AHLA Institutional Review Boards: A Primer (AHLA 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.
Select a format
Select subscription type
Terms & conditions
Subscribers receive the product(s) listed on the Order Form and any Updates made available during the annual subscription period. Shipping and handling fees are not included in the annual price.
Subscribers are advised of the number of Updates that were made to the particular publication the prior year. The number of Updates may vary due to developments in the law and other publishing issues, but subscribers may use this as a rough estimate of future shipments. Subscribers may call Customer Support at 800-833-9844 for additional information.
Subscribers may cancel this subscription by: calling Customer Support at 800-833-9844; emailing email@example.com; or returning the invoice marked "CANCEL".
If subscribers cancel within 30 days after the product is ordered or received and return the product at their expense, then they will receive a full credit of the price for the annual subscription.
If subscribers cancel between 31 and 60 days after the invoice date and return the product at their expense, then they will receive a 5/6th credit of the price for the annual subscription. No credit will be given for cancellations more than 60 days after the invoice date. To receive any credit, subscriber must return all product(s) shipped during the year at their expense within the applicable cancellation period listed above.
The total price includes the product(s) listed in the Order Form and any Updates for a limited period (minimum period of 30 days) after the order is placed ("Order Window"). Shipping and handling fees are not included in the grand total price.
All shipments may be returned, at subscribers' expense, for full credit of the Price within 30 days of receipt.
Shipments may not be returned, and no credits will be issued, more than 30 days after receipt.
After the Order Window, subscribers will receive notice of Updates along with the then-current grand total price and order process as Updates become available. Subscribers will only be shipped those Updates they specifically request.
View a sample of this title using the ReadNow feature
If you are not an AHLA member and would like to purchase this book, click here.
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
eBooks, CDs, downloadable content, and software purchases are noncancelable, nonrefundable and nonreturnable. Click here for more information about LexisNexis eBooks. The eBook versions of this title may feature links to Lexis+® service for further legal research options. A valid subscription to Lexis+ is required to access this content.
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?