AHLA Institutional Review Boards: A Primer (Non-Members)
Institutional Review Boards: A Primer outlines the regulatory requirements and legal challenges associated with the evolving area of human subject research and the role of review boards.
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The new 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 all new 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.
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?