to answer any questions which you ...
... additional responsibilities . We cannot afford to wait any longer to act . It is time for reform . Thank you for the opportunity to testify on this most important topic . At this time , I would be happy to answer any questions which you ...
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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.