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
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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
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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)
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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
5
Tri-Council Policy Statement
“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
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Tri-Council Policy Statement
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
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Tri-Council Policy Statement
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
8
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
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CIHR Human Pluripotent Stem
Cell Research Guidelines
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
10
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
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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
12
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
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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
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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
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AHR Bill ~ C-13
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
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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
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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”
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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
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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.”
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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
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