April 27, 2005

Guidance on Stem Cells

The National Academies on Tuesday proposed a set of guidelines that scientists should follow as they conduct research involving human embryonic stem cells. The guidelines are intended, the academies said, “to enhance the integrity of privately funded human embryonic stem cell research by encouraging responsible practices.”

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The report, which was produced by a joint committee of the National Research Council and the Institute of Medicine, lays out recommendations governing such things as how scientists should deal with stem cell donors, how individual institutions should monitor the research, and how far scientists should go in mixing human and animal cells.

It calls, for instance, for the creation of Embryonic Stem Cell Research Oversight Committees at academic institutions where researchers are conducting the controversial research, to work alongside existing institutional review boards. The boards would review proposals for research and to create additional stem cells lines, and also maintain registries of the stem cell lines stored at that institution.

The report also recommends that a national body be created to “periodically review whether the guidelines need to be updated in light of unforeseen advances in stem cell science and evolving public attitudes.”

The report also states that researchers should tell donors of stem cells that information about them may follow the stem cells, but that their identities will be coded and therefore protected.

The panel that produced the report said that it was necessary to build and sustain public confidence in the research.

“Heightened oversight is essential to assure the public that stem cell research is being carried out in an ethical manner,” said Jonathan D. Moreno, Emily Davie and Joseph S. Kornfeld Professor of Biomedical Ethics and director of the Center for Biomedical Ethics at the University of Virginia, who was co-chairman of the panel that drafted the rules.

“The oversight we call for will in many instances set a higher standard than required by existing laws or regulations. And while we were hesitant to recommend another bureaucratic oversight entity, the burden in this case is justified, given the novel and controversial nature of embryonic stem cell research.”

— Doug Lederman

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