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June 23, 2003 — The American Medical Association approved recommendations by its Council on Ethical and Judicial Affairs (CEJA) that cloning-for-biomedical-research is consistent with medical ethics. The CEJA report that was a source of these recommendations also recognizes that physicians are free to decide whether to participate in this type of research or to use the products that result from this research. The recommendations also note the critical importance of appropriate oversight, of this research and safeguards for subjects participating in this type of research.
At its Annual Meeting, the AMA adopted the following recommendations for biomedical research using stem cells derived from cloned embryos through somatic cell nuclear transfer (SCNT):
· An individual physician must remain free to decide to participate in this research.
· There should be appropriate oversight and monitoring, including ensuring that the technique is used only if uniquely promising.
· Informed consent by subjects participating in this research is governed by standard principles: Voluntary participation and full disclosure of all relevant risks and benefits.
· The informed consent process for potential recipients of stem cells should conform with ethical standards outlined by CEJA (Opinions E-2.07 and E-2.169.)
Stem cells are a unique population of unspecialized cells characterized by their ability to continuously renew themselves for long periods of time through cell division. While stem cells have been isolated from both embryonic and adult tissues, the two types differ in their ability to differentiate into specialized cell lineages. The ability to isolate human embryonic stem cells has rekindled expectations that these cells will play a major role in regenerative medicine.
Human embryonic stem cells are commonly obtained from unused fertilized eggs donated by in vitro fertilization clinics with informed consent of the donor. Alternatively, stem cells have also been obtained from embryos generated from unfertilized eggs using a technique called somatic cell nuclear transfer (SCNT). This technology was designed to produce embryos from which immunologically compatible stem cells could be derived for use in treating human diseases (cloning for biomedical research).
SCNT enables the generation of stem cells that are specifically tailored to an individual. The nuclear material is removed from a recipient oocyte (enucleation) and replaced with the nucleus from a somatic cell (nuclear transfer). SCNT technology is also being utilized in more basic research applications to understand molecular and cellular events underlying human diseases. However, recent federal policy restricting the use of human embryos in research has limited access of U.S. laboratories to human ES cells.