Sherley that's not ethical? A review of US law on embryo research

Should human embryonic stem cell research be deemed unethical for its embryo destruction? The US court decision in Sherley v Sebelius on 27 July 2011 (1) to allow federal funding of this research set a global precedent. The meaning of research was divided into two categories: that which directly involves embryo destruction and that which does not.

Yet it misses the point. Research does not cause embryo destruction; these unwanted IVF embryos would be destroyed even if research using their cells was prevented. The plaintiffs - in effect - were always going to lose.

The plaintiffs in the Sherley case had argued that obtaining stem cell lines by destroying embryos is an integral part of later research using those cells. Dr James Sherley and Dr Theresa Deisher were adult stem cell researchers who felt human embryonic stem cell research unlawfully competed for the same federal grants.

'Research' must be read broadly to include obtaining stem cell lines, they argued, and breaches the Dickey-Wicker Amendment. This amendment prohibits research 'in which an embryo or embryos are destroyed, discarded or knowingly subjected to risk of injury or death'.

The US Government argued that 'research' in the amendment could be narrowly defined to mean research that derives stem cell lines by destroying embryos cannot be federally funded. Later research using those lines, which it has funded since 2001, does not violate the amendment. The plaintiff felt this reading of the amendment was a legal fiction.

Judge Lambeth agreed with the plaintiffs. He said Dickey-Wicker: 'encompasses all 'research in which' an embryo is destroyed, not just the 'piece of research' in which the embryo is destroyed'. His decision was reversed upon appeal. Justices Ginsburg and Griffith from the District of Columbia Court of Appeals said the meaning of 'research' in Dickey-Wicker is ambiguous. Instead, they agreed with the US Government's narrow interpretation of the term.

They admitted the US Government's interpretation was 'not the ordinary reading of the term' research. But they felt it was no more illogical than the plaintiff's alternative 'to treat the one-off act of derivation as though it had been performed anew' when one of the 'hundreds of subsequent research projects… by different scientists… however remote in time or place, uses a stem cell from the resulting line' (2).

This decision, however, shuts the door on a closer examination of the 'causes' of embryo destruction — the ethical elephant in the room. The plaintiffs wouldn't have prevented destruction of unwanted IVF embryos by redefining 'research'. They would have restricted federal funding, sacrificed research and lost potential medical benefits.

The USA only allows cell lines to be derived from donated leftover IVF embryos destined for disposal. If these embryos are not used in research they will be destroyed by routine clinical procedures. The National Institutes of Health (NIH) 2009 guidelines challenged in this case ensure all funded research is on 'ethically and responsibly' derived cells. These are from unwanted embryos altruistically donated by a patient receiving fertility treatment who has given their informed consent.

The decision to donate an embryo's cellular components to research is a secondary choice of how the embryo is to be disposed. First, individuals must decide whether to store or discard an embryo. Preventing IVF embryos from being donated to research no more prevents their destruction than preventing posthumous organ donation would prevent the burial (disposal) of that person's body.

The Sherley decision may have global ramifications, including on the impending European Court of Justice decision in Brüstle v Greenpeace eV. Both cases tackle the ethical implications of how 'research' is defined. Like Justice Lambeth in Sherley, Advocate General Yves Bot in Brüstle rejected a government distinction between research that destroys embryos and subsequent research on embryonic cell lines. But Advocate Bot appealed to emotions instead of discussing definitions.

It may be unrealistic to have expected the Appeals Court to bravely draw conclusions about causation. But it is disappointing that such an internationally-significant judgment does not even reference this commonly overlooked, yet glaringly significant, aspect of human embryonic stem cell research.