1. Distinguishing Research From Other Activities
2. Regulations that Govern Clinical Research in the United States
3. Understanding the Clinical Trial Process
4. Institutional Review Boards
5. The IRB Review Process
6. Using Independent IRBs
7. Children in Research
8. Special Categories of Review
9. Understanding Research Informed Consent
10. Payment to Research Subjects
11. Additional Requirements of HIPAA
12. Conflict of Interest Issues
13. Clinical Trial Billing: General Overview of Rules and Issues
14. Tissue and Data Repositories for Research
15. Relevant Case Law
16. Typical Areas of IRB Noncompliance
17. Conclusion & Additional Guidance for the Research Process
Exhibits
• Sample Exempt Research Checklist
• Sample Protocol Review Checklist
• Sample Continuing Review Notice Letter
• IRB Requirements for Continuing Review of Research
• Humanitarian Device Exemption Information Sheet
• Sample Informed Consent for Off-Label Use of a Drug or Device
• Sample Informed Consent Checklist
• Sample Informed Consent
• Sample HIPAA Authorization
• Sample Waiver or Alteration of Authorization
• Sample Data Use Agreement
• Sample Conflicts of Interest Disclosure Form for IRB Members
• Sample Conflict of Interest Disclosure Form for Investigators
• Guidelines for Initial Review of Studies/Consent Forms for Primary Reviewer
• Primary Reviewer Checklist for Initial Review of Studies and Consent Forms
• HIPAA Checklist for Research
• Index
The newly revised and expanded Second Edition of Institutional Review Boards: A Primer outlines the regulatory requirements and legal challenges associated with the evolving area of human subject research, and presents a thorough discussion of the role that institutional review boards serve in this area. This useful guide not only explains the difference between the various regulations that govern human subject research, it also details the steps to take to set up an institutional review board that can adequately perform its role.
Highlights include:
• Five new chapters that cover topics such as using independent IRBs, children in research, payments to research subjects, clinical trial billing, and tissue and data repositories for research;
• Discussion of important considerations that help define the review boards' role and regulatory requirements, including questions of registration, purpose, the necessary review process, and appropriate written procedures for prompt reporting of adverse events;
• Thorough coverage of the elements of informed consent, the additional factors that must be considered under the Health Insurance Portability and Accountability Act of 1996 (HIPAA), and permissible use of protected health information (PHI);
• Analysis of case law involving well-publicized incidents of research misconduct;
• Examples of typical areas of noncompliance, practical advice to avoid them, and a discussion of the critical role that in-house counsel can play in minimizing incidents;
• Numerous exhibits that serve as examples of human subject research documents, including sample checklists addressing protocol review and consent, a sample HIPAA authorization, and conflict of interest disclosure forms;
AUTHORS: Teresa A. Williams, Esq., Richard G. Korman, Esq., Janet M. Lis, Esq., Melinda G. Murray, Esq.
Kate Bowen, Esq., Amy L. Bradshaw, Esq., Tara Cowell, Esq., Amy Dow, Esq., Kimberly H. Gillespie, JD, MPA, Jennifer R. Henderson, Esq., Marta J. Hoffman, Esq., Veronica A. Marsich, Esq., Tamara J. O'Black, Kay M. Perry, Esq., Carol A. Poindexter, Esq., Stacey Ries, RN, Esq., Martha C. Romney, MS, JD, MPH, Jennifer Sharp, Esq., Sarah Shulman Swank, Esq., Alexandra E. Trinkoff, Esq., Leah A. Voigt, Esq., and Catherine M. With, JD, LLM
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