Objectives: To investigate compliance with applicable regulations by Canadian human embryonic stem cell (hESC) researchers and fertility clinics involved in providing embryos for their research, and to ascertain actual consent practices in the hESC research context.
Method: Telephone interviews were conducted with all hESC researchers, and email interviews were conducted with fertility clinics that provide embryos to these researchers. Consent forms currently used for donation of embryos to hESC research were reviewed. Separate questionnaires were used for the researchers and clinics.
Results: Three of four clinics responded. Of the clinics that responded, each had provided embryos for hESC research to at least one of the researchers. Despite considerable policy attention given to hESC research, very few researchers and clinics are actually involved in the research in Canada. Only cryopreserved embryos are currently being used in hESC research, but one researcher has applied to use fresh embryos. Fertility clinics play a primary role in the consent process, and researchers have no contact with patients/donors. Although representations have been made in academic literature and the popular press suggesting a lack of compliance by Canadian hESC researchers, researchers and clinics report that they are in substantial compliance with applicable regulations. The researchers appear to be very conscious of the ethics of hESC research. In addition, they state that they are willing to follow the rules, but they are frustrated by the lack of regulatory clarity and by delays in the research oversight process.
Conclusion: Empirical research on perceptions other stakeholders (donors, research ethics boards etc.) have of the hESC research process appears essential.