Updated Guidelines for Human Pluripotent Stem Cell Research

(2010-06-30) The "Guidelines for Human Pluripotent Stem Cell Research" have been updated, effective June 30, 2010. These supersede the June 2007 Guidelines.

The following changes have been made from the June 2007 Guidelines:

  • Section 1.0:
    • update to responsibly promote the potential of stem cell research (by removing the adjective "great" from the statement that "Stem cell research holds great potential to treat human disease and prevent suffering")
    • update to the list of diseases that stem cells have the potential to provide treatments for (addition of spinal cord injury)
    • editorial changes to clarify the content
  • Section 2.0:
    • editorial changes to clarify the content
  • Section 3.0:
    • updates to reflect the ability to reprogram adult cells to a pluripotent state
    • editorial changes to clarify the content
  • Section 5.0:
    • updates to clarify the types of human pluripotent stem cell research that require SCOC review
  • Section 6.0:
    • revision to reflect all human embryonic stem cell lines derived under the auspices of an institution that receives any Agency funding be listed in the human embryonic stem cell registry;
    • update to reflect that human induced pluripotent stem cell lines will not be listed in the registry
  • Section 8.1:
    • editorial changes to clarify that the Guidelines apply to research using existing human pluripotent stem cell lines, and not just to the derivation and study of novel lines
    • updates that refer to inducing human pluripotent stem cells
    • updates to the list of known types of human pluripotent stem cells
    • update to clarify that testing the ability of a human stem cell to form a teratoma is research that conforms to the Guidelines
    • editorial changes to clarify the content
  • Section 8.2:
    • updates to the list of known types of human pluripotent stem cells

In addition, the procedures for submitting stem cell research applications, the Policy Highlights, the Frequently Asked Questions, the National registry of human embryonic stem cell lines and the application forms have been updated.

Governing Council recently delegated its authority to approve research using existing SCOC-approved human embryonic stem cell (hESC) lines and/or human induced pluripotent stem (iPS) cells to SCOC, unless the research involves the engraftment of those cells into humans. SCOC will respond to research proposals within its delegated authority within 30 business days of receipt of a complete application. Governing Council's approval is required on all other types of research proposals (e.g., research involving the derivation of hESC from human embryos, the use of hESC lines not yet approved by SCOC, and/or the engraftment of human pluripotent stem cells into human beings).

Human iPS cell research involving grafting experiments that are limited to in vivo experiments to test teratoma formation is exempt from SCOC review, provided that the investigators notify SCOC in writing that the animals will not be used for reproductive purposes.

Please note that the Guidelines are typically updated on an annual basis, and posted in June. CIHR continues to work in close collaboration with Health Canada to ensure that the Guidelines are in harmony with the regulations that are being developed for the Assisted Human Reproduction Act. Should any change to the Act or its regulations require modifications of the Guidelines, outside of the annual update, these will be posted prominently on the CIHR website.

Should you require any additional information, please contact:
Lynne Scholten
Ethics Policy Advisor
Canadian Institutes of Health Research
Room 97, 160 Elgin Street
Ottawa, Ontario K1A 0W9
E-mail: stemcell@cihr-irsc.gc.ca
Phone: 613-952-4264
Fax: 613-954-1800