Appendix D. 
193 
process that meet the criteria for informed consent set forth in 
section II.B.2.b of these Guidelines; 
c. An abstract of the scientific protocol used to derive human 
pluripotent stem cells from fetal tissue; 
d. Documentation of IRB approval of the derivation protocol; 
e. An assurance that the stem cells to be used in the research were 
or will be obtained through a donation or through a payment that 
does not exceed the reasonable costs associated v\nth the 
transportation, processing, preservation, quality control and storage 
of the stem cells; 
f. The title of the research proposal or specific subproject that 
proposes the use of human pluripotent stem cells; 
g. An assurance that the proposed research using human 
pluripotent stem cells is not a class of research that is ineligible for 
NIH funding as set forth in section III of these Guidelines; and 
h. The Principal Investigator's written consent to the disclosure of 
all material submitted under Paragraph B.l of this section, as 
necessary to carry out the public review and other oversight 
procedures set forth in section IV of these Guidelines. 
2. Conditions for the Utilization of Human Pluripotent Stem Cells 
Derived From Fetal Tissue. 
a. Unlike pluripotent stem cells derived from human embryos, 
DHHS funds may be used to support research to derive pluripotent 
stem cells from fetal tissue, as well as for research utilizing such 
cells. Such research is governed by Federal statutory restrictions 
regarding fetal tissue research at 42 U.S.C. 289g-2(a) and the Federal 
regulations at 45 CFR 46.210. In addition, because cells derived from 
fetal tissue at the early stages of investigation may, at a later date, 
be used in human fetal tissue transplantation research, it is the 
policy of NIH to require that all NIH-funded research involving the 
derivation or 
utilization of pluripotent stem cells from human fetal tissue also 
comply with the fetal tissue transplantation research statute at 42 
U.S.C. 289g-l. 
b. Informed Consent 
As a policy matter, NIH-funded research deriving or utilizing 
human pluripotent stem cells from fetal tissue should comply with 
the informed consent law applicable to fetal tissue transplantation 
research (42 U.S.C. 289g-l) and the following conditions. The 
informed consent process should have included discussion of the 
following information with potential donors, pertinent to making the 
decision whether to donate fetal tissue for research purposes. 
Informed consent should have included: 
PRE -PUBLICATION VERSION 
