Conflict of Interest in Medical Research, Education, and Practice

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Collaborations of physicians and researchers with industry can provide valuable benefits to society, particularly in the translation of basic scientific discoveries to new therapies and products. Recent reports and news stories have, however, documented disturbing examples of relationships and practices that put at risk the integrity of medical research, the objectivity of professional education, the quality of patient care, the soundness of clinical practice guidelines, and the public's trust in medicine. Conflict of Interest in Medical Research, Education, and Practice provides a comprehensive look at conflict of interest in medicine. It offers principles to inform the design of policies to identify, limit, and manage conflicts of interest without damaging constructive collaboration with industry. It calls for both short-term actions and long-term commitments by institutions and individuals, including leaders of academic medical centers, professional societies, patient advocacy groups, government agencies, and drug, device, and pharmaceutical companies. Failure of the medical community to take convincing action on conflicts of interest invites additional legislative or regulatory measures that may be overly broad or unduly burdensome. Conflict of Interest in Medical Research, Education, and Practice makes several recommendations for strengthening conflict of interest policies and curbing relationships that create risks with little benefit. The book will serve as an invaluable resource for individuals and organizations committed to high ethical standards in all realms of medicine.

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Product Details

  • ISBN-13: 9780309131889
  • Publisher: National Academies Press
  • Publication date: 9/16/2009
  • Pages: 440
  • Product dimensions: 6.20 (w) x 9.00 (h) x 1.10 (d)

Table of Contents

Summary 1

1 Introduction 23

Overview and Themes of the Report 27

Historical and Policy Context 33

Organization of Report 43

2 Principles for Identifying and Assessing Conflicts of Interest 44

What Is a Conflict of Interest? 45

What Are the Purpose of Conflict of Interest Policies? 48

Why Not Examine the Motives of the Decision Maker or the Validity of the Decision? 50

Should Policies Also Require That Professionals Avoid the "Appearance of Conflict of Interest"? 52

How Can Conflicts of Interest Be Assessed? 52

How Can Conflict of Interest Policies Be Evaluated? 56

Conclusion 60

3 Policies on Conflict of Interest: Overview and Evidence 62

Overview of Conflict of Interest Policies 64

Disclosure: An Essential but Insufficient Element of Policy 67

Prohibiting or Eliminating Conflicts of Interest 79

Evaluating and Managing Conflicts of Interest 80

Recommendations 87

4 Conflicts of Interest in Biomedical Research 97

Collaboration and Discovery in Biomedicine 98

Industry Funding and Relationships in Biomedical Research 101

Concerns About Relationships with Industry 102

Responses to Concerns About Conflicts of Interest in Research 110

Recommendations 116

5 Conflicts of Interest in Medical Education 122

Background and COntext 124

Learning Environments in Medical Schools and Residency Programs 127

The Learning Environment in Accredited Continuing Medical Education 140

Ghostwriting, Speakers Bureaus, and Independence of Publications and Presentations 153

Recommendations 157

6 Conflicts of Interest and Medical Practice 166

The Broader Context: Physician Payment, Self-Referral, and Conflicts of Interest in Medical Practice167

Industry Promotional Activities and Practicing Physicians 170

Responses to Concerns About Industry Relationships and Conflicts of Interest in Community Practice 175

Recommendations 183

7 Conflicts of Interest and Development of Clinical Practice Guidelines 189

Background and Context 190

Groups That Develop Clinical Practice Guidelines 196

Financial Relationships in Guideline Development 198

Policies on Conflicts of Interest in Clinical Practice Guideline Development 204

Recommendations 210

8 Institutional Conflicts of Interest 216

What Are Institutional Conflicts of Interest? 218

Extent of Institutional Relationships with Industry 219

Responses to Institutional Conflicts of Interest 221

Special Challenges in Managing Institutional Conflicts of Interest 224

Recommendations 226

9 Role of Supporting Organizations

How Supporting Organizations Can Influence Medical Institutions 232

Recommendations 235

References 240


A Study Activities 285

B U.S. Public Health Service Regulations: Objectivity in Research (42 CFR 50) 295

C Conflict of Interest in Four Professions: A Comparative Analysis 302

D How Psychological Research Can Inform Policies for Dealing with Conflicts of Interest in Medicine 358

E The Pathway from Idea to Regulatory Approval: Examples for Drug Development 375

F Model for Broader Disclosure 384

G Committee Biographies 392

Index 401

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