trials registration an ethical perspective michael goodyear 1, lisa golec 2 1. department of...
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Trials RegistrationAn Ethical Perspective
Michael Goodyear1, Lisa Golec2
1. Department of Medicine, Queen Elizabeth II Health Sciences Centre,
Dalhousie University, Halifax2. Sunnybrook and Women’s College Health Sciences Centre, University of Toronto,Toronto
Cochrane Symposium Montreal Dec 2, 2005
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
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
Trial Registration
Prior KnowledgeSubjects 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
Cumulative Meta-analysis of Aprotinin for Perioperative Bleeding (3)
Where was Equipoise?
(3) Fergusson, Glass, Hutton, Shapiro: Clinical Trials 2:218, 2005
Ellen Roche, a Healthy Volunteer
Ellen Roche
Would Ellen be alive today, if the Hexamethonium trials had been registered?
Trial Registration
Greater (Highest, Common) Good
Probability of real benefit to an individual is low
Subjects often consent to benefit Society
“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
Jesse Gelsinger
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
Trial Registration
Scope of Registration?
Respect for Persons is Unconditional and Universal
Independent of Study Design, Funding, or Location
Trial Registration
Scope of Registration
Respect for Persons is Unconditional and Universal
Independent of Study Design, Funding, Location
All Human Research
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
Trial Registration
Ethical Review and Registration have Reciprocal Relationship
Registration is essential to ensure maximum Transparency and Accountability
Registration includes ensuring appropriate Ethical Review
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
Trial Registration
Human subject research and review is becoming increasingly complex and evolvingMulti-CentredMulti-SponsoredGlobalised
Registration ‘Joins-the-Dots’, and makes a Net-work, a Culture of Collaboration
Trial RegistrationStakeholders to Collaborators
SocietySubjectsResearchers InstitutionsFundersNetworks/ConsortiaEthical review
community/CAREB
National entities• NCEHR
• Professional bodies
Journals/Reviewers GovernmentWHOProvider/Consumers
No man is an Island (Donne)
Trial Registration
Issues for Consideration
(e.g. Ottawa II)National registries? Few or Many?Seamless linkage between registriesEase of searching for specific knowledgeMechanics of interaction of ethical review
and registration
Trial Registration
Interaction of Ethical Review and Registration: Who goes first?Early registration maximises benefitPotential ’Chicken and Egg’ DilemmaRegister once scientific and ethical review
completeConsider provisional registration prior to
activationBut: No recruitment till both steps in place
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
Authors
Collaborators
Michael GoodyearDalhousie
Sabina WattsMcMaster
Lisa GolecToronto
Elisabeth ClarkMcGill
Thankyou
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