blastocysts for hES cell research and whether the population of frozen blastocysts now residing at IVF clinics needs to be “grandfathered” or exempt from the requirement for sperm donor consent.

To evaluate these effects, the Committee contacted the Society for Assisted Reproductive Technology (SART), which is actively involved in the collection of data on outcomes from its member IVF clinics. SART works closely with the Centers for Disease Control and Prevention in compliance with the Fertility Clinic Success Rate and Certification Act of 1992 (Wyden Act) to reflect accurately outcomes of the procedures commonly used in IVF practices.8 The information returned in response to the Committee’s request indicated that the number of blastocysts created with anonymous donor sperm in SART member practices is only about 3.5 percent.9

Given this small number, it is the Committee’s view that maintaining the requirement for sperm donor consent in cases where human embryonic stem cell lines are to be derived from excess IVF clinic blastocysts should not significantly affect the availability of blastocysts for donation to research. The Committee, therefore, has concluded that it is not necessary to modify the Guidelines by “grandfathering” the frozen embryo population in IVF clinics and exempting them from the informed consent requirement for sperm donors. In light of the inability to determine whether any of these donors would have foregone sperm donation had they known of possible nonreproductive uses of the resulting blastocysts, the existing Guidelines reasonably balance respect for the gamete donors’ expectations with the needs of the research community.

CONSIDERING THE SCIENCE IN hES CELL RESEARCH PROPOSALS: ADVICE FOR ESCRO COMMITTEES

It has been brought to the Committee’s attention that some ESCRO committees would appreciate additional guidance on how to evaluate research proposals that are submitted for ESCRO committee review. In several places, the Guidelines emphasize the need to consider the scientific rationale for an experiment as part of the ethical analysis of the experiment. Although this section of this report does not amend the Guidelines, the

8

See <http://www.sart.org/WhatIsSART.html> for more information about this data collection effort.

9

2004 SART CORS© database.



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