Appendix D. 
191 
2. Conditions for the Utilization of Human Pluripotent Stem Cells 
Derived From Human Embryos 
Studies utilizing pluripotent stem cells derived from human 
embryos may be conducted using NIH funds only if the cells were 
derived (without Federal funds) from human embryos that were 
created for the purposes of fertility treatment and were in excess of 
the clinical need of the individuals seeking such treatment. 
a. To ensure that the donation of human embryos in excess of the 
clinical need is voluntary, no inducements, monetary or otherwise, 
should have been ofrered 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. 
b. There should have been a clear separation between the decision 
to create embryos for fertility treatment and the decision to donate 
human embryos in excess of clinical need for research purposes to 
derive pluripotent stem cells. Decisions related to the creation of 
embryos for fertility treatment should have been made free from the 
influence of researchers or investigators proposing to derive or utilize 
human pluripotent stem cells in research. To this end, the attending 
physician responsible for the fertility treatment and the researcher or 
investigator deriving and/or proposing to utilize human pluripotent 
stem cells should not have been one and the same person. 
c. To ensure that human embryos donated for research were in 
excess of the clinical need of the individuals seeking fertility 
treatment and to allow potential donors time between the creation of 
the embryos for fertility treatment and the decision to donate for 
research purposes, only frozen human embryos should have been 
used to derive human 
pluripotent stem cells. In addition, individuals undergoing fertility 
treatment should have been approached about consent for donation 
of human embryos to derive pluripotent stem cells only at the time of 
deciding the disposition of embryos in excess of the clinical need. 
d. Donation of human embryos should have been made without 
any restriction or direction regarding the individual(s) who may be 
the recipients of transplantation of the cells derived from the human 
pluripotent stem cells. 
e. Informed Consent 
Informed consent should have been obtained from individuals who 
have sought fertility treatment and who elect to donate human 
embryos in excess of clinical need for human pluripotent stem cell 
research purposes. The informed consent process should have 
included discussion of the following information with potential 
PRE -PUBLICATION VERSION 
