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Guidelines for Human Embryonic Stem Cell Research
ance of compliance with the relevant requirements in this report and relevant regulations and a copy of the consent form used for procurement purposes.
Ensuring that Donation Is Voluntary
Preceding sets of guidelines have emphasized the critical requirement of voluntary donation, including the explicit prohibition of monetary inducement or promise of therapeutic benefit. The original National Institutes of Health guidelines for hES cell research developed in 2000 stated “To ensure that the donation of human embryos in excess of the clinical need is voluntary, no inducements, monetary or otherwise, should have been offered for the donation of human embryos for research purposes. Fertility clinics and/or their affiliated laboratories should have implemented specific written policies and practices to ensure that no such inducements are made available.” Likewise, the Canadian guidelines state “Neither the oocyte nor the sperm from which the embryos were created, nor the embryos themselves, were obtained through commercial transactions, including exchange for service.” The European Commission and the U.K. Medical Research Council have instituted similar prohibitions. And the provisions of California’s Proposition 71, passed in 2004, similarly prohibit payment to donors. Thus, there is virtual unanimity that to avoid any temptation for individuals to create extra embryos for research purposes, no payments should be offered for donation of residual embryos created for reproductive purposes in IVF programs. It is also agreed that there should be no added expense or burden to patients when residual blastocysts are donated and all storage costs for frozen blastocysts should be assumed by the investigators once donation has been confirmed.
The explanation of such unanimity might lie in the view that the treatment of the developing human embryo as an entity deserving of respect may be undermined by the introduction of a commercial motive into the solicitation or donation of fetal or embryonic tissue for research purposes. But although the potential for pressure is probably greatest when financial incentives are present, some nonfinancial incentives also should be avoided. For example, a donor’s decisions should not be influenced by anticipated personal medical benefits or by concerns about the quality of later care. Any suggestion of personal benefit to a donor or to a person known to the donor should be avoided. (For obvious reasons, the use of nuclear transfer [NT] to develop hES cells for autologous transplantation requires that the recipient be specified.) Thus, a potential donor should be informed that there is no obligation to donate, that no personal benefit will accrue as a result of a decision to donate (except in cases of autologous transplantation), and that no penalty will result from a decision to refuse to donate. Similarly, people who elect to donate stored blastocysts for research should not be reimbursed for the costs of storage before the decision to donate, because this may be interpreted as an incentive to donate.