190 
Monitoring Stem Cell Research 
Guidelines also designate certain areas of human pluripotent stem 
cell research as ineligible for NIH funding. 
II. Guidelines for Research Using Human Pluripotent Stem Cells That 
Is Eligible for NIH Funding 
A. Utilization of Human Pluripotent Stem Cells Derived From Human 
Embryos 
1. Submission to NIH 
Intramureil 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 human embryos must submit to NIH the 
following: 
a. An assurance signed by the responsible institutional official that 
the pluripotent stem cells were derived from human embryos in 
accordance with the conditions set forth in section II.A.2 of these 
Guidelines and that the institution will maintain documentation in 
support of the assurance; 
b. A sample informed consent document (with patient identifier 
information removed) and a description of the informed consent 
process that meet the criteria for informed consent set forth in 
section II.A.2. e of these Guidelines; 
c. An abstract of the scientific protocol used to derive human 
pluripotent stem cells from an embryo; 
d. Documentation of Institutional Review Board (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 with 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 A.l of this section, as 
necessary to carry out the public review and other oversight 
procedures set forth in section IV of these Guidelines. 
PRE -PUBLICATION VERSION 
