Ethical Issues in Patent LawBiotechnology and Research Ethics

Clinical Research: Conflicts and Controversies

Patricia C. Kuszler, M.D., J.D.University of Washington School of Law

Issues Arising in the Context of Clinical Research

• Numerous Media Exposes

• The Rights of the Human Subject

• The Interests of the Researcher and Study Sponsor

Questions

• When should financial conflicts be disclosed?

• When should non-financial conflicts be disclosed? Are they so insidious that disclosure is not possible?

• Who is a “vulnerable subject” and how should the law protect them?

• Who cares and Why?

Who Cares and Why?

• Patients/Human Subjects

• Funders of Research

• Beneficiaries of Successful Research

• Society and Future Generations

Research Ethics: Human Subjects

• Ethical Principles– Respect for Autonomy – Beneficence/Non-maleficence– Justice

• Medical Standards of Care: Professionally Driven

• Informed Consent: Legal Ramifications• Federal Law: Protections for Subjects

Funders of Clinical Research

• Federal Agencies: costs of the study, data collection and analysis, salary for the researchers, and subject costs

• Private Industry Sponsors: costs of the study, subject costs & the drug, device or biological that is being researched

• Medicare: routine patient care costs, costs of complications -- by National Coverage Decision issued 6/7/00

• Private “third party” Payers: routine patient care costs, costs of complications -- by policy or default

Downstream Gains: Future Products, Patents and Profits

• Stevenson-Wydler Technology Act (1980): cooperative model for technology transfer

• Bayh-Dole Act (1980) : retention of ownership, patenting and licensing of discoveries

• Federal Technology Transfer Act (1986): joint venture Cooperative Research and Development Agreements (CRADA)

Financial Technology Transfer Benefits

• Research University Benefits– Ongoing revenue source in face of decreasing

government subsidy – patents, royalties, licensing– Often tax-free– Transformation into research networks

• Individual Researcher Benefits– Equity, royalty income– Lucrative financial connections to sponsors– New, less encumbered, sources for research

sponsorship

Non-financial Benefits of Clinical Research

• Emotional and Professional Satisfaction

• Academic Prestige and Scientist “Stardom”

• Increased Publications

• Peer Respect

• Improved Posture for Future Funding

Our Duty to Society and Future Generations

• The Legacy of Eugenics and the Tuskegee Study

• Products Liability

• Downstream Harms to Populations and Species

• Societal Backlash and Destruction of the Integrity and Image of Altruism in Science

Law and Policy Addressing Conflicts of Interest in Research

• FDA & PHS Regulations: – Focus on Disclosure

• Institutional Policies: – Focus on Management– Generally Disclosure +– Increasingly Zero Tolerance

• “Conflicts of Interest are ubiquitous and inevitable in ...all professional life”

• David Korn, MD• JAMA, Nov. 1, 2000

• “Conflicts of interest are of concern because of their potential effect on the quality, outcome and dissemination of research, as well as their effects on the public’s perception of and trust in researchers and universities”

• Mildred K. Cho, et al.• JAMA, Nov. 1, 2000

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Challenges in Conflict of Interest

• Institutional conflict of interest: academic and research medical centers equally corruptible

• The Power Differential Problem: Researcher vis-à-vis the vulnerable subject

• The Question of Currency: dollars vs. prestige, fame & ego