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CIOMS GUIDELINES: RELATION TO THE DECLARATION OF HELSINKI

CIOMS GUIDELINES: RELATION TO THE DECLARATION OF HELSINKI. Robert J. Levine Professor of Medicine, Lecturer in Pharmacology, Co- Chair: Interdisciplinary Bioethics Program Yale University Santiago, October 15, 2003. HELSINKI LINK.

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CIOMS GUIDELINES: RELATION TO THE DECLARATION OF HELSINKI

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  1. CIOMS GUIDELINES: RELATION TO THE DECLARATION OF HELSINKI Robert J. Levine Professor of Medicine, Lecturer in Pharmacology, Co- Chair: Interdisciplinary Bioethics Program Yale University Santiago, October 15, 2003

  2. HELSINKI LINK • Purpose in 1982: to advise how the principles of Helsinki “could be effectively applied, particularly in developing countries.” • 1982: Minor deviations; e.g., consent through ‘intermediary’.

  3. CIOMS 1993 • Substantial deviations: circumlocutions. • On phase I drug testing: “The requirement…of Article III.2, ‘subjects should be volunteers – either healthy persons or patients for whom the experimental design is not related to the patient’s illness’ is not to be disregarded lightly.”

  4. HELSINKI REQUIRES REVISION* • Illogical [therapeutic vs. nontherapeutic research] • Out of touch with contemporary ethical thinking [placebo controls] [Friday] • Widely disregarded • Loss of authority *Ottawa WMA Ethics Committee

  5. Short Duration AZT Trials 1997 • Criticism in New England Journal of Medicine. • The most acrimonious debate on ethics of clinical trials since 1970s. • Publicity with unanticipated consequences. [Friday] • WMA and CIOMS each launched document revision projects. • A major objective of each organization was ‘harmony’.

  6. CIOMS 2002 • There is more harmony with Helsinki than there was in 1993. • There are no circumlocutions as regards differences with Helsinki. • Differing Guidelines simply stated. • WMA clarifications 2000-2001 failed to secure consensus: [Friday] • Some think it went too far. • Some deplore loss of substantive standard. • Some think it incomprehensible.

  7. THERAPEUTIC AND NONTHERAPEUTIC RESEARCH • II.6 The doctor can combine medical research with professional care…only to the extent that…research is justified by its potential…therapeutic value for the patient. • III.2 The subjects should be volunteers – either healthy persons or patients for whom the experimental design is not related to the patient’s illness.

  8. FORBIDDEN BY ARTICLE II.6 • Pathogenesis • Pathophysiology [eg, catecholamine role in affective disorders] • Epidemiology

  9. THERAPEUTIC RESEARCH • An incoherent concept • All research has some components that are not intended to be therapeutic • Research is defined as the pursuit of generalizeable knowledge

  10. The fallacy of the package deal • Nontherapeutic components are justified as ‘therapeutic’ • Repeated coronary angiograms; endoscopies • Liver biopsies (to maintain double blind) • Placebos administered into the coronary arteries

  11. COMPONENT ANALYSIS • “…interventions or procedures that [do or do not] hold out the prospect of direct benefit for the individual subject.”

  12. BENEFICIAL PROCEDURES • Justification as in medical practice • Risk justified by anticipated benefit • Relation of anticipated benefit to risk is at least as favorable as that of alternatives

  13. RISK JUSTIFICATION • Procedure or intervention: • Beneficial: limited by personal benefit only • Nonbeneficial: limits and thresholds

  14. Minor increase over minimal risk [vulnerable subjects] • Reasonably commensurate with those in actual or expected situation • Anticipated knowledge of vital importance to understanding the subject’s disorder or condition

  15. HELSINKI REVISION 2000 • 28.The physician may combine medical research with medical care, only to the extent that the research is justified by its potential prophylactic, diagnostic or therapeutic value.

  16. HELSINKI STILL REQUIRES REVISION • Illogical [therapeutic vs. nontherapeutic research] • Out of touch with contemporary ethical thinking [placebo controls] • Widely disregarded • Loss of authority

  17. HELSINKI 2000 • Accomplishments • Clarification of language. • Removal of the language of ‘therapeutic’ and ‘nontherapeutic’ research. • Remaining to be done • Clarification of position on placebo controls • Removal of remnants of ‘therapeutic’ and ‘nontherapeutic’ logic.

  18. CIOMS International Ethical Guidelines: 1993 • [Helsinki] does not provide for controlled clinical trials. Rather it assures the freedom of the physician “to use a new diagnostic or therapeutic method if it offers hope of saving life….[T]here are customary and ethically justified exceptions to…Helsinki. A placebo, for example….[further Friday]

  19. HELSINKI HISTORY • Formation of Ethics Committee 1953 • Repudiation of Nuremberg as a document created by jurists to set standards for criminal prosecution • Cites a need for a document by physicians for physicians

  20. DECLARATION OF HELSINKI • Introduction: The WMA Declaration of Geneva binds the physician with the words: “The health of my patient will be my first consideration.” • Section II refers to ‘doctors’ and ‘patients’ • Section III refers to ‘investigators’, ‘subjects’, ‘volunteers’ and ‘individuals’

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