Washington Editor

WASHINGTON - Scientists receiving federal funding for human embryonic stem cell (hESC) research must use only cells that were derived for reproductive purposes and no longer needed for those reasons, but are prohibited from using hESCs derived from other sources, the National Institutes of Health (NIH) said in new draft guidelines issued Friday.

NIH Acting Director Raynard Kington said the proposed guidelines were based on the agency's "best judgment." But, he added, the NIH is open to public input for the next 30 days before it finalizes the rules on or before July 7.

The draft guidelines were posted Friday on the NIH's website and will be published within the next few days in the Federal Register.

An executive order signed on March 9 by President Barack Obama gave the NIH 120 days to issue a new guidance document governing how federal funding for stem cell research should be distributed and applied. (See BioWorld Today, March 10, 2009, and March 11, 2009.)

The executive order revoked an order signed by George W. Bush on June 20, 2007 and his presidential statement of Aug. 9, 2001, that limited federal funding on research involving hESCs. The Bush administration allowed the NIH to fund hESC research on cell lines created before Aug. 9, 2001, but prohibited research on those created after that date.

"NIH is truly looking forward to expanding research using human embryonic stem cells," Kington told reporters Friday during a media briefing. "In a matter of months, we are likely to increase greatly the number of human embryonic stem cells eligible for federal funding, including stem lines exhibiting greater genetic diversity, stem lines with disease causing mutations. This is a remarkable development that promises to speed the research that may one day fundamentally change how we approach health and disease."

Kington said the NIH "welcomed" the president's executive order and is "moving expeditiously to put guidelines in place that will allow responsible and scientifically worthy research to benefit from NIH funding."

Before investigators and research institutions can use NIH funds, they must ensure that hESCs were derived according to the guidelines and that they maintain appropriate documentation, Kington said.

He noted that funding would continue as normal for research using human adult stem cells and induced-pluripotent stem cells and that, pending issuance of new guidelines, all ongoing NIH-funded research involving approved uses, including hESCs, also would continue. However, until the guidelines are finalized, no new uses of hESCs may be initiated with NIH funding, Kington said.

Any applications previously submitted to NIH and already reviewed, which propose to use hESCs, would be held for funding decisions until the final guidelines are issued, he told reporters, noting that at that time, highly ranked applications can be modified to comply with the guidelines to receive full consideration for funding.

While the NIH will accept applications for research proposing to use hESCs, the review and funding of those applications will be deferred until the agency issues its final guidelines, Kington said.

The draft guidelines proposed that NIH allow funding for research only using hESCs that were derived from embryos created by in vitro fertilization (IVF) for reproductive purposes and were no longer needed for that purpose, Kington explained.

"Specifically, these draft guidelines describe the conditions and informed consent procedures that are required during the derivation of human embryonic stem cells for research using these cells," he said.

Under the proposed guidelines, NIH funding for research using hESCs derived from other sources, including somatic cell nuclear transfer, parthenogenesis or IVF embryos created for research purposes, is prohibited, Kington said.

Researchers also must document that all options pertaining to the use of embryos no longer needed for reproductive purposes were explained to the potential donors and that no inducements were offered for the donation.

In addition, researchers are required to have a policy 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 donors.

The documentation also must show that there was a clear separation between the prospective donor's decision to create human embryos for reproductive purposes and the prospective donor's decisions to donate human embryos for research purposes and that at the time of donation, consent for that donation was obtained from the individuals who had sought reproductive services, Kington said.

Researchers also are required to show that decisions related to the creation of human embryos for reproductive purposes were made free from the influence of researchers proposing to derive or use hESCs in research.

The draft guidelines also require that the attending physician responsible for reproductive clinical care and the researcher deriving or proposing to use hESCs are not the same person, Kington said.

However, he said, the NIH recognizes that there are certain cases where such a requirement may be waived.

Researchers also are required to obtain informed written consent from anyone who sought reproductive services and who elected to donate the embryos for research purposes. Written consent forms must state that donation of the embryos for research was voluntary and that the donor understood alternative options pertaining to use of the embryos.

In addition, donors must consent to allowing the embryos to be used for research and must acknowledge that they are aware that the hESCs derived from the embryos might be maintained for many years.

Donors also must consent that their donation was made without any restriction or direction regarding anyone who may receive medical benefit from the use of the stem cells and that the research was not intended to provide direct medical benefit to the donors.

The donors also must be advised and acknowledge that the results of research using the hESCs may have commercial potential and must state that they would not receive financial or any other benefits from any such commercial development.