New Guidelines for Stem Cell Research

Stem cell research is a controversial subject. From a strictly scientific point of view stem cells could become the cure for many diseases that have no known cure, such as diabetes, Alzheimer’s disease, Parkinson’s disease, and even spinal cord injury.

One area of controversy has been what type of stem cell research, if any, the federal government should provide funding for. Scientists believe that embryonic stem cells are the most viable, since they can become bone, tissue, nerves, any part of the body during the development process. Using embryonic cells is regarded by many as morally repugnant, since many religions regard an embryo as a human being and culling those stem cells destroys a days-old embryo. Embryonic cells, once created, can propagate in lab dishes indefinitely providing material for continued research. The new guidelines allow the use of unused embryos from fertility clinics and specifically ban the use of embryos created only for research purposes.

The National Institute of Health (NIH) had requested comments regarding guidelines for human stem-cell research from scientists, medical groups, religious organizations, members of Congress and private citizens. As a result of over 49,000 comments the final guidelines have been released and stem-cell lines that have not been eligible for federal funding may now qualify for government money.

Many scientists were concerned about the rigid requirements in the draft guidelines, fearing that the research lines already created wouldn’t meet the new standards, including 21 lines which had approval for use by President George W. Bush. The major problem was the “informed consent” part of the proposal. Informed consent is necessary to walk couples or women through the process of donating their embryos to science, and knowing what alternatives are available.

Dr. Raynard Kington, the NIH’s acting director, held a news conference announcing the final guidelines. He said it was clear that the informed consent standards had changed over time and there were a variety of standards from different agencies.  Dr Kington said that lines exist that “reasonable people would all agree were responsibly derived.”

Under the new guidelines scientists would submit a request to a group of 9 or 10 experts now being assembled. The group will assess whether or not the existing stem-cell lines researchers are using meet the standard of “informed consent,” and if so they could be approved for federal funding. Researchers wanting to create new lines must follow the guidelines which go into effect July 7, 2009. Within a few months the NIH will create a registry with a listing of all stem-cell lines approved for federal funding.

The new guidelines do not allow federal funding for somatic-cell nuclear transfer (SCNT). There is some scientific interest in this technique of creating cells that have specific genetic conditions. Kington said that there has been “strong sentiment” supporting government money for embryonic stem cell research but there has been little public discussion on alternate sources. He said the NIH will follow evolving methods and update the guidelines when compelled to do so.