Trials Registration An Ethical Perspective

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Trials RegistrationAn Ethical Perspective
Cochrane Symposium Montreal Dec 2, 2005

• Michael Goodyear1, Lisa Golec2
• 1. Department of Medicine, Queen Elizabeth II
  Health Sciences Centre,
• Dalhousie University, Halifax
• 2. Sunnybrook and Womens College Health Sciences
  Centre,
• University of Toronto,Toronto

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Trial Registration Objectives

• Ethical Principles and Knowledge
• Registration as Ethical Imperative
• Role of Ethical Review
• Relationship between Ethical Review and
  Registration
• Nurturing a collaborative culture
• From Silos to Nets

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Trial Registration

• Collective Duty of Care (Prior and Post)
• Prior Inception
• Decisions based on totality of prior information
• Post Execution
• Information acquired will be disclosed for the
  Highest Derived Good (1)

(1) Kant, Critique of Practical Reason, 1778
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Trial Registration

• Prior Knowledge
• Subjects are entitled to believe that decisions
  and information provided are based on all
  knowledge
• But Prior Knowledge is Incomplete and Selective
• Research may be unnecessarily Duplicative (2) -

(2) Young C, Horton R. Lancet 3666 107, 2005
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Cumulative Meta-analysis of Aprotinin for
Perioperative Bleeding (3)
Where was Equipoise?
(3) Fergusson, Glass, Hutton, Shapiro Clinical
Trials 2218, 2005
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Ellen Roche
Would Ellen be alive today, if the Hexamethonium
trials had been registered?
Ellen Roche, a Healthy Volunteer
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Trial Registration

• Greater (Highest, Common) Good
• Probability of real benefit to an individual is
  low
• Subjects often consent to benefit Society

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Jesse Gelsinger
What's the worst that can happen to me? I
die, and it's for the babies." (4)
(4) New York Times, 28 Nov 1999
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Trial Registration

• Subjects have the right to believe that any
  information derived from their participation will
  be fully and freely disclosed for the common good

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Trial Registration

• Scope of Registration?
• Respect for Persons is Unconditional and
  Universal
• Independent of Study Design, Funding, or Location

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Trial Registration

• Scope of Registration
• Respect for Persons is Unconditional and
  Universal
• Independent of Study Design, Funding, Location
• All Human Research

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Trial Registration

• Ethical Review and Registration
• Determine state of knowledge, including prior,
  current and planned studies
• Determine role of other ethical review bodies
• Ensure continuing disclosure

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Trial Registration

• Ethical Review and Registration have Reciprocal
  Relationship
• Registration is essential to ensure maximum
  Transparency and Accountability
• Registration includes ensuring appropriate
  Ethical Review

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Trial Registration

• Ethical review bodies can use registry data to
  monitor other ethical review and ongoing
  disclosure
• Unique identifiers can be used to link all
  documentation, including ethics review and
  subject materials

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Trial Registration

• Human subject research and review is becoming
  increasingly complex and evolving
• Multi-Centred
• Multi-Sponsored
• Globalised
• Registration Joins-the-Dots, and makes a
  Net-work, a Culture of Collaboration

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Trial RegistrationStakeholders to Collaborators

• Society
• Subjects
• Researchers
• Institutions
• Funders
• Networks/Consortia
• Ethical review community/CAREB

• National entities
• NCEHR
• Professional bodies
• Journals/Reviewers
• Government
• WHO
• Provider/Consumers

No man is an Island (Donne)
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Trial Registration

• Issues for Consideration
• (e.g. Ottawa II)
• National registries? Few or Many?
• Seamless linkage between registries
• Ease of searching for specific knowledge
• Mechanics of interaction of ethical review and
  registration

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Trial Registration

• Interaction of Ethical Review and Registration
  Who goes first?
• Early registration maximises benefit
• Potential Chicken and Egg Dilemma
• Register once scientific and ethical review
  complete
• Consider provisional registration prior to
  activation
• But No recruitment till both steps in place

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Trial Registration Conclusions

• Registration is central to ethical integrity
• Ethical review is greatly enhanced by
  registration
• Ethical review bodies need to work in a
  collaborative research culture

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Thankyou
Authors
Michael Goodyear Dalhousie
Lisa Golec Toronto
Collaborators
Sabina Watts McMaster
Elisabeth Clark McGill