Medical Device Daily Washington Editor

WASHINGTON – In an attempt to clarify some of the confusion and “enhance the integrity” related to embryonic stem cell studies, the National Academies on Tuesday released a report of recommended research guidelines.

According to the committee that wrote the report, the guidelines are offered to foster “responsible practices” in carrying out privately funded human embryonic stem cell research.

“Human embryonic stem cell research is very important and very controversial,” said Bruce Alberts, PhD. “Because there is limited federal funding and federal oversight, many scientist believe the scientific community should commit to conducting research in a way that is sensitive to ethical and other concerns.”

The report urges all institutions conducting stem cell research to establish oversight committees to ensure that the new guidelines will be followed.

“Heightened oversight is essential to assure the public that stem cell research is being carried out in an ethical manner,” said Jonathan Moreno, co-chair of the report committee, professor of biomedical ethics, and director of the Center for Biomedical Ethics at the University of Virginia (Charlottesville).

The oversight recommended in the report will set a higher standard than currently mandated by existing laws or regulations, Moreno said. “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,” he added.

The report offers researchers and institutions a number of recommendations.

The guidelines suggest the formation of Embryonic Stem Cell Research Oversight (ESCRO) committees that should include experts in biology and stem cell research, in addition to legal and ethical experts, and public representatives. ESCRO committees are intended to augment not replace other research compliance bodies such as institutional review boards.

ESCRO committees should review and approve all proposals to generate additional human embryonic stem cell lines, according to report guidelines.

The report adds that human embryos used for research should not be grown in culture for longer than 14 days or until the point when the body axis and central nervous system – called the primitive streak – begin to form.

An area of the guidelines that may prove complex for researchers is in the area of donor consent.

Donor consent must be obtained before a blastocyst – the four- or five-day-old balls of cells from which stem cells are gathered – is used to generate stem cells, the report said. And donors should be informed that they have the right to withdraw their consent at any point before a stem cell line is derived. The report also emphasizes that no payments should be made to donors.

Committee members said that donors should be told that information about them, including their names, may be retained and available to those working with resulting stem cell lines, but that donors’ identities will be encoded and not readily available.

According to the report, ESCRO committees should maintain a registry of stem cell lines banked at an institution, and the registry should include a proof of informed consent, a medical history of the donors, and a characterization of any genetic markers on the cell lines. Repositories of stem cell lines also need a secure coding system to protect the identity of donors.

The Academies’ guidelines also addressed how far scientists should go in mixing human and animal cells, which researchers may need to do in order to test the therapeutic potential of human stem cells in animal models.

The guidelines say no animal embryonic stem cells should be transplanted into a human blastocyst without approval from an ESCRO committee. Also, no animal into which human embryonic stem cells have been introduced should be allowed to breed. In addition, no human embryonic stem cells should be put into nonhuman primate blastocysts, the study urged.

Human embryonic stem cells should be introduced into nonhuman mammals only under circumstances where no other experiment can provide the information needed.

“Experiments in which there is a possibility that human cells could contribute in a major organized way to the brain of an animal require strong scientific justification,” the committee said.

The committee also urged the formation of a national independent body to periodically review whether the guidelines need to be updated in light of unforeseen advances in stem cell science and evolving public attitudes.

President George Bush announced strict limits on federal funding of human embryo research in August of 2001. Federally funded research is limited to stem cells that already existed at that time. Opponents of stem cell use believe destroying a human embryo for any reason is wrong.

Proponents of their use say limits on research hamper work toward treatments for such diseases as juvenile diabetes, Parkinson’s disease and cancer.

So far, despite public pressure, the White House has maintained its position on human embryonic stem cell research. Some lawmakers on Capitol Hill have even said they would try to limit privately funded research that uses embryonic stem cells.

The scientific community hopes a middle ground can be reached.

“The law at its best provides wise restraints that keep us free,” said Harvey Fineberg, PhD, president of the Institute of Medicine (IOM; Washington). “These guidelines are intended to provide the way that will allow freedom of inquiry to flourish.”

Robert Goldstein, MD, chief scientific officer of the Juvenile Diabetes Research Foundation (New York), said the report provides a “much-needed ethical framework.”

“What’s needed now is an expansion of the federal policy that’s limiting this promising field of research,” he said.

“This is a step forward and they offer what appears to be a reasonable framework,” said Andy Cohn, government and public relations manager for the Wisconsin Alumni Research Foundation (WARF; Madison). “But the devil is in the details,” Cohn cautioned.

The WiCell Research Institute, part of WARF, provides human embryonic stem cells for research purposes and conducts basic research on stem cells and their application in prevalent cell-based diseases.

The National Academies’ report was funded with additional support from the Ellison Medical Foundation(Bethesda, Maryland) and the Greenwall Foundation (New York). The National Academies consist of the National Academy of Sciences, National Academy of Engineering, Institute of Medicine, and National Research Council.

The project was a joint effort between the National Academies’ National Research Council and the IOM and was not supported by any federal funding, committee members said.