The Niche

Some NIH Registry Lines Fall Outside Informed Consent Guidelines

UPDATE: When reporting this last week, I was told that Stanford had made a decision to disallow certain lines but had not announced it. On Monday, I received a note that Stanford had not reached a final decision. Please see the end of the blog for this full notice.

Research oversight committees across the country will need to rethink what experiments they will allow on human embryonic stem cell lines, following revelations that several lines eligible for federal funding do not meet standards of informed consent. Stanford University has decided not to allow experiments to be conducted on five of the 21 lines approved for federal funding, according to some prvy to the school’s oversight committee. The official announcement should come once affected scientists have been notified.

The analysis follows research by University of Wisconsin bioethicist Robert Strieffer, who published his analysis of informed consent forms in the Hastings Center Report this May. In 2001, President George Bush declared that federal monies could only be used to support research on embryonic stem cell lines that had been derived before his declaration and that came from donated embryos originally created for reproduction.


Last year, a U.S. National Academy of Sciences advisory committee declared that all lines approved for US funding could be considered ethically acceptable for research. Even though the guidelines were not in place when the lines were derived, the committee decided that embryos “were donated under protocols that were substantially similar” to guidelines issued in 2005. Oversight committees, said NAS, could accept the NIH approval as documentation that the lines had been acceptably derived.

But Strieffer examined copies of the consent forms given to donors and said they fall short in several ways. For example, he says, most forms do not state explicitly that embryos would be destroyed in creating the cell lines or describe other options for storing or disposing of embryos. None of the forms states that cells might be genetically altered or studied in animal models.

Strieffer says inadequacies are mainly due to a lack of experience rather than candor on the researchers’ parts. “The consent forms were written before the guidelines were ever dreamed of, and you can’t expect them to be perfect.”

The lines Streiffer found most problematic and the ones that Stanford will now disallow are also the least used. These were derived by Cellartis in Sweden and Bresagen in Athens, Georgia. Representatives from both companies told me that they had proper consent for the lines at the time they were gathered. Cellartis said that Streiffer was apparently unaware that donors had twice been recontacted for amendments to the original consent forms.

Experts contacted expressed the hope that some over-arching organization like the California Institute of Regenerative Medicine, the National Academy of Science, or the National Institutes of Health would take the lead in deciding which lines could be allowed for research. Some also pointed out that the decisions would not matter to researchers who are not dependent on federal funding, as they have already switched to newer lines derived after the guidelines were published.

Look for more details in the next issue of Nature.

Update: I received this note from Paul Costello on Monday morning.

Your blog is not correct. Stanford has not finalized a policy on the use of the stem cell lines.

You can use the below statement:

Whether or not to use these lines is clearly a complex matter as the lines have been approved by different stem cell banks around the world. At this time, Stanford is reviewing it’s policy on the use of the NIH registered lines stem cell lines. We will further define our final policy through collaboration with the NIH, CIRM and other peer institutions and with consideration for the many implications of such policy on research, on human subjects, and the investigators who conduct human embryonic stem cell research

Please let me know if you have any questions.

Paul

Paul B. Costello

Executive Director

Stanford University School of Medicine

Office of Communication & Public Affairs

Comments

Comments are closed.