Sherley vs. Sebelius and the redefinition of “research”

The Sherley vs. Sebilius case that has put human embryonic stem cell research on pause throughout the country has an interesting new twist. According to ScienceInsider the Boston Biomedical Research Institute, which employs James Sherley, one of the two scientists who sued to block federal funding for human embryonic stem cell research, has joined the pro stem cell side. They filed a motion explaining the many ways BBRI researchers intend to use human embryonic stem cells in the future.

That case is due to be heard December 6 and has a number of key scientific leaders in addition to the BBRI weighing in on the side of the NIH. The University of Wisconsin filed an amicus brief, which both the Genetics Policy Institute and the Coalition for the Advancement of Medical Research asked to join.

There’s one interesting aspect to the case that hasn’t received much attention. It came up in an amicus brief filed by the regents of the University of California. The brief, which is remarkably entertaining reading (no really), makes the point that the case would fundamentally redefine what is meant by a piece of “research.” The logic goes like this:

• The plaintiffs argue that the Dickey-Wicker Amendment prohibits the destruction of human embryos (so far so good).
• And that deriving new human embryonic stem cell lines from IVF embryos does, in fact, destroy the embryo (still good – this is why the NIH can’t fund the creation of new lines)
• And that since human embryonic stem cell research requires using stem cell lines that once resulted in the destruction of an embryo, that work also can’t be funded by the NIH (huh?)
• So, a piece of a research in a proposal to the NIH includes not only the proposed work, but everything that came before it.

The UC Regents brief had this to say:

If an activity is included within the proposed project and is funded by the NIH grant, then, by definition, that activity is part of the funded research. If the activity is not included in the request for funds, no NIH funds are made available for that activity, no NIH grant funds are used for that activity, and, by definition, the activity is not part of the funded project. Thus, if grantees do not request funds for the derivation of hESCs or the creation of hESC lines and NIH does not award funds for those activities, by definition, NIH has not funded any research in which embryonic stem cells are derived or propagated.

(Emphasis added)

So, by the logic of the plaintiffs, if a researcher proposes carrying out research with iPS cells that follows up on knowledge gained from work with embryonic stem cells, is that iPS work also the indirect result of a destroyed embryo and therefore not fundable by the NIH?

It doesn’t make a lot of sense.

A.A.