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Copyright, 1996 © Dale Carnegie & Associates, Inc.
CLINICAL TRIALS AND HUMAN SUBJECT
PROTECTION:
A PLAINTIFF’S PERSPECTIVE
ALAN MILSTEIN SHERMAN SILVERSTEIN KOHL ROSE & PODOLSKY WWW.SSKRPLAW.COM
THERAPY VS. RESEARCH
EXPERIMENTAL THERAPY VS EXPERIMENT
NONTHERAPEUTIC RESEARCH CLINICAL TRIALS CHALLENGE STUDY
THERAPEUTIC RESEARCH NEW VS. EXISTING THERAPY NO THERAPEUTIC ALTERNATIVE
ETHICAL REQUIREMENTS
NUREMBERG CODE HELSINKI DECLARATION BELMONT REPORT THE COMMON RULE FUNDAMENTAL RIGHT TO BE
TREATED WITH ESSENTIAL HUMAN DIGNITY
WHY ALL THE CONTROVERSY?
DEATH OF JESSE GELSINGER
DEATH OF ELLEN ROCHE
DEATH OF NICOLE WAN
UNIVERSITY OF OKLAHOMA
MELANOMA TRIAL
THE MYTH 0F SUBJECT PROTECTION: EVERYBODY’S WATCHING
THE TRUTH: THE RESEARCHER’S ETHICS Currently more than 100,000 trials involving 7-
8,000,000 participants At some major institutions, 4000 current trials 5000 IRBs
THE SOLUTION
Reduce the number of trials; stop trivial research; devote resources to subject protection
CONFLICTS OF INTEREST
THE TRUTH Financial and other interests that potentially take the
focus away from protection of the subject cannot be managed.
THE SOLUTION Institutions and researchers should have no financial
stake in the outcome of an experiment or in the decision of the subject to participate.
EXPERIMENT MUST BE ETHICALLY DESIGNED
PRECLINICAL UNDERSTANDING OF UNIVERSE OF HARM
VALID SCIENCE: LIKELIHOOD OF GAINING KNOWLEDGE
VALUABLE: FRUITFUL RESULTS FOR GOOD OF SOCIETY
RISKS MINIMIZED AND OUTWEIGHED BY BENEFITS NONTHERAPEUTIC: SHOMEIR P’TAYIM THERAPEUTIC: CLINICAL EQUIPOISE
ETHICAL USE OF PLACEBOS
SELECTION CRITERIA
MUST BE EQUITABLE ABSENCE OF COERCION AVOIDS VULNERABLE POPULATIONS
INFORMED CONSENT
PURPOSE PROCEDURE RISKS BENEFITS SELECTION ALTERNATIVES FINANCIAL INTERESTS
UNINFORMED CONSENT:THE MYTH OF INFORMED CONSENT
THE TRUTH: The document neither evidences the participant is informed or that he or she consents.
THE DOCUMENT
• Presumes Consent vs Informed Choice• Study/Clinical Trial/Research• Average time: 10 minutes• Conveyed and Understood• Competent to give consent• Whose role?
Therapeutic Misconception
70% believed proven best treatment 50% believed standard treatments and
procedures 70% believed best therapeutic alternative 90% believed purpose to benefit them not
future patients
National Cancer Institute: Reasons to Enroll
o Access to new drugs and interventions before widely available
o Opportunity to be the first to benefit if approach found helpful
o Better care than standard best therapyo Often the best therapeutic alternative
SOLUTIONS
Tell it like it is: A human experiment Use subject advocates Explain Phase 1, Phase 2, Phase 3 Know whether best therapeutic alternative Stop selling
RESPONSIBLE PROTECTORS OF HUMAN SUBJECTS
Investigators IRB members Subject Advocates OHRP RAC FDA All Of Us