Clinical Research Compliance Manual: An Administrative Guide

For anyone receiving or applying for clinical research funding, Clinical Research Compliance Manual: An Administrative Guide covers today's most crucial topics, including:

• Human subject protections
• Institutional Review Board regulations and requirements
• Conflicts of interest
• Scientific misconduct
• Reimbursement issues
• And much more!

Clinical Research Compliance Manual helps you establish best practices and carry out all administrative tasks in a compliant manner while keeping you completely up-to-date on the most recent developments:

• Covers the major clinical research issues - with chapters written by experts in the field
• Provides legal explanations of the major regulatory issues in an easy-to-understand format
• Includes summaries of federal regulatory agencies, analysis of major cases, flow-charts, checklists, and footnotes to in compliance program development, auditing and monitoring

Clinical Research Compliance Manual has been updated to include:

• A new chapter on "Protecting Research Materials, Research Results, and Inventions: A University's Perspective"
• A new section on "Recent Proposed Changes to the Common Rule"
• Updated discussion of federal-wide assurance (FWA)
• OHRP's revision of its FAQs to be consistent with its Final Guidance on Engagement of Institutions in Human Subject Research
• Recent OHRP guidance on when institutions are not engaged in human subject research
• And much more!

• 1. OVERVIEW OF CLINICAL RESEARCH PRINCIPLES AND REGULATORY ENVIRONMENT
  • Background of Human Subject Protection and Sources of Ethical Guidance
  • Privacy and Confidentiality of Research Records and Information
  • Conflicts of Interest in Clinical Research
  • Reimbursement Issues Related to Clinical Trials
  • Anti-Kickback Fraud and Abuse Implications of Clinical Trials
  • Intellectual Property Issues in Clinical Research
  • International Regulation and Global Ethics in Clinical Research
• 2. HUMAN SUBJECT PROTECTIONS IN CLINICAL RESEARCH
  • Historical Overview of Human Subject Protection in Clinical Research
  • FDA Human Subject Protection Regulations and Their Distinctions from HHS Regulations
  • Detailed Analysis of the Common Rule and OHRP Regulations for the Protection of Human Subjects
  • Additional Protections for Vulnerable Populations
  • Detailed Analysis of FDA Regulations for the Protection of Human Subjects
  • Compliance with Human Subject Protection Regulations
  • Guidances on Human Subject Protections
  • Exhibit 2-1 Guidance on Engagement of Institutions in Human Subject Research
  • Exhibit 2-2 OHRP Correspondence, Jan. 13, 2009: Determining When Institutions Are Engaged in Research
  • Exhibit 2-3 Final Rule: Institutional Review Boards: Registration Requirements
  • Exhibit 2-4 Comparison of FDA and HHS/OHRP Human Subject Protection Regulations
  • Exhibit 2-5 Glossary of Terms for Human Subject Protections
• 3. INFORMED CONSENT IN FEDERALLY REGULATED RESEARCH
  • The Federal Requirements for Consent in Clinical Research
  • Federal Documentation Requirements for Consent in Clinical Research
  • Special Populations Recognized in Federal Clinical Research Regulations on Consent
  • Clinical Trials Consent Provisions and the FDA
  • State Laws on Consent in Clinical Research
  • The Effect of Regulatory Guidance on Consent in Clinical Research
  • Consent Litigation and Clinical Research
  • Emerging Issues in Clinical Research and Consent
  • Avoiding Consent Litigation in Clinical Research
  • Exhibit 3-1 71 Fed. Reg. 32,827-32,834 (June 7, 2006)
  • Exhibit 3-2 Office for Human Research Protections: Applicability of 45 C.F.R. Part 46 to Clinical Investigations Conducted Under FDA's Interim Final Rule at 21 C.F.R. §50.23(e)
• 4. INSTITUTIONAL REVIEW BOARDS: THEIR ROLE AND RESPONSIBILITIES IN CLINICAL RESEARCH PROGRAMS
  • Regulatory Structure of IRBs
  • Registration of IRBs—HHS/OHRP
  • Criteria for Approval of Research—HHS/OHRP
  • Conduct of IRB Review—HHS/OHRP
  • Unanticipated Problems, Adverse Event Reporting, and Protocol Deviation/Violation—HHS/OHRP
  • FDA-Specific IRB Regulations
  • Criteria for IRB Approval of Research—FDA
  • Adverse Event Reporting—FDA
  • Registration of IRBs—FDA
  • Registration of Clinical Trials—FDA
  • Alternative (Independent) IRBs
  • Data Monitoring Committees
  • Protection of Vulnerable Human Subjects
  • Legal and Ethical Challenges Facing IRBs
  • Lessons Learned from the Johns Hopkins Experience
  • Exhibit 4-1 Categories of IRM Membership
  • Exhibit 4-2 Guidance on Continuing Review
  • Exhibit 4-3 Examples of Adverse Events That DoNot Represent Unanticipated Problems and Do Not Need to Be Reported Under the HHS Regulations at 45 C.F.R. Part 46
  • Exhibit 4-4 Examples of Adverse Events That Represent Unanticipated Problems and Need to Be Reported Under the HHS Regulations at 45 C.F.R. Part 46
  • Exhibit 4-5 Examples of Unanticipated Problems That Do Not Involve Adverse Events and Need to Be Reported Under the HHS Regulations at 45 C.F.R. Part 46
  • Exhibit 4-6 Algorithm for Determining Whether an Adverse Event Is an Unanticipated Problem
  • Exhibit 4-7 Guidance on Reporting Incidents to OHRP
  • Exhibit 4-8 Guidance for Institutional Review Boards and Clinical Investigators
  • Exhibit 4-9 IRB Reviewer Checklist: Children as Research Subjects
  • Exhibit 4-10 IRB Reviewer Checklist: Prisoners as Research Subjects
  • Exhibit 4-11 IRB Reviewer Checklist: Pregnant Women, Fetuses, and Newborns as Research Subjects
  • Exhibit 4-12 Glossary of Terms
  • Exhibit 4-13 Frequently Asked Questions About the Protocol Registration System
  • Exhibit 4-14 Data Elements for Interventional Trials
  • Exhibit 4-15 Quickguide to Facilitated Review
  • Exhibit 4-16 CIRB Procedure
  • Exhibit 4-17 Guidance for Clinical Trial Sponsors: Establishment and Operation of Clinical Trial Data
  • Monitoring Committees
• 5. OVERVIEW OF FEDERAL GRANTS ADMINISTRATION
  • What Are Federal Grants?
  • Sources of Law and Policy
  • Overview of Key OMB Circulars
  • Conclusion
• 6. ADMINISTRATION OF NIH-SUPPORTED CLINICAL RESEARCH
  • Select Pre-Award Requirements
  • Select Post-Award Requirements
  • After Award Requirements
  • Administrative Requirements for State, Local, and Tribal Governments
  • Monitoring, Enforcement, and Disputes
  • Conclusion
• 7. KEY GRANTS MANAGEMENT AND ACCOUNTING ISSUES
  • Financial Management Overview
  • Internal Controls
  • Allowable Costs
  • Budget or Project Changes
  • New Issues in NIH Grants Management
  • Conclusion
• 8. CONFLICT OF INTEREST RULES FOR FEDERALLY REGULATED CLINICAL RESEARCH
  • Defining the Terms and Players
  • Institutional Interests: The Bayh-Dole Act
  • Conflict of Interest Regulations and Guidelines
  • Enforcement: The Federal False Claims Act
  • Association Codes of Conduct
  • Conclusion: Practically Speaking
• 9. MISCONDUCT IN CLINICAL RESEARCH
  • What Government Agency Oversees Misconduct in Research?
  • The Definition of Research Misconduct
  • The Final Rule Expanded
  • Required ORI Policies and Procedures
  • Role of the Institutional Official
  • Role of Journal Editors and Peer Reviewers in Detecting and Preventing Research Misconduct
  • Proving a Finding of Research Misconduct—the Evidentiary Standard
  • The Process for Investigating an Allegation of Research Misconduct
  • Case Summaries
  • Exhibit 9-1 Glossary of Research Misconduct Terms
  • Exhibit 9-2 Requirements for Institutional Policies and Procedures on Research Misconduct Under the New PHS Policies on Research Misconduct, 42 C.F.R. Part 93
  • Exhibit 9-3 Sample Provisions for Institutional Policies and Procedures on Research Misconduct
  • Exhibit 9-4 Research Misconduct Policy Checklist
  • Exhibit 9-5 Sample Research Misconduct Policy
  • Exhibit 9-6 42 C.F.R. Part 93—Public Health Policies on Research Misconduct, Final Rule
• 10. A PRACTICAL GUIDE TO GOOD CLINICAL PRACTICE STANDARDS
  • Good Clinical Practices Are Born
  • The Core of the Consolidated GCP Guidance
  • GCP Risk Areas
  • The Basics of Good Clinical Practices
  • Selected Areas of Compliance Risk
  • Developing a Plan for Improving Compliance with GCPs
  • Exhibit 10-1 Draft Guidance on Important Considerations for When Participation of
  • Human Subjects in Research Is Discontinued
  • Exhibit 10-2 Clinical Trial Documentation Checklist
  • Exhibit 10-3 GCP Checklist: Assessing the Health of Your Institution
  • Exhibit 10-4 Proposed Rule: Reporting Information Regarding Falsification of Data, 75 Fed. Reg. 7412
  • (Feb. 19, 2010)
• 11. KEY CONCEPTS IN REIMBURSEMENT FOR CLINICAL TRIALS
  • Medical Research Issues Relevant for Reimbursement Considerations
  • Reimbursement Rules
  • Enforcement Activities
  • Exhibit 11-1 Glossary of Terms
  • Exhibit 11-2 States with Legislation Affecting Clinical Trial Reimbursement
  • Exhibit 11-3 NCD for Routine Costs in Clinical Trials
  • Exhibit 11-4 Final Decision for Clinical Trial Policy Q's and A's
  • Exhibit 11-5 NCD with Data Collection
  • Exhibit 11-6 CMS Tracking Sheet
  • Exhibit 11-7 CMS Decision Memo (Oct. 17, 2007)
• 12. BEST PRACTICES AND LEGAL PRINCIPLES IN CLINICAL RESEARCH COMPLIANCE
  • Key Steps for Effective Compliance
  • Developing an Educational and Training Program
  • Assisting Research Personnel in Responding to and Coordinating Internal or Independent Auditors with Compliance Reviews and Monitoring Activities
  • Continual Assessment of Training Programs
  • Identification and Assessment of Risks
  • Independent Monitoring of Clinical Research Billing
  • Draft Compliance Program Guidance for Recipients of Public Health Research Awards
  • Legal Issues Associated with Clinical Research Billing
  • Exhibit 12-1 Clinical Research Compliance Education Matrix
  • Exhibit 12-2 Clinical Research Billing Compliance Checklist
  • Exhibit 12-3 Clinical Research Billing Monitoring Protocol Instructions
  • Exhibit 12-4 Action Item Grid for Supplemental Compliance Program Guidance for Hospitals
  • Exhibit 12-5 70 Fed. Reg. 71,312-71,320 (Nov. 28, 2005)
  • Exhibit 12-6 OIG NEWS: NSTC Launches Government-wide Initiative Based on OIG Draft Guidance for HHS Research Grants
• 13. INTELLECTUAL PROPERTY ISSUES AND DATA EXCLUSIVITY IN CLINICAL RESEARCH
  • Exemption from Patent Infringement During Clinical Trials
  • Non-Patent Market Exclusivity
  • Hatch-Waxman Patent-Based Exclusivity: Orange Book Listings
  • Patent Term Extensions for Regulatory Delay
  • Disclosure of Clinical Data
  • Conclusion
• 14. RESEARCH PRIVACY ANDSECURITY: MYTHS, FACTS AND PRACTICAL APPROACHES
  • Federal Privacy Rules
  • State Privacy and Mandatory Disclosure Laws
  • Electronic Records and Signatures
  • Information Security and Human Research
  • Conclusion
  • Exhibit 14-1 HIPAA Authorization Exceptions for Research
  • Exhibit 14-2 Sample Data Use Agreement
  • Exhibit 14-3 Compliance Checklist for 21 C.F.R. Part 11: FDA Electronic Signature Mandates
• 15. INTERNATIONAL REGULATION AND GLOBAL ETHICS IN CLINICAL RESEARCH
  • U.S. Federal Standards for Research in Foreign Countries
  • International Standards for Human Subject Protections and Clinical Research Ethics
  • Beyond Regulations: Ethics in Cross-Cultural Contexts
  • Concluding Considerations: Cultural Competence and Social Projection
• Table of Cases
• Index