that the results of research using the hESCs may have commercial potential, and that the donor(s) would not receive financial or any other benefits from any such commercial development;
whether information that could identify the donor(s) would be available to researchers.
Applicant institutions proposing research using hESCs derived from embryos donated in the U.S. before 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 in one of two ways:
By complying with Section II (A) of the Guidelines; or
By submitting materials to a Working Group of the Advisory Committee to the Director (ACD), which will make recommendations regarding eligibility for NIH funding to its parent group, the ACD. The ACD will make recommendations to the NIH Director, who will make final decisions about eligibility for NIH funding.
The materials submitted must demonstrate that the hESCs were derived from human embryos: 1) that were created using in vitro fertilization for reproductive purposes and were no longer needed for this purpose; and 2) that were donated by donor(s) who gave voluntary written consent for the human embryos to be used for research purposes.
The Working Group will review submitted materials, e.g., consent forms, written policies or other documentation, taking into account the principles articulated in Section II (A), 45 C.F.R. Part 46, Subpart A, and the following additional points to consider. That is, during the informed consent process, including written or oral communications, whether the donor(s) were: (1) informed of other available options pertaining to the use of the embryos; (2) offered any inducements for the donation of the embryos; and (3) informed about what would happen to the embryos after the donation for research.
For embryos donated outside the United States before the effective date of these Guidelines, applicants may comply with either Section II (A) or (B). For embryos donated outside of the United States on or after the effective date of the Guidelines, applicants seeking to