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Book:Softbound, 368 pages
3rd Edition
ISBN/ISSN: 9781522166672
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3rd Edition
ISBN/ISSN: 9781522166689
In Stock
Best value
3rd Edition
ISBN/ISSN: 9781522166689
In Stock
Best value
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The Third Edition explains the changes under the revised Common Rule requirements, providing solutions for both new and common problems that Institutional Review Boards (IRBs) face. Compliance with the revised Common Rule requires a close examination of IRB, facility, and research practices. This book provides full explanations of important changes such as:

  • Changes in applicability and exemptions
  • Collection, use, and storage of private information and bio specimens
  • Use of broad consent
  • And more

In addition, the Third Edition incorporates a number of chapters which address:

  • Investigator Responsibilities including coverage of supervision, compliance, recordkeeping, and reporting
  • IRB Compliance and Internal Audits addressing regulatory requirements, assignment of responsibility and delegation of duties, information collection, components of a compliance audit, elements of a compliance plan, common deficiencies, and areas of risk
  • Secondary Findings in Genomic Research with analysis of the ethical, legal, and practical considerations involved in deciding whether to communicate findings to subjects
  • Scientific Misconduct in Clinical Research including how to identify, investigate, and respond to allegations of misconduct

EDITORS: Gary W. Eiland, Richard G. Korman, Janet M. Lis, Teresa A. Williams
AUTHORS: Haley N. Bavasi, Valerie H. Bonham, Kate Bowen, Eve Brunts, Dale H. Cowan, Payal P. Cramer, Amy K. Dow, Heather L. Fields, Jennifer S. Geetter, Kimberly H. Gillespie, Gabrielle Goldstein, Michele R. Goodman, Igor Gorlach, Ann T. Hollenbeck, Jacqueline A. Holz, Beverly H. Lorell, Alice K. Marcee, Ernessa B. McKie, Melinda G. Murray, Katayoun (Kat) Neal, Laura M. Odwazny, David Peloquin, Mary Holloway Richard, Martha C. Romney, Chelsea M. Rutherford, Thomas D. Shrack, Lynn E. Smith, Katherine B. Steuer, Gelvina Rodriguez Stevenson, Sarah E. Swank, Leslie Thornton, Leah A. Voigt

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Published December, 2018.


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Table of contents

Chapter 1  Distinguishing Research from Other Activities 

Chapter 2  Regulations that Govern Clinical Research in the United States

Chapter 3  Understanding the Clinical Trial Process

Chapter 4  Introduction to Institutional Review Boards

Chapter 5  The IRB Review Process

Chapter 6  Roles and Responsibilities of Investigators

Chapter 7  Children in Research

Chapter 8  Special Categories of Review

Chapter 9  Understanding Research Informed Consent

Chapter 10  HIPAA Compliance in Clinical Trials

Chapter 11  Payment to Research Subjects

Chapter 12  Conflict of Interest Issues

Chapter 13  Billing for Clinical Trial Services: General Overview

Chapter 14  Use of Biospecimens and Private Information in Research and Research Repositories

Chapter 15  Secondary Findings in Genomic Research: Ethics, Law, and Practicality

Chapter 16  Typical Areas of IRB Noncompliance

Chapter 17  IRB Compliance and Internal Audits

Chapter 18  Scientific Misconduct in Clinical Research

PLUS downloadable Exhibits & Sample Forms


The revised Common Rule takes effect on January 21, 2019, implementing fundamental changes to the rules surrounding human subjects research. Are you prepared to comply?