The Canadian Institutes of Health Research (CIHR), the Natural Sciences and Engineering Research Council of Canada (NSERC) and the Social Sciences and Humanities Research Council of Canada (SSHRC) adopted Interim Tri-Agency Measures for human pluripotent stem cell research in 2003. The reasons for their adoption and extension are noted below.

Rationale

These Interim Tri-Agency Measures have been adopted for three reasons:

First, national and international scientific inquiry into the therapeutic potential of human stem cell research has accelerated interest and funding in Canada and abroad. Such research must be undertaken in a manner consistent with basic ethical and legal norms.

Second, the federal legislative and regulatory framework relevant to pluripotent stem cell research continues to evolve. When these Interim Measures were originally adopted, the Parliament of Canada was debating assisted human reproduction legislation relevant to some human stem cell research. With the passage of the legislation in 2004, the Government of Canada has begun work on a regulatory framework and licensing body that affects research aimed at deriving human embryonic stem cells. The details of those regulations will unfold in 2005-07 and enter into public consultation for refinement and eventual finalization. Tri-Agency policy must, of course, harmonize with the forthcoming regulations.

Third, in March 2002, CIHR adopted guidelines for human pluripotent stem cell research, Human Pluripotent Stem Cell Research: Guidelines for CIHR-Funded Research (Guidelines). They and related documents were updated in June 2005.¹ CIHR, NSERC and SSHRC have asked the Interagency Advisory Panel on Research Ethics (PRE) for its advice on how to incorporate the Guidelines into the Tri-Council Policy Statement: Ethical Conduct for Research Involving Humans (TCPS) of 1998, which currently does not explicitly address human stem cell research. PRE will require time to complete the review.

These needs and developments have prompted the adoption of Interim Tri-Agency Measures on human pluripotent stem cell research.

Interim Tri-Agency Measures

Basic Requirements: All new or ongoing human stem cell research that is:

• funded by the Agencies; or
• conducted under the auspices of an institution that receives any Agency funding, whether on-site or off-site; or
• conducted elsewhere with any source of funding by faculty, staff or students from an institution that receives Agency funding,

must have adhered to the original Guidelines effective March 2002, and must adhere to the updated Guidelines effective June 7, 2005. As well, all such research must adhere to the TCPS.

Basic requirements are set out in the Guidelines and detailed in a set of on-line Frequently Asked Questions (FAQs).²

In particular, it should be noted that certain new and ongoing human stem cell research protocols need to be submitted to and approved by the Stem Cell Oversight Committee (SCOC), in addition to the normal review by local Research Ethics Boards (REBs).³ To facilitate SCOC review, procedures for submitting information to the SCOC have been outlined.⁴

Detailed Information: The Guidelines and information on their implementation, details on the operations of SCOC, and other related documents are posted on the CIHR Web site.⁵

Period: The Interim Tri-Agency Measures will be in effect from June 2003 until formal incorporation of the Guidelines into the TPCS or until further notice. If significant legislative or policy developments necessitate changes to the Interim Measures, you will be promptly notified. As well, any technical modifications of the Measures will be shared with the community.

Contact: If you have questions about the Interim Tri-Agency Measures or the FAQs, please contact CIHR: stemcell@cihr-irsc.gc.ca. The Agencies appreciate your help in implementing these Interim Tri-Agency Measures.