Summary and Background
The Hope Offered Through Principled and Ethical Stem Cell Research Act or HOPE Act, S.30, would promote research into finding alternative ways to derive stem cells that do not involve: 1) the creation of an embryo for research purposes; or 2) the destruction or discarding of, or risk of injury to an embryo, other than an embryo that is “naturally dead.”
The President’s Council on Bioethics evaluated possible alternative sources of stem cells in a white paper published in May 2005. The paper discussed four approaches: 1) extracting cells from embryos that are considered not viable; 2) extracting cells through biopsies of living embryos; 3) extracting cells from artificially created non-embryonic but embryo-like cellular systems; and 4) inducing differentiated somatic cells to return back into their previous pluripotent state.
Current work on finding alternative sources of stem cells is at its earliest stages and is largely theoretical. Moreover, some of these proposed alternative methods for deriving stem cells raise their own ethical questions. With respect to the idea of deriving stem cells from embryos that are thought to be biologically dead, scientists haven’t developed a reliable mechanism to determine an embryo’s “death,” and there is no scientific evidence that stem cells derived from these embryos would have the necessary characteristics or be safe and effective for human therapies. Accordingly, the great majority of stem cell scientists believe that development of alternative sources of stem cells, as contemplated by this legislation, should be a complement to, not a substitute for, existing mechanisms for generating embryonic stem cells.
Human Pluripotent Stem Cell Research
S.30 would direct the Secretary of Health and Human Services (hereafter referred to as the Secretary) to conduct and support basic and applied research to develop techniques for the isolation, derivation, production, or testing of stem cells, including stem cells that are pluripotent (that is, capable of producing all of the cell types of the body), provided that such activities will not involve: 1) the creation of an embryo for research purposes; or 2) the destruction or discarding of, or risk of injury to an embryo, other than an embryo that is “naturally dead.” The legislation provides that an embryo is “naturally dead” if it has “naturally and irreversibly lost the capacity for integrated cellular division, growth, and differentiation that is characteristic of an organism, even if some cells of the former organism may be alive in a disorganized state.”
The Secretary, after consulting with the Director of the National Institutes of Health (NIH), would be required to issue final guidelines no later than 90 days after enactment. These guidelines would:
· Provide guidance on the next steps required for additional research, including a determination of the extent to which specific techniques may require additional animal research to ensure that any research involving human cells using these techniques would clearly be consistent with the standards established under this section;
· Prioritize research with the greatest potential for near-tern clinical benefit;
· Take into account techniques outlined by the President’s Council on Bioethics and any other appropriate techniques and research; and
· In the case of research involving stem cells from a “naturally dead” embryo, require assurances from grant applicants that no alteration of the timing, methods, or procedures used to create, maintain, or intervene in the development of a human embryo was made solely for the purpose of deriving stem cells.
The bill would require the Secretary to prepare and submit to the appropriate committees of Congress a report on the activities carried out under this legislation during each fiscal year, including a description of research conducted. The reports will be prepared and submitted no later than January 1 of each year.
S.30 includes a rule of construction stating that nothing in the bill is to be construed to alter the policy in effect on the date of the bill’s enactment regarding the eligibility of stem cell lines for NIH funding. The bill also authorizes the appropriation of such sums as may be necessary to carry out the activities described above.
National Amniotic and Placental Stem Cell Bank
S.30 provides that the Secretary shall enter into a contract with the Institute of Medicine to conduct a study to determine an optimal structure for an amniotic and placental stem cell bank program, and to address pertinent issues to maximize the potential of amniotic and stem cell banking technology. The bill would require the Institute of Medicine to complete the study within 180 days of enactment and submit to the Secretary and the appropriate Congressional committees a report on the results of the study.
S.30 was introduced by Senator Coleman and Senator Isakson on March 29, 2007. On that same date a unanimous consent agreement was reached, pursuant to which the Senate will consider two bills: S.5 (modified) the Stem Cell Research Enhancement Act of 2007, and S.30. Each bill will require 60 votes in order to pass. Floor debate is scheduled to begin on April 10. Debate will be limited to 20 hours, with time divided as follows:
– Five hours each under the control of the Majority and Republican Leaders, or their designees; and
– Five hours each under the control of Senators Harkin and Brownback, or their designees.
Under the consent agreement, no amendments will be in order.
The Bush Administration has expressed its support for S.30.