Princeton University Library Catalog

Institutional review board : management and function / [edited by] Elizabeth A. Bankert, Robert J. Amdur.

Sudbury, Mass. : Jones and Bartlett, c2006.
2nd ed.
xxvii, 530 p. ; 29 cm.
Rev. ed. of: Institutional review board / Robert J. Amdur, Elizabeth A. Bankert. c2002.
Bibliographic references:
Includes bibliographical references (p. [519]-[520]) and index.
  • Foreword : Jesse's intent / Paul Gelsinger -- Preface / Elizabeth A. Bankert and Robert J. Amdur -- An ethics primer for institutional review boards / Harold Y. Vanderpool -- Reflections of an outsider / Mark R. Yessian -- A unified human-research protection program / Sanford Chodosh -- A shared responsibility for protecting human subjects / Steven Peckman -- A brief history of public responsibility in medicine and research and institutional review board education / Joan Rachlin -- The institutional review board : definition and federal oversight / Robert J. Amdur and Elizabeth A. Bankert -- The limits of institutional review board authority / Robert J. Amdur -- Administrative reporting structure for the institutional review board / Ernest D. Prentice, Sally L. Mann and Bruce G. Gordon -- Documentation, policies, and procedures / Celia S. Walker and Deborah Barnard -- Tracking systems using information technology / Patricia M. Scannell and Denise Niles Canales -- Support staff / Helen McGough -- Audit systems / Ernest D. Prentice, Ada Sue Selwitz, Gwenn S. F. Oki and Judi Kuhl -- Charging for institutional review board review / Ernest D. Prentice, Sally L. Mann and Bruce G. Gordon -- Reflections on chairing an institutional review board / Robert J. Levine -- The institutional review board chair / Robert J. Amdur and Robert M. Nelson -- The institutional review board administrative director / Elizabeth A. Bankert and Robert J. Amdur -- The role of an attorney / Susan Nicholson -- Committee size, alternates, and consultants / Robert J. Amdur and Elizabeth A. Bankert -- Length, frequency, and time of institutional review board meetings / Robert J. Amdur and Elizabeth A. Bankert -- Institutional review board subcommittees / Robert J. Amdur -- Social science versus biomedical institutional review boards / Robert J. Amdur and Elizabeth A. Bankert -- Exempt from institutional review board review / Ernest D. Prentice and Gwenn S. F. Oki -- Expedited institutional review board review / Gwenn S. F. Oki and John A. Zaia -- Identifying intent : is this project research? / Robert J. Amdur, Marjorie Speers and Elizabeth Bankert -- Compassionate use and emergency use exemption / Elizabeth A. Bankert and Robert J. Amdur -- Waiver of consent in emergency medicine research / Helen McGough -- Overview of initial protocol review / Sarah T. Khan and Susan Z. Kornetsky -- Evaluating study design and quality / Robert J. Amdur -- The study population : women, minorities, and children / Amy L. Davis -- Community consultation to assess and minimize group harms / William L. Freeman, Francine C. Romero and Sayaka Kanade -- Privacy and confidentiality / David G. Forster -- Recruitment of research subjects / Mattew D. Whalen and Felix A. Khin-Maung-Gyi -- Advertisements for research / Rachel Hepp, Rachel Krebs, Linda Medwar, Christina Di Tomasso and Anne Dyson -- Paying research subjects / Bruce G. Gordon, Joseph S. Brown, Christopher J. Kratochvil and Toby L. Schonfeld -- Provisions for data monitoring / Robert J. Amdur -- Conflict of interest : researchers / Daniel K. Nelson -- Conflict of interest : recruitment incentives / Daniel K. Nelson -- Conflict of interest : institutional review boards / Daniel K. Nelson -- Administrative tasks before each instutional review board meeting / Rebecca Carson Rogers -- Guidelines for review, discussion, and voting / Robert J. Amdur and Elizabeth A. Bankert -- Administrative tasks after each institutional review board meeting / Jan Trott and Rebecca Carson Rogers -- The institutional review board's role in editing the consent document / Robin L. Penslar -- The consent document / Angela J. Bowen -- Exculpatory language in informed consent documents / Michele Russell-Einhorn and Thomas Puglisi -- Requiring a witness signature on the consent form / Michele Russell-Einhorn and Thomas Puglisi -- Deception of research subjects / Laurie Slone and Jay Hull -- Research without consent or documentation thereof / Marianne M. Elliott -- Selecting a surrogate to consent to medical research / Robert J. Amdur, Natalie Bachir and Elizabeth Stanton -- Research-related injuries / Daniel R. Vasgird -- Informing subjects about research results / Thomas G. Keens -- Explaining the cost of research participation / Kevin M. Hunt -- Improving informed consent / Jeffrey A. Cooper and Pamela Turner -- Informed consent evaluation feedback tool / Elizabeth A. Bankert and Robert J. Amdur -- Revisions to an approved study / Sherry Bye and Ann O'Hara -- Protocol renewal / Karen M. Hansen -- Institutional review board review of adverse events / Christopher J. Kratochvil, Ernest D. Prentice, Kevin J. Epperson and Bruce G. Gordon -- Data and safety monitoring / Allen McCutchan -- Noncompliance, complaints, deviations, and eligibility exceptions / Lucille Pearson and Tracy Ostler -- Institutional review board closure of study files / Sandra P. Kaltman and John M. Isidor -- Health insurance portability and accountability act and research / Lawrence H. Muhlbaier -- Office for human research protections federalwide assurance / Jeffrey M. Cohen -- International conference on harmonisation / David G. Forster and Gary L. Chadwick -- The role of the institutional biosafety committee : human gene transfer research / Michael B. Blayney -- Understanding the Food and Drug Administration's investigational new drug process / Dale E. Hammerschmidt -- Differences between Department of Health and Human Services and Food and Drug Administration regulations / Robert J. Amdur -- Veterans Administration research guidelines / Peter Marshall and Kathy Schulz -- State law / Sandra P. Kaltman and John M. Isidor -- Institutional review board member liability / Sandra P. Kaltman and John M. Isidor -- Certificates of confidentiality / Sandra P. Kaltman and John M. Isidor -- Training institutional review board members / Jeffrey A. Cooper and Pamela Turner -- Investigator training / Jeffrey A. Cooper and Pamela Turner -- Accreditation of human research protection programs / Susan S. Fish -- Certification of institutional review board professionals / Susan J. Delano, Sallyann Henry and Gary L. Chadwick -- Preparing for a Food and Drug Administration audit / Gary L. Chadwick -- Preparing for an office for human research protections site visit / Thomas Puglisi and Michele Russell-Einhorn -- Vulnerability in research / James M. DuBois -- Research in public schools / Lorna Hicks -- Phase I clinical trials in healthy adults / Cynthia S. Way -- Requiring birth control to participate in research / Bruce G. Gordon, Toby L. Schonfeld and Ernest D. Prentice -- Research involving fetuses and in vitro fertilization / Ronald M. Green -- Research involving pregnant women / Angela J. Bowen -- Research involving children / Robert M. Nelson -- Research involving adults with decisional impairment / Susan J. Delano -- Regulatory issues of research involving prisoners / Christopher J. Kratochvil, Ernest D. Prentice, Bruce G. Gordon and Gail D. Kotulak -- Research involving college students / Jennifer J. Tickle and Todd F. Heatherton -- When are research risks reasonable in relationship to anticipated benefits? / Charles Weijer and Paul B. Miller -- Internet research : a brief guide for institutional review boards / Jeffrey M. Cohen -- Qualitative social science research / Dean R. Gallant and Alan Bliss -- Ethnographic research / Elisabeth Smith Parrott -- Health services research / Ann Barry Flood -- Epidemiology/public health research / Marjorie A. Speers -- Survey research / J. Michael Oakes -- Research involving a medical device / Erica J. Heath -- Humanitarian use devices / Robert J. Amdur -- Banking of human biological materials for research / Mark Sobel and Karen Hansen -- The placebo-controlled clinical trial / Robert J. Amdur and C. J. Biddle --
  • Treatment-withholding studies in psychiatry / Richard B. Ferrell -- Phase I oncology trials / Matthew Miller -- Research involving genetic testing / Eric C. Larsen -- International research / David A. Borasky -- Alternative medicine research / Timothy Callahan -- Ethical codes -- The Nuremberg Code -- The Belmont Report -- Selected U.S. government regulations -- Code of Federal Regulations : Title 45, Part 46 -- Code of Federal Regulations : Title 21, Part 50 -- Code of Federal Regulations : Title 21, Part 56 -- Expedited review criteria.
Institutional review boards (Medicine)Management [Browse]
0763730491 (case bound)
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C - S