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