Rather, the breast cancer mutation screen was classified as a type of medical device with obligations for the company to reduce risks to customers.
October 10, 2017|
PIXABAY, DRKONTOGIANNIIVFFor several years, scientists have experimented on human embryos with a powerful genome editing tool called CRISPR to see if they could correct genetic errors or reduce the risk of disease. In September, Kathy Niakan at the Francis Crick Institute in London and her colleagues reported they had used this tool on human embryos for a very different purpose—to better understand human development.
The use of CRISPR (pronounced “crisper”) to modify human embryos has prompted a healthy debate on the ethics of human genetic technologies. This tool is controversial, in part, because changes that are made to the embryo could be passed down to future generations. Niakan’s recent research is novel, and less ethically fraught than some other genome-editing research.
Research labs around the world are using CRISPR to selectively insert, delete, or replace DNA with far greater precision and at a lower cost than other genome-editing techniques. Since 2015, five reports have detailed its use in human embryos to correct disease-causing mutations or create resistance to infectious disease.
Scientists have modified the genes responsible for β-thalassemia (an inherited blood disorder), favism (a reaction to eating fava beans), and a type of heart disease. Another experiment used CRISPR to introduce a mutation into a protein called CCR5 in an effort to prevent HIV infection.
From an ethics standpoint, Mitalipov’s research is more controversial than Niakan’s. The goal of his experiments was to make changes to the human embryo that could be passed on to future generations. Niakan’s research, on the other hand, aimed to develop our understanding of human embryology.
The project led by Niakan had a starkly different aim. It used CRISPR to peek at the earliest stages of human embryonic development by targeting a gene called OCT4, which is active in the cells that go on to form the embryo.
Niakan’s immediate objective was to better understand the early aspects of human development. But her research eventually may help reveal why some pregnancies end in miscarriages and may improve the success of in vitro fertilization.
Much of the global discussion over the ethics of modifying human embryos has focused on whether the technique might be unsafe or used for non-medical purposes. Niakan’s recent project brings other aspects of this debate to light. How do scientists acquire the embryos they use in their research, and how are their projects approved?
So far, these types of experiments have been done in China, the United Kingdom, and the United States. With only limited data available on the experiments conducted in China, it makes sense to focus the discussion on the experiments based in the United States and in the United Kingdom.
Earlier this year, Shoukhrat Mitalipov, a reproductive biologist at Oregon Health and Science University (OHSU), and his colleagues used CRISPR in human embryos to repair a mutation that causes heart disease. From an ethics standpoint, Mitalipov’s research is more controversial than Niakan’s. The goal of his experiments was to make changes to the human embryo that could be passed on to future generations. Niakan’s research, on the other hand, aimed to develop our understanding of human embryology.
To do the experiments, Mitalipov’s team had to create human embryos from donated eggs and sperm. In contrast, Niakan’s project used embryos that were left over from fertility treatments. This is an important difference.
For Mitalipov’s study, the women who donated their eggs for research were exposed to the risks associated with hormonal stimulation and egg retrieval. These risks include abdominal pain, vomiting, rapid weight gain, shortness of breath, and damage to the organs that are close to the ovaries. A particularly serious risk is ovarian hyperstimulation syndrome that can require hospitalization.
With Niakan’s study, women assumed these risks in connection with their IVF treatment, not their participation in research. These women weighed the potential harms of hormonal stimulation and egg retrieval against the potential benefits of having a child using assisted human reproduction. Embryos remaining after fertility treatment were donated to research.
It’s also worth examining how these studies were approved. Several committees, panels, and review boards from OHSU provided input and guidance prior to granting Mitalipov permission to do his experiments. OHSU is Mitalipov’s home institution. This raises the spectre of institutional conflict of interest because OHSU stands to benefit from Mitalipov’s research if his work attracts more research funding or enhances the university’s reputation.
In the United Kingdom, the governance and oversight of human embryo research lies in the hands of authorities that are legally regulated and are at arms length to the institutions conducting the research. Ethics review of human embryo research occurs at both the national and regional level. The Human Fertilisation and Embryology Authority and the regional research ethics committee reviewed Niakan’s proposal before she could begin her experiments.
As genome editing of human embryos becomes more widespread, it is important to understand the differences between one project and the next so that we can meaningfully discuss the range of ethical, social, political, and regulatory issues associated with the research.
October 13, 2017
The societal relationship between rights and duties in both law and ethics demands that society be willing to ascertain, establish and maintain guidelines as it relates to activities pertinent to its existence. Being proactive regarding genetic editing will have both immediate and long term benefits and assure a queasy public that society’s moral codes are not collapsing.
When the NAS wrote their report “Human Genome Editing: Science, Ethics and Governance” their guidelines were set on basic principles of ethics to include autonomy, informed consent, beneficence and nonmaleficence.
There is to be:
1. An absence of reasonable alternatives.
3. Restriction to editing genes that have been convincingly demonstrated to cause or to strongly predispose to the disease or condition.
4. Restriction to converting such genes to versions that are prevalent in the population and are known to be associated with ordinary health with little or no evidence of adverse effects.
6. Ongoing, rigorous oversight during clinical trials of the effects of the procedure on the health and safety of the research participants.
7. Comprehensive plans for long-term, multigenerational follow-up while still respecting personal autonomy.
8. Maximum transparency consistent with patient privacy.
9. Continued reassessment of both health and societal benefits and risks, with broad, on-going participation and input by the public.
10. Reliable oversight mechanisms to prevent extension to uses other than preventing a
serious disease or condition.
Parenthetical continuity commands the consideration that somatic cell editing is ultimately very minor considering the tumultuous state of genetic alterations made each and every day in human endeavors. Evolution is a moving target and as such microevolution as a change in allele frequencies is due to four different processes: mutation, selection as natural and artificial, gene flow, and genetic drift. Therefore, genetic editing as an artificial form of selection can be considered a part of evolution as much as any other alteration to include breeding, environment, personal habits, and so forth. This the public can understand. But because germline editing is passed to progeny these guidelines take on a different focus. As a facet of genetic editing, germ line editing may be an inevitable scion of genetic editing but the outcome of its use is far too nebulous at this time. But to deny it’s use is self-defeating.
It is important to remember that the legal definition of guideline is a practice that allows leeway in its interpretation. Interpretation, especially in the medical arena, rides a fine line between empirical premise and an ethical slippery slope scenario. To assert that some event must inevitably follow from another without rational argument or means of inevitably is a slippery slope scenario and is a fallacy.
However, an empirical premise as something guided by practical experience and not theory is something that currently cannot be considered a viable option in germ line editing due primarily to the omnibus spending bill H.R. 83 – Consolidated and Further Continuing Appropriations Act, 2015 which prohibits taxpayer funding for “the creation of a human embryo or embryos for research purposes.” Congress has also banned the U.S. Food and Drug Administration from considering a clinical trial of embryo editing. These limit, as noted above, the “Availability of credible preclinical and/or clinical data on risks and potential health benefits of the procedures.”
Therefore, for germ line editing, it is the paucity of compelling cases via clinical trials and the availability of alternate venues of treatment that should command the ethics of the situation for persuasion based on above board, transparent and informative consideration. To say that counseling is of critical importance is moot.
Also, autonomy and informed consent as ethical concerns can be considered questionable regarding the children of germ line editing. This has to be noted as a parenthetical slippery slope scenario because ultimately adults are acting in their best interest. Therefore, 2. Restriction to preventing a serious disease or condition and 3. Restriction to editing genes that have been convincingly demonstrated to cause or to strongly predispose to the disease or condition should be of paramount consideration.
Change is inevitable. It is a relational difference between states. There are expectations which when developed as a working hypothesis are linked to exploratory research and purpose in empirical investigation within a framework for qualitative and quantitative research.