1. 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

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

3. 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: 2 nd edition released

4. Consultation re: Proposed Revisions Why: TCPS 2 is a living, evolving document Who: Anyone interested in TCPS 2 When: Deadline for co mments is January 15, 2014 How: Written comments Where: secretariat@rcr.ethics.gc.ca All comments will be posted unless author advises SRCR not to post.

5. Proposed Revisions Types of changes 1.Clarification 2.New guidance 3.Harmonization – Clinical Trials 4.Integration – Stem Cell Guidance

6. 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)

7. 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)

8. 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.”

9. 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

10. 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 a)permit researchers principal investigators to access all trial data; b)permit researchers to access all trial data collected at their respective sites; c)permit all researchers to access all trial data in cases where no principal investigator is named. Harmonization: Chapter 11, Clinical Trials

11. 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.”

12. 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

13. 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 15 th, 2014 Ongoing evolution of Chapter 11 will not affect substance of guidance for clinical trials

14. Education resources On-line tutorial Webinars Interpretation service www.rcr.ethics.gc.ca

15. To contact us: PANEL ON RESEARCH ETHICS 350 Albert Street Ottawa, ON K1A 1H5 Tel.: 613 996-0072 secretariat@rcr.ethics.gc.ca www.pre.ethics.gc.ca

16. Questions?