HFEA and CIRM face the same issue of consent as they contemplate CRISPR/Cas9 embryo editing

The minutes of the January 14, 2016, meeting of the Licence Committee of the Human Fertilisation & Embryology Authority (HFEA) () of the U.K. make fascinating reading.  They document the Licence Committee’s approval of CRISPR/Cas9 embryo editing, on a very limited basis, and subject to future approval by a Research Ethics Committee (REC).

This approval is of an application from Centre 0246 (The Francis Crick Institute at Mill Hill) “for research licence renewal for research project R0162.”

Both this document and a recent report from a meeting of the California Institute for Regenerative Medicine (CIRM) contain references to the same legal-ethical issue:  can embryos donated to research prior to the current availability of new gene editing techniques be used for research employing these methods?  In other words, can they be edited using CRISPR/Cas9?

The British, in Section 1.13 of these minutes, raise the question of “whether these [existing consent forms] adequately covered the additional research activities including gene editing.” 

The Californians, in the report cited above, in Question 2, ask “Can we use CRISPR on previously donated materials/samples where general consent was given without knowing that these technologies could be available or can we only use it on biomaterials to be collected going forward.”

While approval by the HFEA is necessary for this research to go forward, it is not sufficient.  The HFEA has required, as part of the approval, in Section 2.2, that “None of the additional research activities are to be undertaken until approval for them has been obtained from an appropriately constituted research ethics committee and evidence of this has been provided to and acknowledged by the HFEA Executive.”

It’s possible, then, that the only embryos that can be used in these experiments are ones donated by IVF patients who give explicit prior permission to the researchers to edit these embryos’ genomes using CRISPR/Cas9 technology.  Or maybe not.  

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