Final Stem-Cell Research Rules Issued

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ePT--the Electronic Newsletter of Pharmaceutical Technology

The National Institutes of Health (NIH) issued on July 7, 2009, final guidelines for human stem-cell research that widen the door to the cell lines that can be used if they meet certain ethical requirements.

The National Institutes of Health (NIH) issued on July 7, 2009, final guidelines for human stem-cell research that widen the door to the cell lines that can be used if they meet certain ethical requirements. Based on President Barack Obama’s March 9 executive order to reinstate and increase federal funding of research involving human stem-cell research, the guidelines provide final rules on conducting “responsible, scientifically worthy human stem-cell research, including human embryonic stem-cell (hESC) research.” Taking effect on July 7, the guidelines apply to NIH funds for research using hESCs and certain uses of induced pluripotent stem cells.

The guidelines have taken into account public comments received in April and May 2009 based on NIH’s draft guidelines, which were issued on Apr. 23, 2009. NIH received approximately 49,000 comments, according to the July 7 Federal Register release. The comments are available on the NIH website.

NIH’s final guidelines define hESCs as “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 tissues of the three primary germ layers. Although hESCs are derived from embryos, such stem cells are not themselves human embryos,” state the guidelines.

The guidelines also clarify the supporting documentation that must accompany requests for NIH funding for hESCs research. The institutes plan to issue additional guidance on how to implement the guidelines and how to manage pending applications, according to an NIH notice. In the meantime, “ongoing NIH-supported research involving previously approved hESC lines may continue,” however, “no new uses of hESCs may be initiated in ongoing funded studies unless reviewed and approved by the NIH,” says the notice.


According to the final guidelines, hESCs that can be used should have been derived from human embryos:
    "1. That were created using in vitro fertilization for reproductive purposes and were no longer needed for this purpose;
    2. 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
    3. For which all of the following can be assured and documentation provided, such as consent forms, written policies, or other documentation, provided:
      a. All options available in the healthcare 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;
      b. No payments, cash or in kind, were offered for the donated embryos;
      c. Policies and/or procedures were in place at the healthcare 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);
      d. There was a clear separation between the prospective donor(s)'s decision to create human embryos for reproductive purposes and the prospective donor(s)'s decision to donate human embryos for research purposes; and
      e. During the consent process, the donor(s) were informed…” in detail about the use of the cells and any research information obtained from the cells (more specific details are included in the final guidelines).

Applicants wishing to use hESCs that were derived from embryos before July 7, 2009, must meet the above requirements or must submit materials to a working group at NIH. The working group will make recommendations to the NIH Director, who will then decide on eligibility for NIH funding. Applications submitted to the working group still have to meet certain ethical requirements.
An online NIH registry will soon list hESCs that may be used in NIH-supported research.