MARC record from Internet Archive

LEADER: 10459pam a22004454a 4500
001 5500159
005 20221110050534.0
008 050625t20062006mau b 001 0 eng
010 $a 2005018289
015 $aGBA609339$2bnb
016 7 $a101251051$2DNLM
016 7 $a013366776$2Uk
020 $a0763730491 (case bound)
029 1 $aNLM$b101251051
035 $a(OCoLC)ocm60776744
035 $a(NNC)5500159
035 $a5500159
040 $aDNLM/DLC$cDLC$dYDX$dNLM$dBAKER$dUKM$dOrLoB-B
042 $apcc
050 00 $aR852.5$b.A46 2006
060 00 $aW 20.5$bI6173 2006
082 00 $a616/.027$222
245 00 $aInstitutional review board :$bmanagement and function /$c[edited by] Elizabeth A. Bankert, Robert J. Amdur.
250 $a2nd ed.
260 $aSudbury, Mass. :$bJones and Bartlett,$c[2006], ©2006.
300 $axxvii, 530 pages ;$c29 cm
336 $atext$btxt$2rdacontent
337 $aunmediated$bn$2rdamedia
505 00 $tForeword : Jesse's intent /$rPaul Gelsinger -- $tPreface /$rElizabeth A. Bankert and Robert J. Amdur -- $tAn ethics primer for institutional review boards /$rHarold Y. Vanderpool -- $tReflections of an outsider /$rMark R. Yessian -- $tA unified human-research protection program /$rSanford Chodosh -- $tA shared responsibility for protecting human subjects /$rSteven Peckman -- $tA brief history of public responsibility in medicine and research and institutional review board education /$rJoan Rachlin -- $tThe institutional review board : definition and federal oversight /$rRobert J. Amdur and Elizabeth A. Bankert -- $tThe limits of institutional review board authority /$rRobert J. Amdur -- $tAdministrative reporting structure for the institutional review board /$rErnest D. Prentice, Sally L. Mann and Bruce G. Gordon -- $tDocumentation, policies, and procedures /$rCelia S. Walker and Deborah Barnard -- $tTracking systems using information technology /$rPatricia M. Scannell and Denise Niles Canales -- $tSupport staff /$rHelen McGough -- $tAudit systems /$rErnest D. Prentice, Ada Sue Selwitz, Gwenn S. F. Oki and Judi Kuhl -- $tCharging for institutional review board review /$rErnest D. Prentice, Sally L. Mann and Bruce G. Gordon -- $tReflections on chairing an institutional review board /$rRobert J. Levine -- $tThe institutional review board chair /$rRobert J. Amdur and Robert M. Nelson -- $tThe institutional review board administrative director /$rElizabeth A. Bankert and Robert J. Amdur -- $tThe role of an attorney /$rSusan Nicholson -- $tCommittee size, alternates, and consultants /$rRobert J. Amdur and Elizabeth A. Bankert -- $tLength, frequency, and time of institutional review board meetings /$rRobert J. Amdur and Elizabeth A. Bankert -- $tInstitutional review board subcommittees /$rRobert J. Amdur -- $tSocial science versus biomedical institutional review boards /$rRobert J. Amdur and Elizabeth A. Bankert -- $tExempt from institutional review board review /$rErnest D. Prentice and Gwenn S. F. Oki -- $tExpedited institutional review board review /$rGwenn S. F. Oki and John A. Zaia -- $tIdentifying intent : is this project research? /$rRobert J. Amdur, Marjorie Speers and Elizabeth Bankert -- $tCompassionate use and emergency use exemption /$rElizabeth A. Bankert and Robert J. Amdur -- $tWaiver of consent in emergency medicine research /$rHelen McGough -- $tOverview of initial protocol review /$rSarah T. Khan and Susan Z. Kornetsky -- $tEvaluating study design and quality /$rRobert J. Amdur -- $tThe study population : women, minorities, and children /$rAmy L. Davis -- $tCommunity consultation to assess and minimize group harms /$rWilliam L. Freeman, Francine C. Romero and Sayaka Kanade -- $tPrivacy and confidentiality /$rDavid G. Forster -- $tRecruitment of research subjects /$rMattew D. Whalen and Felix A. Khin-Maung-Gyi -- $tAdvertisements for research /$rRachel Hepp, Rachel Krebs, Linda Medwar, Christina Di Tomasso and Anne Dyson -- $tPaying research subjects /$rBruce G. Gordon, Joseph S. Brown, Christopher J. Kratochvil and Toby L. Schonfeld -- $tProvisions for data monitoring /$rRobert J. Amdur -- $tConflict of interest : researchers /$rDaniel K. Nelson -- $tConflict of interest : recruitment incentives /$rDaniel K. Nelson -- $tConflict of interest : institutional review boards /$rDaniel K. Nelson -- $tAdministrative tasks before each instutional review board meeting /$rRebecca Carson Rogers -- $tGuidelines for review, discussion, and voting /$rRobert J. Amdur and Elizabeth A. Bankert -- $tAdministrative tasks after each institutional review board meeting /$rJan Trott and Rebecca Carson Rogers -- $tThe institutional review board's role in editing the consent document /$rRobin L. Penslar -- $tThe consent document /$rAngela J. Bowen -- $tExculpatory language in informed consent documents /$rMichele Russell-Einhorn and Thomas Puglisi -- $tRequiring a witness signature on the consent form /$rMichele Russell-Einhorn and Thomas Puglisi -- $tDeception of research subjects /$rLaurie Slone and Jay Hull -- $tResearch without consent or documentation thereof /$rMarianne M. Elliott -- $tSelecting a surrogate to consent to medical research /$rRobert J. Amdur, Natalie Bachir and Elizabeth Stanton -- $tResearch-related injuries /$rDaniel R. Vasgird -- $tInforming subjects about research results /$rThomas G. Keens -- $tExplaining the cost of research participation /$rKevin M. Hunt -- $tImproving informed consent /$rJeffrey A. Cooper and Pamela Turner -- $tInformed consent evaluation feedback tool /$rElizabeth A. Bankert and Robert J. Amdur -- $tRevisions to an approved study /$rSherry Bye and Ann O'Hara -- $tProtocol renewal /$rKaren M. Hansen -- $tInstitutional review board review of adverse events /$rChristopher J. Kratochvil, Ernest D. Prentice, Kevin J. Epperson and Bruce G. Gordon -- $tData and safety monitoring /$rAllen McCutchan -- $tNoncompliance, complaints, deviations, and eligibility exceptions /$rLucille Pearson and Tracy Ostler -- $tInstitutional review board closure of study files /$rSandra P. Kaltman and John M. Isidor -- $tHealth insurance portability and accountability act and research /$rLawrence H. Muhlbaier -- $tOffice for human research protections federalwide assurance /$rJeffrey M. Cohen -- $tInternational conference on harmonisation /$rDavid G. Forster and Gary L. Chadwick -- $tThe role of the institutional biosafety committee : human gene transfer research /$rMichael B. Blayney -- $tUnderstanding the Food and Drug Administration's investigational new drug process /$rDale E. Hammerschmidt -- $tDifferences between Department of Health and Human Services and Food and Drug Administration regulations /$rRobert J. Amdur -- $tVeterans Administration research guidelines /$rPeter Marshall and Kathy Schulz -- $tState law /$rSandra P. Kaltman and John M. Isidor -- $tInstitutional review board member liability /$rSandra P. Kaltman and John M. Isidor -- $tCertificates of confidentiality /$rSandra P. Kaltman and John M. Isidor -- $tTraining institutional review board members /$rJeffrey A. Cooper and Pamela Turner -- $tInvestigator training /$rJeffrey A. Cooper and Pamela Turner -- $tAccreditation of human research protection programs /$rSusan S. Fish -- $tCertification of institutional review board professionals /$rSusan J. Delano, Sallyann Henry and Gary L. Chadwick -- $tPreparing for a Food and Drug Administration audit /$rGary L. Chadwick -- $tPreparing for an office for human research protections site visit /$rThomas Puglisi and Michele Russell-Einhorn -- $tVulnerability in research /$rJames M. DuBois -- $tResearch in public schools /$rLorna Hicks -- $tPhase I clinical trials in healthy adults /$rCynthia S. Way -- $tRequiring birth control to participate in research /$rBruce G. Gordon, Toby L. Schonfeld and Ernest D. Prentice -- $tResearch involving fetuses and in vitro fertilization /$rRonald M. Green -- $tResearch involving pregnant women /$rAngela J. Bowen -- $tResearch involving children /$rRobert M. Nelson -- $tResearch involving adults with decisional impairment /$rSusan J. Delano -- $tRegulatory issues of research involving prisoners /$rChristopher J. Kratochvil, Ernest D. Prentice, Bruce G. Gordon and Gail D. Kotulak -- $tResearch involving college students /$rJennifer J. Tickle and Todd F. Heatherton -- $tWhen are research risks reasonable in relationship to anticipated benefits? /$rCharles Weijer and Paul B. Miller -- $tInternet research : a brief guide for institutional review boards /$rJeffrey M. Cohen -- $tQualitative social science research /$rDean R. Gallant and Alan Bliss -- $tEthnographic research /$rElisabeth Smith Parrott -- $tHealth services research /$rAnn Barry Flood -- $tEpidemiology/public health research /$rMarjorie A. Speers -- $tSurvey research /$rJ. Michael Oakes -- $tResearch involving a medical device /$rErica J. Heath -- $tHumanitarian use devices /$rRobert J. Amdur -- $tBanking of human biological materials for research /$rMark Sobel and Karen Hansen -- $tThe placebo-controlled clinical trial /$rRobert J. Amdur and C. J. Biddle --
500 $aRev. ed. of: Institutional review board / Robert J. Amdur, Elizabeth A. Bankert. c2002.
504 $aIncludes bibliographical references (p. [519]-[520]) and index.
505 80 $tTreatment-withholding studies in psychiatry /$rRichard B. Ferrell -- $tPhase I oncology trials /$rMatthew Miller -- $tResearch involving genetic testing /$rEric C. Larsen -- $tInternational research /$rDavid A. Borasky -- $tAlternative medicine research /$rTimothy Callahan -- $tEthical codes -- $tThe Nuremberg Code -- $tThe Belmont Report -- $tSelected U.S. government regulations -- $tCode of Federal Regulations : Title 45, Part 46 -- $tCode of Federal Regulations : Title 21, Part 50 -- $tCode of Federal Regulations : Title 21, Part 56 -- $tExpedited review criteria.
650 0 $aInstitutional review boards (Medicine)$xManagement.
650 12 $aEthics Committees, Research$xorganization & administration.$0https://id.nlm.nih.gov/mesh/D028744Q000458
650 12 $aEthics, Medical.$0https://id.nlm.nih.gov/mesh/D004992
700 1 $aBankert, Elizabeth A.$0http://id.loc.gov/authorities/names/n2001017040
700 1 $aAmdur, Robert J.$0http://id.loc.gov/authorities/names/n2001017039
700 1 $aAmdur, Robert J.$tInstitutional review board.
856 41 $3Table of contents$uhttp://www.loc.gov/catdir/toc/ecip0515/2005018289.html
852 00 $boff,hsl$hR852.5$i.A46 2006