Research Involving Humans

1. Research Involving Humans Federal Governance Glenn Rivard, Department of Justice 02/XI/22

2. Research is increasing in quantity and complexity Multi-site, multi-national Stem cell and genetic research Vulnerable populations – unresolved ethical issues Protect health and safety of thousands of Canadian research subjects International, including American, standards being raised Address liability risk for federal research Why federal governance of research involving humans?

3. Federal Governance Instruments • Tri-Council Policy Statement on Ethical Conduct for Research Involving Humans (TCPS) • CIHR Human Pluripotent Stem Cell Research Guidelines • Clinical Trial Regulations (Food & Drugs Act) • Health Canada Research Ethics Board • Assisted Human Reproduction Act ~ Bill C-13

4. Tri-Council Policy Statement • Three federal research funding agencies: • Canadian Institutes of Health Research (CIHR) • ~ replaced Medical Research Council • Social Sciences and Humanities Research Council (SSHRC) • Natural Sciences and Engineering Research Council (NSERC)

5. Tri-Council Policy Statement • 1998 ~ TCPS published • Establishes ethical guidelines • Applies to: • All research funded by any of the agencies • All research conducted at an institution that receives funding from any of the agencies

6. “All research that involves living human subjects requires review and approval by an REB in accordance with this Policy statement …” Including human remains, cadavers, tissues, biological fluids, embryos or foetuses Applies to: Bio-medical Social science Humanities Tri-Council Policy Statement

7. Guiding Principles: Respect for human dignity Respect for free & informed consent Respect for vulnerable persons Respect for privacy & confidentiality Respect for justice and inclusiveness Balancing harms and benefits Minimizing harm Maximizing benefit Tri-Council Policy Statement

8. REB authority, membership, procedure Ethical principles governing harms and benefits of research Free & informed consent Privacy & confidentiality Conflict of interest Researchers REB members Institutions Vulnerable populations Bio-medical issues Tri-Council Policy Statement

9. CIHR Human Pluripotent Stem Cell Research Guidelines • March, 2002; based on the TCPS • Stem cells from embryos, foetal tissue & amniotic fluid, umbilical cord & placenta, and human somatic tissue (adult stem cells) • CIHR will not fund creation of embryos for research or cloning • Embryos created for reproduction may be donated, with consent, for research

10. Guiding principles potential health benefits consent privacy and confidentiality no payment for donation of material CIHR Stem Cell Oversight Committee + local REB review National registry of embryonic stem cell lines CIHR Human Pluripotent Stem Cell Research Guidelines

11. Clinical Trial Regulations (Food & Drugs Act) • Clinical trial sponsors must apply for authorization from Health Canada to use drugs in clinical trials • Authorization only if clinical trial sponsor files attestation from REB that it has approved the clinical trial

12. Clinical Trial Regulations (Food & Drugs Act) • Standard: “good clinical practices means generally accepted clinical practices that are designed to ensure the protection of the rights, safety and well-being of clinical trial subjects and other persons …” including • Scientifically sound • REB approval • Written informed consent

13. Health Canada REB • Established September, 2002 • Complies with TCPS • Reviews all research involving humans • Conducted by Health Canada • Contracted for by Health Canada • Otherwise funded by Health Canada • Provides advice to Chief Scientist

14. AHR Bill ~ C-13 • Scope of Bill: • creation, use & transplantation of in vitro embryos, including • treatment of gametes used to create an embryo • use of in vitro embryos for research purposes - created for reproduction but no longer required for this purpose • Once embryo transplanted, Bill has no application

15. AHR Bill ~ C-13 • Declaration of Principles • benefits enhanced by protecting health • priority to health & well-being of children • all affected, but women more than men • free, informed consent • non-commercial • human individuality & diversity, integrity of human genome

16. Prohibitions respecting creation, use of embryos ~ that relate to research Cloning Creating in vitro embryo, except for reproduction or improving assisted reproduction procedures Maintaining embryo outside woman after 14 developmental days Germ line alteration Transplanting animal gametes, embryo, foetus into human Chimeras AHR Bill ~ C-13

17. AHR Bill ~ C-13 • Embryo research • cannot create embryos for research • limited exception - to improve assisted reproduction procedures • embryos created for reproduction, but no longer required for this purpose • can be donated for research with consent

18. AHR Bill ~ C-13 • Embryo research (cont’d) • licence required in all cases • must conform to regulations • Assisted Human Reproduction Agency of Canada must be “satisfied that the use [of the embryo] is necessary for the purpose of the proposed research”

19. Conclusion • Since 1998, steady growth in federal governance of research involving humans • Use of a number of instruments ~ ethical (funding) guidelines, Health Canada REB, Clinical Trial Regulations, AHR Bill • Reach of federal governance instruments is significant

20. Conclusion • September Speech from the Throne ~ • The Government of Canada “will work with provinces to implement a national system for the governance of research involving humans, including national research ethics and standards.”

21. Conclusion • Health Canada is the lead government department with responsibility to fulfill this SFT commitment • Health Canada will work toward the development of a national standard with all of the provinces and stakeholders