Research involving the in vitro embryo - 2004

Canadians' views on the use of the in vitro human embryo, whether for treatment for reproductive purposes or for research, are diverse and the legislation recognizes this fact. The Act ensures that all research involving the use of the in vitro human embryo is carefully regulated.

Regulated research involving the in vitro embryo has important applications. It may answer many questions about the causes of infertility. It may also aid in the development of treatments for conditions such as Alzheimer's, Parkinson's, cancer and spinal cord injuries.

By no means does, the AHR legislation promote embryo research. Rather, it establishes clear boundaries, where none existed before, as to what constitutes acceptable research and under what conditions this research can be undertaken.

What the AHR legislation says about embryo research:

The AHR legislation establishes a framework for the use of in vitro embryos in research, and strict regulations will be developed to ensure that such research is conducted in an appropriate manner, whether in the public or private sector. The Assisted Human Reproduction Agency of Canada (Agency) will implement and oversee the legislation and regulations.

Researchers intending to use an in vitro embryo in their research must satisfy the Agency that they have undertaken certain steps before being issued a licence to proceed. The Act allows for the in vitro embryo to be used only if the following conditions are met, including:

• it is demonstrated to the Agency that the use of an in vitro embryo is necessary for the purposes of the research (s. 40(2));
• the in vitro embryo is no longer needed for reproductive purposes, as an embryo cannot be specifically created for research purposes (s.5(1)(b));
• fully informed and written consent was obtained from the individual(s) for whom the embryo was created (s. (8));
• no one has purchased, sold or advertised to sell the in vitro embryo(s) (s.(7(2)); and
• the researcher has obtained a licence from the Agency to undertake the research (s.10(2)).

The regulatory framework to be developed under the Act will provide further protection by ensuring that any proposed research project has undergone a peer and ethics review. Regulations and licences will stipulate the type of research that may be allowed and the strict conditions under which research may be carried out. Also, regulations will stipulate that each research proposal will be subjected to the same process of scrutiny. A licence for one research project cannot be applicable for another.

What are embryonic stem cells?

Stem cells are "undifferentiated" cells which have the capacity to self-renew indefinitely in culture and differentiate, or "mature", into any one of the more than 200 specialized cell types in the human body. These cells have been the subject of scientific studies for decades. However, stem cell research did not garner widespread public interest until a major scientific breakthrough occurred in 1998 when, for the first time, researchers in the U.S. successfully derived stem cells from human embryonic and foetal tissues.

The landmark research from the U.S. opened the door to new scientific studies and possible therapeutic applications. It created the possibility of cell-based therapies in which stem cells could be grown in vitro and then used to repair tissues that have degenerated or been destroyed by diseases such as Parkinson's or Alzheimer's.

Stem cells are found at different stages of development (i.e., embryonic, foetal, and adult) in a wide range of tissues. While stem cell research seems promising, there is considerable debate regarding the potential of stem cells derived at the different stages of development. For example, stem cells derived from an in vitro embryo (i.e., at the embryonic stage) have demonstrated an ability to self-renew and differentiate, however, it is not yet clear whether stem cells from adult sources are equal in potential.

What the AHR legislation says about embryonic stem cell research:

As is the case in all research projects involving the in vitro embryo, whether stem cells are to be derived or not, certain conditions must be met (see above bullet points).

However, specific to embryonic stem cell research, the Act states ¹ that the Agency shall not issue a licence unless it has received the written consent of the embryo provider and of the original gamete providers (if different from the embryo provider).

It is important to recognize that the Act does not address research involving cells already derived from an in vitro embryo (e.g., pre-existing embryonic stem cell lines). However, such research would be addressed by other oversight mechanisms such as the Canadian Institutes of Health Research.

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¹ An Act respecting assisted human reproduction and related research, s.40(3.1)