To Womb it may Concern
Which comes first, clinical trials or ethical consensus about policy?
Sorry, reader, the substack is a little late this time around. I had my own medical encounter that sidelined me for a week or so. Vertigo is not fun. zero stars. Would not recommend.
I do have an interesting argument for you and your students to consider.
One of the most troublesome questions in research ethics is when should we charge forward and when should we hold back on innovation because of the law of unintended consequences?
That argument about risk averse and risk prone research is usually about the facts of the case. Something in the situation, some unknown, urges caution because the research might violate some established ethical principle or cause some actual harm to individuals.
For instance, does HIV vaccine research in third world countries exploit disparities in healthcare? Does Phase 1 (i.e. first in human) clinical trials violate beneficence by putting terminally ill people at risk of debilitating side effects? Does this matter given their consent? Is such consent legitimate given their desperation? (See chapter 4 of Practical Bioethics).
Rarer is the argument that we shouldn’t press on in research because the ethical implications just haven’t been thought out yet. Consider this op-ed in Scientific American “It is Too Soon for Clinical Trials on Artificial Wombs”.
The authors admit that artificial womb technology could be very beneficial:
An artificial womb could provide severely premature newborns with an environment like the uterus by suspending the fetus in a flexible container filled with lab-made amniotic fluid. This innovation—so far tested only in animals—might mitigate or even prevent complications of prematurity by allowing the fetus’s underdeveloped heart and lungs to continue to grow.
Despite this, the authors reject further research and not primarily for concerns about harm to either mother or fetus itself.
A technology meant to help severely premature infants raises questions of inequity and may someday threaten parents’ rights to decide
These are not minor reasons. I question, however, if they suffice to halt research. Fairness and parental rights are significant concerns about distribution and undue influence, Normally these are concerns for implementation of approved technology aren’t they? I mean, we don’t halt an established medical procedure just because it is employed unfairly. We fix the inequity while continuing the procedure. The same would seem to apply to parental rights.
What’s going on here? Let’s look at both prongs of the argument. Starting with the parental rights:
The decision to use an artificial womb would put enormous pressure on expecting parents who will have very little time to make agonizing decisions about trial participation, to the point of substantially compromising their ability to consent with a full understanding of the risks of participation.
Okay, so the worry here is that candidates for artificial womb trials will come from emergent patients who will be pressured in a way that will compromise their ability to consent. Desperation undermines consent. A familiar worry in medicine. That pressure, however, happens every day with even established treatments. ECMO (life support) for infants is a risky but established treatment. The option puts a lot of pressure on parents but we don’t therefore think the parents’ consent is invalid or so undermined as to be morally illicit.
Without clear regulatory protection of parental autonomy in making these decisions, and better animal studies delineating potential benefits, artificial wombs could exacerbate an already fraught landscape, by pressuring and constraining parents' decision-making.
So there are two reasons in this quote and if you don’t parse them out, you might miss which is which. “Regulatory protection of parental autonomy” is first. The second is more animal studies to show the artificial womb can be a viable option.
The authors are concerned that parents will feel too much pressure to opt for an artificial womb to escape state laws requiring bringing the baby to term. Fair enough. There is a small but interesting literature on how ectogestation will substantially change the abortion debate. (cf. Christopher Stratman’s “Ectogestation and the Problem of Abortion” for an excellent discussion of this.) We’ve already seen this with Texas’ legal injunctions regarding Karen Cox (“New Semester, New Case”). However, it might seem a bit overkill to halt research until federal law fixes state statutes.
The second concern about more animal testing seems odd. The FDA has clear established guidelines about when there is enough evidence to move from animal to human trials. If the authors are arguing these guidelines have been skirted, then they should say so. If there hasn’t been enough animal research to establish clinical efficacy, that would count as a potent reason to hold off Phase 1 clinical trials.
Far down in the article, the authors articulate what I think is a strong moral concern: artificial wombs would require c-sections.
Most current iterations of the technology require a cesarean section, one that is much riskier at earlier stages in pregnancy than a typical cesarean and may compromise future fertility. Achieving truly informed consent given all these pressures and complexities at a literal do-or-die moment in childbearing could be impossible.
Here’s the “desperation invalidates consent” concern again. C-sections at this early stage are more risky, however I would like to draw attention to the backhanded paternalism being smuggled in phrases like “truly informed consent. . . could be impossible.” Given the history of bioethics and the trend toward patient autonomy, this sort of strategy of “it’s wrong to even offer the option to the patient because they can’t handle it” is still paternalism.
Safe and effective artificial wombs could be used to argue that the fetus not only has a right to live, but also has the right to any and all medical care available. Such an argument could promote legislation that requires dangerous surgery despite a patient’s objection.
This would be a serious concern. The scenario where a state law to protect the fetus required a c-section to save the child over the objections of the mother would smash the duty of beneficence into patient autonomy.
Arguably this sort of worry seems overwrought. Conservative leaning states would have a very hard time passing a law that compelled women to have risky abdominal surgery. This might violate several Supreme Court decisions and potentially the 3rd and 4th amendments.
What’s really going on here?
What might be underlying the author's concern is the Supreme Court’s Dobbs decision. Many have the fear that since Dobbs overturned Roe v. Wade everything is up for grabs in terms of state laws so let’s not hand them another way to attack reproductive rights. But again, if this is a legitimate worry, it is a reason to delay FDA approval, perhaps not to halt research.
The second argument is one about justice.
From a perspective of reproductive justice, this technology is unlikely to be equitably available.
Again, this is a fair moral concern but is it sufficient to stop clinical trials? Inequity is a problem for any scarce resource, and just about every medical resource is a scarce resource. future inequity is something to correct, not a reason to stop research until some undetermined future where inequity is solved?
If I could summarize the argument here, it would be something like, “Since the Dobbs decision took power away from the federal government, we just don’t know how this new technology would be used. The possibility of states using artificial wombs to violate patient rights is a sound reason to stop further research. Since the technology will probably be expensive, we shouldn’t study it until we are sure it will be available for everyone regardless of cost.”
Are these good enough reasons to halt scientific research? It occurs to me that this argument has, at its heart, a vague precautionary principle of the kind that anti-vaccination proponents often employ. We just don’t know enough to continue research and if this new vaccine is offered it will put too much pressure on parents to comply.
The difference, of course, is that the anti-vaccination argument is about fear of unknown physical harms, but the Scientific American op-ed is about fear of social harms.
