NIH Issues New Rules for Funding Human Embryonic Stem Cell Research

On July 7, the National Institutes of Health (NIH) published its final guidelines for federal funding of human embryonic stem cell (hESC) research. These guidelines implement the Executive Order issued by President Obama in March and dramatically change federal funding policy for this research. All institutions and researchers seeking to use federal funds for embryonic stem cell research must follow the rules outlined by the guidelines.

The guidelines detail explicit rules regarding funding eligibility. They also expressly prohibit federal funding using hESCs that are not derived according to these criteria or are derived using other techniques.

The agency based its rules on two fundamental principles:

1. responsible research using hESCs has the potential to improve understanding of human health and could lead to cures and treatments for many diseases and disabilities
2. individuals donating embryos for research purposes should do so without duress and only after providing voluntary and informed consent

NIH will establish a new registry listing hESCs eligible for use in NIH-funded research. All hESCs that have been deemed eligible by NIH in accordance with these guidelines will be posted on this registry.

The agency notes that although federal funding of embryo research is prohibited, since hESCs are not embryos, NIH has the legal authority to issue funding guidelines and fund hESC research.

Eligibility for Federal Funding

Grants for Research Using hESCs Derived From Embryos Donated On or After July 7, 2009

Institutions applying for NIH grants using hESCs derived from embryos donated in the United States on or after July 7, 2009, may use hESCs that are posted on the NIH Registry. Alternatively, they may establish eligibility for NIH funding by submitting an assurance of compliance with the following criteria.

To be eligible, hESCs must have been derived from human embryos:

1. that were created using in vitro fertilization (IVF) for reproductive purposes and were no longer needed for this purpose
2. that were donated by individuals who sought reproductive treatment and who gave voluntary written consent for the embryos to be used for research purposes
3. for which all of the following can be assured and documentation provided:

• all options available in the health care facility where treatment was sought were explained to the individual(s) who sought reproductive treatment
• no payments – cash or in kind – were offered for the donated embryos
• policies were in place at the facility ensuring that neither consenting nor refusing to donate embryos for research would affect the quality of care provided to potential donors
• there was a clear separation between the prospective donor’s decision to create embryos for reproductive purposes and the decision to donate embryos for research purposes
• during the consent process, the donor(s) were informed of the following:
  • that the embryos would be used to derive hESCs for research
  • what would happen to the embryos in the derivation of hESCs for research
  • that hESCs might be kept for many years
  • that the donation was made without restriction or direction regarding individuals who may receive medical benefits from the use of hESCs
  • that the research was not intended to provide direct medical benefit to the donor(s)
  • that the results of research using hESCs may have commercial potential and that the donor(s) would not receive financial or other benefits from any commercial development
  • whether information that could identify the donor(s) would be available to researchers

Grants for Research Using hESCs Derived From Embryos Donated Before July 7, 2009

Institutions applying for NIH grants using hESCs derived from embryos donated in the United States before July 7, 2009, may use hESCs that are posted on the NIH Registry. Alternatively, they may establish eligibility for NIH funding by complying with the requirements noted above or in the following way.

Institutions may submit materials that make recommendations regarding eligibility for NIH funding to a Working Group of the Advisory Committee to the NIH director (ACD). The Working Group will make its recommendations to the ACD that, in turn, will make recommendations to the director. The NIH director will make the final eligibility determination.

The materials submitted must demonstrate that the hESCs were derived from human embryos that: (1) were created using IVF for reproductive purposes and were no longer needed for that purpose; and (2) were donated by donor(s) who gave voluntary written consent for the embryos to be used for research purposes.

According to the guidelines, the Working Group will review submitted materials (such as consent forms or other documentation), “taking into account” the principles articulated for eligibility of other hESCs, as well as whether during the informed consent process, including written and oral communications, the donor(s) were informed of other available options pertaining to the use of the embryos, offered any inducements for the donation of the embryos, and informed about what would happen to the embryos after the donation for research.

Grants for Research Using hESCs From Embryos Donated Outside the United States

For embryos donated before July 7, 2009, applicants may comply with either set of rules enunciated above. For embryos donated on or after July 7, applicants seeking to determine eligibility for NIH funding may submit an assurance that the hESCs comply with the new rules or that the alternative procedural standards of the foreign country where the embryo was donated provide protection “at least equivalent” to those provided by these guidelines. The materials will be reviewed by the NIH ACD Working Group that will recommend to the ACD whether such equivalence exists. Final determinations will be made by the NIH director.

Research Not Eligible for NIH Funding

The guidelines specifically prohibit NIH funding for certain hESC (and other stem cell) research. Specifically, applicants cannot receive federal funds for research in which hESCs or other induced pluripotent stem cells are introduced into non-human primate blastocysts, or for research involving the breeding of animals where the introduction of hESCs may contribute to the germ line.

In addition, federal funds may not be used to derive hESCs since federal funding that causes destruction of human embryos is prohibited. Moreover, research using hESCs derived from other sources such as nuclear transfer (so-called “therapeutic cloning”), parthenogenesis, and IVF embryos created for research purposes is not eligible for NIH funding.

NIH will periodically review and update the guidelines.