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Monitoring Stem Cell Research 
(i) A statement that fetal tissue 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 fetal tissue; 
(iii) A statement as to whether or not information that could 
identify the donors of the fetal tissue, 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; and 
(vi) A statement that the research is not intended to provide direct 
medical benefit to the donor. 
c. 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. 
III. Areas of Research Involving Human Pluripotent Stem Cells That 
Are Ineligible for NIH Funding 
Areas of research ineligible for NIH funding include: 
A. The derivation of pluripotent stem cells from human embryos; 
B. Research in which human pluripotent stem cells are utilized to 
create or contribute to a humam embryo; 
C. Research utilizing pluripotent stem cells that were derived from 
human embryos created for research purposes, rather than for 
fertility treatment; 
D. Research in which human pluripotent stem cells are derived 
using somatic cell nuclear transfer, i.e., the transfer of a human 
somatic cell nucleus into a human or animal egg; 
E. Research utilizing human pluripotent stem cells that were 
derived using somatic cell nuclear transfer, i.e., the transfer of a 
human somatic cell nucleus into a human or animal egg; 
F. Research in which human pluripotent stem cells are combined 
with an animal embryo; and 
G. Research in which human pluripotent stem cells are used in 
combination with somatic cell nuclear transfer for the purposes of 
reproductive cloning of a human. 
PRE -PUBLICATION VERSION 
