内容

目次

1 Protection of Human Research Subjects; Melissa L. Markey 1.1 Protection of Human Subjects 1.2 Background of Human Subject Protection and Sources of Ethical Guidance 1.3 Informed Consent and Research Conclusion 2 Institutional Review Boards: Ensuring the Protection of Human Research Participants; Melissa L. Markey 2.1 The Development of Human Subject Protection in the United States 2.2 Federal Regulation of Research 2.3 Applicability of Federal IRB Regulations 2.4 Composition of the IRB 2.5 The IRB Review Process 2.6 Vulnerable Populations 2.7 Conclusion 3 A Brief Overview of the Federal Regulatory Approval Process for Pharmaceuticals, Biologics, Medical Devices, and Combination Products; David S. Weinstock and Jamie K. Wolszon 3.1 Introduction 3.2 FDA's Role 3.3 The Human Drug Development Process 3.4 Investigational New Drug Application (IND) 3.5 Stages of a Clinical Trial 3.6 New Drug Application (NDA) 3.7 Abbreviated New Drug Application (ANDA) 3.8 Regulatory Process Relating to Biologics 3.9 Regulation of Medical Devices 3.10 Combination Products Exhibit A--Drug Review Steps Exhibit B--Select Glossary/Common Abbreviations Exhibit C--Useful Citations and Resources 4 Regulatory Oversight and Investigations; David S. Weinstock 4.1 FDA 4.2 Office for Human Research Protections 4.3 Office of Research Integrity 4.4 National Institutes of Health 4.5 Office of Inspector General 5 An Overview of Intellectual Property for the Healthcare Law Practitioner; Jonathan Holda, E. Scott Johnson, and Christopher F. Lonegro 5.1 Basis of U.S. Intellectual Property Rights 5.2 What is a Patent? 5.3 What is a Trademark? 5.4 What is a Copyright? 5.5 Privacy Policy 5.6 What is a Trade Secret? 5.7 Sample Relevant Legal Developments Addendum A--Overview of the Patent Application Process Exhibit A--Patent Claims: A Primer Addendum B--Sample Patent Claims Addendum C--Dealing with Allegations of Patent Infringement Addendum D--Dos and Don'ts of Laboratory Notebooks Exhibit B--Institutional Intellectual Property (IP) Checklist and Sample IP Clauses 6 HIPAA, HITECH and Information Management in Clinical Research; Sarah E. Swank and Aaron J. Rabinowitz 6.1 Introduction 6.2 Federal Laws Governing Information Protection and Management 6.3 Other Legal Considerations 6.4 Conclusion 7 Insurance Coverage for Clinical Trial Services; Lawrence W. Vernaglia, Leeann M. Habte, Monica R. Chmielewski, and Torrey K. Young 7.1 General Concepts and Funding for Clinical Trials 7.2 Medicare Coverage for Clinical Trials 7.3 Specific Criteria for Medicare Coverage of Clinical Trials 7.4 Medicare Coverage for Medical Device Trials 7.5 Medicaid and Commercial Insurance Coverage for Clinical Trials 7.6 Ten Steps to Successful Billing 7.7 Enforcement Activities 7.8 Landmark Case--The Rush Settlement Index