Objective: To identify main ethical and legal issues that arise with d
onation of embryos left over from IVF treatments of infertility or cre
ated from separate gamete donations. Design: Analysis of ethical comme
ntary, advisory committee reports, statutes, court cases, and legal co
mmentary relating to gamete and embryo donation and assisted reproduct
ion to assess their effect on donation of created or leftover embryos.
Results: Donation of surplus embryos or embryos created from separate
gamete donations would help a subset of infertile couples to form fam
ilies. A program undertaking embryo donation will have to coordinate t
he donation of embryos from its own patients or other programs or arra
nge for separate gamete donations to form embryos. The main ethical is
sues concern the effect on offspring, consent and counseling of donors
and recipients, avoidance of mixing embryos or gametes from different
sources, and payment of donor expenses. The main legal issues concern
whether embryo donation is viewed as gamete donation or adoption; the
rearing rights and duties of donors and recipients in resulting offsp
ring; liability; and compensation issues; and the legality of monetary
compensation for donors. Donation of embryos for research raises sepa
rate issues. Conclusion: Human embryo donation is an ethically and leg
ally acceptable way for infertile couples to form families.