192 
Monitoring Stem Cell Research 
donors, pertinent to making the decision whether or not to donate 
their embryos for research purposes. 
Informed consent should have included: 
(i) A statement that the embryos will be used to derive human 
pluripotent stem cells for research that may include human 
transplantation research; 
(ii) A statement that the donation is made without any restriction 
or direction regarding the individual(s) who may be the recipient(s) 
of transplantation of the cells derived from the embryo; 
(iii) A statement as to whether or not information that could 
identify the donors of the embryos, directly or through identifiers 
linked to the donors, will be removed prior to the derivation or the 
use of human pluripotent stem cells; 
(iv) A statement that derived cells and/or cell lines may be kept for 
many years; 
(v) Disclosure of the possibility that the results of research on the 
human pluripotent stem cells may have commercial potential, and a 
statement that the donor will not receive financial or any other 
benefits from any such future commercial development; 
(vi) A statement that the research is not intended to provide direct 
medical benefit to the donor; and 
(vii) A statement that embryos donated will not be transferred to a 
woman's uterus and will not survive the human pluripotent stem cell 
derivation process. 
f. Derivation protocols should have been approved by an IRB 
established in accord with 45 CFR 46.107 and 46.108 or FDA 
regulations at 21 CFR 56.107 and 56.108. 
B. Utilization of Human Pluripotent Stem Cells Derived From Human 
Fetal Tissue 
1. Submission to NIH 
Intramural or extramural investigators who are intending to use 
existing funds, are requesting an administrative supplement, or are 
applying for new NIH funding for research using human pluripotent 
stem cells derived from fetal tissue must submit to NIH the following: 
a. An assurance signed by the responsible institutional official that 
the pluripotent stem cells were derived from human fetal tissue in 
accordance with the conditions set forth in section II.A.2 of these 
Guidelines and that the institution v\hll maintcdn documentation in 
support of the assurance; 
b. A sample informed consent document (with patient identifier 
information removed) and a description of the informed consent 
PRE-PUBLICATION VERSION 
