AHLA Clinical Research Practice Guide (Non-Members)
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With this important guide from AHLA, those who represent healthcare entities will gain insight into the growing interrelationship between health law and life sciences, as well as the growing risks and compliance issues facing clients involved in this complex area.
The Second Edition of the popular Practice Guide is extensively enhanced and updated with coverage of:
- Changes to HIPAA that affect research and IRBs
- New Food and Drug Administration guidance and finalization of draft guidance
- Changes to patent law due to the America Invents Act
- HITECH and enhanced coverage of the Security Rule
- New requirements for group health plans and health insurers to cover routine patient costs in an approved clinical trial
Covers the Full Spectrum of Related Legal Issues
Clinical trials play an essential role in the advancement of healthcare in the U.S. and abroad. They are designed to evaluate the safety and efficacy of new drugs, devices, treatments, or preventative measures using human subjects. Comprehensive coverage is both analytical and practical, with thorough treatment of:
- The development of human subject protections and the important function played by both institutional review boards (IRBs) and federal regulatory agencies
- The federal approval process for pharmaceuticals, medical devices, and biologics
- The responsibility for regulatory oversight and investigations, with a discussion of which agency in the U.S. Department of Health and Human Services has responsibility for ensuring compliance
- Intellectual property considerations, including an extensive discussion of the basics of intellectual property rights in the U.S.
- Information management, including the sources for human subject protection: the Federal Common Rule, FDA Guidance, and HIPAA
- Insurance payments for clinical trial services, whether through private insurance or federal reimbursement and the top ten steps to ensure that the application for billing is appropriate
The eBook versions of this title feature links to Lexis Advance for further legal research options.
R. Harold McCard is Vice President and Deputy General Counsel for Community Health Systems in Franklin, TN. Hal has practiced healthcare law for 25 years.
Monica R. Chmielewski (Chapter 7) is special counsel with Foley & Lardner LLP and co-chair of the Life Sciences Industry Team.
M. Leeann Habte (Chapter 7) is an associate with Foley & Lardner LLP and a Certified Information Privacy Professional.
Jonathan M. Holda (Chapter 5) is an intellectual property and business attorney with Rosenberg Martin Greenberg LLP in Baltimore, Maryland.
E. Scott Johnson (Chapter 5) is Chair of the Intellectual Property Group of OBER|KALER, a law firm with offices in Maryland, Virginia and Washington, D.C.
Christopher F. Lonegro (Chapter 5) is a member of the intellectual property practice in OBER|KALER's Baltimore office where he counsels clients on issues relating to acquisition, protection and transfer of patents, trademarks and copyrights.
Melissa L. Markey (Chapter 1; Chapter 2) is a shareholder in Hall, Render, Killian, Heath & Lyman PLLC a top national health law firm and is licensed as an attorney in Texas and Michigan.
Aaron J. Rabinowitz (Chapter 6) is an attorney in OBER|KALER's Health Law Group.
Sarah E. Swank (Chapter 6) is a principal in OBER|KALER's Health Law Group based in the Washington, D.C. office and co-founder of the OBER|KALER Health Care General Counsel Institute.
Lawrence W. Vernaglia, J.D., M.P.H. (Chapter 7), is a partner with Foley & Lardner LLP and is Chair of the firm's national Health Care Industry Team--named Health Law Firm of the Year by U.S. News 2011–2012 & 2012–2013.
David S. Weinstock (Chapter 3; Chapter 4) is the Corporate Counsel of LifeCell, Inc.
Jamie K. Wolszon (Chapter 3) is an associate in the law firm of Hyman, Phelps & McNamara.
Torrey K. Young (Chapter 7) is an associate with Foley & Lardner LLP and is a member of their Health Care Practice Group.
Table of Contents
Table of Contents
About the Coordinating Editor
About the Authors
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
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
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
3.2 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
4.2 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?
5.6 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—nstitutional Intellectual Property (IP) Checklist and Sample IP Clauses
6 HIPAA, HITECH and Information Management in Clinical Research; Sarah E. Swank and Aaron J. Rabinowitz
6.2 Federal Laws Governing Information Protection and Management
6.3 Other Legal Considerations
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