The National Academies Releases 2008 Amendments for Human Embryonic Stem Cell Research
September 17, 2008 – The National Academies' Human Embryonic Stem Cell Research Committee released the updated Guidelines for Human Embryonic Stem Cell Research on September 5, 2008. The guidelines were established by a joint effort of the National Research Council and the Institute of Medicine in 2005 to provide a set of ethical national standards for research involving human embryonic stem cells (hES). A standing advisory committee established to monitor and review scientific advances in this area clarified the language of the guidelines in 2007 and, most recently, revised it to reflect the rapid pace of scientific development in the field of stem cell research.
The 2008 amendments to the Guidelines for hES include considerations for derivation and use of the recently described induced pluripotent cells (iPS), new kind of human stem cells. These non-embryonic adult cells can be reprogrammed to resemble stem cells by modulating their gene expression, and these cells can be manipulated to develop into different kinds of specialized body cells. Although the derivation of iPS cells and multipotent adult stem cells (cells capable of differentiation into a limited spectrum of specialized cells) does not require the use of embryos, the use of such cells may raise similar issues to those for embryonically-derived cells. The amended Guidelines are extended to include iPS cells, multipotent adult stem cells, and other non-embryonic human pluripotent stem cells (hPS). Although the Committee states that the derivation of these cells does not require additional oversight, the introduction of some of these cells into animals should be subject to the same review process as for the embryonically-derived cells:
- The derivation of human non-embryonic hPS is covered by existing Institutional Review Board (IRB) regulations and does not require additional review by the Embryonic Stem Cell Research Oversight (ESCRO) committee.
- The use of hPS cells in purely in vitro experiments need not be subject to any review beyond that necessary for any human cell line, except that any experiments designed or expected to yield gametes (oocytes or sperm) should be subject to ESCRO committee review.
- Research involving transplantation of hPS cells derived from non-embryonic sources into non-human animals at any stage of embryonic, fetal, or postnatal development should be reviewed by ESCRO committees and Institutional Animal Care and Use Committees (IACUCs), as are similar experiments that use hES cells.
The amended guidelines also clarify that an institutional ESCRO committee may conduct an expedited review of the research proposals for exclusively in vitro research on previously derived hES cell lines (that is, if this research can be done an a laboratory dish or test tube, and if it does not create new lines of stem cells but uses already existing human embryonic stem cell lines):
- The "expedited review" means that the ESCRO committee chair or others designated by the committee chair can act on behalf of the committee to determine that the hES cells have been acceptably derived and report to the entire committee.
To promote the public's trust in institutions performing responsible stem cell research, the Committee recommended informing the public of the types of stem cell research performed by the institution. Moreover, it was strongly suggested that the institutions conducting hES research should perform periodic audits of their ESCRO committees to ensure their proper performance:
- An institution conducting stem cell research should make information from the registries (including, but not necessarily limited to, project abstracts and sources of funding) available to the public and the media through the institution's Web site.
- An institution that maintains its own ESCRO committee should conduct periodic audits of the committee to verify that it is carrying out its responsibilities appropriately. Auditable records include documentation of decisions regarding the acceptability of research proposals and verification that cell lines in use at the institution were acceptably derived. Institutions should make the results of the audits available to the public.
Finally, the amended Guidelines also update the term "direct expenses" for which the women donating their eggs for stem cell research can be reimbursed for, as determined by an IRB:
- Direct expenses may include costs associated with travel, housing, child care, medical care, health insurance, and actual lost wages.
This language updates the 2005 guidelines that stated that women who undergo hormonal induction to generate eggs specifically for research purposes should be reimbursed only for "direct expenses" that incurred as a result of the procedure, but did not specify which expenses qualified as direct. The Committee stressed that reimbursement for lost wages is not a payment for eggs; the intent is to leave all donors neither better off nor worse off financially.
These guidelines are expected to remain a working document, to be updated, and revised to reflect the rapid developments in the field of human stem cell research. The Committee is in the process of gathering more information to generate a debate on the recently raised ethical and policy questions regarding the derivation of some existing pre-2001 "NIH-approved" or "presidential" hES cell lines in order to consider whether any future changes in the guidelines are warranted.