tcps 2 consultation: revisions relevant to clinical trials laura-lee balkwill, phd, policy analyst...
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TCPS 2 Consultation: Revisions Relevant to Clinical Trials
Laura-Lee Balkwill, PhD, Policy Analyst
Secretariat on Responsible Conduct of Research
CAREB Atlantic - Fredericton
November, 2013
Agenda
• Overview of the TCPS 2 Consultation
• Proposed changes to TCPS 2 relevant to clinical trials
• Questions and answers
Origin of TCPS 2
• Tri-Council Policy Statement: Ethical Conduct for Research Involving Humans created in 1998 by:– Canadian Institutes of Health Research
– Natural Sciences and Engineering Research Council
– Social Sciences and Humanities Research Council
• Scope: all research involving humans conducted under the auspices of institutions eligible for funding by the Agencies
• December 2010: 2nd edition released
Consultation re: Proposed Revisions
Why: TCPS 2 is a living, evolving document
Who: Anyone interested in TCPS 2
When: Deadline for comments is January 15, 2014
How: Written comments
Where: [email protected]
All comments will be posted unless author advises SRCR not to post.
Proposed Revisions
Types of changes
1.Clarification 2.New guidance3.Harmonization – Clinical Trials 4.Integration – Stem Cell Guidance
Clarification
• definition of “disciplined inquiry” (Art. 2.1)
• guidance on alteration of consent requirements (Art. 3.7)
• definition of “highest body” of the Institution that establishes an REB (Art. 6.2)
• possible application of Ch. 9 beyond FNIM communities (Intro. Ch. 9)
• assessment of identifiability is context specific (Arts. 5.5A and 12.3A)
New Guidance
New guidance regarding:
•when researchers must disclose material incidental findings (Art. 3.4)
•when annual renewals of more-than-minimal-risk research may be done by delegated review (Art. 6.12)
Harmonization: Chapter 11, Clinical Trials
• Information required for registration of clinical trials (11.3)– “Clinical trials shall be registered in a registry that is compliant with the
criteria set by the World Health Organization (WHO) or International Committee of Medical Journal Editors (ICMJE) as of November 2010. All fields outlined in the WHO Trial Registration Data Set (TRDS) must
be completed in order for a trial to be considered fully registered.
• Information required to be added to the clinical trial registry– any changes to the trial (e.g. new information, decisions to stop or unblind,
unanticipated events, safety reports, etc.) are reported in the public trial registry (four additions to Arts.11.8 and 11.9)
e.g. “Researchers must also update the publicly accessible trial registry where their trial is registered.”
• Requirement to report findings and new information to the publicly accessible registry (11.12)
– “…researchers and institutions have an ethical responsibility to make reasonable efforts to publicly disseminate the findings of clinical trials in a timely manner by publications and by the inclusion of the findings in a publicly accessible registry where the trial will be registered.”
– “Furthermore, any new information that has an effect on the welfare of participants that comes to light at, or after, the end of the trial should be reported in subsequent publications.”
Harmonization: Chapter 11, Clinical Trials
Harmonization: Chapter 11, Clinical Trials
Other Proposed Changes to Chapter 11
• Resolve terminology inconsistency re: findings (11.12)
– Reportable results will be described as ‘findings’
– Replaces ‘results’, ‘research data’, ‘research materials’ and ‘raw data’
– Researchers are encouraged to make raw data available for further analysis and verification by peers
• Definition of clinical trials (Introduction)– “For the purposes of this Policy, a clinical trial, a form of clinical research
(also known as patient-oriented research), is any investigation involving participants that evaluates the effects of one or more health-related interventions on health outcomes.”
Ongoing Evolution of Chapter 11
• Interpretation requests indicated need for:– clearer definition of what is, and what is not, a clinical trial and;
– what kinds of research may fall within the scope of Chapter 11
• Panel Sub-Committee recommended expansion of scope to all studies in which:
a) The methodology includes prospective assignment to one or more interventions, and
b) The intervention(s) involves more than minimal risk to participants
• New draft of chapter in the works
Summary
• TCPS 2 applies to clinical trials conducted under the auspices or jurisdiction of an eligible institution
• Comments on proposed revisions are due on January 15th, 2014
• Ongoing evolution of Chapter 11 will not affect substance of guidance for clinical trials
Education resources
• On-line tutorial • Webinars • Interpretation service
www.rcr.ethics.gc.ca
To contact us:
PANEL ON RESEARCH ETHICS 350 Albert Street
Ottawa, ON K1A 1H5Tel.: 613 996-0072
www.pre.ethics.gc.ca
Questions?