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| 008 | 070202s2007 mdu b 001 0 eng d | ||
| 010 | _a 2006012326 | ||
| 011 | _aBIB MATCHES WORLDCAT | ||
| 020 |
_a0801885019 _qhardcover (alk. paper) |
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| 020 |
_a9780801885013 _qhardcover (alk. paper) |
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| 020 |
_a0801885027 _qpbk. (alk. paper) |
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| 020 |
_a9780801885020 _qpbk. (alk. paper) |
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| 035 | _a(OCoLC)66524999 | ||
| 035 | _a(DLC) 2006012326 | ||
| 040 |
_aDLC _beng _erda _dATU |
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| 050 | 0 | 0 |
_aR853.H8 _bM39 2007 |
| 082 | 0 | 0 |
_a174.28 _222 |
| 100 | 1 |
_aMazur, Dennis John, _eauthor. _91063859 |
|
| 245 | 1 | 0 |
_aEvaluating the science and ethics of research on humans : _ba guide for IRB members / _cDennis J. Mazur. |
| 246 | 3 | 0 | _aGuide for IRB members |
| 264 | 1 |
_aBaltimore : _bJohns Hopkins University Press, _c2007. |
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| 300 |
_axi, 252 pages ; _c23 cm |
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| 336 |
_atext _btxt _2rdacontent |
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| 337 |
_aunmediated _bn _2rdamedia |
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| 338 |
_avolume _bnc _2rdacarrier |
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| 504 | _aIncludes bibliographical references (pages 239-245) and index. | ||
| 505 | 0 | 0 |
_tIntroduction/what can the new IRB member expect? -- _g1. _tWhat is an IRB, and what does it do? -- _g2. _tBasic terms and concepts used in IRB work -- _g3. _tWhat is risk? -- _g4. _tPrescreening of proposals -- _g5. _tThe scientific protocol -- _g6. _tThe informed consent form -- _g7. _tRecruitment, selection, and compensation of study participants -- _g8. _tResearch involving questionnaires and surveys -- _g9. _tProtection of participants' privacy in research data and specimens -- _g10. _tThe ethical issues of informed consent -- _g11. _tContinuing review, communication, and feedback -- _g12. _tWhere are IRBs making mistakes, and how can we minimize mistakes? -- _g13. _tStrategies for managing the IRB workload and supporting IRB decision making -- _g14. _tDecision-making capacity and accountability in research -- _tSummary : the IRB's key role -- _gApp. 1. _tA check list for reviewing a scientific protocol -- _gApp. 2. _tA check list for reviewing an informed consent form. |
| 520 | _a"Biomedical research on humans is an important part of medical progress. But, when lives are at risk, safety and ethical practices need to be the top priority. The need for the committees that regulate and oversee such research -- institutional review boards, or IRBs -- is growing. IRB members face difficult decisions every day. Evaluating the Science and Ethics of Research on Humans is a guide for new and veteran members of IRBs that will help them better understand the issues involved and the tasks they will be required to perform. The most important purpose of an IRB is to protect the lives of human participants. For three major research areas -- drugs, medical devices, and genetic information -- Dennis J. Mazur shares the methods he has found useful in protecting human participants through the systematic review of scientific protocols and informed consent forms and through adherence to the federal regulations that apply. New members will gain understanding of how proposed research projects are to be reviewed from both scientific and ethical dimensions, how and when to ask key questions of principal investigators, how to work with principal investigators and research teams to ensure the best protection of human participants, and why to schedule regularly spaced reviews of a project that may have adverse outcomes.Based on Mazur's thirty years of research experience, this accessible and informative guide will give all IRB members the tools they need to protect human lives and facilitate the research process."--Publisher description. | ||
| 588 | _aMachine converted from AACR2 source record. | ||
| 650 | 0 |
_aHuman experimentation in medicine _xMoral and ethical aspects _9745973 |
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| 650 | 0 |
_aMedical ethics. _9320610 |
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| 650 | 0 |
_aMedicine _xResearch _xMoral and ethical aspects _9808082 |
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| 650 | 2 |
_aEthics Committees, Research _xorganization & administration _9357828 |
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| 650 | 2 |
_aHuman Experimentation _xethics _9361478 |
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| 650 | 2 |
_aHuman Experimentation _xstandards _9361476 |
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| 650 | 2 |
_aEthical Review _9357762 |
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| 651 | 2 |
_aUnited States. _9368210 |
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| 856 | 4 | 2 |
_3Contributor biographical information _uhttp://www.loc.gov/catdir/enhancements/fy0668/2006012326-b.html |
| 907 |
_a.b11256904 _b10-06-19 _c27-10-15 |
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