tissues of the three primary germ layers.2 Although hESCs are derived from embryos, such stem cells are not themselves human embryos. All of the processes and procedures for review of the eligibility of hESCs will be centralized at the NIH as follows:
Applicant institutions proposing research using hESCs derived from embryos donated in the U.S. on or after the effective date of these Guidelines may use hESCs that are posted on the new NIH Registry or they may establish eligibility for NIH funding by submitting an assurance of compliance with Section II (A) of the Guidelines, along with supporting information demonstrating compliance for administrative review by the NIH. For the purposes of this Section II (A), hESCs should have been derived from human embryos:
that were created using in vitro fertilization for reproductive purposes and were no longer needed for this purpose;
that were donated by individuals who sought reproductive treatment (hereafter referred to as “donor(s)”) and who gave voluntary written consent for the human embryos to be used for research purposes; and
for which all of the following can be assured and documentation provided, such as consent forms, written policies, or other documentation, provided:
All options available in the health care facility where treatment was sought pertaining to the embryos no longer needed for reproductive purposes were explained to the individual(s) who sought reproductive treatment.
No payments, cash or in kind, were offered for the donated embryos.
Policies and/or procedures were in place at the health care facility where the embryos were donated that neither consenting nor refusing to donate embryos for research would affect the quality of care provided to potential donor(s).
On February 23, 2010, NIH issued a request for public comment in the Federal Register on changing this definition to the following:
For the Purpose of the Guidelines, ‘human embryonic stem cells (hESCs)’ are pluripotent cells that are derived from early stage human embryos, up to and including the blastocyst stage, are capable of dividing without differentiating for a prolonged period in culture, and are known to develop into cells and tissues of the three primary germ layers.
As of the publication of this report, no revisions have been formally issued. Readers are encouraged to consult <http://stemcells.nih.gov/> for the NIH current guidelines.