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Research Involving Humans. Federal Governance. 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

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research involving humans

Research Involving Humans

Federal Governance

Glenn Rivard, Department of Justice 02/XI/22

why federal governance of research involving humans
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?
federal governance instruments
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
tri council policy statement
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)
tri council policy statement5
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
tri council policy statement6
“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
tri council policy statement7
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
tri council policy statement8
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
cihr human pluripotent stem cell research guidelines
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
cihr human pluripotent stem cell research guidelines10
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
clinical trial regulations food drugs act
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
clinical trial regulations food drugs act12
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
health canada reb
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
ahr bill c 13
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
ahr bill c 1315
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
ahr bill c 1316
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
ahr bill c 1317
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
ahr bill c 1318
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”
conclusion
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
conclusion20
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.”
conclusion21
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