Clinical Research and the Law

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John Wiley & Sons, Apr 24, 2012 - Medical - 280 pages
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This book provides a comprehensive resource for medical professionals on the various legal aspects involved in conducting clinical research. It encompasses legal and ethical issues such as duty of care, research malpractice and negligence, standards of care, informed consent, liability issues for Institutional Review Boards (IRB), conflicts of interest, insider trading and the disclosure and withholding of clinical trial results. It will also provide legal guidance on research contracts, setting up clinical trials and common legal pitfalls encountered in medical research.
 

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Contents

97 Mail and Wire FraudMaking False Statements to Government Officials
98 Proposed New FDA Rule
101 Key TermsScope of Study
103 Data
104 Intellectual Property
106 Publications
I Introduction
II Background

22 Do Sponsors Have a Legal Duty?
31 Research Malpractice and Using Expert Testimony to Establish the Standard of Care
32 Lessons Learned from Surgical Innovation Cases
33 Standard of Care and Informed Consent Cases
Background
42 Informed Consent As Applied to the Research Setting
43 Informed Consent and Federal Regulations
45 Clinical Trials and Pediatric Patients
Appendix to Chapter 4Title 45 of the code of federal regulations
46117 Documentation of Informed Consent
51 Liability for Negligence
52 Standard of Care
53 Proximate Cause and Damages
54 Defense
the Need for Indemnification
61 Overview
Road to Creating Financial Conflicts of Interest
Evidence that Financial Conflicts of Interest Are Problematic
64 RegulationsLegislation
65 Litigation Involving Financial Conflicts of Interest in Clinical Trials
66 Applying Novel Legal Theories to Financial Conflicts of Interest Cases
67 Other Clinical Trial Cases Involving Financial Conflicts of Interest Claiming Constitutional Violations
71 GlaxoSmithKline
72 Vioxx and Merck
73 Government and Other Clinical Trial Disclosure Requirements
74 Medical Journal Editors and Disclosure of Clinical Trial Information
a Statement from the International Committee of Medical Journal Editors52
81 Purpose of Insider Trading Laws
82 Proving Insider Trading
83 Penalties
84 Insider Trading Cases and Clinical Trials
Investigators and Relationships with the Investment Industrya Risk of Recent Vintage
86 Setting the Stage
91 How Clinical Trial Investigators Have Been Implicated in Criminal Acts
93 Clinical Trial False Claims Act Cases
94 Enforcement of the False Claims Act Against Institutions
95 AntiKickback Law
96 HealthCare Fraud
III Policy
IV Implementation
V Definitions
VI Decision Tree for Participation of Children in Research
VII Additional Requirements for Research that Includes Children
SECTION 1 SHORT TITLE
SEC 3 RESEARCH FUND FOR THE STUDY OF DRUGS
SEC 4 WRITTEN REQUEST TO HOLDERS OF APPROVED APPLICATIONS FOR DRUGS THAT HAVE MARKET EXCLUSIVITY
SEC 5 TIMELY LABELING CHANGES FOR DRUGS GRANTED EXCLUSIVITY DRUG FEES
SEC 6 OFFICE OF PEDIATRIC THERAPEUTICS
SEC 7 NEONATES
SEC 9 DISSEMINATION OF PEDIATRIC INFORMATION
SEC 10 CLARIFICATION OF INTERACTION OF PEDIATRIC EXCLUSIVITY UNDER SECTION 505A OF THE FEDERAL FOOD DRUG AND ...
SEC 11 PROMPT APPROVAL OF DRUGS UNDER SECTION 505J WHEN PEDIATRIC INFORMATION IS ADDED TO LABELING
SEC 12 STUDY CONCERNING RESEARCH INVOLVING CHILDREN
SEC 13 FOUNDATION FOR THE NATIONAL INSTITUTES OF HEALTH
SEC 14 PEDIATRIC PHARMACOLOGY ADVISORY COMMITTEE
SEC 15 PEDIATRIC SUBCOMMITTEE OF THE ONCOLOGIC DRUGS ADVISORY COMMITTEE
SEC 16 REPORT ON PEDIATRIC EXCLUSIVITY PROGRAM
SEC 17 ADVERSEEVENT REPORTING
SEC 18 MINORITY CHILDREN AND PEDIATRICEXCLUSIVITY PROGRAM
SEC 19 TECHNICAL AND CONFORMING AMENDMENTS
SECTION 1 SHORT TITLE
SEC 3 TECHNICAL AND CONFORMING AMENDMENTS
SEC 4 EFFECTIVE DATE
Sec 5050 IRB Duties
Sec 5051 Clinical Investigations Not Involving Greater Than Minimal Risk
Sec 5053 Clinical Investigations Involving Greater Than Minimal Risk and No Prospect of Direct Benefit to Individual Subjects But Likely to Yield ...
Sec 5054 Clinical Investigations Not Otherwise Approvable that Present an Opportunity to Understand Prevent or Alleviate a Serious Problem Affecti...
Sec 5055 Requirements for Permission by Parents or Guardians and for Assent by Children
Sec 5056 Wards
INTRODUCTION
PROPOSED STANDARDIZED HARMONIZED CLAUSES FOR COMPANYSPONSORED CLINICAL TRIAL AGREEMENTS
PROPOSED STANDARDIZED HARMONIZED CLAUSES FOR INVESTIGATOR INITIATED CLINICAL TRIAL AGREEMENTS
TITLE 42PUBLIC HEALTH
TITLE 45PUBLIC WELFARE
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About the author (2012)

Patricia M. Tereskerz, JD, Ph.D. Associate Professor, Research Director, Program in Ethics & Policy
Patti Tereskerz joined the University of Virginia Center for Biomedical Ethics in the fall of 2001. She is Director of the Program in Ethics and Policy at the Center and chairs the Conflicts of Interest Committee for the University. Previously she served as Assistant Professor of Internal Medicine and Director of Health Law and Policy at the University's International Healthcare Worker Safety Center, where she was a recipient of the AORN Journal's Excellence in Research Award. Prior to joining the faculty of the Medical School, Tereskerz practiced law with Buck, Hogshire & Tereskerz, Ltd., in Charlottesville, and remains of counsel with the firm, now Buck, Toscano &Tereskerz, Ltd. Tereskerz has many publications in areas of both law and medical research, some of which have appeared in the New England Journal of Medicine, the Journal of the American Medical Association (JAMA), and the Milbank Quarterly (See attached CV). She and a colleague have recently published several articles on patent law and proposed patent reform, including two which appeared in Nature Biotechnology and another article is forthcoming in Nature Biotechnology in September. She is also author of a published handbook on needlestick injuries and the law, and is co-author of a book on the prevention and management of occupational exposure to HIV. She has served on various editorial boards.

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