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May 06, 2010

Further challenges for research following AHRC resignations

by Ubaka Ogbogu

The recent resignation of two members of the Board of Directors of Assisted Human Reproduction Canada (AHRC), the federal regulatory agency responsible for implementing the provisions of the Assisted Human Reproduction Act, has once again raised questions regarding the composition, progress and relevance of the agency’s governing body, which I outline below. Such weaknesses have prevented the Board, which was constituted in December 2006, from enabling the agency to fulfill key aspects of its statutory mandate, including implementing and administering the licensing framework for controlled activities under the Act, and enforcing compliance with the Act. 

For many, the membership structure of the Board has been controversial since its inception. The Act expressly excludes licensees or license applicants, or persons affiliated with them, from eligibility and selection as Board members. This provision has received some criticism, chiefly because it prevents experts such as stem cell scientists or fertility experts from serving on the Board, thus ensuring that those most knowledgeable about the technologies regulated by the Act are excluded from their oversight and implementation. This strategy seems particularly injudicious when one considers that many of these technologies – stem cell research being a prime example – constitute emergent and constantly evolving areas of knowledge where specific expertise is most essential. In keeping with the provisions of the Act, the current Board does not include any obstetrician or gynecologist, patient representatives, or stem cell researchers. This is in sharp contrast to similar regulatory agencies in other jurisdictions, most notably in the U.K., where the board of the equivalent Human Fertilisation and Embryology Authority (HFEA) includes fertility experts and scientists.

The Canadian rule appears to have been motivated by concerns that interested experts will unduly influence policy implementation and enforcement in an area fraught with scientific and ethical uncertainties. However, it is not clear how the inclusion of experts in the agency’s Board will differ from other research contexts such as cancer research, where ethical oversight and governance is handled by scientists involved in the research. In any event, such fears can be met and addressed by instituting stringent conflict of interest disclosure and mitigation rules, as is indeed the case in other research contexts, and with the HFEA.

While what prompted the resignations is unknown at the present time (the Board members signed confidentiality agreements), one thing is clear – there is a need to reassess the rules regarding membership of the Board. The Board as currently constituted lacks the necessary expertise to perform the crucial functions mandated by the Act. Furthermore, in Canada, there is a very limited pool of knowledgeable persons – both in the scientific and research ethics realms – without ties to research developments in the fields regulated by the Act. This by itself does not translate to impropriety or unethical behaviour, but is in fact partly the product of persistent efforts by the Canadian government to mobilize Canadian research excellence and promote the training and concentration of highly skilled personnel in cutting-edge science and technology research. 

It may also be difficult to find replacement appointees – of the same calibre as the resignees or otherwise – who would not seem out of place on a board overseeing such a specialized field. This will further diminish the competence and representativeness of the Board’s membership, as well as the Board’s ability to render responsible and responsive governance in tune with rapid developments and advances in controlled areas like stem cell research.  

Lastly, the lack of any serious activity from the Board (or Agency) since its inception raises questions about its continued relevance, especially as regards the governance of embryo research. For regulated activities such as human embryonic stem cell research (using supernumerary IVF embryos), this lack of activity has had some stifling effect on research. However, Canadian stem cell scientists have continued to make important basic research discoveries (through methods outside the scope of the Agency’s regulatory authority). It is quite possible that by the time the Agency begins work in earnest, advancements in the field would have far outpaced its regulatory mandate.    


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