Institutional Review Board : Management and Function

Institutional Review Board : Management and Function

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  • 製本 Hardcover:ハードカバー版/ページ数 582 p.
  • 言語 ENG,ENG
  • 商品コード 9780763716868
  • DDC分類 619

Table of Contents

Acknowledgments                                    xiii
Foreword: Jesse's Intent xv
Paul Gelsinger
Preface xxv
Robert J. Amdur
Elizabeth A. Bankert
Contributing Authors xxvii
PART 1 Background and Overview Topics 2 (31)
An Ethics Primer for IRBs 3 (6)
Harold Y. Vanderpool
Reflections from the Office of the Inspector 9 (4)
General
Mark R. Yessian
A Unified Human-Research Protection Program 13 (4)
Sanford Chodosh
A Shared Responsibility for Protecting Human 17 (5)
Subjects
Steven Peckman
The Tension Between Science and Ethics 22 (2)
Marian G. Secundy
A Brief History of PRIM&R and IRB Education 24 (3)
Joan Rachlin
The IRB: Definition and Federal Oversight 27 (3)
Robert J. Amdur
The Limits of IRB Authority 30 (3)
Robert J. Amdur
PART 2 Organizing the Office 33 (44)
Administrative Reporting Structure for the IRB 35 (2)
Ernest D. Prentice
Sally L. Mann
Bruce G. Gordon
Documenting Compliance with Federal 37 (6)
Regulations
Deborah L. Barnard
IRB Policies and Procedures 43 (7)
Celia S. Walker
Tracking Systems 50 (8)
Patricia M. Scannell
Support Staff 58 (8)
Helen McGough
Audit Systems 66 (9)
Ernest D. Prentice
Ada Sue Selwitz
Gwenn S. F. Oki
Charging for IRB Review 75 (2)
Ernest D. Prentice
Sally L. Mann
Bruce G. Gordon
PART 3 Organizing the IRB Committee 77 (32)
Reflections on Chairing an IRB 79 (3)
Robert J. Levine
The IRB Chair 82 (4)
Robert J. Amdur
Robert M. Nelson
The IRB Administrative Director 86 (5)
Elizabeth A. Bankert
Robert J. Amdur
The Role of an Attorney 91 (5)
Susan Nicholson
Committee Size, Alternates, and Consultants 96 (3)
Robert J. Amdur
Elizabeth A. Bankert
Length, Frequency, and Time of IRB Meetings 99 (2)
Robert J. Amdur
Elizabeth A. Bankert
IRB Subcommittees 101 (4)
Robert J. Amdur
Elizabeth A. Bankert
Social Science Versus Biomedical IRBs 105 (4)
Robert J. Amdur
Elizabeth A. Bankert
PART 4 Review Categories Other Than Full Board 109 (32)
Review
Exempt from IRB Review 111 (3)
Ernest D. Prentice
Gwen S. F. Oki
Expedited IRB Review 114 (4)
Gwen S. F. Oki
John Zaia
Identifying Research Intent 118 (7)
Robert J. Amdur
Marjorie A. Speers
IRB Triage of Projects That Involve Medical 125 (4)
Record Review
Robert J. Amdur
Marjorie A. Speers
Elizabeth A. Bankert
``Compassionate Use'' and Emergency Exemption 129 (3)
from IRB Approval
Elizabeth A. Bankert
Robert J. Amdur
Waiver of Consent in Emergency Medicine 132 (9)
Research
Helen McGough
PART 5 Initial Protocol Review and the 141 (90)
Full-Committee Meeting
Overview of Initial Protocol Review 143 (9)
Susan Z. Kornetsky
Evaluating Study Design and Quality 152 (3)
Robert J. Amdur
The Study Population: Women, Minorities, and 155 (5)
Children
Amy L. Davis
Community Consultation to Evaluate Group Risk 160 (5)
William L. Freeman
Francine C. Romero
Requiring Birth Control to Participate in 165 (4)
Research
Bruce G. Gordon
Ernest D. Prentice
Privacy and Confidentiality 169 (7)
David G. Forster
Recruitment of Research Subjects 176 (4)
Felix A. Khin-Maung-Gyi
Matthew D. Whalen
Advertisements for Research 180 (5)
Rachel Homer
Rachel Krebs
Linda Medwar
Paying Research Subjects 185 (6)
Bruce G. Gordon
Joseph Brown
Christopher Kratochvil
Ernest D. Prentice
Provisions for Data Monitoring 191 (6)
Robert J. Amdur
Conflict of Interest: Researchers 197 (7)
Daniel K. Nelson
Conflict of Interest: Recruitment Incentives 204 (4)
Daniel K. Nelson
Conflict of Interest: IRBs 208 (6)
Daniel K. Nelson
Administrative Tasks Before the Meeting 214 (5)
Rebecca Carson Rogers
Elizabeth A. Bankert
Guidelines for Review, Discussion, and Voting 219 (7)
Robert J. Amdur
Elizabeth A. Bankert
Administrative Tasks After Each IRB Meeting 226 (5)
Jan Trott
Elizabeth A. Bankert
PART 6 Informed Consent 231 (56)
The IRB's Role in Editing the Consent Document 233 (3)
Robin L. Penslar
The Consent Document 236 (3)
Angela J. Bowen
Exculpatory Language in Informed Consent 239 (3)
Documents
Michele Russell-Einhorn
Thomas Puglisi
Requiring a Witness Signature on the Consent 242 (2)
Form
Michele Russell-Einhorn
Thomas Puglisi
Deception of Research Subjects 244 (6)
Laurie Slone
Jay Hull
Research Without Consent or Documentation 250 (6)
Thereof
Marianne M. Elliott
Active Versus Passive Consent 256 (2)
Linda J. Kobokovich
Robert J. Amdur
Elizabeth A. Bankert
Selecting a Surrogate to Consent to Medical 258 (7)
Research
Robert J. Amdur
Natalie Bachir
Elizabeth Stanton
Research-Related Injuries 265 (3)
Daniel R. Vasgird
Informing Subjects About Research Results 268 (4)
Thomas G. Keens
Explaining the Cost of Research Participation 272 (5)
Kevin M. Hunt
Improving Informed Consent 277 (5)
Jeffrey A. Cooper
Pamela Turner
Informed Consent Evaluation Feedback Tool 282 (5)
Elizabeth A. Bankert
Robert J. Amdur
PART 7 Continuing Review 287 (24)
Revisions of an Approved Protocol 289 (4)
Sherry Bye
Protocol Renewal 293 (4)
Karen M. Hansen
IRB Review of Adverse Events 297 (6)
Ernest D. Prentice
Kevin J. Epperson
Christopher J. Kratochvil
Bruce G. Gordon
Data and Safety Monitoring 303 (3)
J. Allen McCutchan
Noncompliance/Complaint Procedure 306 (5)
Lucille Pearson
PART 8 Administrative and Regulatory Issues 311 (60)
OHRP Federal-Wide Assurance 313 (3)
Jeffrey M. Cohen
International Conference on Harmonisation 316 (5)
David G. Forster
Gary L. Chadwick
Gene Therapy Oversight 321 (2)
Bambi Grilley
Understanding the FDA's IND Process 323 (6)
Dale E. Hammerschmidt
Differences Between DHHS and FDA Regulations 329 (2)
Robert J. Amdur
Veterans Administration Research Guidelines 331 (8)
Peter Marshall
State Law 339 (3)
Sandra P. Kaltman
John M. Isidor
IRB Member Liability 342 (3)
Sandra P. Kaltman
John M. Isidor
Certificates of Confidentiality 345 (2)
Sandra P. Kaltman
John M. Isidor
Educating IRB Members 347 (2)
Jeffrey A. Cooper
Pamela Turner
Investigator Training 349 (4)
Jeffrey A. Cooper
Pamela Turner
Accreditation of an IRB 353 (3)
Susan S. Fish
Certification of IRB Professionals 356 (3)
Susan J. Delano
Sallyann Henry
Gary L. Chadwick
Preparing for an FDA Audit 359 (6)
Gary L. Chadwick
Preparing for an OHRP Site Visit 365 (6)
Thomas Puglisi
Michele Russell-Einhorn
PART 9 Issues Based on Study Population 371 (30)
Research Involving Fetuses and In Vitro 373 (7)
Fertilization
Ronald M. Green
Research Involving Pregnant Women 380 (3)
Angela J. Bowen
Research Involving Children 383 (6)
Robert M. Nelson
Research Involving Adults with Decisional 389 (5)
Impairment
Susan J. Delano
Research Involving Prisoners 394 (5)
Ernest D. Prentice
Bruce G. Gordon
Christopher J. Kratochvil
Gail D. Kotu
Research Involving College Students 399 (2)
Jennifer J. Tickle
Todd F. Heatherton
PART 10 IRB Issues Based On Study Design or 401 (86)
Category
Qualitative Social Science Research 403 (4)
Dean R. Gallant
Ethnographic Research 407 (8)
Elisabeth Smith Parrott
Oral History Research 415 (4)
Alan Bliss
Health Services Research 419 (5)
Ann Barry Flood
Epidemiology/Public Health Research 424 (4)
Marjorie A. Speers
Survey Research 428 (6)
J. Michael Oakes
Research Involving a Medical Device 434 (7)
Erica J. Heath
Humanitarian Use Devices 441 (2)
Robert J. Amdur
Banking of Biological Materials for Research 443 (7)
Karen M. Hansen
Robert J. Amdur
Elizabeth A. Bankert
The Placebo-Controlled Clinical Trial 450 (8)
Robert J. Amdur
C. J. Biddle
Research Involving Sham Surgery 458 (3)
Robert M. Zwolak
Treatment-Withholding Studies in Psychiatry 461 (4)
Richard B. Ferrell
Phase I Oncology Trials 465 (11)
Matthew Miller
Research Involving Genetic Testing 476 (5)
Eric C. Larsen
International Research 481 (2)
David A. Borasky
Alternative Medicine Research 483 (4)
Timothy Callahan
PART 11 Reference Material and Contact 487 (84)
Information
Elizabeth A. Bankert
Ethical Codes 489 (12)
The Nuremberg Code 490 (2)
The Belmont Report 492 (7)
World Medical Association Declaration of 499 (2)
Helsinki
Selected U.S. Government Regulations 501 (33)
Code of Federal Regulations: Title 45, Part 502 (15)
46
Code of Federal Regulations: Title 21, Part 517 (6)
50
Code of Federal Regulations: Title 21, Part 523 (9)
56
Expedited IRB Review Criteria 532 (2)
U.S. Government Guidance and Resources 534 (1)
International Guidelines 535 (1)
Selected Books 536 (1)
Periodicals and IRB Forum 537 (1)
Video Recordings 538 (1)
Selected Organizations 539 (1)
Standardized IRB Forms 540 (31)
Elizabeth A. Bankert
Index 571