Under the Obama administration's proposed rules for funding embryonic stem cell research, hundreds of existing cell lines could be ineligible, even those that qualified under President Bush.

The guidelines were written by the National Institutes of Health and are currently in draft form and expected to be finalized in July. But in their current state, they restrict funding to stem cell lines produced according to new rules that are only now being established. Few existing cell lines will meet those requirements.

"The so-called Presidential lines aren't suitable for actual medical application," said Patrick Taylor, deputy counsel at Children's Hospital Boston, who criticized the NIH guidelines in a paper published Thursday in *Cell Stem Cell. *"But we're talking about many, many more lines. The new lines were created with extensive ethical oversight. They're at stake here."

When President Barack Obama announced on March 9 that research restrictions enforced by President Bush would be overturned, scientists rejoiced. Under Bush, only 21 embryonic stem cell lines already established by August 2001 qualified for federal funding.

A few scientists chafed at Obama's remaining restrictions on research cloning, produced through cloning, but most believed the new rules would finally let researchers to pursue the awesome medical promise of embryonic stem cells with full governmental support.

In recent weeks, however, scholars parsing the NIH's draft guidelines, released April 18, have realized they could prove even more restrictive. At issue are informed consent requirements for women who donated eggs left unused during fertility treatments, and eventually used to generate embryonic stem cells.

Though egg collection has long been governed by widely lauded consent standards established by the National Research Council and International Society for Stem Cell Research, those standards didn't previously meet the letter of the NIH's proposed law.

The NIH requires consent forms that clearly mention human embryonic stem cell research, forbid donating eggs for the benefit of a specific person, and contain various other stipulations that were generally mentioned during older consent processes, but not rigorously codified. These rules could have a massive impact on existing and proposed research.

"The NIH estimated that their draft guidelines would make available 700 new lines of ESCs derived over the past 10 years," said Sean Morrison, a University of Michigan cell biologist. "My personal guess is that unless they loosen the informed consent standard that they're going to retroactively apply, then most of those 700 lines would not be eligible."

Morrison said the new consent standards are good, but should be applied to future cell lines, not old ones. "The standards for informed consent evolve over time," he said. "It would make no sense to take out lines that, 10 years ago, everyone agreed were ethically derived, just because they don't meet the letter of the new requirements."

Patrick Taylor agreed with Morrison. "If someone's been doing clinical research and they apply a new protocol, we don't ask them to go back and do all that research over again," he said. "We ask them to change their conduct going forward."

Taylor noted that removing federal support for ESC lines supported by Bush wouldn't only affect use of the cells, but all the work done to characterize line-specific behaviors and tendencies. "When you take a cell line and say we're not going to use it any more, you're talking about a tremendous body of information," he said.

Researchers who currently receive federal support for research on Bush-approved lines would be able to continue working until their grants run out, but the grants would not be renewed, said Morrison. Most ESC lines that are not now eligible would never become eligible.

The NIH will accept public comments on the guidelines until May 26. The comment form form can be found on the NIH website, and the International Society for Stem Cell Research has provided a form letter for use by commenters.

"Nobody thinks those lines weren't ethically derived. It's just that some of the details weren't there because nobody thought of writing them down in informed consent documents," said Morrison. "And now they'd be forcing scientists to abandon their work and start from scratch on new lines."

See Also:

Image: Michigan State University

Citation: Retroactive Ethics in Rapidly Developing Scientiﬁc Fields." By Patrick L. Taylor. Cell Stem Cell, Vol. 4 No. 6, June 2009.

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