Research Involving Humans

Glenn Rivard, Department of Justice 02/XI/22

Research Involving Humans

Federal Governance

2

Why federal governance of research involving

humans?Research is increasing in quantity and complexity

Multi-site, multi-nationalStem cell and genetic researchVulnerable populations – unresolved ethical issues

Protect health and safety of thousands of Canadian research subjectsInternational, including American, standards being raisedAddress liability risk for federal research

3

Federal Governance Instruments

Tri-Council Policy Statement on Ethical Conduct for Research Involving Humans (TCPS)CIHR Human Pluripotent Stem Cell Research GuidelinesClinical Trial Regulations (Food & Drugs Act)Health Canada Research Ethics BoardAssisted 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 guidelinesApplies to:

All research funded by any of the agenciesAll research conducted at an institution that receives funding from any of the agencies

6

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-medicalSocial scienceHumanities

7

Tri-Council Policy Statement

Guiding Principles:Respect for human dignityRespect for free & informed consentRespect for vulnerable personsRespect for privacy & confidentiality

Respect for justice and inclusivenessBalancing harms and benefitsMinimizing harmMaximizing benefit

8

Tri-Council Policy Statement

REB authority, membership, procedureEthical principles governing harms and benefits of researchFree & informed consent

Privacy & confidentialityConflict of interest

ResearchersREB membersInstitutions

Vulnerable populationsBio-medical issues

9

CIHR Human Pluripotent Stem Cell Research

GuidelinesMarch, 2002; based on the TCPSStem 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 cloningEmbryos created for reproduction may be donated, with consent, for research

10

CIHR Human Pluripotent Stem Cell Research

GuidelinesGuiding principles

potential health benefitsconsentprivacy and confidentialityno payment for donation of material

CIHR Stem Cell Oversight Committee + local REB reviewNational registry of embryonic stem cell lines

11

Clinical Trial Regulations (Food & Drugs Act)

Clinical trial sponsors must apply for authorization from Health Canada to use drugs in clinical trialsAuthorization 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 soundREB approvalWritten informed consent

13

Health Canada REBEstablished September, 2002Complies with TCPSReviews all research involving humans

Conducted by Health CanadaContracted for by Health CanadaOtherwise funded by Health Canada

Provides advice to Chief Scientist

14

AHR Bill ~ C-13Scope of Bill:

creation, use & transplantation of in vitro embryos, includingtreatment of gametes used to create an embryouse 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-13Declaration of Principles

benefits enhanced by protecting healthpriority to health & well-being of childrenall affected, but women more than menfree, informed consentnon-commercialhuman individuality & diversity, integrity of human genome

16

AHR Bill ~ C-13Prohibitions respecting creation, use of embryos ~ that relate to research

CloningCreating in vitro embryo, except for reproduction or improving assisted reproduction procedures

Maintaining embryo outside woman after 14 developmental daysGerm line alterationTransplanting animal gametes, embryo, foetus into humanChimeras

17

AHR Bill ~ C-13Embryo research

cannot create embryos for researchlimited 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-13Embryo research (cont’d)

licence required in all casesmust conform to regulationsAssisted Human Reproduction Agency of Canada must be “satisfied that the use [of the embryo] is necessary for the purpose of the proposed research”

19

ConclusionSince 1998, steady growth in federal governance of research involving humansUse of a number of instruments ~ ethical (funding) guidelines, Health Canada REB, Clinical Trial Regulations, AHR BillReach of federal governance instruments is significant

20

ConclusionSeptember 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

ConclusionHealth Canada is the lead government department with responsibility to fulfill this SFT commitmentHealth Canada will work toward the development of a national standard with all of the provinces and stakeholders