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.
2. Restriction to preventing a serious disease or condition.
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.
5. Availability of credible preclinical and/or clinical data on risks and potential health benefits of the procedures.
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.