individual, 45 C.F.R. § 46.102(f). The HHS Office for Human Research Protections (OHRP) considers biological material, such as cells derived from human embryos, to be individually identifiable when they can be linked to specific living individuals by the investigators either directly or indirectly through coding systems. Thus, in certain circumstances, IRB review may be required, in addition to compliance with these Guidelines. Applicant institutions are urged to consult OHRP guidances at http://www.hhs.gov/ohrp/policy/index.html#topics.
To ensure that the greatest number of responsibly derived hESCs are eligible for research using NIH funding, these Guidelines are divided into several sections, which apply specifically to embryos donated in the U.S. and foreign countries, both before and on or after the effective date of these Guidelines. Section II (A) and (B) describe the conditions and review processes for determining hESC eligibility for NIH funds. Further information on these review processes may be found at www.NIH.gov. Sections IV and V describe research that is not eligible for NIH funding.
These guidelines are based on the following principles:
Responsible research with hESCs has the potential to improve our understanding of human health and illness and discover new ways to prevent and/or treat illness.
Individuals donating embryos for research purposes should do so freely, with voluntary and informed consent.
As directed by Executive Order 13505, the NIH shall review and update these Guidelines periodically, as appropriate.
For the purpose of these Guidelines, “human embryonic stem cells (hESCs)” are cells that are derived from the inner cell mass of blastocyst stage human embryos, are capable of dividing without differentiating for a prolonged period in culture, and are known to develop into cells and