CIOMS GUIDELINES: RELATION TO THE DECLARATION OF HELSINKI

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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

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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.

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CIOMS 1993

• Substantial deviations circumlocutions.
• On phase I drug testing The requirementof
  Article III.2, subjects should be volunteers
  either healthy persons or patients for whom the
  experimental design is not related to the
  patients illness is not to be disregarded
  lightly.

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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

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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.

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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.

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THERAPEUTIC AND NONTHERAPEUTIC RESEARCH

• II.6 The doctor can combine medical research with
  professional careonly to the extent
  thatresearch is justified by its
  potentialtherapeutic 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
  patients illness.

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FORBIDDEN BY ARTICLE II.6

• Pathogenesis
• Pathophysiology eg, catecholamine role in
  affective disorders
• Epidemiology

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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

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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

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COMPONENT ANALYSIS

• interventions or procedures that do or do not
  hold out the prospect of direct benefit for the
  individual subject.

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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

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RISK JUSTIFICATION

• Procedure or intervention
• Beneficial limited by personal benefit only
• Nonbeneficial limits and thresholds

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Minor increase over minimal risk vulnerable
subjects

• Reasonably commensurate with those in actual or
  expected situation
• Anticipated knowledge of vital importance to
  understanding the subjects disorder or condition

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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.

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HELSINKI STILL REQUIRES REVISION

• Illogical therapeutic vs. nontherapeutic
  research
• Out of touch with contemporary ethical thinking
  placebo controls
• Widely disregarded
• Loss of authority

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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.

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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.There are customary and ethically
  justified exceptions toHelsinki. A placebo, for
  example.further Friday

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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

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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