Lisa Ikemoto Guest Piece on Human Germline Genetic Modification

lisa ikemotoLisa C. Ikemoto, Professor, U.C. Davis School of Law

I have been following the reports about genetic editing technology with concern. The fact that some scientists are calling for moratoria on gene editing of human embryos heartens me. Frankly, I had little confidence that any group of scientists could bring themselves to call for limits on research. The call for a moratorium is as much a game changer as the technology itself. It creates an opportunity for research transparency and open exchange between the scientific community and the lay public. Germline modification raises a wide range of scientific, social and ethical issues that we have only begun to consider. The call for a moratorium puts those issues front and center and, if implemented, gives us valuable time for consideration.

In the meantime, as Paul Knoepfler has pointed out, we need is a practical plan for proceeding. His ABCD plan proposes use of SCROs for approval and oversight of in vitro research. The use of existing oversight mechanisms makes sense, although in practice, both IRB and SCRO review is only as rigorous as local institutional culture allows. SCRO review is a decentralized oversight mechanism through which research standards are subject to variable interpretation. However, as Knoepfler points out, SCROs are already in place.

As a bioethics scholar and teacher, I find the bioethics training appealing, fascinating, and daunting, given the wide range of potential issues. I’m glad to see that Knoepfler has flagged sourcing of human oocytes as one issue. In the fertility context, human oocyctes are procured through a largely unregulated and rapidly expanding market. The process of soliciting young women to provide oocytes for others’ use is often degrading and expresses eugenic ideals. (See my recent blogpost here). Federal guidelines and a few state laws prohibit payment to research donors. But I worry that the notion of free market individualism used to explain treating women as sources of raw materials and exposing healthy young women to the risks of ovarian stimulation and oocyte retrieval is being used in research, as well. Do we really want to superimpose market thinking on human beings, in the name of science?

I would hope that bioethics training would take the concerns of disability rights activists seriously. Genetic modification is a form of genetic selection. We have a long, bad history of mis-using human genetic selection. Genetic selection technology use can, and probably will, expand the list of conditions and traits considered undesirable. As the list expands, so will the therapeutic justification for genetic modification. The most important concern is that as the list expands, acceptance of persons with disabilities will narrow. The Americans with Disabilities Act has effected important legal and social changes for people with disabilities, and the Genetic Information Nondiscrimination Act provides some protection against genetic discrimination. But neither limits the use of genetic selection. While this concern applies most obviously to in vivo research, it starts with in vitro research agendas.

2 thoughts on “Lisa Ikemoto Guest Piece on Human Germline Genetic Modification


  1. Dear Lisa Ikemoto – I read your guest post with interest and had a few comments, which I hope you’ll read and reply to.

    I’m not in favor either of stopping in-vitro gene editing research. I believe it’s important to continue apace with the investigation into how and when it may be possible to correct terminal mutations. That is to say genetic diseases that are currently beyond our near to medium term horizon expectations of a somatic cell solution, once established in the germline. To not continue to delve into this aspect of the science would in itself be unethical IMO. As a society we owe it to the memory of those that have been lost and to the very real families that carry those mutated genes. Progress towards cures for tomorrow’s children is the priority.

    There are definitely broader questions generally with regard to other possible uses of the technology in the germline – those I would agree are diverse and need exploring fully, with the appropriate international standards, regulatory governance & guidelines established. It may be ambitious to expect a global accord but one could look to adapt and build upon already agreed to principles – which I believe is the idea.

    You mention a couple of concerns in your post – namely eggs and genetic discrimination.

    The Egg is indeed a key to life but it, in itself, is not such. The issue of the need for Eggs for research doesn’t negate the importance of germline science nor it’s continued progress. Btw I agree women should not be paid for Egg donations. I’d like to point out that there are millions of frozen IVF embryos and regular supplies of non-viable tissue from the fertility process that I would imagine would be suitable for basic research into germline editing. Perhaps this is pertinent as the “rejected” sperm, eggs & embryos are ideal candidates for germline research. As a further note we have discussed here at Paul’s house the emerging technology of synthetic iPS sperm, eggs and embryos – certainly a floodgate potential for research purposes there, No? In-vitro only at this stage. One additional observation on hEggs – evidentially there are significant differences in quality which relate to success ratios. This area of the science should be carried forward as a part of the studies as it may increase pregnancy & development efficiencies.

    By lowering the need for supernumerary embryos, increasing the success ratios of pregnancies & reducing the hard decisions of parents to be the ethic debate of old on the dual use dilemma can be positively turned on it’s head. Not a zero sum result by any means and part of the Middle Way solution…

    Paul’s plan to move forward on the research authority & oversight seems practical – I’d only add my vote, from a non-investigator pov, for open access, as walled off reporting on this issue is objectionable. In regard to adding to the list I’d suggest International co-operation as a prerequisite for research authorization – this being an opportunity driver for cooperative engagement and regulatory participation. Perhaps framework harmonization of policy standards would be a topline agenda item for country participation prior adding sponsored investigators. Also International “Hubs” should be created with academic centers of excellence as leaders with industry support.

    My comment on the genetic discrimination issue you raise is somewhat general as I can’t see how limiting the technology to specific germline diseases that are incurable post embryo implantation/birth would impact this issue? I can see how the broader scope of enhanced gene editing a la carte would but that isn’t on my radar and if it ever was convincingly presented with data & considered I believe it would be necessary to have a universal application policy.

    Cheers

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