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Trials Registration An Ethical Perspective

Trials Registration An Ethical Perspective. Cochrane Symposium Montreal Dec 2, 2005. Michael Goodyear 1 , Lisa Golec 2 1. Department of Medicine, Queen Elizabeth II Health Sciences Centre, Dalhousie University, Halifax 2. Sunnybrook and Women’s College Health Sciences Centre,

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Trials Registration An Ethical Perspective

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  1. 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 Women’s College Health Sciences Centre, University of Toronto,Toronto

  2. 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

  3. 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

  4. 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

  5. Cumulative Meta-analysis of Aprotinin for Perioperative Bleeding (3) Where was Equipoise? (3) Fergusson, Glass, Hutton, Shapiro: Clinical Trials 2:218, 2005

  6. Ellen Roche Would Ellen be alive today, if the Hexamethonium trials had been registered? Ellen Roche, a Healthy Volunteer

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

  8. 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

  9. 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

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

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

  12. 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

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

  14. 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

  15. 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

  16. Society Subjects Researchers Institutions Funders Networks/Consortia Ethical review community/CAREB National entities NCEHR Professional bodies Journals/Reviewers Government WHO Provider/Consumers Trial RegistrationStakeholders to Collaborators No man is an Island (Donne)

  17. 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

  18. 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

  19. 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

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

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