NIH released its final Guidelines for Human Stem Cell Research on July 6. They fulfill Executive
Order 13505, which President Obama issued Mar. 9 to remove “barriers to responsible
scientific research involving human stem cells.” The guidelines, announced online and in a telebriefing by acting NIH director Dr. Raynard Kington, were finalized after officials
spent about 5 weeks reviewing more than 49,000 public comments on the draft guidelines
that were received from the scientific
community, patient advocacy groups, and medical and religious organizations, as well as from private citizens and many members of Congress. The comments are posted on the NIH stem cell information web site at http://stemcells.nih.gov.
“We believe the final guidelines we are releasing
today achieve both of the President’s clearly
stated goals of advancing the field of human embryonic stem cell research and raising the bar of ethical standards,” Kington said. “With these goals in mind, and reflecting on the many thoughtful comments we received, we have crafted guidelines to allow NIH to fund scientifically
worthy research using responsibly derived human embryonic stem cells.” The new policy took effect on July 7.
The Final: What’s New, What’s Not
Most major elements of the draft were left intact (see sidebar). “No changes were made to the basic requirements of eligibility as described in the draft guidelines,” Kington pointed out.
Only research being conducted on human embryonic stem cells (hESCs) that were derived from embryos created
by in vitro fertilization (IVF) for reproductive purposes only and that were in excess of what donor(s) needed for reproductive purposes will be eligible for NIH funding. The donor(s) must be the individual(s) who sought reproductive treatment and must have given voluntary written
consent for the human embryos to be used for research purposes.
To aid investigators in identifying hESCs that are eligible for NIH funding,
the final policy also establishes a new NIH Stem Cell Registry that will replace the previous one. Once a stem cell line has passed NIH muster, it will be added to the registry. Cell lines listed on the registry can then be used without further requests for federal approval.
Under prior presidential policy, 21 lines were listed on the NIH Registry. Since then, additional cell lines—estimated at about 700—have been derived with non-NIH sources of funding. Under the new policy, NIH will review any hESC lines for which information is provided by scientists
through a web-based application form currently under development; the form will be posted soon on the NIH web site. The agency does not know how many of the existing lines will be eligible or are viable or available.
The final guidelines recognize that “informed consent is a process,” Kington said. “It’s not just what is written in an informed consent document.”
Therefore, exact wording for an informed consent form is not provided in the guidelines. Instead, he explained, the rules endorse a process
“where all necessary details are explained to and understood by embryo donors.”
Finally, stem cells derived via somatic cell nuclear
transfer (SCNT, also called cloning) remain ineligible in the final rules.
The Basics of Eligibility
As in the draft document, the new guidelines clearly spell out how the human embryonic stem cells (hESCs) must have been derived.
- must have been created for reproductive purposes, via in vitro fertilization,
- must be in excess of clinical need,
- and must have been donated voluntarily.
Written informed consent for research must have been obtained from the donor(s).
Information about hESC research must have been provided to the donor(s) in a robust informed consent
No research involving hESCs derived from a cloned embryo or parthenote (further-developed unfertilized human egg), or created by IVF but specifically for research, will be funded.
Donors cannot have been offered payment either in cash or in kind.
Read the entire policy at http://stemcells.nih.gov/index.asp.
The Review Process
For hESC lines that meet the new requirements exactly, there will be an administrative review that makes sure the documents submitted show that the requirements were met. However,
some scientists may want to use cell lines that existed before July 7 but that do not meet the guidelines perfectly. Or perhaps the applicants
will want to use lines developed from embryos donated in countries that have different
but equal eligibility requirements. For these hESC lines, NIH will form an ACD (advisory committee to the director) working group.
The documents the applicants would submit to the work group include informed consent forms and other evidence that the principles of the new regulations were met. In the case of lines derived from non-U.S. donations, the documents must show informed consent protections that are equivalent to the S. requirements.
Although specifics have not been finalized, Kington said the work group would include at least one or two ACD members in addition to other scientists, ethicists, specialists in IVF and representatives from the public. The working group will report to the ACD, which will then report to the NIH director, who will make the final decision.
So, scientists who want federal funds to use hESCs will proceed in one of two ways:
- Submit proof that the stem cells they intend to use comply with the new policy and await NIH administrative approval, or
- Provide documentation and related information
to the ACD work group, which will determine
whether the cell lines were derived with the ethical integrity of the new NIH rules.
In all cases, NIH will make the final decision on which stem cell lines are eligible and therefore which stem cell research can be funded.
Funding, Timing Considered
Investigators, including those in the intramural
program, with ongoing hESC research using previously eligible lines can continue. The first NIH grants for research using hESCs under the new guidelines could be awarded as early as the current fiscal year, Kington said, in answer to a reporter’s question. In anticipation of the new guidelines, NIH set aside grant applications that proposed to use ARRA funds, for example. Those applications will now be reviewed, with the new hESC policy in mind.
The Executive Order allows the NIH to revisit the rules whenever warranted.
“We believe the policy we put forth now is the right policy for where we are scientifically now,” Kington concluded. “We will not confine ourselves
to a calendar. We will closely watch, closely
follow the evolution of the science and the evolution of the ethical debate and standards, and when we feel a compelling need to update the guidelines, we will.”