TCPS 2 Consultation: Revisions Relevant to Clinical Trials

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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
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Agenda

• Overview of the TCPS 2 Consultation
• Proposed changes to TCPS 2 relevant to clinical
  trials
• Questions and answers

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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

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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 secretariat_at_rcr.ethics.gc.ca
• All comments will be posted unless
• author advises SRCR not to post.

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Proposed Revisions

• Types of changes
• Clarification
• New guidance
• Harmonization Clinical Trials
• Integration Stem Cell Guidance

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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)

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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)

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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.

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Harmonization Chapter 11, Clinical Trials

• 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.

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Harmonization Chapter 11, Clinical Trials

• To eliminate potential conflict between TCPS 2
  and the model clinical trials agreement (mCTA)
  (11.12)
• mCTA is a CIHR template intended for use by
  clinical trial sites and sponsors in negotiating
  phase II and phase III clinical trial agreements.
• http//www.cihr-irsc.gc.ca/e/44186.html
• Conflict was perceived in TCPS 2 guidance re
  access to trial data
• Proposed revision clarifies that all
  confidentiality and publication clauses
• permit researchers principal investigators to
  access all trial data
• permit researchers to access all trial data
  collected at their respective sites
• permit all researchers to access all trial data
  in cases where no principal investigator is named.

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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.

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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
• The methodology includes prospective assignment
  to one or more interventions, and
• The intervention(s) involves more than minimal
  risk to participants
• New draft of chapter in the works

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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

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Education resources

• On-line tutorial
• Webinars
• Interpretation service

www.rcr.ethics.gc.ca
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To contact us
PANEL ON RESEARCH ETHICS 350 Albert
Street Ottawa, ON K1A 1H5 Tel. 613
996-0072 secretariat_at_rcr.ethics.gc.ca www.pre.ethi
cs.gc.ca
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Questions?