May 17, 2005

New stem cell guidelines may complicate research

The National Academies—a private, nonprofit society of elected scholars—recently released a new set of guidelines on embryonic stem cell research, which may further complicate research at major American universities. The recommendations, co-written by the National Academies' National Research Council and the Institute of Medicine call on American universities to voluntarily adopt the new guidelines, ostensibly to reduce public fear and instill confidence in the controversial field of stem cell research.

Janet Rowley—the Blum-Riese Distinguished Service Professor at the University and member the President's Council on Bioethics—was on the committee that formulated the new guidelines. She said she was unsure how the University would respond to the report, especially since it might not have had time to formally discuss the matter. Rowley, nevertheless, maintained that the report had, "by and large received a positive response."

The new report contains over 30 recommendations, although the most prominent recommendations include implementing national oversight committees to govern experimental protocol, as well as new restrictions on how institutions derive embryonic stem cell lines.

According to Harinder Singh, the Louis Block Professor in Molecular Genetics & Cell Biology and an investigator with the Howard Hughes Medical Institute at the University, the recommendation to form national oversight committees, in conjunction and coordination with existing oversight agencies, goes a long way in streamlining previous ambiguities in national stem cell research.

"I actually think the new guidelines will enhance research possibilities because the guidelines provide a very clear framework for the kind of experiments that are endorsed by the National Academy of Sciences," Singh said. "It is very useful to suggest guidelines that provide a framework which is currently missing."

"My own personal view is that the guidelines are quite reasonable and one that we should endorse," he added. "My guess is that we will adopt it."

Singh noted that in the absence of one set of universal regulations, each institution, including the University, independently decides how to conduct embryonic stem cell research.

The University's current policy on embryonic stem cell research, Singh explained, sanctions most experiments that utilize embryonic stem cells in culture, derived before August 2001 from the National Institute of Health (NIH). Experiments at the University that utilize embryonic stem cells out of culture must be first sanctioned by existing university and national committees before they can be conducted.

Singh added that few researchers at the University are currently using human embryonic stem cells.

Rowley said the National Academies' report also puts a "great deal of emphasis on how stem cells are derived." The report particularly recommends obtaining donor consent before generating stem cells, and informing donors that they have the right to withdraw their consent at any point before the generation of stem cells. Additionally, the report calls on "scrutinizing" institutional practices to obtain stem cells to avoid any potential conflicts of interest.

The National Academies, in this respect, go further than President Bush, who approved 78 lines of existing embryonic stem cell lines for research. The National Academies' recommendations only allows for 22 lines of existing embryonic stem cell lines to be utilized in research.

"The guidelines are more stringent than those currently used," Rowley observed.

While the new guidelines reduce the number of existing embryonic stem cell lines available to scientists, Singh felt that the move was appropriate. "I endorse the criteria that they have in place because you don't want the exploitation of people, nor do you want to derive cell lines without explicit consent of a couple," he said. "It allays the concerns of people who are opposed to this type of work because they think that it is not being appropriately overseen."

The National Academies' recommendations, however, according to Singh, go a long way in articulating the scientific community's future aspirations for deriving embryonic stem cells. "The guidelines are indicating that it is appropriate to go ahead and derive new embryonic stem cell lines and to be able to use them for experimental purposes," Singh said.

"The reports come down on a freer system," he added. "It is a major advance."

The report, however, is largely symbolic and does not nullify current federal government restrictions on embryonic stem cell research, although Singh was hopeful that it might place political pressure on government officials.