Development and investigation of a free and informed choice process for embryo donation to stem cell research in Canada.

Objectives: To develop and investigate a consent process that satisfies the Assisted Human Reproduction (AHR) Act and the Canadian Institutes of Health Research (CIHR) Stem Cell Guidelines, furthers free and informed choice, and fosters embryo donation to human embryonic stem cell (hESC) research.

Methods: Consultations were undertaken with an hESC scientist, in vitro fertilization (IVF) team members, and the ethicist-author of the CIHR Guidelines to review the AHR Act, the CIHR Stem Cell Guidelines, the established consent process for embryo donation at University Hospital, London Health Sciences Centre, the characteristics of patients appropriate for contact, and strategies for sensitive recruitment. Invitation-to-participate packages were sent to patients.

Results: Patients deemed appropriate for contact had indicated their intent to donate embryos to research, had embryos that had been cryopreserved for more than five years, had not received donor gametes, and had publicly listed addresses, with no suggestion of separation of the parties. Strategies developed to promote anonymity, confidentiality, and informed choice included a "firewall" between clinical and research teams and documents reiterating that, if embryos were donated, the woman would have to undergo additional IVF treatment to have a child. Of 40 couples contacted, only 22 agreed to donate embryos to the hESC study. One couple no longer wished to donate embryos to research, one package was returned as undeliverable, and no response was received from 16 couples.

Conclusions: The consent requirements of the AHR Act and the CIHR Stem Cell Guidelines should be met. Consider delaying the request for final consent until a significant time after IVF treatment to ensure that patients no longer want their embryos for reproductive purposes and are free from perceptions of coercion. A consent process promoting free and informed choice, sensitive recruitment, and donation of embryos for hESC research should be developed by the Canadian professional bodies.