Presentation Outline

1. National Standard of Canada for Research Ethics Boards Reviewing Biomedical Clinical TrialsPatricia A. Wait and Monique A. Grabowski Canadian General Standards BoardACAHO/R&GS Meeting - 14 November 2008

2. Presentation Outline • Standards and Standardization • CGSB Overview • Standard Development Process • Standard for Research Ethics Boards Reviewing Biomedical Clinical Trials • Questions

3. Standards and Standardization

4. Definitions • What are standards? • Documents that describe essential characteristics of products, services or systems • What is standardization? • The process of bringing a variety of interests together to develop standards • The application of those standards

5. Benefits of Standards and Standardization • Who benefits? • Consumers (health and safety) • Business (trade, economy) • Governments (alternative or compliment to regulation)

6. Why standards work • Standards work because they are: • based on expert knowledge • financially and technically feasible • widely accepted • compatible with international standards

7. The National Standards System

8. CGSB Overview

9. CGSB Overview Since 1934… The Canadian General Standards Board provides standards development and conformity assessment services, including programs for certification of products and services, registration of quality and environmental management systems, and related services. Legislative framework • Sections 7, 15 and 16 of the Department of Public Works and Government Services Act • 1998 Order-in-Council • Standards Council of Canada Act (Industry Canada)

10. CGSB Overview (cont.) • Charter participant of the National Standards System (NSS) • Accreditation by the Standards Council of Canada (SCC) to national and international standards and criteria • Volunteers

11. Standards Services CGSB develops… • National Standards of Canada • CGSB Standards • Specifications • Government of Canada Forms In support of… • Acquisitions • Stakeholders’ health and safety, quality, economic and environmental interests Based on… • Canadian context • Harmonization to national and international standards

12. Major Initiatives • Competencies of persons and services (e.g. research ethics boards, information management (IM) competencies, non-destructive testing personnel, forms management, security guards, translation services) • National security (e.g. chemical, biological, radiological and nuclear (CBRN) protection for first responders) • Health and safety (e.g. surgical gloves, transportation of dangerous goods, protective clothing) • Government purchasing (e.g. bio-diesel fuels and lubricants, furniture) • Food (e.g. food safety, organic agriculture, labelling of genetically engineered food)

13. Standard Development Process

14. Standards Development Philosophy

15. CGSB Project Manager Chair Information Members Committee Matrix Typical Voting Matrix • General Interest • Producer Interest • Regulatory Authorities • User Interest

16. Standards Development Process of voluntary-standards development • Problem is identified or request is made. • Look for solution internationally. • Secure resources and establish committee. • Committee reviews the issues and develops a standard. • Public review. • Committee vote. • Achieve consensus. • Procedural review. • Edit and translation. • Publication.

17. Statement of National Public Interest The Committee will ensure, to the extent possible, that the proposed National Standard of Canada addresses the national public interest by considering the following elements: 1.Advancing the national economy, 2.Supporting sustainable development, 3.Benefiting the health, safety and welfare of workers and the public 4.Assisting and protecting consumers, and 5.Facilitating trade.

18. Consensus • Standards are developed through a consensus process, by committees of volunteers, representing public and private sector stakeholders who are experts in their fields working according to approved procedures. • Consensus: • is substantial agreement, characterized by the absence of sustained opposition to substantial issues by any important part of the concerned interests, • entails a process seeking to take into account the views of all parties concerned and to reconcile any conflicting arguments, and • it implies much more than a simple majority, but not unanimity.

19. Standard for Research Ethics Boards Reviewing Biomedical Clinical Trials

20. Background Health Canada regulations for clinical trials require that all applications be reviewed and approved by a duly constituted research ethics board (REB). The basic composition of the REB is set in the regulations, but a wide variation exists in the operations of these REBs. Health Canada, as the Project Sponsor, wanted to assist these REBs in functioning to similar operating standards in order to enhance harmonization and increase human research participant protection.

21. Background • The standard will exist to complement existing research ethics policies and standards - ICH-GCP, TCPS. • The current regulations do not reference either document. • Some Canadian research institutions have to be compliant with the US Common Rule.

22. Benefits The Standard: • will provide REBs with a common approach while allowing for the flexibility necessary for each research institution, • would allow other players such as Health Canada’s Inspectorate to offer guidance on appropriate process for REB operations, • may allow REBs to establish mutual recognition agreements that can increase efficiencies in multi-centred trials.

23. Benefits The standard will: • assist researchers by giving them a basis for understanding the REB role and function, • benefit Sponsors of multi-site clinical trials giving them confidence that protocols are reviewed across different sites based on a common standard.

24. Benefits The Committee ensures that: • the safety, rights, dignity and well-being of participants in clinical trials is of the utmost consideration, • the standard promotes efficiency and effectiveness by REBs, • the standard furthers and fosters ethical biomedical research in Canada.

25. Committee • Chair – Dr. Glenn Griener (National Council on Ethics in Human Research) • Vice-Chair – Francis Rolleston (Canadian Blood Services) • 41 Voting members • 26 Information members • Representation from various jurisdictions - federal, provincial, industry, associations and professional associations, REBs and Associations of Institutions, participants and subjects

26. Standard Scope 1 Scope This proposed National Standard of Canada (NSC) applies to Research Ethics Boards (REBs) that review and approve biomedical clinical trials covered by the Food and Drugs Act and Regulations and/or good clinical practices. The breadth of this scope is a continuum that includes clinical trials involving drugs under Division 5, plus clinical trials involving natural health products or medical devices under Health Canada regulations.

27. Content of the Standard 0 INTRODUCTION 1 SCOPE 2 NORMATIVE REFERENCES 3 TERMINOLOGY • REQUIREMENTS 4.1 Governance, Mandate, Authorities 4.2 REB Personnel 4.3 REB Operations 4.4 Documentation and Record Keeping 4.5 Quality Management Systems Standard

28. What’s been done… • The CGSB Committee on the Development of a National Standard of Canada for Research Ethics Boards Reviewing Clinical Trials was assembled in 2007 • March 2007 – 1st Exploratory meeting • 5 committee meetings held between June 2007 and June 2008 • 1st Working Draft prepared based on various working group reports • Summer 2008 - Draft revised by a Working Group • October 2008 – WG met to prepare 1st Committee Draft

29. Where we are now… • 6th Committee meeting to be held 10-11 December 2008 • To review 1st Committee Draft of the proposed Standard • Decision to be taken to circulate draft for public review

30. Where we go from here… • Draft revised and prepared for public review (60 days) • Comments collated and addressed • Draft revised and prepared for Committee Ballot • Draft to be circulated for ballot (30 days) • Comments collated and addressed • If consensus has been reached… • Internal Review • Procedural Review • Edited, translated and published • If not…meeting, revision, ballot, revision (etc.)

31. Contact Canadian General Standards Board 11 Laurier Street Place du Portage, Phase III, 6B1 Gatineau, Quebec, K1A 0S5 Web site: www.ongc-cgsb.gc.ca Fax: 819-956-5740 Patricia A. Wait, Monique Grabowski Team Leader, Standards Standards Specialist Phone: 819-956-0777 Phone: 819-956-7315 Patricia.Wait@tpsgc-pwgsc.gc.caMonique.Grabowski@tpsgc-pwgsc.gc.ca

32. Questions?